FDA releases March 2013 510(k) clearances

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March 2013 510(k) Clearances

510(k) summaries or 510(k) statements for final decisions rendered during the period March 2013.
TOTAL 510(k)s THIS PERIOD   255                                    
TOTAL WITH SUMMARIES        243                                    
TOTAL WITH STATEMENTS        12

DEVICE: OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K123365(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147  
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 01-MAR-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIGOLD GIARDIA
TRINITY BIOTECH                   510(k) NO: K120001(TRADITIONAL)
ATTN: LUPE  KAGAN                 PHONE NO : 760 929 0500  
5919 FARNSWORTH CT.               SE DECISION MADE: 01-MAR-13
CALIFORNIA CA 92008               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
BAXTER HEALTHCARE CORP.           510(k) NO: K130245(SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 224 270 3312  
32650 N WILSON RD.                SE DECISION MADE: 01-MAR-13
ROUND LAKE IL 60073 0490          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLUTION BILIARY STENT SYSTEM
COOK IRELAND LTD                  510(k) NO: K121430(TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 353 613 34440
O HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 01-MAR-13
LIMERICK    IE 000                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
DEPUY ORTHOPAEDICS                510(k) NO: K123924(TRADITIONAL)
ATTN: CORRENE  RAMY               PHONE NO : 574 371 4981  
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 01-MAR-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM – CSS
ORPHEUS MEDICAL, LTD.             510(k) NO: K123426(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303  
11925 WEST I-70 FRONTAGE RD. STE 9SE DECISION MADE: 01-MAR-13
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITA ENAMIC STAINS
INNOVATION MEDITECH GMBH          510(k) NO: K123761(TRADITIONAL)
ATTN: ELIZABETH  WOLFSEN          PHONE NO : 714 961 6200  
3150 E. BIRCH ST.                 SE DECISION MADE: 01-MAR-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123812(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 602 8157  
4040 NELSON AVE.                  SE DECISION MADE: 01-MAR-13
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUID ASSAYED MULTIQUAL PREMIUM
BIO-RAD LABORATORIES              510(k) NO: K130162(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467  
9500 JERONIMO RD.                 SE DECISION MADE: 01-MAR-13
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX THERMOSENS RIGID
VERTEX-DENTAL B.V.                510(k) NO: K123220(TRADITIONAL)
ATTN: MASON  DIAMOND              PHONE NO : 603 369 3550  
154 MAIN ST.                      SE DECISION MADE: 01-MAR-13
CHARLESTOWN NH 03603              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
TERUMO MEDICAL CORPORATION        510(k) NO: K122590(SPECIAL)
ATTN: STACY A KLUESNER, MS, RAC   PHONE NO : 732 302 4900  
265 DAVIDSON AVE, STE 320         SE DECISION MADE: 01-MAR-13
SOMERSET NJ 08873                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
MEDICA CORP.                      510(k) NO: K123802(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892  
5 OAK PARK DRIVE                  SE DECISION MADE: 01-MAR-13
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: REXTAR, REXTAR LCD
META BIOMED, INC.                 510(k) NO: K122016(TRADITIONAL)
ATTN: BLIX  WINSTON               PHONE NO : 301 607 9185  
2600 MULLINIX MILL ROAD           SE DECISION MADE: 01-MAR-13
MT. AIRY MD 21771                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
WRIGHT HEALTH GROUP LTD.          510(k) NO: K122955(ABBREVIATED)
ATTN: STEPHEN T MLCOCH            PHONE NO : 631 744 0059  
30 NORTHPORT ROAD                 SE DECISION MADE: 01-MAR-13
SOUND BEACH NY 11764              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILAB ULTRASOUND IMAGING SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K130243(SPECIAL)
ATTN: LORI R SMITH                PHONE NO : 510 624 1698  
47215 LAKEVIEW BLVD               SE DECISION MADE: 01-MAR-13
FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TM ARDIS INTERBODY SYSTEM INSERTER
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K123602(TRADITIONAL)
ATTN: JUDITH  ROSEN               PHONE NO : 973 576 0032  
10 POMEROY RD.                    SE DECISION MADE: 01-MAR-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK BLOOD PRESSURE MONITOR
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K123780(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 01-MAR-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K123749(TRADITIONAL)
ATTN: CHO  SOW FONG               PHONE NO : 603 339276 16
LOT 16632, 5 1/4 MILES, JALAN MERUSE DECISION MADE: 01-MAR-13
SELANGOR DARUL EHSAN    MY 41050  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
COLOPLAST A/S                     510(k) NO: K123675(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987  
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 01-MAR-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE
SCION MEDICAL TECHNOLOGIES LLC    510(k) NO: K123606(SPECIAL)
ATTN: JOSEPH  OSTENDORF           PHONE NO : 503 784 6756  
23879 BLUE SPRUCE RD              SE DECISION MADE: 01-MAR-13
SAUK CENTRE MN 56378              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM ESSENZA WITH SYNGO MR D14
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130262(SPECIAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918  
51 VALLEY STREAM PKWY.            SE DECISION MADE: 01-MAR-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K130155(SPECIAL)
ATTN: KRISTIN  PABST              PHONE NO : 414 721 3104  
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 01-MAR-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCENTUM
ULRICH GMBH & CO. KG              510(k) NO: K123717(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268  
612 TRADE CENTER BLVD             SE DECISION MADE: 04-MAR-13
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACLEARA, THERACLEAR
THERAVANT CORPORATION             510(k) NO: K123889(TRADITIONAL)
ATTN: MARCY  MOORE                PHONE NO : 919 363 2432  
131 KELEKENT LANE                 SE DECISION MADE: 04-MAR-13
CARY NC 27518                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URSA ANGIOGRAPHIC CATHETER
CURATIVE MEDICAL TECHNOLOGY, INC. 510(k) NO: K123818(SPECIAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622  
6518 TAMARIND SKY LANE            SE DECISION MADE: 04-MAR-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INBONE ( I AND II) TOTAL ANKLE SYSTEMS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K123059(TRADITIONAL)
ATTN: RYAN  BORMANN               PHONE NO : 901 867 4409  
5677 AIRLINE RD.                  SE DECISION MADE: 04-MAR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURA COLLIMATOR
CURA MEDICAL TECHNOLOGIES, LLC    510(k) NO: K123893(TRADITIONAL)
ATTN: THOMAS H FARIS              PHONE NO : 650 996 1192  
23 RANCHO CIRCLE                  SE DECISION MADE: 04-MAR-13
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVENIR MULLER STEM
ZIMMER GMBH                       510(k) NO: K123392(TRADITIONAL)
ATTN: KAREN  O’LEARY              PHONE NO : 574 371 8515  
P.O. BOX 708                      SE DECISION MADE: 04-MAR-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
DORNOCH MEDICAL SYSTEMS, INC.     510(k) NO: K123188(SPECIAL)
ATTN: LARRY  SMITH                PHONE NO : 816 505 2226  
200 Nw Parkway Rd                 SE DECISION MADE: 04-MAR-13
RIVERSIDE MO 64150                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
CELONOVA  BIOSCIENCES, INC.       510(k) NO: K130307(SPECIAL)
ATTN: NICOLE  BARBER              PHONE NO : 210 497 6682  
18615 TUSCANY STONE SUITE 100     SE DECISION MADE: 04-MAR-13
SAN ANTONIO TX 78258              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC SCALER
NAKANISHI, INC.                   510(k) NO: K113717(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554  
