TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 238
TOTAL WITH STATEMENTS 17
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD MARCH 2014
DEVICE: AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
APEX BIOTECHNOLOGY CORP. 510(k) NO: K131750(TRADITIONAL)
ATTN: HSUE-MEI LEE PHONE NO : 011 866 35641952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 06-MAR-14
HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP MULTI-DRUG TEST KEY CUPS
UCP BIOSCIENCES, INC. 510(k) NO: K132812(TRADITIONAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 06-MAR-14
SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K140248(TRADITIONAL)
ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 11-MAR-14
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREND TSH (REAGENT CARTRIDGE)
NANOEN TEK USA, INC. 510(k) NO: K131928(TRADITIONAL)
ATTN: JUDITH E LOEBEL PHONE NO : 203 881 1032
1 JACKS’ HILL ROAD, STE 1 (A&B) SE DECISION MADE: 14-MAR-14
OXFORD CT 06478 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
DIAZYME LABORATORIES 510(k) NO: K133410(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 14-MAR-14
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
THE BINDING SITE 510(k) NO: K140105(TRADITIONAL)
ATTN: PAUL KENNY PHONE NO : 440 121456 9500
8 Calthorpe Road Edgbaston SE DECISION MADE: 18-MAR-14
BIRMINGHAM GB B15 1QT 510(k) STATEMENT
DEVICE: VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K140465(TRADITIONAL)
ATTN: MORT MINAEE PHONE NO : 408 207 4201
203 Ravendale Dr SE DECISION MADE: 20-MAR-14
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
NOVA BIOMEDICAL CORPORATION 510(k) NO: K131703(TRADITIONAL)
ATTN: PAUL W MCDONALD PHONE NO : 781 894 0800
200 Prospect St SE DECISION MADE: 25-MAR-14
WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K133673(TRADITIONAL)
ATTN: MICHELLE L SMITH PHONE NO : 513 271 3700
3471 River Hills Dr SE DECISION MADE: 25-MAR-14
CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIPLIVUE HSV 1&2 ASSAY
QUIDEL CORPORATION 510(k) NO: K140029(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3300
10165 MCKELLAR COURT SE DECISION MADE: 26-MAR-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
SEBIA 510(k) NO: K133344(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 800 835 6497
1705 CORPORATE DRIVE SUITE 400 SE DECISION MADE: 28-MAR-14
NORCROSS GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SFI-ANCHOR
CENDRES & METAUX SA 510(k) NO: K130618(TRADITIONAL)
ATTN: TANJA BONGNI PHONE NO : 415 836023 02
RUE DE BOUJEAN 122 SE DECISION MADE: 03-MAR-14
BIEL/BIENNE SZ 2501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISICLEAR SMOKE EVACUATION SYSTEM
BUFFALO FILTER CO., INC. 510(k) NO: K131402(TRADITIONAL)
ATTN: CARRIE TERMIN PHONE NO : 716 835 7000
5900 GENESEE STREET SE DECISION MADE: 03-MAR-14
LANCASTER NY 14086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPM WOUND GEL BIO
GLYCOBIOSCIENCES, INC 510(k) NO: K123193(TRADITIONAL)
ATTN: KEVIN DRIZEN PHONE NO : 905 854 0631
7 TIMBER COURT SE DECISION MADE: 03-MAR-14
GERGETOWN, ONTARIO CA L7G 4S4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTELL
AGFA HEALTHCARE N.V. 510(k) NO: K132800(TRADITIONAL)
ATTN: SHAEANN CAVANAGH PHONE NO : 864 421 1766
10 SOUTH ACADEMY STREET SE DECISION MADE: 03-MAR-14
GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOERAE VEIN PREPARATION KIT
MOERAE MATRIX, INC. 510(k) NO: K131659(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650 593 5225
25 HARTFORD AVENUE SE DECISION MADE: 03-MAR-14
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
SHOULDER OPTIONS, INC. 510(k) NO: K133668(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704 512 0000
100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 03-MAR-14
WAXHAW NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE SYSTEM ONE WITH NXVIEW
NXSTAGE MEDICAL, INC. 510(k) NO: K133547(TRADITIONAL)
ATTN: MARY LOU STROUMBOS PHONE NO : 978 687 4872
350 MERRIMACK STREET SE DECISION MADE: 03-MAR-14
LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITHM ID ELECTROPHYSIOLOGY CATHETER
SYNAPTIC MEDICAL LIMITED 510(k) NO: K133028(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 04-MAR-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDON BLOOD PRESSURE CUFF
ANDON HEALTH CO., LTD 510(k) NO: K133117(TRADITIONAL)
ATTN: LIU YI PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 04-MAR-14
TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
ZIMMER DENTAL INC. 510(k) NO: K133339(TRADITIONAL)
ATTN: JULIE L CORMAN PHONE NO : 760 929 4300
1900 ASTON AVE. SE DECISION MADE: 04-MAR-14
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVOPORE DRESSING
POLYNOVO BIOMATERIALS PTY LTD 510(k) NO: K132936(TRADITIONAL)
ATTN: CARRIE HETRICK PHONE NO : 512 327 9997
816 CONGRESS AVE. SUITE 1400 SE DECISION MADE: 04-MAR-14
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHSTATS A-PULSE CASPAL + AND MC3100 MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K131788(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114
S65 W35739 PIPER ROAD SE DECISION MADE: 04-MAR-14
EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
MEDTEC, INC. 510(k) NO: K132908(TRADITIONAL)
ATTN: AMANDA STAHLE PHONE NO : 319 248 6628
1401 8TH ST. S.E. SE DECISION MADE: 04-MAR-14
Orange City IA 51041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTHOUSE URINARY CATHETER
SEEDINGS LIFE SCIENCE VENTURES, LL510(k) NO: K140099(TRADITIONAL)
ATTN: KEN SOLOVAY PHONE NO : 954 336 0777
230 EAST 15TH STREET SUITE 1-A SE DECISION MADE: 04-MAR-14
NEW YORK NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEM-7320
OMRON HEALTHCARE, INC. 510(k) NO: K133383(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DR. SE DECISION MADE: 04-MAR-14
BONITA SPRINGS FL 34134 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
CHANGZHOU DEAN MEDICAL INSTRUMENT 510(k) NO: K133525(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 212281 5850
P.O. BOX 120-119 SE DECISION MADE: 04-MAR-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
SOUFLON PHARMACEUTICALS LTD 510(k) NO: K133472(TRADITIONAL)
ATTN: CHRISTOPHER SMEJKAL PHONE NO : 44 208 3224200
49-53 YORK STREET SE DECISION MADE: 04-MAR-14
TWICKENHAM UK TW1 3LP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOFIXTM INTERBODY FUSION SYSTEM
U&I CORP. 510(k) NO: K132926(TRADITIONAL)
ATTN: GYEONG JE-KWON PHONE NO : 823 18 520102X610
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 05-MAR-14
Uijeongbu-si KR 480-859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
VISION SCIENCE CO LTD 510(k) NO: K132714(TRADITIONAL)
ATTN: BRET ANDRE PHONE NO : 503 372 5226
21225 NW WILKINS ST. SE DECISION MADE: 05-MAR-14
BEAVERTON OR 97006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLURA XPER FD; OR TABLE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133292(ABBREVIATED)
ATTN: KLIEN VAN DAM PHONE NO : 310 402795 225
VEENPLUIS 4-6 SE DECISION MADE: 05-MAR-14
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTEC ELECTROCARDIOGRAPH
CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K131900(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122815 850