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 05-MAR-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORTIVA PORCINE DERMIS
RTI BIOLOGICS, INC.               510(k) NO: K123356(TRADITIONAL)
ATTN: ESTHER  CARBON              PHONE NO : 386 418 8888  
11621 RESEARCH CIRCLE P.O. BOX 265SE DECISION MADE: 05-MAR-13
ALACHUA FL 32616 1627             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLS® FIXATION SYSTEM
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K120740(SPECIAL)
ATTN: PATRICIA  DONNARD           PHONE NO : 332 985 59895
ZI DE KERNEVEZ-6 RUE NOBEL        SE DECISION MADE: 05-MAR-13
QUIMPER    FR 29000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALLISTO EYE
CARL ZEISS MEDITEC AG             510(k) NO: K123464(TRADITIONAL)
ATTN: JUDY  BRIMACOMBE            PHONE NO : 925 557 4616  
5160 HACIENDA DRIVE               SE DECISION MADE: 05-MAR-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIMVA UNIVERSAL
THERAPEUTIC MONITORING SYSTEMS (TM510(k) NO: K123472(TRADITIONAL)
ATTN: CRAIG J COOMBS              PHONE NO : 510 337 0140  
1193 SHERMAN ST                   SE DECISION MADE: 05-MAR-13
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDAS LYME IGG
BIOMERIEUX SA                     510(k) NO: K122986(TRADITIONAL)
ATTN: CATHERINE  FRITSCH          PHONE NO : 334 788723 98
CHEMIN DE L ORME                  SE DECISION MADE: 05-MAR-13
MARCY L ETOILE    FR 69280        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
MISONIX, INC.                     510(k) NO: K123980(SPECIAL)
ATTN: RONALD  MANNA               PHONE NO : 631 694 9555  
1938 NEW HIGHWAY                  SE DECISION MADE: 05-MAR-13
FARMINGDALE NY 11735              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTOCORE/DENTOCORE BODY
ITENA CLINICAL                    510(k) NO: K121769(ABBREVIATED)
ATTN: LOUIS- PAUL  MARIN          PHONE NO : 514 928 5576
500 BOUL CARTIER WEST             SE DECISION MADE: 05-MAR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERIOR LATERAL VARIAX CLAVICLE PLATE
STRYKER TRAUMA AG                 510(k) NO: K130116(SPECIAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461  
325 CORPORATE DRIVE               SE DECISION MADE: 05-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPLE NAME
TOP CALIBRE SDN BHD               510(k) NO: K123819(TRADITIONAL)
ATTN: ROSNITA  MAODIN             PHONE NO : 603 329 10516
1-1,2 JALAN SETIA PRIMA U13/S SETISE DECISION MADE: 05-MAR-13
SHAH ALAM, SELANGOR    MY 40170   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K123837(SPECIAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597  
3333 DIAMOND CANYON RD.           SE DECISION MADE: 05-MAR-13
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JMS SAFE WING CATH (SWC)
JMS NORTH AMERICA CORPORATION     510(k) NO: K121488(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674  
1468 HARWELL AVE.                 SE DECISION MADE: 05-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K123993(TRADITIONAL)
ATTN: TREVOR  DENBO               PHONE NO : 760 494 6951  
5818 EL CAMINO REAL               SE DECISION MADE: 05-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORELLE Y CONTOUR
COLOPLAST A/S                     510(k) NO: K123914(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922  
1601 WEST RIVER ROAD N            SE DECISION MADE: 05-MAR-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMONDE LARVAE
BIOMONDE (A TRADING NAME OF ZOOBIO510(k) NO: K123449(TRADITIONAL)
ATTN: ROSINA  ROBINSON RN, MED, RAPHONE NO : 508 597 6000  
225 TURNPIKE ROAD                 SE DECISION MADE: 05-MAR-13
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
PHILIPS MEDICAL SYSTEMS           510(k) NO: K120815(TRADITIONAL)
ATTN: PETER  SCHIPELLITI          PHONE NO : 978 687 1501  
3000 MINUTEMAN RD.                SE DECISION MADE: 06-MAR-13
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KANGAROO NASAL MASK
RESPIRONICS INC.                  510(k) NO: K122847(SPECIAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146  
1001 Murry Ridge Lane             SE DECISION MADE: 06-MAR-13
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAUTILUS SPINAL SYSTEM
LIFE SPINE                        510(k) NO: K123373(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117  
2401 Hassell Rd Ste 1535          SE DECISION MADE: 06-MAR-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARED UNDER GRAFTON II EDBM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122513(TRADITIONAL)
ATTN: KELLY  ANGLIN               PHONE NO : 901 396 3133  
1800 PYRAMID PLACE                SE DECISION MADE: 06-MAR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITTLE ANGELS SWADDLING BLANKET
BIONIX DEVELOPMENT CORP.          510(k) NO: K123411(TRADITIONAL)
ATTN: JAMES  HUTTNER              PHONE NO : 419 727 8421  
5154 ENTERPRISE BLVD.             SE DECISION MADE: 07-MAR-13
TOLEDO OH 43612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
NXSTAGE MEDICAL, INC.             510(k) NO: K123395(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872  
350 Merrimack St                  SE DECISION MADE: 07-MAR-13
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
MACLIN POWER INC.                 510(k) NO: K121511(TRADITIONAL)
ATTN: ENRICO  BISSON              PHONE NO : 39 049 8630080
VIA MARZIA, 9                     SE DECISION MADE: 07-MAR-13
ABANO TERME, PD    IT 35031       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K122476(TRADITIONAL)
ATTN: DONNA  DI GANGI             PHONE NO : 805 541 3344  
4 LOS VERDES DRIVE                SE DECISION MADE: 07-MAR-13
SAN LUIS OBISPO CA 93401          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAM JUNCTIONAL TOURNIQUET
SAM MEDICAL PRODUCTS              510(k) NO: K123694(TRADITIONAL)
ATTN: JACK N MCCUTCHEON           PHONE NO : 503 639 5474  
27350 SW 95th Ave Ste 3038 Bldg 30SE DECISION MADE: 07-MAR-13
Wilsonville OR 97070              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE SOFT TISSUE FASTENER
MEDSHAPE, INC                     510(k) NO: K123350(TRADITIONAL)
ATTN: JACK C GRIFFIS III          PHONE NO : 678 235 3311  
1575 NORTHSIDE DRIVE, SUITE 440   SE DECISION MADE: 07-MAR-13
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K123677(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805  
500 GBC DRIVE M/S 514             SE DECISION MADE: 07-MAR-13
NEWARK DE 19702                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESIS HEALTH RECORD SYSTEM, (GHRS)
GENESIS HEALTH TECHNOLOGIES       510(k) NO: K123136(TRADITIONAL)
ATTN: KATHLEEN  JOHNSON           PHONE NO : 641 472 0775  
P.O. OX 2042                      SE DECISION MADE: 07-MAR-13
FAIRFIELD IA 52556                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERO GRAFT
HEMOSHPERE, INC., A CRYOLIFE COMPA510(k) NO: K124039(TRADITIONAL)
ATTN: LAURIE  LYNCH               PHONE NO : 952 582 6909  
6545 CITY WEST PARKWAY            SE DECISION MADE: 07-MAR-13
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
MICRO THERAPEUTICS, INC D/B/A: EV3510(k) NO: K124007(TRADITIONAL)
ATTN: ANALIA  STAUBLY             PHONE NO : 949 680 1201  
9775 TOLEDO WAY                   SE DECISION MADE: 07-MAR-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVRF SYSTEM
F CARE SYSTEMS NV                 510(k) NO: K130283(TRADITIONAL)
ATTN: E. J SMITH                  PHONE NO : 410 451 0639  
1468 HARWELL AVE                  SE DECISION MADE: 07-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
AAP BIOMATERIALS GMBH & CO. KG    510(k) NO: K123081(ABBREVIATED)
ATTN: VOLKER  STIRNAL             PHONE NO : 496 07 1929220
LAGERSTRASSE 11-15                SE DECISION MADE: 07-MAR-13
DIEBURG    GM 64807               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHUNTCHECK
NEURODX DEVELOPMENT LLC           510(k) NO: K123554(TRADITIONAL)
ATTN: FREDERICK J FRITZ           PHONE NO : 609 865 4426  
3333 Street Rd Suite 210          SE DECISION MADE: 07-MAR-13
Bensalem PA 19020                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
KAWASUMI LABORATORIES, INC.       510(k) NO: K123344(TRADITIONAL)
ATTN: CHRISTINA  HENZA            PHONE NO : 262 842 1257  
7401 104TH AVE. STE 160           SE DECISION MADE: 07-MAR-13
KENOSHA WI 53142                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.                      510(k) NO: K122189(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100  
10165 MCKELLAR CT.                SE DECISION MADE: 08-MAR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
BIOSPACE CORPORATION LIMITED      510(k) NO: K123228(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735  
8870 RAVELLO CT                   SE DECISION MADE: 08-MAR-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS 100/200
DRAGER MEDICAL GMBH               510(k) NO: K123776(ABBREVIATED)
ATTN: BETH  ZIS                   PHONE NO : 978 379 8255  
6 TECH DRIVE                      SE DECISION MADE: 08-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
PHILOSYS CO. LTD                  510(k) NO: K113636(TRADITIONAL)
ATTN: LINDA  CHAN                 PHONE NO : 646 454 5401  
304 PARK AVENUE SOUTH SUITE 218   SE DECISION MADE: 08-MAR-13
NEW YORK NY 10010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
ASAHI INTECC CO., LTD.            510(k) NO: K122468(SPECIAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252  
2500 RED HILL SUITE 210           SE DECISION MADE: 08-MAR-13
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
ASAHI INTECC CO., LTD.            510(k) NO: K122469(SPECIAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252  
2500 RED HILL AVE, SUITE 210      SE DECISION MADE: 08-MAR-13
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTPACK CONTROL KIT
QUALIGEN, INC.                    510(k) NO: K123725(TRADITIONAL)
ATTN: MICHAEL  POIRIER            PHONE NO : 760 918 9165  
2042 CORTE DEL NOGAL              SE DECISION MADE: 08-MAR-13
CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNI-PICC
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K130034(TRADITIONAL)
ATTN: NOLA  BENSTOG               PHONE NO : 801 773 7798  
803 N. 1250 W. SUITE 1            SE DECISION MADE: 08-MAR-13
CENTERVILLE UT 84014              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAVAN OSA
NEW JERSEY SNORING SOLUTIONS      510(k) NO: K121285(TRADITIONAL)
ATTN: DEBORAH  STEIN              PHONE NO : 973 736 0111  
769 NORTHFIELD AVENUE SUITE 154   SE DECISION MADE: 08-MAR-13
WEST ORANGE NJ 07052              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
QUIDEL CORP.                      510(k) NO: K123998(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100  
10165 MCKELLAR CT.                SE DECISION MADE: 08-MAR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGE WORKS PANOURA
MIC INTERNATIONAL                 510(k) NO: K122806(TRADITIONAL)
ATTN: IZUMI  MARUO                PHONE NO : 813 38 188577
4-1-17 HONGO BUNKYO-KU            SE DECISION MADE: 08-MAR-13
TOKYO    JA 113-0033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNOVIS COLLAGEN MATRIX (TBD)
SYNOVIS SURGICAL INNOVATIONS      510(k) NO: K122306(TRADITIONAL)
ATTN: JODI  JORGENSON             PHONE NO : 651 736 7399  
2575 UNIVERSITY AVE. WEST         SE DECISION MADE: 08-MAR-13
ST. PAUL MN 55114 1024            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSEE MODEL 8000 U-SCOPE
ENDOSEE CORP                      510(k) NO: K123151(TRADITIONAL)
ATTN: XIAOLONG(BRUCE)  OUYANG     PHONE NO : 650 397 5174  
4546 EL CAMINO REAL, SUITE 215    SE DECISION MADE: 08-MAR-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
ETHICON ENDO-SURGERY, LLC         510(k) NO: K123212(TRADITIONAL)
ATTN: LIPING  WU                  PHONE NO : 513 337 3135  
4545 CREEK ROAD                   SE DECISION MADE: 08-MAR-13
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
LIFE TECHNOLOGIES CORPORATION     510(k) NO: K123955(TRADITIONAL)
ATTN: DEANNA  VELLA               PHONE NO : 760 918 3000  
5791 VAN ALLEN WAY                SE DECISION MADE: 08-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVOIS IMPLANT SYSTEM
RIEMSER ARZNEIMITTEL AG           510(k) NO: K113042(SPECIAL)
ATTN: JAMES M CLINTON             PHONE NO : 919 247 0479  
5105 FAIRROADS RD.                SE DECISION MADE: 08-MAR-13
DURHAM NC 27712                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY ACETABULAR SYSTEM
CORIN MEDICAL                     510(k) NO: K130128(SPECIAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469  
5670 W. CYPRESS STREET SUITE C    SE DECISION MADE: 08-MAR-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSO GS1 CANNULATED SCREW SYSTEM
GOLD STANDARD ORTHOPAEDICS, LLC   510(k) NO: K123487(TRADITIONAL)
ATTN: DAVID  BAUGHMAN             PHONE NO : 502 581 8770  
1226 ROWAN ST.                    SE DECISION MADE: 11-MAR-13
LOUISVILLE KY 40203               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY TMAX MANUAL WHEELCHAIR
OTTO BOCK HEALTHCARE, LP          510(k) NO: K113164(TRADITIONAL)
ATTN: WILLIAM  KABITZ             PHONE NO : 763 553 9464  
2 CARLSON PKWY. N., SUITE 100     SE DECISION MADE: 11-MAR-13
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP RADIUS SET 2.5
AAP IMPLANTATE AG                 510(k) NO: K123875(TRADITIONAL)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 49 307501 9193
LORENZWEG 5                       SE DECISION MADE: 11-MAR-13
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS-MAG II
BIOMAGNETIK-PARK GMBH             510(k) NO: K121825(TRADITIONAL)
ATTN: THOMAS  WEBER               PHONE NO : 49 40 4710360
BEIM STROHHAUSE 27                SE DECISION MADE: 11-MAR-13
HAMBURG    GM 20097               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILEX SACROILIAC JOINT FUSION SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K123702(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN, M.D.      PHONE NO : 937 847 8400  
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 11-MAR-13
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K123073(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 52 28516789
Building 6 and 7, Zhu Keng IndustrSE DECISION MADE: 11-MAR-13
Shenzhen    CN 518118             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
TRUDELL MEDICAL INTL.             510(k) NO: K123614(TRADITIONAL)
ATTN: DARRYL  FISCHER             PHONE NO : 519 455 7060
725 THIRD ST.                     SE DECISION MADE: 11-MAR-13
LONDON    CA N5V 5G4              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K123815(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320  
911 HANSEN WAY                    SE DECISION MADE: 11-MAR-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO LACTATE TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K130113(TRADITIONAL)
ATTN: DENNIS M BLEILE             PHONE NO : 510 675 6515  
3240 WHIPPLE RD.                  SE DECISION MADE: 11-MAR-13
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYNECOLOGY STERILIZATION TRAY
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K121904(TRADITIONAL)
ATTN: JANICE  HASELTON            PHONE NO : 978 749 1494  
150 Minuteman Rd                  SE DECISION MADE: 11-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DX-D IMAGING PACKAGE
AGFA HEALTHCARE N.V.              510(k) NO: K122736(TRADITIONAL)
ATTN: DAVID  LEDWIG               PHONE NO : 828 862 8555  
PO BOX 1927                       SE DECISION MADE: 11-MAR-13
BREVARD NC 28712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEREOS WORKSTATION
EOS IMAGING INC.                  510(k) NO: K130395(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638  
555 THIRTEENTH ST, NW             SE DECISION MADE: 11-MAR-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
PHILIPS MEDICAL SYSTEMS           510(k) NO: K130153(TRADITIONAL)
ATTN: MARK  PUOPOLO               PHONE NO : 978 659 4244  
3000 Minuteman Rd                 SE DECISION MADE: 12-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOPROCARE
SOPRO                             510(k) NO: K121685(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 856 222 9988  
124 GAITHER DRIVE SUITE 140       SE DECISION MADE: 12-MAR-13
MT. LAUREL NJ 08054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEMORY METAL STAPLES, EASYCLIP
STRYKER CORP.                     510(k) NO: K122113(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 5718  