P.O. BOX 120-119 SE DECISION MADE: 05-MAR-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVLIFE Q-SWITCHED ND:YAG LASER SYSTEM
CYNOSURE, INC. 510(k) NO: K133254(TRADITIONAL)
ATTN: HUDA YUSUF PHONE NO : 781 993 2311
5 CARLISLE ROAD SE DECISION MADE: 05-MAR-14
WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K140258(ABBREVIATED)
ATTN: ASHA GARTLAND PHONE NO : 914 524 3257
511 BENEDICT AVENUE SE DECISION MADE: 05-MAR-14
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K140208(SPECIAL)
ATTN: LINDSAY MARTIN PHONE NO : 801 565 5388
12050 LONE PEAK PKWY SE DECISION MADE: 05-MAR-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K133618(TRADITIONAL)
ATTN: PATRICK CHOW PHONE NO : 008 52 28516789
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 05-MAR-14
SHENSHEN, GUANG DONG CH 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K133619(TRADITIONAL)
ATTN: PATRICK CHOW PHONE NO : 008 52 28516789
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 05-MAR-14
SHENSHEN, GUANG DONG CH 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K133740(TRADITIONAL)
ATTN: CHRISTOPHER SMEJKAL PHONE NO : 44 20832 24200
49-53 YORK ST. SE DECISION MADE: 05-MAR-14
TWICKENHAM, MIDDLESEX UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI PICC IV
NAVILYST MEDICAL, INC. 510(k) NO: K140266(SPECIAL)
ATTN: BRANDON M BRACKETT PHONE NO : 508 658 7984
26 FOREST STREET SE DECISION MADE: 05-MAR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOVAC CANNULA
VORTEX MEDICAL INC 510(k) NO: K133445(TRADITIONAL)
ATTN: LORRAINE M HANLEY PHONE NO : 508 658 7945
26 FOREST ST. SE DECISION MADE: 05-MAR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
CABIN PLASTIC CO., LTD. 510(k) NO: K130751(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG. 1.JIANXIANG YUAN NO.SE DECISION MADE: 05-MAR-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
LEXION MEDICAL, LLC. 510(k) NO: K140263(SPECIAL)
ATTN: BERNARD HORWATH PHONE NO : 651 231 1761
4486 TIMBERLINE CT SE DECISION MADE: 05-MAR-14
VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K131627(TRADITIONAL)
ATTN: LUKE MEIDELL PHONE NO : 801 565 6212
12050 LONE PEAK PKWY SE DECISION MADE: 06-MAR-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRWAY SUPPORT SYSTEM / AIRPORT
ABEON MEDICAL CORPORATION 510(k) NO: K131506(TRADITIONAL)
ATTN: ALLISON SLAGA PHONE NO : 440 262 6000
8000 Katherine Boulevard SE DECISION MADE: 06-MAR-14
Brecksville OH 44141 510(k) STATEMENT
DEVICE: CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
TELEFLEX, INC. 510(k) NO: K131912(TRADITIONAL)
ATTN: AMANDA WEBB PHONE NO : 919 433 8050
2917 WECK DR. SE DECISION MADE: 06-MAR-14
RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
AMENDIA INC. 510(k) NO: K133036(TRADITIONAL)
ATTN: RICH JANSEN PHONE NO : 612 281 5505
11821 BRAMBLE COVE DRIVE SE DECISION MADE: 06-MAR-14
FT. MYERS FL 33905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROTABLE SYSTEM
FRED HAER COMPANY, INC. 510(k) NO: K132611(TRADITIONAL)
ATTN: KERI SEITZ PHONE NO : 207 666 5651
1201 MAIN STREET SE DECISION MADE: 06-MAR-14
BOWDOIN ME 04287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N-FORCE FIXATION SYSTEM
INNOVISION, INC. 510(k) NO: K132244(TRADITIONAL)
ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800
1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 06-MAR-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHE NIOV VENTILATION SYSTEM
BREATHE TECHNOLOGIES 510(k) NO: K131562(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 650 380 2474
1193 SHERMAN ST SE DECISION MADE: 06-MAR-14
ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEDVIEW
LEXI CO., LTD. 510(k) NO: K133022(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440 546 9810
5905 FAWN LANE SE DECISION MADE: 06-MAR-14
CLEVELAND OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL-BASED RSA SOFTWARE
HALIFAX BIOMEDICAL, INC. 510(k) NO: K133966(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 06-MAR-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O2 NASAL CANNULA WITH CO2 MONITORING
FLEXICARE MEDICAL LTD. 510(k) NO: K140113(TRADITIONAL)
ATTN: CHRIS WATKINS PHONE NO : 44 0 1443474647
CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 06-MAR-14
MID GLAMORGAN UK CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OPTIGLAZE COLOR
GC AMERICA INC. 510(k) NO: K133836(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 597 0900
3737 W. 127TH STREET SE DECISION MADE: 06-MAR-14
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTRIPOINT MEDICAL SYSTEM
VENTRIPOINT, INC. 510(k) NO: K140153(TRADITIONAL)
ATTN: JIM BODTKE PHONE NO : 206 283 0221
24 ROY ST. #445 SE DECISION MADE: 06-MAR-14
SEATTLE WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH BITE
3M ESPE AG 510(k) NO: K133400(TRADITIONAL)
ATTN: RUEDIGER FRANKE PHONE NO : 49 8152 7001802
ESPE PLATZ SE DECISION MADE: 06-MAR-14
SEEFELD GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K133754(TRADITIONAL)
ATTN: ELIZABETH MCMENIMAN PHONE NO : 781 565 1347
311 ENTERPRISE DRIVE SE DECISION MADE: 06-MAR-14
PLAINSBORO NJ 08535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAX VOLUME VIEWING 3.0
AGFA HEALTHCARE N.V. 510(k) NO: K133135(TRADITIONAL)
ATTN: KOEN COBBAERT PHONE NO :
SEPTESTRAAT 27 SE DECISION MADE: 07-MAR-14
MORTSEL BE B 2640 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
I.T.S. GMBH 510(k) NO: K132945(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858
3150 E. 200TH STREET SE DECISION MADE: 07-MAR-14
PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKBIRD SPINAL SYSTEM
CHOICE SPINE, LP 510(k) NO: K133214(TRADITIONAL)
ATTN: KIM FINCH PHONE NO : 865 246 3333
400 Erin Dr SE DECISION MADE: 07-MAR-14
KNOXVILLE TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEINE MINI 3000(R) OPHTHALMOSCOPE
HEINE OPTOTECHNIK GMBH & CO. KG. 510(k) NO: K131959(ABBREVIATED)
ATTN: MANFRED BARTSCH-TITTMANN PHONE NO : 49 815238 419
KIENTALSTRASSE 7 SE DECISION MADE: 07-MAR-14
HERRSCHING GM D-82211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE LATEX CONDOM
NULATEX SDN. BHD. 510(k) NO: K132107(ABBREVIATED)
ATTN: AI SIANG TEO PHONE NO : 607 777 1820
LOT 1870, 4TH MILES JALAN MENGKIBOSE DECISION MADE: 07-MAR-14
KLUANG, JOHOR MY 86000 510(k) STATEMENT
DEVICE: VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
VOLCANO CORPORATION 510(k) NO: K140291(SPECIAL)
ATTN: MARCUS GARCIA PHONE NO : 978 439 3312
1 FORTUNE DR SE DECISION MADE: 07-MAR-14
BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-TOE HAMMERTOE FIXATION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K140148(TRADITIONAL)
ATTN: VAL MYLES PHONE NO : 901 290 5162
5677 AIRLINE RD. SE DECISION MADE: 07-MAR-14
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
OSSTEM GERMANY GMBH 510(k) NO: K133527(TRADITIONAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001
85 BEN FAIRLESS DR SE DECISION MADE: 07-MAR-14
FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TABLE
ANATOMAGE INC. 510(k) NO: K140093(TRADITIONAL)
ATTN: MIKE MENDEZ PHONE NO : 408 885 1474