325 CORPORATE DRIVE               SE DECISION MADE: 12-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS, INC.    510(k) NO: K123939(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274  
3773 CORPORATE PWKY.              SE DECISION MADE: 12-MAR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IODOFOAM IODOPHOR FOAM DRESSING
PROGRESSIVE WOUNDCARE TECHNOLOGIES510(k) NO: K122634(TRADITIONAL)
ATTN: MASON  DIAMOND              PHONE NO : 508 333 0108  
150 LEVINBERG LANE                SE DECISION MADE: 12-MAR-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO, CT BONE READING
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123584(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912  
51 VALLEY STREAM PKWY.            SE DECISION MADE: 12-MAR-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERKINELMER 226 SAMPLE COLLECTION DEVICES
PERKINELMER, INC.                 510(k) NO: K121864(ABBREVIATED)
ATTN: KAY A TAYLOR                PHONE NO : 317 418 1735  
17 P&N DRIVE                      SE DECISION MADE: 12-MAR-13
GREENVILLE SC 29611               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER NEXEL TOTAL ELBOW
ZIMMER, INC.                      510(k) NO: K123862(TRADITIONAL)
ATTN: JOANNA L SURMA              PHONE NO : 574 371 1642  
1800 WEST CENTER STREET           SE DECISION MADE: 12-MAR-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GETINGE 400HC-E / SERIES STEAM STERILIZER
GETINGE SOURCING LLC              510(k) NO: K122071(TRADITIONAL)
ATTN: BARB  SMITH                 PHONE NO : 585 214 6049  
1777 EAST HENRIETTA RD.           SE DECISION MADE: 12-MAR-13
ROCHESTER NY 14623 3133           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
RAYENCE CO., LTD                  510(k) NO: K123345(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607  
12946 KIMBERLEY LN                SE DECISION MADE: 12-MAR-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAYSCAN A-EXPERT 3D
RAY CO., LTD                      510(k) NO: K122981(TRADITIONAL)
ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000  
8920 WILSHIRE BLVD SUITE 603      SE DECISION MADE: 12-MAR-13
BEVERLY HILLS CA 90211            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
TERUMO CORPORATION                510(k) NO: K130493(SPECIAL)
ATTN: GARRY A COURTNEY, MBA, RAC  PHONE NO : 800 283 7866  
125 BLUE BALL ROAD                SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISIOFOCUS
TECNIMED S.R.L.                   510(k) NO: K122412(SPECIAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 2630  
110 E. GRANADA BLVD SUITE 209     SE DECISION MADE: 13-MAR-13
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
NOBEL BIOCARE AB                  510(k) NO: K122602(TRADITIONAL)
ATTN: PHUONG  NGUYEN SON          PHONE NO : 714 282 4800  
22715 SAVI RANCH PKWY.            SE DECISION MADE: 13-MAR-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESOPHAGUS BOUGIE SET
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K130251(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320  
911 HANSEN WAY                    SE DECISION MADE: 13-MAR-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123370(TRADITIONAL)
ATTN: KAREN  JONES                PHONE NO : 801 565 6231  
12050 LONE PEAK PKWY              SE DECISION MADE: 13-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVON VITALS CHARTING SYSTEM
NUVON, INC.                       510(k) NO: K130234(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794  
555 THIRTEENTH STREET NW          SE DECISION MADE: 13-MAR-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGENESIS IMPLANT SYSTEM
LK CONSULTING GROUP               510(k) NO: K120089(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080  
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 13-MAR-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSIGNIA WITH ITERO
ORMCO CORP.                       510(k) NO: K123416(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602  
1717 WEST COLLINS AVENUE          SE DECISION MADE: 13-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
ASHITAKA FACTORY OF TERUMO CORP.  510(k) NO: K130520(SPECIAL)
ATTN: EILEEN  DORSEY              PHONE NO : 800 262 3304  
150 MAIMAIGI-CHO                  SE DECISION MADE: 13-MAR-13
FUJINOMIYA, SHIZUOKA    JA 418-001510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULMOSAL
PHARMACARIBE                      510(k) NO: K130091(SPECIAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155  
24301 WOODSAGE DRIVE              SE DECISION MADE: 13-MAR-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
CARTICEPT MEDICAL, INC.           510(k) NO: K124053(SPECIAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3800  
6120 Windward Pkwy Ste 220        SE DECISION MADE: 13-MAR-13
Alpharetta GA 30005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
PHADIA AB                         510(k) NO: K121156(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957  
4169 COMMERCIAL AVENUE            SE DECISION MADE: 13-MAR-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORALID
FORWARD SCIENCE LLC               510(k) NO: K123169(TRADITIONAL)
ATTN: BRIAN  PIKKULA              PHONE NO : 855 696 7254  
2511 WIND FALL LN                 SE DECISION MADE: 13-MAR-13
SUGAR LAND TX 77479               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA MR450W
GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K123522(TRADITIONAL)
ATTN: MICHELLE  HUETTNER          PHONE NO : 262 521 6102  
3200 N. GRANDVIEW BLVD            SE DECISION MADE: 13-MAR-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
TERUMO CORPORATION                510(k) NO: K130280(SPECIAL)
ATTN: GARRY A COURTNEY, MBA, RAC  PHONE NO : 800 283 7866  
125 BLUE BALL ROAD                SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K130333(SPECIAL)
ATTN: SUZANNE  GRENIER            PHONE NO : 800 262 3304  
125 BLUE BALL RD.                 SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K130359(SPECIAL)
ATTN: SUZANNE  GRENIER            PHONE NO : 800 262 3304  
125 BLUE BALL RD.                 SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K SERIES CPAP SYSTEMS
CURATIVE MEDICAL INC.             510(k) NO: K123897(SPECIAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622  
6518 TAMARIND SKY LN.             SE DECISION MADE: 13-MAR-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STA- COAG CONTROL (N+ABN) PLUS
DIAGNOSTICA STAGO, INC.           510(k) NO: K120014(TRADITIONAL)
ATTN: KEVIN  WYCKOFF              PHONE NO : 973 631 1200  
5 CENTURY DR.                     SE DECISION MADE: 14-MAR-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122534(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270  
511 BENEDICT AVE.                 SE DECISION MADE: 14-MAR-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYCARE ONLINE
RESMED LTD.                       510(k) NO: K123557(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081  
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 14-MAR-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
POLYMED THERAPEUTICS, INC         510(k) NO: K122907(TRADITIONAL)
ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046  
27001 LA PAZ ROAD, SUITE 266B     SE DECISION MADE: 14-MAR-13
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CATALYST II AND III
CARDIVA MEDICAL, INC.             510(k) NO: K130124(TRADITIONAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 925 254 5228  
8 SNOWBERRY CT.                   SE DECISION MADE: 14-MAR-13
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAPORT V2 BLADELESS OPTICAL TROCAR
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K130435(SPECIAL)
ATTN: SARAH  RIZK                 PHONE NO : 203 492 5493  
60 Middletown Ave                 SE DECISION MADE: 14-MAR-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHINA NAILS AND ACCESSORIES
SMITH & NEPHEW, INC.              510(k) NO: K123948(TRADITIONAL)
ATTN: JASON  SELLS                PHONE NO : 901 399 5520  
1450 BROOKS RD.                   SE DECISION MADE: 14-MAR-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
SMARTGUARD, INC.                  510(k) NO: K123161(TRADITIONAL)
ATTN: SHELLY  GARG                PHONE NO : 305 372 2421  