111 N. MARKET STREET #800 SE DECISION MADE: 07-MAR-14
SAN JOSE CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE (TM) SNAP-OFF SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K133713(SPECIAL)
ATTN: LESLIE FITCH PHONE NO : 901 867 4120
5677 AIRLINE RD. SE DECISION MADE: 07-MAR-14
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K134026(TRADITIONAL)
ATTN: DAPHNEY GERMAIN-KOLAWOLE PHONE NO : 484 896 5691
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 07-MAR-14
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR HD URETERAL ACCESS SHEATH SETS
BOSTON SCIENTIFIC 510(k) NO: K140323(SPECIAL)
ATTN: NICHOLE RIEK PHONE NO : 508 683 4175
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 07-MAR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
LDR SPINE, USA, INC. 510(k) NO: K133363(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 337 7579
4628 NORTHPARK DRIVE SE DECISION MADE: 07-MAR-14
COLORADO SPRING CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH AR; FLASH AR QUICK
3M DEUTSCHLAND GMBH 510(k) NO: K133436(TRADITIONAL)
ATTN: DESI SOEGIARTO PHONE NO : 49 815270 01169
ESPE PLATZ SE DECISION MADE: 07-MAR-14
SEEFELD, BAVARIA GM 82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
CORDIS, A JOHNSON & JOHNSON CO. 510(k) NO: K140286(SPECIAL)
ATTN: SHAMSA KARIMI PHONE NO : 510 248 2896
6500 PASEO PADRE PARKWAY SE DECISION MADE: 07-MAR-14
FREMONT CA 94555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFUSIONARY BEBE
ROCKY MOUNTAIN BIOSYSTEMS, INC. 510(k) NO: K121123(TRADITIONAL)
ATTN: AMY BENEDICT PHONE NO : 303 277 1140
3930 YOUNGFIELD STREET SE DECISION MADE: 10-MAR-14
WHEAT RIDGE CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T4/T5 HYTREL TOGAS
STRYKER CORPORATION 510(k) NO: K121664(TRADITIONAL)
ATTN: CASEY A METZGER PHONE NO : 269 389 3761
4100 E. MILHAM AVE SE DECISION MADE: 10-MAR-14
KALAMAZOO MI 49001 510(k) STATEMENT
DEVICE: MM-SEAL
MICRO-MEGA SOCIETE ANONYME 510(k) NO: K123276(TRADITIONAL)
ATTN: PHILIPPE CONCHE PHONE NO : 330 381544 229
5-12 RUE DU TUNNEL SE DECISION MADE: 10-MAR-14
CEDEX BESANCON FR 25006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAN HIP FRACTURE SYSTEM
EPIX ORTHOPAEDIC, CORP. 510(k) NO: K133104(TRADITIONAL)
ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800
1331 H STREET, NW, 12TH FLOOR SE DECISION MADE: 10-MAR-14
WASHINGTON DC 20008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWTRON P5, NEWTRON P5 B.LED
SATELEC-ACTEON GROUP 510(k) NO: K132267(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 10-MAR-14
MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PINNACLE ALTRX ACETABULAR LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K132959(TRADITIONAL)
ATTN: MEGAN BURNS PHONE NO : 574 372 7745
700 ORTHOPAEDIC DR. SE DECISION MADE: 10-MAR-14
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPACT MODEL 323 ASPIRATOR
IMPACT INSTRUMENTATION, INC. 510(k) NO: K133196(TRADITIONAL)
ATTN: ALAN GIORDANO PHONE NO : 973 882 1212
27 FAIRFIELD PL. P.O. BOX 508 SE DECISION MADE: 10-MAR-14
WEST CALDWELL NJ 07006 0508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BWCSH-1 SHARPS CONTAINER
BRADFORD WRIGHT COMPANIES, INC 510(k) NO: K131708(TRADITIONAL)
ATTN: MIKE DEMELLO PHONE NO : 503 635 6908
4092 ORCHARD WAY SE DECISION MADE: 10-MAR-14
LAKE OSWEGO OR 97035 1871 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140267(ABBREVIATED)
ATTN: FATIMA PACHECO PHONE NO : 914 524 2450
511 BENEDICT AVENUE SE DECISION MADE: 10-MAR-14
TARRYTOWN NY 10591 5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED SUTURE ANCHOR SYSTEM
ACUMED, LLC 510(k) NO: K133469(TRADITIONAL)
ATTN: LINO TSAI PHONE NO : 503 207 1370
5885 NW CORNELIUS PASS ROAD SE DECISION MADE: 10-MAR-14
HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMC MINI TIGHTROPE
ARTHREX, INC. 510(k) NO: K140328(SPECIAL)
ATTN: NANCY HOFT PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 10-MAR-14
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMABOND PRINEO SKIN CLOSURE SYSTEM
ETHICON, INC. 510(k) NO: K133864(SPECIAL)
ATTN: DONNA MARSHALL PHONE NO : 908 541 3990
ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 10-MAR-14
SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWTRON P5 XS B.LED
SATELEC-ACTEON GROUP 510(k) NO: K132322(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 11-MAR-14
MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BPROSOFT CASP PC SOFTWARE
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K131916(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114
565 W35739 PIPER ROAD SE DECISION MADE: 11-MAR-14
EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCURO 3000 ULTRASOUND SCANNER
RIVANNA MEDICAL, LLC 510(k) NO: K132736(TRADITIONAL)
ATTN: WILLIAM MAULDIN PHONE NO : 828 612 8191
1304 STONEGATE CT. SE DECISION MADE: 11-MAR-14
CROZET VA 22932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIOS ALPHA
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K132094(TRADITIONAL)
ATTN: DARREN DORMAN PHONE NO : 610 219 9066
51 VALLEY STREAM PARKWAY SE DECISION MADE: 11-MAR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISYS 1 (U.S),ACCESSORY, NON-STERILE
ISYS MEDIZINTECHNIK GMBH 510(k) NO: K131433(TRADITIONAL)
ATTN: CORNELIA DAMSKY PHONE NO : 203 323 7535
56 WESTCOTT ROAD SE DECISION MADE: 11-MAR-14
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERE STABILIZATION SYSTEM
GLOBE MEDICAL, INC. 510(k) NO: K133350(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 11-MAR-14
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOWA SL-17
KOWA CO. LTD. 510(k) NO: K133755(TRADITIONAL)
ATTN: HIROYUKI KOIDE PHONE NO : 814 244450 79
4-14, NIHONBASHI-HONCHO 3-CHOME SE DECISION MADE: 11-MAR-14
CHUO-KU, TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133401(TRADITIONAL)
ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 11-MAR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
PORTABLE THERAPEUTIX 510(k) NO: K133483(TRADITIONAL)
ATTN: SHARYN ORTON, PH.D. PHONE NO : 401 330 8264
2001 HONOR AVE. SE DECISION MADE: 11-MAR-14
ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMUM EV HEMOSTASIS INTRODUCER
ST. JUDE MEDICAL 510(k) NO: K140327(SPECIAL)
ATTN: LOUCINDA BJORKLUND PHONE NO : 651 756 5400
5050 NATHAN LANE N SE DECISION MADE: 11-MAR-14
PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K133386(TRADITIONAL)
ATTN: MIKE ENSIGN PHONE NO : 801 553 9991
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 11-MAR-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE SUPPRESSION SOFTWARE
CARESTREAM HEALTH, INC. 510(k) NO: K133442(TRADITIONAL)
ATTN: CAROLYN WAGNER PHONE NO : 585 627 6588
150 VERONA STREET SE DECISION MADE: 11-MAR-14
ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISLEEVE WOUND PROTECTOR
COVIDIEN 510(k) NO: K140064(TRADITIONAL)
ATTN: MICHAEL KOCZOCIK PHONE NO : 203 492 6312
60 MIDDLETOWN DR SE DECISION MADE: 12-MAR-14
NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNAP WOUND CARE SYSTEM
SPIRACUR, INC. 510(k) NO: K132080(TRADITIONAL)
ATTN: SARAH L CANIO PHONE NO : 408 400 0856