601 BRICKELL KEY DRIVE SUITE 104  SE DECISION MADE: 14-MAR-13
MIAMI FL 33131                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
GLOBUS MEDICAL, INC.              510(k) NO: K123783(TRADITIONAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800  
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 14-MAR-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
MARVAO MEDICAL DEVICES, LTD.      510(k) NO: K121933(TRADITIONAL)
ATTN: MARYBETH  GAMBER            PHONE NO : 508 351 8632  
368 WEST MAIN STREET SUITE 7      SE DECISION MADE: 14-MAR-13
NORTHBOROUGH MA 01532             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIDEK RS-3000, RS-3000 LITE
NIDEK CO., LTD.                   510(k) NO: K121622(TRADITIONAL)
ATTN: LENA  SATTLER               PHONE NO : 440 554 3706  
1667 RIDGEWOOD RD                 SE DECISION MADE: 14-MAR-13
WADSWORTH OH 44281                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
CALGARY SCIENTIFIC, INC.          510(k) NO: K123186(TRADITIONAL)
ATTN: KYLE  PETERSON              PHONE NO : 403 767 7945
SUITE 208, 1210 20TH AVENUE SE    SE DECISION MADE: 14-MAR-13
CALGARY, ALBERTA    CA T2G 1M8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARAGON HIP SYSTEM
GLOBAL MANUFACTURING TECHNOLOGY   510(k) NO: K123782(TRADITIONAL)
ATTN: HOLLACE S RHODES            PHONE NO : 202 552 5800  
1331 H STREET NW                  SE DECISION MADE: 14-MAR-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEGOPAL+
BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K123929(ABBREVIATED)
ATTN: HEIKE  GUSTKE               PHONE NO : 49 421202 8112
WILHELM-HERBST-STRASSE 1          SE DECISION MADE: 14-MAR-13
BREMEN    GM 28359                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS – CEFTAROLINE
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K123933(TRADITIONAL)
ATTN: ELISABETH  WARRINER         PHONE NO : 916 374 3244  
1584 ENTERPRISE BLVD.             SE DECISION MADE: 14-MAR-13
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
INTERSURGICAL INCORPORATED        510(k) NO: K121747(TRADITIONAL)
ATTN: MICHAEL  ZALEWSKI           PHONE NO : 315 451 2900  
417 ELECTRONICS PARKWAY           SE DECISION MADE: 14-MAR-13
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
PIVOT MEDICAL INC.                510(k) NO: K130351(SPECIAL)
ATTN: JON  COOK                   PHONE NO : 408 774 1452  
247 HUMBOLDT CT                   SE DECISION MADE: 14-MAR-13
SUNNYVALE CA 94089 0000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
RADIOMETER MEDICAL APS            510(k) NO: K130236(TRADITIONAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 3827 3114
AKANDEVEJ 21                      SE DECISION MADE: 15-MAR-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-FIX DYNAMIC EXTERNAL DISTRACTOR
AREX USA LLC                      510(k) NO: K122415(TRADITIONAL)
ATTN: CHARLES  HOKANSON           PHONE NO : 610 715 3263  
1709 HILL ST.                     SE DECISION MADE: 15-MAR-13
EDGEWATER FL 32132                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC NEBULIZER (MESH TYPE)
K-JUMP HEALTH CO., LTD.           510(k) NO: K121520(ABBREVIATED)
ATTN: JM  LIN                     PHONE NO : 886 2 22991378
NO. 56, WU KUNG 5TH RD., NEW TAIPESE DECISION MADE: 15-MAR-13
NEW TAIPEI    TW 24890            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAYSCAN A-EXPERT
RAY CO., LTD                      510(k) NO: K122918(TRADITIONAL)
ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000  
8920 WILSHIRE BLLVD SUITE 603     SE DECISION MADE: 15-MAR-13
BEVERLY HILLS CA 90211            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
3M COMPANY                        510(k) NO: K121593(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052  
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 15-MAR-13
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123298(TRADITIONAL)
ATTN: DANNETTE  CROOMS            PHONE NO : 801 565 6209  
12050 LONE PEAK PKWY              SE DECISION MADE: 15-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLIXENE IFG VASCULAR GRAFT
ATRIUM MEDICAL CORPORATION        510(k) NO: K130142(TRADITIONAL)
ATTN: MEGAN  MCCAGH, RAC, CTBS    PHONE NO : 603 880 1436  
5 WENTWORTH DR                    SE DECISION MADE: 15-MAR-13
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
AAP BIOMATERIALS GMBH & CO. KG    510(k) NO: K123225(ABBREVIATED)
ATTN: VOLKER  STIRNAL             PHONE NO : 49 607 1929220
LAGERSTRASSE 11-15                SE DECISION MADE: 15-MAR-13
DIEBURG    GM 64807               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TVC IMAGING SYSTEM MODEL NIRS-MC7-70
INFRAREDX, INC.                   510(k) NO: K123108(TRADITIONAL)
ATTN: STEVEN J CHARTIER           PHONE NO : 781 221 0053  
34 Third Avenue                   SE DECISION MADE: 15-MAR-13
Burlington MA 01803               510(k) STATEMENT

DEVICE: GALILEOS FAMILY
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123070(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251163 294
FABRIKSTRASSE 31                  SE DECISION MADE: 15-MAR-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDELA THOPAZ
MEDELA AG                         510(k) NO: K130210(TRADITIONAL)
ATTN: MARKUS  BUETLER             PHONE NO : 041 769515 1247
LAETTICHSTRASSE 4B                SE DECISION MADE: 15-MAR-13
BAAR, ZUG    SZ CH-6341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
ROCHE DIAGNOSTICS CORP.           510(k) NO: K130138(SPECIAL)
ATTN: JUSTIN  DAVIS               PHONE NO : 317 521 6204  
9115 HAGUE RD.                    SE DECISION MADE: 15-MAR-13
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
BIOMET SPORTS MEDICINE            510(k) NO: K123485(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176  
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 18-MAR-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
FILLIGENT LIMITED                 510(k) NO: K122702(TRADITIONAL)
ATTN: KAI  DEUSCH                 PHONE NO : 852 254224 00
7TH FLLOR, 69 JERVOIS STREET, SHEUSE DECISION MADE: 18-MAR-13
HONG KONG    CH HK                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M ATTEST(TM) AUTO-READER
3M COMPANY                        510(k) NO: K123546(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052  
3M CENTER, BLDG. 275–05-W-06     SE DECISION MADE: 18-MAR-13
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE LATEX SURGICAL GLOVE
LUCENXIA PRESCIENCE AG            510(k) NO: K123628(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 41 417689 126
RATHAUSSTRASSE 7                  SE DECISION MADE: 18-MAR-13
BAAR    SZ 6341                   510(k) STATEMENT

DEVICE: LANX FUSION SYSTEM- SA
LANX, INC.                        510(k) NO: K123767(TRADITIONAL)
ATTN: ALAN  BURKHOLDER            PHONE NO : 303 443 7500  
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 18-MAR-13
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
SMITH & NEPHEW, INC.              510(k) NO: K122059(TRADITIONAL)
ATTN: KARIN  DESJARDINS           PHONE NO : 508 337 4035  
150 MINUTEMAN RD.                 SE DECISION MADE: 18-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URGOCLEAN ABSORBENT WOUND DRESSING
LABORATOIRES URGO                 510(k) NO: K123219(TRADITIONAL)
ATTN: SOPHIE  FORTIN              PHONE NO : 333 804428 78
EXCELLENCE 2000 2 AVENUE DE STRASBSE DECISION MADE: 18-MAR-13
CHEVIGNY SAINT SAUVEUR    FR 21801510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED CANNULATED SCREW SYSTEM
ACUMED LLC                        510(k) NO: K123890(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412  
5885 NW Cornelius Pass Rd         SE DECISION MADE: 18-MAR-13
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K123351(TRADITIONAL)
ATTN: JULIA A NELSON              PHONE NO : 763 514 9844  
7611 NORTHLAND DR.                SE DECISION MADE: 19-MAR-13
MINNEAPOLIS MN 55432              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
COOK, INC.                        510(k) NO: K122940(TRADITIONAL)
ATTN: ELYSIA  EASTON              PHONE NO : 812 339 2235  
750 DANIELS WAY                   SE DECISION MADE: 19-MAR-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOGYN ENDOSCOPE