755 N. MATHILDA AVENUE SE DECISION MADE: 12-MAR-14
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODIHEALTH SYSTEM
EPRT TECHNOLOGIES, INC. 510(k) NO: K131675(SPECIAL)
ATTN: JEFF MORGAN PHONE NO : 253 208 3430
468 N CAMDEN DRIVE SUITE 269C SE DECISION MADE: 12-MAR-14
BEVERLY HILLS CA 90210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORRENT IRRIGATION SYSTEM
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K140405(SPECIAL)
ATTN: CARROLL MARTIN PHONE NO : 440 358 6259
5976 HEISLEY RD. SE DECISION MADE: 12-MAR-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
EMERGE MEDICAL 510(k) NO: K140119(TRADITIONAL)
ATTN: MEREDITH MAY MS, RAC PHONE NO : 719 337 7579
EMPIRICAL CONSULTING 4628 NORTHPARSE DECISION MADE: 12-MAR-14
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K133746(TRADITIONAL)
ATTN: VIVIAN KELLY, MS, RAC PHONE NO : 973 299 9300
399 JEFFERSON ROAD SE DECISION MADE: 12-MAR-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
BIOSENSE WEBSTER 510(k) NO: K140318(SPECIAL)
ATTN: MARINA GUEVREKIAN PHONE NO : 909 839 8714
3333 DIAMOND CANYON RD. SE DECISION MADE: 12-MAR-14
BALDWIN BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARIS PC VISION ENHANCEMENT SYSTEM
BAUSCH & LOMB 510(k) NO: K133486(TRADITIONAL)
ATTN: TIMOTHY W CAPEHART PHONE NO : 636 226 3017
3365 TREE CT. INDUSTRIAL BLVD SE DECISION MADE: 12-MAR-14
ST. LOUIS MO 63122 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
EMERGE MEDICAL 510(k) NO: K140098(TRADITIONAL)
ATTN: MEREDITH MAY MS, RAC PHONE NO : 719 337 7579
4628 NORTHPARK DRIVE ATTN: EMPIRICSE DECISION MADE: 12-MAR-14
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
AVERY DENNISON BELGIE, BVBA 510(k) NO: K133764(SPECIAL)
ATTN: LISA BARTAKOVICS PHONE NO : 312 629 4608
TIEBLOKKENLAAN 1 SE DECISION MADE: 13-MAR-14
TURNHOUT BE B-2300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTENSIF
ENDYMED MEDICAL LTD 510(k) NO: K130501(TRADITIONAL)
ATTN: PHONE NO :
31 HAAVODA ST. SE DECISION MADE: 13-MAR-14
BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
SUMMIT MEDICAL, INC. 510(k) NO: K133015(TRADITIONAL)
ATTN: NICOLE DOVE PHONE NO : 651 789 3939
815 NORTHWEST PKWY, STE 100 SE DECISION MADE: 13-MAR-14
ST. PAUL MN 55121 510(k) STATEMENT
DEVICE: HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
INSTRUMENTATION LABORATORY CO. 510(k) NO: K133005(SPECIAL)
ATTN: JACQUELINE EMERY PHONE NO : 781 861 4250
180 HARTWELL ROAD SE DECISION MADE: 13-MAR-14
BEDFORD MA 01730 510(k) STATEMENT
DEVICE: E-Z LINK
DUOJECT MEDICAL SYSTEMS, INC. 510(k) NO: K133097(TRADITIONAL)
ATTN: MARIE-CHRISTINE MESSIER PHONE NO : 450 534 3666
50 RUE DE GASPE COMPLEX B-5 SE DECISION MADE: 13-MAR-14
BROMONT, QC. CA J2L 2N8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133205(TRADITIONAL)
ATTN: JULIE BASSETT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 13-MAR-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACONGRUENT INSERT
UNITED ORTHOPEDIC CORPORATION 510(k) NO: K132752(TRADITIONAL)
ATTN: FANG-YUAN HO PHONE NO : 886 3577 3351X2212
NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 13-MAR-14
HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARSENAL SPINAL FIXATION SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K133221(TRADITIONAL)
ATTN: RENEE L MURPHY PHONE NO : 760 494 6739
5830 El Camino Real SE DECISION MADE: 13-MAR-14
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE SUCTION INSTRUMENTS
MEDTRONIC NAVIGATION, INC. 510(k) NO: K133665(TRADITIONAL)
ATTN: CHARLES M COPPERBERG PHONE NO : 720 890 2291
826 COAL CREEK CIR. SE DECISION MADE: 13-MAR-14
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI ARC MONOBLOCK HIP STEM
OMNILIFE SCIENCE 510(k) NO: K133381(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 774 226 1835
10 O’CONNELL WAY, STE 10 SE DECISION MADE: 13-MAR-14
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K140276(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 344 0807
1800 PYRAMID PLACE SE DECISION MADE: 13-MAR-14
MEMPHIS TN 38135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL DISTAL RADIUS SET
EMERGE MEDICAL 510(k) NO: K140107(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 337 7579
EMPIRICAL CONSULTING 4628 NORTHPARSE DECISION MADE: 13-MAR-14
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
TOTAL JOINT ORTHOPEDICS, INC. 510(k) NO: K133832(TRADITIONAL)
ATTN: BEN CASEY PHONE NO : 801 486 6070
1567 E. Stratford Avenue SE DECISION MADE: 13-MAR-14
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-OX PLUS GENERATION II
AIR LIQUIDE HEALTHCARE AMERICA 510(k) NO: K131386(TRADITIONAL)
ATTN: ANGIE BEYER PHONE NO : 713 624 8268
2700 POST OAK BLVD. SUITE 1800 SE DECISION MADE: 14-MAR-14
HOUSTON TX 77056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERCOM II CEMENT
DENALI CORPORATION 510(k) NO: K132393(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781 826 9190
134 OLD WASHINGTON STREET SE DECISION MADE: 14-MAR-14
HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART SEGMENTATION – KNOWLEDGE BASED CONTOURING
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K133227(TRADITIONAL)
ATTN: PETER J CORONADO PHONE NO : 650 424 6320
3100 HANSEN WAY SE DECISION MADE: 14-MAR-14
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BG MORSELS
PROSIDYAN, INC 510(k) NO: K132805(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 14-MAR-14
PHILADELPIHA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTOUCH FIXATION SYSTEM
VIA SURGICAL LTD. 510(k) NO: K132698(TRADITIONAL)
ATTN: LEO BASTA PHONE NO : 617 834 9866
93 BENEFIT ST. SE DECISION MADE: 14-MAR-14
PROVIDENCE RI 02904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHINTERLINK BEACON
HEALTHINTERLINK, LLC 510(k) NO: K133252(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516 482 9001
55 NORTHERN BLVD, STE. 200 SE DECISION MADE: 14-MAR-14
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SW-THERM
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K131899(TRADITIONAL)
ATTN: JIANPING KANG PHONE NO : 867 55 27652471
No. 3 Building XiliBaimang XushengSE DECISION MADE: 14-MAR-14
SHENZHEN CN 518108 510(k) STATEMENT
DEVICE: MANUKA FILL WOUND DRESSING
LINKS MEDICAL PRODUCTS, INC. 510(k) NO: K131796(TRADITIONAL)
ATTN: JAMES SMITH, PH.D. PHONE NO : 949 340 7261
29442 POINTE ROYALE SE DECISION MADE: 14-MAR-14
LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO IFR MODALITY
VOLCANO CORPORATION 510(k) NO: K133323(TRADITIONAL)
ATTN: NEETA SHARMA PHONE NO : 858 720 4187
3721 VALLEY CENTRE DR. SUITE 500 SE DECISION MADE: 14-MAR-14
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
GE HUNGARY KFT 510(k) NO: K132944(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 262 548 4992
DBA GE HEALTHCARE 3000 N GRANDVIEWSE DECISION MADE: 14-MAR-14
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS PULSE 120H
LUMENIS LTD. 510(k) NO: K140388(SPECIAL)
ATTN: MERAV YARMUS PHONE NO : 972 3 6123281
155 BIALIK STREET SE DECISION MADE: 14-MAR-14
RAMAT GAN IS 5252346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERASMART
GC AMERICA, INC. 510(k) NO: K133824(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 597 0900
3737 WEST 127TH ST. SE DECISION MADE: 14-MAR-14
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS 8100 3D
TROPHY 510(k) NO: K133406(TRADITIONAL)
ATTN: MARIE PIERRE PHONE NO : 33 1 64808526
4 RUE F. PELLOUTIER CROISSY BEAUBOSE DECISION MADE: 14-MAR-14
MARNE LA VALLEE CEDEX 2 FR 7743510(k) STATEMENT
DEVICE: RADIANCE 330 PROTON THERAPY SYSTEM
PROTOM INTERNATIONAL, INC. 510(k) NO: K134052(TRADITIONAL)
ATTN: JOHN J SMITH, MD, JD PHONE NO : 202 637 3638
555 13TH ST. NW SE DECISION MADE: 14-MAR-14
WASHINGTON DC 20001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
C.R. BARD, INC. 510(k) NO: K140345(SPECIAL)
ATTN: JAMES R DAVIS PHONE NO : 801 522 5000
605 NORTH 5600 WEST SE DECISION MADE: 14-MAR-14
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERISPINE LC CAGE
SAFE ORTHOPAEDICS 510(k) NO: K133893(ABBREVIATED)
ATTN: PIERRE DUMOUCHEL PHONE NO : 330 134 215000
Parc des Bellevues Allee R.LuxemboSE DECISION MADE: 14-MAR-14
Eragny sur Oise FR 95610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINIA
BICON, LLC 510(k) NO: K133608(ABBREVIATED)
ATTN: RICHARD WU PHONE NO : 800 882 4266
501 Arborway SE DECISION MADE: 14-MAR-14
Boston MA 02130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATURN DENTAL IMPLANT
CORTEX DENTAL IMPLANTS INDUSTRIES,510(k) NO: K131258(TRADITIONAL)
ATTN: SIMHA SIBONY PHONE NO : 972 498532 92
MOBILE POST ASHRAT SE DECISION MADE: 17-MAR-14
MOBILE POST ASHRAT IS 25201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORESEE (4C) IMAGING SYSTEM
DIAGNOSTIC PHOTONICS, INC 510(k) NO: K133209(TRADITIONAL)
ATTN: JANICE HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 17-MAR-14
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
BOVIE MEDICAL CORPORATION 510(k) NO: K134054(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727 803 8513
5115 ULMERTON ROAD SE DECISION MADE: 17-MAR-14
CLEARWATER FL 33760 4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC BASAL BODY THERMOMETER
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K131210(TRADITIONAL)
ATTN: IVY CHEN PHONE NO : 086 0755 26715351
KEJI NAN NO. 12 ROAD, HI-TECH PARKSE DECISION MADE: 18-MAR-14
SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINNITUS SOUNDSUPPORT
OTICON A/S 510(k) NO: K133308(TRADITIONAL)
ATTN: SOREN JUEL WITT PHONE NO : 45 3917 7100
KONGEBAKKEN 9 SE DECISION MADE: 18-MAR-14
SMORUM DA DK-2765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI GAIA FIRST, SECOND, THIRD
ASAHI INTECC CO., LTD. 510(k) NO: K133865(TRADITIONAL)
ATTN: CANDACE CEDERMAN PHONE NO : 410 674 2060
5523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 18-MAR-14
BALTIMORE MD 21228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHINX JR
ALLMED SYSTEMS INC. 510(k) NO: K132975(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 925 468 0433
9232 KLEMETSON DRIVE SE DECISION MADE: 18-MAR-14
PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V. 510(k) NO: K133894(TRADITIONAL)
ATTN: M.J. AERTS PHONE NO : 321 638 1211
INTERLEUVENLAAN 40 SE DECISION MADE: 18-MAR-14
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MELYS ATRIAL FIBRILLATION SCREENING MONITOR
ADVANCED FLUIDICS, LLC 510(k) NO: K132206(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 888 729 9674
1468 HARWELL AVE SE DECISION MADE: 19-MAR-14
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEED XL
BIOMEDICAL ENT., INC. 510(k) NO: K133780(TRADITIONAL)
ATTN: JOE SOWARD PHONE NO : 210 677 0354
14785 OMICRON DR., SUITE 205 SE DECISION MADE: 19-MAR-14
SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRRUS PHOTO
CARL ZEISS MEDITEC AG 510(k) NO: K133217(TRADITIONAL)
ATTN: MANDY AMBRECHT PHONE NO : 925 557 4561
5160 HACIENDA DRIVE SE DECISION MADE: 19-MAR-14
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
CROSSBAY MEDICAL, INC. 510(k) NO: K133144(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 650 343 4813
17141 MURPHY AVE, SUITE 5C SE DECISION MADE: 19-MAR-14
IRVINE CA 94901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METALLIC INTRAMEDULLARY NAIL SYSTEM
TIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K132078(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122815 850
P.O. BOX 120-119 SE DECISION MADE: 19-MAR-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SRS ENDOSCOPIC STAPLING SYSTEM
MEDIGUS, LTD. 510(k) NO: K132151(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 19-MAR-14
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K133374(TRADITIONAL)
ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861
375 RIVER PARK CIRCLE SE DECISION MADE: 19-MAR-14
MARQUETTE MI 49855 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K140398(SPECIAL)
ATTN: LUKE MEIDELL PHONE NO : 801 565 6212
12050 LONE PEAK PKWY SE DECISION MADE: 19-MAR-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEAL SINGLE-USE BIOPSY VALVE
ENDOCHOICE, INC. 510(k) NO: K133734(SPECIAL)
ATTN: JANNA BABSON PHONE NO : 678 708 4773
11810 WILLS RD. SE DECISION MADE: 19-MAR-14
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVUE 500
OPTOVUE, INC. 510(k) NO: K133892(TRADITIONAL)
ATTN: MICHAEL J SARRASIN PHONE NO : 510 897 1575
2800 BAYVIEW DRIVE SE DECISION MADE: 19-MAR-14
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRC-PEX, RADIC-SEALER
KM CORPORATION 510(k) NO: K132123(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E KATELLA AVE UNIT 2115 SE DECISION MADE: 20-MAR-14
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM60/IM70 PATIENT MONITOR
EDAN INSTRUMENTS, INC. 510(k) NO: K131971(TRADITIONAL)
ATTN: CHERRY SUN PHONE NO : 86 755268 56469
NANHAI RD 1019 NO. SHEKOU, NANSHANSE DECISION MADE: 20-MAR-14
SHENZHEN, GUANGDONG CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGORA OPTIME
INSTRUMENTARIUM DENTAL, PALODEX GR510(k) NO: K133231(SPECIAL)
ATTN: TERHO TURKUMAKI PHONE NO : 358 503209 113
NAHKELANTIE 160 SE DECISION MADE: 20-MAR-14
TUUSULA, FINLAND FI 04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRTOUGH
KURARAY NORITAKE DENTAL INC. 510(k) NO: K133211(TRADITIONAL)
ATTN: MICHIO TAKIGAWA PHONE NO : 813 6701 1706
700 12TH STREET NW, SUITE 1100 SE DECISION MADE: 20-MAR-14
WASHINGTON DC 20005 20005 510(k) STATEMENT
DEVICE: VARIOGUIDE DRILL KIT
MRI INTERVENTIONS, INC. 510(k) NO: K132436(TRADITIONAL)
ATTN: E. F WADDELL PHONE NO : 949 900 6833
5 Musick SE DECISION MADE: 20-MAR-14
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAIR DRIVE, NEUTRACLEAR
CAIR LGL 510(k) NO: K133073(TRADITIONAL)
ATTN: IRVING WIESEN PHONE NO : 212 381 8774
420 LEXINGTON AVE. STE. 2400 SE DECISION MADE: 20-MAR-14
NEW YORK NY 10170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
LUMENIS LTD. 510(k) NO: K133319(TRADITIONAL)
ATTN: IMAN KHORSHID PHONE NO : 972 4 9599000
6 HAKIDMA STREET, YOKNEAM INDUSTRISE DECISION MADE: 20-MAR-14
YOKNEAM IS 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMBER SPINE DIAGON OBLIQUE CAGE
CAMBER SPINE 510(k) NO: K134038(SPECIAL)
ATTN: DANIEL A PONTECORVO PHONE NO : 484 420 4671
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 20-MAR-14
NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
MAQUET CRITICAL CARE AB 510(k) NO: K133958(ABBREVIATED)
ATTN: LIA LIEBGOLD PHONE NO : 973 709 7340
45 BARBOUR POND DRIVE SE DECISION MADE: 20-MAR-14
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA-LOCK DENTAL IMPLANTS
INTRA-LOCK INTERNATIONAL, INC. 510(k) NO: K133613(TRADITIONAL)
ATTN: MARY L JEAN PHONE NO : 561 447 8282
6560 W. ROGERS CIRCLE SUITE 24 SE DECISION MADE: 20-MAR-14
BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMBER SPINE COVERIS CERVICAL CAGE
CAMBER SPINE 510(k) NO: K133529(TRADITIONAL)
ATTN: DANIEL A PONTECORVO PHONE NO : 484 420 4671
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 20-MAR-14
NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140253(TRADITIONAL)
ATTN: CORDELL FIELDS PHONE NO : 610 219 8518
51 VALLEY STREAM PARKWAY, MAILCODESE DECISION MADE: 20-MAR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PEDIATRIC MANDIBLE DISTRACTOR
STRYKER 510(k) NO: K133398(TRADITIONAL)
ATTN: MANISH PATEL PHONE NO : 269 389 4271
750 TRADE CENTRE WAY STE 200 SE DECISION MADE: 20-MAR-14
PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYBER MEDICAL TRAUMA SCREW
TYBER MEDICAL LLC 510(k) NO: K133842(TRADITIONAL)
ATTN: JEFF TYBER PHONE NO : 303 717 5060
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 20-MAR-14
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
DORNOCH MEDICAL SYSTEMS, INC. 510(k) NO: K133786(TRADITIONAL)
ATTN: LARRY SMITH PHONE NO : 816 505 2226
200 Nw Parkway Rd SE DECISION MADE: 21-MAR-14
RIVERSIDE MO 64150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVE II, SAVE II BASIC
AUTOMEDX INC. 510(k) NO: K131877(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
1420 Lakeside Parkway, Suite 102 SE DECISION MADE: 21-MAR-14
Flower Mound TX 75028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
AEA SRL 510(k) NO: K132011(ABBREVIATED)
ATTN: MICHELE MENGONI PHONE NO : 003 907 318161
Via Fiume 16 SE DECISION MADE: 21-MAR-14
Angeli di Rosora IT 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
AXIS-SHIELD POC AS 510(k) NO: K132031(TRADITIONAL)
ATTN: KARI SKINNEMOEN PHONE NO : 47 240560 00
P.O. BOX 6863 RODELOKKA SE DECISION MADE: 21-MAR-14
OSLO NO N-0504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERATOR
LK CONSULTING GROUP USA, INC. 510(k) NO: K132144(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 21-MAR-14
FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K131652(TRADITIONAL)
ATTN: BERNICE LIN PHONE NO : 408 732 3856
670 Almanor Ave SE DECISION MADE: 21-MAR-14
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIBRA SOFT-TISSUE FORCE SENSOR
KAMM & ASSOCIATES 510(k) NO: K132104(SPECIAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 21-MAR-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTRA
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K131553(TRADITIONAL)
ATTN: BARRY SALL, RAC, FRAPS PHONE NO : 781 434 4742
195 WEST STREET SE DECISION MADE: 21-MAR-14
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NS 2500 HOLMIUM LASER SYSTEM
NEW STAR LASERS, INC. 510(k) NO: K132607(TRADITIONAL)
ATTN: PAMELA M BUCKMAN, MSN PHONE NO : 925 980 7007
2800 PLEASANT HILL RD. STE #175 SE DECISION MADE: 21-MAR-14
PLEASANT HILL CA 94523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K2M, INC. 510(k) NO: K133944(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 21-MAR-14
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA FA DR SYSTEM
SEDECAL SA 510(k) NO: K133782(SPECIAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT. SE DECISION MADE: 21-MAR-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY PET/CT 710
GE MEDICAL SYSTEMS, LLC 510(k) NO: K133657(TRADITIONAL)
ATTN: DAVID DUERSTELER PHONE NO : 262 312 7029
3000 N GRANDVIEW BLVD. SE DECISION MADE: 21-MAR-14
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
YUNG SHENG OPTICAL CO., LTD. 510(k) NO: K133735(TRADITIONAL)
ATTN: WEN-HAN CHEN PHONE NO : 886 425658 384
3F-1, NO. 6, JHONGKE ROAD, DAYA DISE DECISION MADE: 21-MAR-14
TAICHUNG CITY TW 42881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
TERATECH CORP. 510(k) NO: K140524(TRADITIONAL)
ATTN: BEN CHIAMPA PHONE NO : 781 270 4143
77-79 TERRACE HALL AVE. SE DECISION MADE: 21-MAR-14
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WITHINGS BLOOD PRESURE MONITOR
WITHINGS 510(k) NO: K133125(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 33 1 41460460
20 RUE ROUGET DE LISLE SE DECISION MADE: 24-MAR-14
ISSY LES MOULINEAUX FR 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K133232(TRADITIONAL)
ATTN: BRIAN YOUNG PHONE NO : 210 255 6137
6203 FARINON DRIVE SE DECISION MADE: 24-MAR-14
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
INTEGRA LIFE SCIENCES CORPORATION 510(k) NO: K132250(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 609 903 0325
311 ENTERPRISE DRIVE SE DECISION MADE: 24-MAR-14
PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODENSE BONE GRAFT SUBSTITUTE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K132656(TRADITIONAL)
ATTN: LESLIE FITCH PHONE NO : 901 867 4120
5677 AIRLINE RD. SE DECISION MADE: 24-MAR-14
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QB TEST
QBTECH AB 510(k) NO: K133382(TRADITIONAL)
ATTN: HANS BOSTROM PHONE NO : 46 70633 9209
Kungsgatan 29 SE DECISION MADE: 24-MAR-14
Stockholm SE 11156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
ENCORE MEDICAL, L.P. 510(k) NO: K130550(TRADITIONAL)
ATTN: WILLIAM GARZON PHONE NO : 512 834 6391
9800 METRIC BLVD. SE DECISION MADE: 24-MAR-14
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX DISTAL RADIUS PLATING SYSTEM
STRYKER LEIBINGER GMBH 510(k) NO: K133974(TRADITIONAL)
ATTN: ELIJAH N WREH PHONE NO : 201 831 5691
325 CORPORATE DRIVE SE DECISION MADE: 24-MAR-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T:SLIM INSULIN DELIVERY SYSTEM
TANDEM DIABETES CARE, INC. 510(k) NO: K133593(SPECIAL)
ATTN: JOHN SHERIDAN PHONE NO : 858 255 6345
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 24-MAR-14
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOVERA
MYOSCIENCE INC 510(k) NO: K133453(TRADITIONAL)
ATTN: BIJESH CHANDRAN PHONE NO : 650 474 2600
1600 SEAPORT BLVD, STE 450 NORTH LSE DECISION MADE: 24-MAR-14
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HC550 RESPIRATORY HUMIDIFIER, RT100 ADULT VENTILATOR CIRCUIT
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K132017(TRADITIONAL)
ATTN: ELIZABETH GOLDSTEIN PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 25-MAR-14
EAST TAMAKI NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLACE SOUND GENERATORS
AMPLISOUND HEARING PRODUCTS & SERV510(k) NO: K132965(ABBREVIATED)
ATTN: RALPH T CAMPAGNA PHONE NO : 860 779 6500
594 PUTNAM ROAD SE DECISION MADE: 25-MAR-14
DANIELSON CT 06239 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO COLOR 2MP
BARCO N.V. 510(k) NO: K133663(TRADITIONAL)
ATTN: PHONE NO :
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 25-MAR-14
KORTRIJK BE 8500 510(k) STATEMENT
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K140449(SPECIAL)
ATTN: GREGORY MASCHEK PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 25-MAR-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASIR-V
GE MEDICAL SYSTEMS, LLC 510(k) NO: K133640(TRADITIONAL)
ATTN: HUY DOAN PHONE NO : 262 312 7751
3000 N GRANDVIEW BLVD. SE DECISION MADE: 25-MAR-14
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY BIOPSY NEEDLE SYSTEM
PFM MEDICAL, INC 510(k) NO: K140137(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760 758 8749
1815 ASTON AVE, SUITE 106 SE DECISION MADE: 25-MAR-14
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASPIRE CRISTALLE
FUJIFILM MEDICAL SYSTEMS, USA INC.510(k) NO: K133972(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203 602 3576
419 WEST AVE. SE DECISION MADE: 25-MAR-14
STANFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
RANDOX LABORATORIES LIMITED 510(k) NO: K140393(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 28 94422413
55 DIAMOND RD. SE DECISION MADE: 25-MAR-14
CRUMLIN, CO.ANTRIM UK BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILEX SACROILIAC JOINT FUSION SYSTEM
X-SPINE SYSTEMS, INC 510(k) NO: K140079(TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400
452 Alexandersville Rd SE DECISION MADE: 25-MAR-14
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAUTILUS SPINAL SYSTEM
LIFE SPINE, INC 510(k) NO: K140457(SPECIAL)
ATTN: RANDY LEWIS PHONE NO : 847 884 6117
2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 25-MAR-14
HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS WORKSTATION
PIE MEDICAL IMAGING 510(k) NO: K133993(TRADITIONAL)
ATTN: FLORIE DANIELS PHONE NO : 33 43 3281328
PHILIPSWEG 1 SE DECISION MADE: 25-MAR-14
MAASTRICHT, LIMBURG NT 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA KNEE SYSTEM
AESCULAP IMPLANT SYSTEMS 510(k) NO: K140452(SPECIAL)
ATTN: JULIE TOM WING PHONE NO : 610 984 9147
3773 CORPORATE PWKY. SE DECISION MADE: 25-MAR-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHIP MIX PREPPIES PLUS
WHIP-MIX CORP. 510(k) NO: K131760(TRADITIONAL)
ATTN: JOHN P WATERS PHONE NO : 502 634 5357
361 FARMINGTON AVE. SE DECISION MADE: 26-MAR-14
LOUISVILLE KY 40217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICO DH-W35 OPHTHALMOSCOPE SERIES
AMICO DIAGNOSTIC INCORPORATED 510(k) NO: K131939(TRADITIONAL)
ATTN: LAUREN CHRAPOWITZKY PHONE NO : 813 645 2855
445 APOLLO BEACH BLVD. SE DECISION MADE: 26-MAR-14
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTRAIN
DOLPHYS MEDICAL B.V. 510(k) NO: K132759(TRADITIONAL)
ATTN: FABIENNE PETERS PHONE NO : 310 40 7516020
DE LISMORTEL 31 SE DECISION MADE: 26-MAR-14
EINDHOVEN NL 5612AR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE CL RESPIRATION POD
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K132320(TRADITIONAL)
ATTN: JOHANNES SCHMID PHONE NO : 49 7031 4631315
HEWLETT-PACKARD STR.2 SE DECISION MADE: 26-MAR-14
BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLUTIONMD MOBILE
CALGARY SCIENTIFIC, INC. 510(k) NO: K133508(TRADITIONAL)
ATTN: KYLE PETERSON PHONE NO : 403 767 7945
SUITE 208, 1210 20TH AVENUE SE SE DECISION MADE: 26-MAR-14
CALGARY, ALBERTA CA T2G 1M8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORGRIP
CORPAK MEDSYSTEMS 510(k) NO: K133599(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847 403 3484
1001 ASBURY DR SE DECISION MADE: 26-MAR-14
BUFFALO GROVE IL 60089 0000 510(k) STATEMENT
DEVICE: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
ROTATION MEDICAL, INC. 510(k) NO: K140300(TRADITIONAL)
ATTN: JEFF SIMS PHONE NO : 763 746 7502
15350 25TH AVENUE N SUITE 100 SE DECISION MADE: 26-MAR-14
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
EXCITON TECHNOLOGIES INC. 510(k) NO: K133775(SPECIAL)
ATTN: MELANIE USSYK PHONE NO : 780 248 5868
SUITE 4000, 10230 JASPER AVE SE DECISION MADE: 26-MAR-14
EDMONTON, ALBERTA CA T5Z 3N5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 – X-MARS US, PRISMAFLEX CONTROL UNIT
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K133807(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303 222 6724
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 26-MAR-14
LAKEWOOD CO 80401 510(k) STATEMENT
DEVICE: MONOTEX
RIVERPOINT MEDICAL 510(k) NO: K140415(ABBREVIATED)
ATTN: DOUGLAS ROWLEY PHONE NO : 503 517 8001
825 NE 25TH AVE. SE DECISION MADE: 26-MAR-14
PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL ACROSS
MEDTRONIC VASCULAR 510(k) NO: K133539(TRADITIONAL)
ATTN: DIANA JOHNSON PHONE NO : 707 591 2656
3576 UNOCAL PLACE SE DECISION MADE: 26-MAR-14
SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OP300
PALODEX GROUP OY 510(k) NO: K133544(SPECIAL)
ATTN: TERHO TURKUMAKI PHONE NO : 358 10270 2000
NAHKELANTIE 160 SE DECISION MADE: 26-MAR-14
TUUSULA FI 04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE SYSTEM
SIESTA MEDICAL, INC. 510(k) NO: K133680(TRADITIONAL)
ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626
101 CHURCH STREET SUITE 3 SE DECISION MADE: 26-MAR-14
LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEREGRINE SYSTEM INFUSION CATHETER
ABLATIVE SOLUTIONS, INC. 510(k) NO: K140637(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714 695 9269
801 Hermosa Way SE DECISION MADE: 26-MAR-14
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOMET ACCESS SYSTEM
BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K132373(TRADITIONAL)
ATTN: VIVIAN KELLY, MS, RAC PHONE NO : 973 299 9300
399 JEFFERSON ROAD SE DECISION MADE: 27-MAR-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTED MILLEX -GV, CATHIVEX -GV
MERCK MILLIPORE LTD. 510(k) NO: K133004(TRADITIONAL)
ATTN: CINDY PENNY PHONE NO : 951 514 4367
28820 SINGLE OAK DRIVE SE DECISION MADE: 27-MAR-14
TEMECULA CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
FLOWER ORTHOPEDICS CORPORATION 510(k) NO: K133930(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 215 394 8903
100 Witmer Rd Ste 280 SE DECISION MADE: 27-MAR-14
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
RAYNER INTRAOCULAR LENSES LTD. 510(k) NO: K132002(TRADITIONAL)
ATTN: JULIETTE E COOK PHONE NO : 44 127320 5401
1-2 SACKVILLE ROAD SE DECISION MADE: 27-MAR-14
HOVE, EAST SUSSEX UK BN3 7AN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MANDREL GUIDEWIRE
LAKE REGION MEDICAL 510(k) NO: K140485(SPECIAL)
ATTN: MATHEW PEXA PHONE NO : 952 488 5111
340 LAKE HAZELTINE DRIVE SE DECISION MADE: 27-MAR-14
CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL TS
ROCHE DIAGNOSTICS 510(k) NO: K140534(TRADITIONAL)
ATTN: JANE PHILLIPS PHONE NO : 317 521 3338
9115 HAGUE ROAD SE DECISION MADE: 27-MAR-14
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEXIPLIANT DILATOR SHEATH SET
SPECTRANETICS CORPORATION 510(k) NO: K133631(TRADITIONAL)
ATTN: STACEY A STRAND PHONE NO : 719 447 2706
9965 FEDERAL DRIVE SE DECISION MADE: 27-MAR-14
COLORADO SPRINGS CO 80921 3617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, INC510(k) NO: K140106(SPECIAL)
ATTN: SHARYN ORTON PHONE NO : 401 330 8264
200 HOMER AVE. SE DECISION MADE: 27-MAR-14
ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFAST CTNL CALIBRATORS
MITSUBISHI CHEMICAL MEDIENCE CORPO510(k) NO: K130603(SPECIAL)