IOGYN, INC.                       510(k) NO: K123330(TRADITIONAL)
ATTN: MARY J EDWARDS              PHONE NO : 952 227 3394  
5353 WAYZATA BOULEVARD STE. 505   SE DECISION MADE: 19-MAR-13
MINNEAPOLIS MN 55416              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIA MICROCATHETER, VIA PLUS MICROCATHETER
SEQUENT MEDICAL, INC              510(k) NO: K123477(TRADITIONAL)
ATTN: MELANIE  PARRAVI            PHONE NO : 949 830 9600  
11A COLUMBIA                      SE DECISION MADE: 19-MAR-13
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORBIT INFUSION SET
YPSOMED AG                        510(k) NO: K130468(SPECIAL)
ATTN: BENJAMIN  REINMANN          PHONE NO : 41 34 4243117
BRUNNMATTSTRASSE 6                SE DECISION MADE: 19-MAR-13
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL RETINAL CAMERA
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K123208(TRADITIONAL)
ATTN: IZUMI  MARUO                PHONE NO : 813 381885 77
4-1-17 HONGO                      SE DECISION MADE: 19-MAR-13
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
SOFLEX LIMITED                    510(k) NO: K122220(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412  
33 GOLDEN EAGLE LANE              SE DECISION MADE: 19-MAR-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: DEUTOETCH QUICKBOND BOND ACTIRATOR
ITENA CLINICAL                    510(k) NO: K122522(TRADITIONAL)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 19-MAR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDEZILLA GUIDE EXTENSION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K123765(TRADITIONAL)
ATTN: HOLLY  RAMIREZ              PHONE NO : 763 494 2113  
ONE SCIMED PLACE                  SE DECISION MADE: 19-MAR-13
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADWELL DISPOSABLE PROBE HANDLE
CADWELL                           510(k) NO: K123589(TRADITIONAL)
ATTN: CHRIS  BOLKAN               PHONE NO : 509 735 6481  
909 N. KELLOGG ST.                SE DECISION MADE: 19-MAR-13
KENNEWICK WA 99336                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
BIODENTA SWISS AG                 510(k) NO: K123415(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174711 11
TRAMSTRASSE 16                    SE DECISION MADE: 19-MAR-13
BERNECK, ST.GALLEN    SZ 9442     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K130157(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942  
1959 KELLOGG AVE.                 SE DECISION MADE: 19-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERVENTIONAL HEMOSTATIC BANDAGE
Z-MEDICA CORPORATION              510(k) NO: K120782(TRADITIONAL)
ATTN: SHEILA  WALLIN              PHONE NO : 203 294 0000  
4 FAIRFIELD BLVD.                 SE DECISION MADE: 20-MAR-13
Wallingford CT 06492              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEREC BLOCS C IN
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123952(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 49 625116 0
FABRIKSTRASSE 31                  SE DECISION MADE: 20-MAR-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALM BLADDER SCANNER
MIANYANG MEIKE ELECTRONIC EQUIPMEN510(k) NO: K130229(ABBREVIATED)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182
ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 20-MAR-13
WENZHOU, ZHEJIANG    CH 325000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
SORIN GROUP ITALIA S.R.L.         510(k) NO: K130433(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313  
14401 W. 65TH WAY                 SE DECISION MADE: 20-MAR-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
PENTAX OF AMERICA, INC.           510(k) NO: K130247(SPECIAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880  
3 PARAGON DRIVE                   SE DECISION MADE: 20-MAR-13
MONTVALE NJ 07645                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
ST. JUDE MEDICAL                  510(k) NO: K130252(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 593 2960  
15900 VALLEY VIEW CT.             SE DECISION MADE: 20-MAR-13
SYLMAR CA 91342 3577              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
ST. JUDE MEDICAL                  510(k) NO: K130257(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 493 2960  
15900 VALLEY VIEW CT.             SE DECISION MADE: 20-MAR-13
SYLMAR CA 91342 3577              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-Z CHEK BLOOD LEAK TEST STRIPS
REPROCESSING PRODUCTS CORP.       510(k) NO: K123805(TRADITIONAL)
ATTN: TED  WILLIAMS               PHONE NO : 520 888 5551  
P.O. BOX 35849                    SE DECISION MADE: 20-MAR-13
TUCSON AZ 85740                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIDCORAPID V2 MONITOR
LIDCO LTD.                        510(k) NO: K122247(TRADITIONAL)
ATTN: GREGORY  SPELLER            PHONE NO : 442 077 491500
16 ORSMAN RD.                     SE DECISION MADE: 20-MAR-13
LONDON    UK N15QJ                510(k) STATEMENT

DEVICE: OPTETRAK LOGIC POROUS FEMORAL COMPONENT
EXACTECH, INC.                    510(k) NO: K123687(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140  
2320 N.W. 66TH CT.                SE DECISION MADE: 20-MAR-13
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIRADA RTX
MIRADA MEDICAL LTD.               510(k) NO: K130393(TRADITIONAL)
ATTN: GWILYM  OWEN                PHONE NO : 440 186581 1172
OXFORD CENTRE FOR INNOVATION NEW RSE DECISION MADE: 20-MAR-13
OXFORD, OXFORDSHIRE    UK OX1 1BY 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: TX1 TISSUE REMOVAL SYSTEM
TENEX HEALTH                      510(k) NO: K123640(TRADITIONAL)
ATTN: DAVID  SALZBERG             PHONE NO : 949 580 1266  
26902 VISTA TERRACE               SE DECISION MADE: 20-MAR-13
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUITEHEART
NEOSOFT, LLC                      510(k) NO: K130228(TRADITIONAL)
ATTN: JACKIE  SCHWABE             PHONE NO : 262 522 6120  
N27 W23910A PAUL RD.              SE DECISION MADE: 20-MAR-13
PEWAUKEE WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANGUARD XP KNEE SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K122160(TRADITIONAL)
ATTN: TRACY  BICKEL JOHNSON       PHONE NO : 574 267 6639  
56 EAST BELL DRIVE                SE DECISION MADE: 20-MAR-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEMI ULTRA
KERR CORPORATION                  510(k) NO: K123468(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602  
1717 WEST COLLINS AVENUE          SE DECISION MADE: 20-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD ALCOHOL SWAB
BECTON DICKINSON & CO.            510(k) NO: K121655(TRADITIONAL)
ATTN: AVITAL  LAKES               PHONE NO : 201 847 4739  
1 BECTON DR.                      SE DECISION MADE: 20-MAR-13
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
STRYKER TRAUMA AG                 510(k) NO: K123403(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461  
325 CORPORATE DRIVE               SE DECISION MADE: 20-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
PENTAX OF AMERICA, INC.           510(k) NO: K130206(SPECIAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880  
3 PARAGON DR.                     SE DECISION MADE: 20-MAR-13
MONTVALE NJ 07645 1782            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
THE ORTHOPAEDIC IMPLANT COMPANY (O510(k) NO: K123832(TRADITIONAL)
ATTN: ITAI  NEMOVICHER            PHONE NO : 775 636 8281  
316 CALIFORNIA AVE #701           SE DECISION MADE: 20-MAR-13
RENO NV 89509                     510(k) STATEMENT

DEVICE: HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
MEDIMECCA CO., LTD.               510(k) NO: K130221(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789  
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 21-MAR-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHENZHEN MED-LINK PULSE OXIMETER PROBE
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K113727(TRADITIONAL)
ATTN: RHONDA  ALEXANDER           PHONE NO : 757 224 0177  
144 RESEARCH DRIVE                SE DECISION MADE: 21-MAR-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BETA-TCP GRANULES
SKELETAL KINETICS, LLC            510(k) NO: K120354(TRADITIONAL)
ATTN: CHRISTINE  KUO              PHONE NO : 408 350 5242  