ATTN: JUDI SMITH PHONE NO : 240 316 3377
2 BETHESDA METRO CENTER SUITE 850 SE DECISION MADE: 27-MAR-14
BETHESDA MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K133455(TRADITIONAL)
ATTN: EMILY DOWNS PHONE NO : 906 225 5602
375 RIVER PARK CIRCLE SE DECISION MADE: 27-MAR-14
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE STERILE SYRINGE WITH NEEDLE
JIANGXI KELUN MEDICAL DEVICES MANU510(k) NO: K133493(ABBREVIATED)
ATTN: HELEN NAN PHONE NO : 086 577886 06182
ROOM 302, NO.21 BUILDING KAIYU GARSE DECISION MADE: 27-MAR-14
WENZHOU CH 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDE-NEO
HAMAMATSU PHOTONICS, K.K. 510(k) NO: K133719(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO PHONE NO : 202 737 9633
700 13TH STREET, NW SUITE 1200 SE DECISION MADE: 27-MAR-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
AJEX MEDITECH., LTD 510(k) NO: K122298(TRADITIONAL)
ATTN: WILLIAM LITTLE PHONE NO : 516 513 1330
52 NEWTOWN PLAZA SE DECISION MADE: 28-MAR-14
PLAINVIEW NY 11803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-RAY TV SYSTEM SONIAL VISION G4
SHIMADZU CORP. 510(k) NO: K131075(ABBREVIATED)
ATTN: DON KARLE PHONE NO : 310 217 8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 28-MAR-14
TORRANCE CA 90502 1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD 50/100S/200 TEST PACK
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K130263(TRADITIONAL)
ATTN: NANCY CHU PHONE NO : 949 453 6435
33 TECHNOLOGY DR. SE DECISION MADE: 28-MAR-14
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDEO EXTENDED LENGTH TRAY (PLASTIC – RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC – RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
CONMED CORPORATION 510(k) NO: K133116(TRADITIONAL)
ATTN: NANCY GERTLAR PHONE NO : 509 496 2248
134 FLANDERS ROAD SE DECISION MADE: 28-MAR-14
WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-HIP TOTAL HIP SYSTEM
ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K132572(TRADITIONAL)
ATTN: MARC E RUHLING PHONE NO : 574 269 4266
4130 CORRIDOR DRIVE SE DECISION MADE: 28-MAR-14
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&B BUBBLER
S & T MEDICAL TECHNOLOGIES, INC. 510(k) NO: K133210(TRADITIONAL)
ATTN: DERICK CORRENTE PHONE NO : 760 929 9972
1954 KELLOGG AVENUE SUITE 100 SE DECISION MADE: 28-MAR-14
CARLSBAD CA 92008 510(k) STATEMENT
DEVICE: ORTHOSCAN FD MINI C-ARM
ORTHOSCAN, INC. 510(k) NO: K133174(TRADITIONAL)
ATTN: ADAM MENZIES PHONE NO : 480 503 8010
8212 E Evans Rd SE DECISION MADE: 28-MAR-14
SCOTTSDALE AZ 85260 510(k) STATEMENT
DEVICE: DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
INTUITIVE SURGICAL, INC. 510(k) NO: K131861(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 408 523 2100
1266 KIFER ROAD SE DECISION MADE: 28-MAR-14
SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL COUGH
LUNG ASSIST, INC. 510(k) NO: K132988(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303 530 3279
4655 KIRKWOOD COURT SE DECISION MADE: 28-MAR-14
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOCAP
MAXTEC, INC. 510(k) NO: K133540(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
6526 SOUTH COTTONWOOD ST. SE DECISION MADE: 28-MAR-14
SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
CONFORMIS, INC. 510(k) NO: K133560(TRADITIONAL)
ATTN: AMITA SHAH PHONE NO : 781 345 9164
28 Crosby Dr SE DECISION MADE: 28-MAR-14
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
BIOMET UK LTD. 510(k) NO: K133940(TRADITIONAL)
ATTN: JASON HECKAMAN PHONE NO : 574 374 3707
56 EAST BELL DRIVE SE DECISION MADE: 28-MAR-14
WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSTAR TMS THERAPY SYSTEM
NEURONETICS 510(k) NO: K133408(TRADITIONAL)
ATTN: JUDY P WAYS, PH.D. PHONE NO : 610 640 4202
3222 PHOENIXVILLE PIKE SE DECISION MADE: 28-MAR-14
MALVERN PA 19355 1245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONIS 5MP
BARCO NV 510(k) NO: K133984(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 28-MAR-14
KORTRIJK BE 8500 510(k) STATEMENT
DEVICE: PEEK FUSION IMPLANT
MTP SOLUTIONS LLC 510(k) NO: K133515(TRADITIONAL)
ATTN: ROBERT HOY PHONE NO : 614 448 6358
124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 28-MAR-14
LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTREMITY MEDICAL HAMMERTOE DEVICE
EXTREMITY MEDICAL, LLC. 510(k) NO: K133636(TRADITIONAL)
ATTN: BRIAN SMEKAL PHONE NO : 973 588 8980
300 INTERPACE PKWY, STE 410 SE DECISION MADE: 28-MAR-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI ALOKA MEDICAL,LTD. (HITACH510(k) NO: K134016(TRADITIONAL)
ATTN: ANGELA VANARSDALE PHONE NO : 203 269 5088
10 FAIRFIELD BLVD. SE DECISION MADE: 28-MAR-14
WALLINGFORD CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXERA 2 ACCESS SYSTEM
ARSTASIS, INC. 510(k) NO: K140201(TRADITIONAL)
ATTN: GRACE LI PHONE NO : 650 261 8039
740 BAY ROAD SE DECISION MADE: 28-MAR-14
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
PURICORE INC. 510(k) NO: K131848(TRADITIONAL)
ATTN: ART MORSE PHONE NO : 484 321 2700
508 LAPP RD. SE DECISION MADE: 31-MAR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
RTI SURGICAL, INC. 510(k) NO: K132850(TRADITIONAL)
ATTN: ESTHER CARBON PHONE NO : 386 418 8888
11621 Research Cir SE DECISION MADE: 31-MAR-14
ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES SYNSONIC ULNA NAIL
SYNTHES (USA) 510(k) NO: K131984(TRADITIONAL)
ATTN: THOMAS N SHEA PHONE NO : 610 719 6809
1302 WRIGHTS LANE EAST SE DECISION MADE: 31-MAR-14
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIROMATRIX BIOLOGICAL MESH
MIROMATRIX MEDICAL INC. 510(k) NO: K134033(TRADITIONAL)
ATTN: STEPHEN RHODES PHONE NO : 301 579 3700
400 N. WASHINGTON ST., STE 100 SE DECISION MADE: 31-MAR-14
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140505(ABBREVIATED)
ATTN: FATIMA PACHECO PHONE NO : 914 524 2450
511 BENEDICT AVENUE SE DECISION MADE: 31-MAR-14
TARRYTOWN NY 10591 5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICEROD CX CRYOABLATION NEEDLE
GALIL MEDICAL LTD. 510(k) NO: K140584(SPECIAL)
ATTN: LYNNE DAVIES PHONE NO : 651 287 5098
4364 ROUND LAKE ROAD SE DECISION MADE: 31-MAR-14
ARDEN HILLS MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
CARDIOTEK, B.V. 510(k) NO: K134044(TRADITIONAL)
ATTN: MELISSA WALKER PHONE NO : 636 405 7498
1324 CLARKSON CLAYTON CENTER #332 SE DECISION MADE: 31-MAR-14
BALLWIN MO 6301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
PINNACLE SPINE GROUP, LLC 510(k) NO: K133721(TRADITIONAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
1601 ELM ST STE 1930 SE DECISION MADE: 31-MAR-14
Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITE IBF
INNOVA SPINAL TECHNOLOGIES, LLC 510(k) NO: K133459(TRADITIONAL)
ATTN: RICH JANSEN, PHARM. D. PHONE NO : 612 281 5505
11821 BRAMBLE COVE DRIVE SE DECISION MADE: 06-MAR-14
FT. MYERS FL 33905 510(k) STATEMENT
DEVICE: FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
CORDIS CORP. 510(k) NO: K130981(TRADITIONAL)
ATTN: KIM FONDA PHONE NO : 510 248 2480
6500 PASEO PADRE PARKWAY SE DECISION MADE: 12-MAR-14
FREMONT CA 94555 510(k) STATEMENT