10201 BUBB RD.                    SE DECISION MADE: 21-MAR-13
CUPERTINO CA 95014 4167           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNIER MEDILAS UROPULSE
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K130344(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163  
1155 ROBERTS BLVD.                SE DECISION MADE: 21-MAR-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121772(ABBREVIATED)
ATTN: FRANS  JACOBS               PHONE NO : 31 40 2799709
VEENPLUIS 4-6                     SE DECISION MADE: 21-MAR-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNRAY FETAL MONITOR
SUNRAY MEDICAL APPARATUS CO., LTD.510(k) NO: K123335(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 86 7558 6329133
B102 NANSHAN MEDICAL DEVICES INDUSSE DECISION MADE: 21-MAR-13
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BP652N (HEM-6300-Z)
OMRON HEALTHCARE, INC.            510(k) NO: K123498(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155  
24301 WOODSAGE DRIVE              SE DECISION MADE: 21-MAR-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130619(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO :
685 East Middlefield Road         SE DECISION MADE: 21-MAR-13
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: CAPNO MODULE, 92517
SPACELABS HEALTHCARE              510(k) NO: K130112(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232  
P.O. BOX 3018                     SE DECISION MADE: 21-MAR-13
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCE TOTAL KNEE SYSTEM-PATELLA
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K122218(SPECIAL)
ATTN: DANIELLE  MUELLER           PHONE NO : 901 290 5904  
5677 AIRLINE RD.                  SE DECISION MADE: 21-MAR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PINPOINTE FOOTLASER
NUVOLASE, INC.                    510(k) NO: K130413(SPECIAL)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586 3113  
26 REBECCA CT                     SE DECISION MADE: 21-MAR-13
HOMOSASSA FL 34446                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEEDA 100% COTTON MENSTRUAL TAMPON
NATURALENA BRANDS, INC.           510(k) NO: K130609(TRADITIONAL)
ATTN: JOSH  ELLIS                 PHONE NO : 435 238 4961  
1875 S. GRANT ST. SUITE 570       SE DECISION MADE: 21-MAR-13
SAN MATEO CA 94402                510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: PASS OCT SPINAL SYSTEM
MEDICREA INTERNATIONAL            510(k) NO: K121979(TRADITIONAL)
ATTN: LAURA  AVIRON-VIOLET        PHONE NO : 334 720 18787
14 Porte du Grand Lyon            SE DECISION MADE: 21-MAR-13
NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K121981(TRADITIONAL)
ATTN: PHILIP  LIU                 PHONE NO : 914 524 2443  
511 BENEDICT AVENUE               SE DECISION MADE: 21-MAR-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S9 VPAP TX
RESMED LTD.                       510(k) NO: K123511(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081  
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 21-MAR-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEVER TD-7001NEBULIZER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K122060(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 21-MAR-13
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GARAVENTA X3 INCLINED PLATFORM LIFT
GARAVENTA (CANADA) LTD [DBA GARAVE510(k) NO: K122206(SPECIAL)
ATTN: JAY  MANSOUR                PHONE NO : 678 908 8180  
845 ARONSON LAKE COURT            SE DECISION MADE: 21-MAR-13
ROSWELL GA 30075                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APPS-HEALTH01
ANDON HEALTH CO., LTD             510(k) NO: K122098(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 260 526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 21-MAR-13
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K121894(TRADITIONAL)
ATTN: LUBNA  SYED                 PHONE NO : 416 593 4323
439 UNIVERSITY AVE. Suite 900     SE DECISION MADE: 21-MAR-13
TORONTO    CA M5G 1Y8             510(k) STATEMENT

DEVICE: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K120771(ABBREVIATED)
ATTN: ERIC  GRACE                 PHONE NO : 305 380 2728  
11800 SW 147TH AVE.               SE DECISION MADE: 22-MAR-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMORAL ACCESS VENOUS CANNULAE
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123303(TRADITIONAL)
ATTN: DANNETTE  CROOMS            PHONE NO : 801 565 6209  
12050 LONE PEAK PKWY              SE DECISION MADE: 22-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRII CRAINIAL DRILL
MRI INTERVENTIONS, INC.           510(k) NO: K122456(TRADITIONAL)
ATTN: E.F.  WADDELL               PHONE NO : 949 900 6833  
5 Musick                          SE DECISION MADE: 22-MAR-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC.                  510(k) NO: K123652(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8500  
7800 3RD ST N., SUITE 600         SE DECISION MADE: 22-MAR-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIAX 2 COMPRESSION PLATING SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K130009(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461  
325 CORPORATE DRIVE               SE DECISION MADE: 22-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC INTRODUCER
NOVADAQ TECHNOLOGIES, INC.        510(k) NO: K123013(TRADITIONAL)
ATTN: TIM  VERSPAGEN              PHONE NO : 604 232 9861
13155 DELF PLACE, UNIT 250        SE DECISION MADE: 22-MAR-13
RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K130141(TRADITIONAL)
ATTN: ERIKA B AMMIRATI, RAC, MT (APHONE NO : 650 949 2768  
630 CLYDE COURT                   SE DECISION MADE: 22-MAR-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIS-SHIELD ACVTIVE-B12
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K121946(TRADITIONAL)
ATTN: SIMON JOHN  RICHARDS        PHONE NO : 44 13 82422000
THE TECHNOLOGY PARK, LUNA PLACE   SE DECISION MADE: 22-MAR-13
DUNDEE, SCOTLAND    UK DD2 1XA    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122037(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 800 876 3133  
1800 PYRAMID PLACE                SE DECISION MADE: 22-MAR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALCO-SCREEN
CHEMATICS, INC.                   510(k) NO: K121247(TRADITIONAL)
ATTN: CARL  REYNOLDS              PHONE NO : 513 265 6257  
P.O. BOX 293 HIGHWAY 13 SOUTH     SE DECISION MADE: 22-MAR-13
NORTH WEBSTER IN 46555            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
MEDTRONIC NAVIGATION, INC.        510(k) NO: K124004(TRADITIONAL)
ATTN: MICHAEL  BLASCO             PHONE NO : 720 890 3391  
826 COAL CREEK CIRCLE             SE DECISION MADE: 22-MAR-13
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION EXL WITH LM SYSTEM
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K130276(TRADITIONAL)
ATTN: PAMELA A JURGA              PHONE NO : 302 631 8891  
500 GBC DRIVE M/S 514 P.O. BOX 610SE DECISION MADE: 22-MAR-13
NEWARK DE 19714 3026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEINE MINI 3000 LED OPHTHALMOSCOPE
HEINE OPTOTECHNIK GMBH & CO. KG.  510(k) NO: K123587(ABBREVIATED)
ATTN: JOERG  ROENNAU              PHONE NO : 49 8152 38269
KIENTALSTRASSE 7                  SE DECISION MADE: 22-MAR-13
HERRSCHING    GM D-82211          510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: PROCARE MONITOR B20
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K122253(SPECIAL)
ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063  
8200 WEST TOWER AVE               SE DECISION MADE: 22-MAR-13
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BALANCED KNEE SYSTEM HIGH FLEX PS
ORTHO DEVELOPMENT CORP.           510(k) NO: K123457(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991  
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 22-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MORTARA SURVEYOR PATIENT MONITOR
MORTARA INSTRUMENT, INC.          510(k) NO: K123556(ABBREVIATED)
ATTN: AMY  YANG                   PHONE NO : 414 354 1600  
7865 NORTH 86TH ST.               SE DECISION MADE: 22-MAR-13
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAIMAN SEAL AND CUT TECHNOLOGY
AESCULAP, INC.                    510(k) NO: K130596(SPECIAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076  
3773 CORPORATE PARKWAY            SE DECISION MADE: 22-MAR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXERA 2 ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K123618(TRADITIONAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 261 8073  
740 Bay Rd                        SE DECISION MADE: 24-MAR-13
Redwood City CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL READIPLAS TIN
INSTRUMENTATION LABORATORY CO.    510(k) NO: K122584(TRADITIONAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4350  
180 HARTWELL ROAD                 SE DECISION MADE: 24-MAR-13
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAMPART O AND RAMPART P
SPINEOLOGY, INC.                  510(k) NO: K130396(SPECIAL)
ATTN: BRYAN  BECKER               PHONE NO : 612 256 8534  
7800 3RD ST N., SUITE 600         SE DECISION MADE: 25-MAR-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
LAUER MEMBRAN WASSERTECHNIK GMBH  510(k) NO: K124059(TRADITIONAL)
ATTN: STEPHAN  KRIETEMEYER        PHONE NO : 49 7621 927015
9 SPEICHERMATT                    SE DECISION MADE: 25-MAR-13
WITTLINGEN    GM DE 79599         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
BIOMECANICA INDUSTRIA E COMERICO D510(k) NO: K123745(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077  
18851 NE 29TH AVE 720             SE DECISION MADE: 25-MAR-13
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFELINES IEEG
KVIKNA EHF                        510(k) NO: K123665(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674  
1468 HARWELL AVE                  SE DECISION MADE: 25-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K130754(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 650 969 9112  
685 EAST MIDDLEFIELD RD.          SE DECISION MADE: 25-MAR-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: SMART-WELL INCUBATOR
MESA LABORATORIES, INC.           510(k) NO: K122362(SPECIAL)
ATTN: JOLE  WILSON                PHONE NO : 303 987 8000  
12100 W. 6TH AVENUE               SE DECISION MADE: 26-MAR-13
LAKEWOOD CO 80228                 510(k) STATEMENT

DEVICE: INSIGNIA DIGICAST
ORMCO CORP.                       510(k) NO: K123118(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602  
1717 WEST COLLINS AVENUE          SE DECISION MADE: 26-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOBELCLINICIAN
NOBEL BIOCARE AB                  510(k) NO: K123976(TRADITIONAL)
ATTN: PHUONG  NGUYEN              PHONE NO : 714 282 4800  
22715 SAVI RANCH PARKWAY          SE DECISION MADE: 26-MAR-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
PAN-AMERICA HYPERBARICS, INC.     510(k) NO: K122560(TRADITIONAL)
ATTN: WILLIAM M GATES, RRT        PHONE NO : 913 674 3118  
1510 PARK PLACE DRIVE             SE DECISION MADE: 26-MAR-13
ATCHISON KS 66002                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGH METABOLITE QUALICHECK
RADIOMETER MEDICAL APS            510(k) NO: K130415(TRADITIONAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 382731 14
AAKANDEVEJ 21                     SE DECISION MADE: 26-MAR-13
BROENSHOEJ    DA DK-2700          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASAFE PLUS PASSIVE NEEDLE GUARD
SAFETY SYRINGES, INC.             510(k) NO: K123743(TRADITIONAL)
ATTN: SUZANNE  RICHARDSON         PHONE NO : 760 918 9908  
2875 LOKER AVENUE EAST            SE DECISION MADE: 26-MAR-13
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENACURE EVLT NEVERTOUCH PROCEDURE KIT
ANGIODYNAMICS, INC.               510(k) NO: K130671(SPECIAL)
ATTN: TERI  JUCKETT               PHONE NO : 518 795 1142  
603 QUEENSBURY AVE.               SE DECISION MADE: 26-MAR-13
QUEENSBURY NY 12804               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TBD
LENSAR, INC.                      510(k) NO: K123859(TRADITIONAL)
ATTN: SHIRLEY K MCGARVEY          PHONE NO : 702 524 3701  
2800 DISCOVERY DRIVE SUITE 100    SE DECISION MADE: 27-MAR-13
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
THE BINDING SITE GROUP LTD        510(k) NO: K113823(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121456 9500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 27-MAR-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
INTERNATIONAL BIOPHYSICS CORPORATI510(k) NO: K122480(TRADITIONAL)
ATTN: H. DAVID  SHOCKLEY JR.      PHONE NO : 512 326 3244  
2101 E. ST ELMO ROAD SUITE 275    SE DECISION MADE: 27-MAR-13
AUSTIN TX 78744                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
HEMOSTASIS, LLC                   510(k) NO: K122494(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 855 1466  
5000 Township Pkwy                SE DECISION MADE: 27-MAR-13
Saint Paul MN 55110               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
WESCOR, INC.                      510(k) NO: K121823(TRADITIONAL)
ATTN: DAWN T PERDUE               PHONE NO : 435 752 6011  
370 WEST 1700 SOUTH               SE DECISION MADE: 27-MAR-13
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLINE FLEXIBLE LIGATING SHEARS
MICROLINE SURGICAL, INC           510(k) NO: K124029(TRADITIONAL)
ATTN: DEAN  CIPORKIN              PHONE NO : 978 867 1758  
800 CUMMING CENTER SUITE 166T     SE DECISION MADE: 27-MAR-13
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
MEGAGEN IMPLANT CO., LTD.         510(k) NO: K123870(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114  
325 N PUENTE STREET UNIT B        SE DECISION MADE: 27-MAR-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGE AUTOMATIC WRIST BLOOD PRESSURE MONITOR
AGELESS HEALTH INDUSTRIAL         510(k) NO: K123645(TRADITIONAL)
ATTN: VICTOR  WAN                 PHONE NO : 07 698115 8038
NO.33 SHENBEI RD, SIMA VILLAGE CHASE DECISION MADE: 28-MAR-13
DONGGUAN CITY, GUANGDONG PROVINCE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOMEM
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K122272(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001  
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 28-MAR-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
MIMOSA ACOUSTICS, INC.            510(k) NO: K123624(SPECIAL)
ATTN: PATRICIA S JENG             PHONE NO : 217 359 9740  
335 N Fremont St                  SE DECISION MADE: 28-MAR-13
CHAMPAIGN IL 61820                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
SUNMED LLC                        510(k) NO: K121743(TRADITIONAL)
ATTN: WU  TINGJIE                 PHONE NO : 86 757 28091300
5/F – 6/F, BLOCK A, GUPO GONGMAO BSE DECISION MADE: 28-MAR-13
DALIANG, SHUNDE, FOSHAN    CH 5283510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
ASI MEDICAL, INC.                 510(k) NO: K123139(TRADITIONAL)
ATTN: JOHN  MCPEEK                PHONE NO : 303 766 3646  
14550 E EASTER AVE. SUITE 700     SE DECISION MADE: 28-MAR-13
CENTENNIAL CO 80112               510(k) STATEMENT

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM
BIODENTA SWISS AG                 510(k) NO: K123512(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174711 11
TRAMSTRASSE 16                    SE DECISION MADE: 28-MAR-13
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTIEN MEASUREMENT SYSTEM
RADI MEDICAL SYSTEMS AB           510(k) NO: K123984(SPECIAL)
ATTN: ANNA-LISA  TIENSUU          PHONE NO : 46 18 161000
PALMBLADSGATAN 10                 SE DECISION MADE: 28-MAR-13
UPPSALA    SW S-754 50            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
EIZO NANAO CORPORATION            510(k) NO: K130336(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627424 68
153 SHIMOKASHIWANO, HAKUSAN       SE DECISION MADE: 28-MAR-13
ISHIKAWA    JA 924-8566           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
NEOCOIL, LLC                      510(k) NO: K123272(ABBREVIATED)
ATTN: KATIE  GONZALEZ             PHONE NO : 262 347 1250  
N27 W23910A PAUL RD.              SE DECISION MADE: 28-MAR-13
PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA

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    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
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    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

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