We are convinced that a healthy, vibrant smile is the most attractive feature around. Through our comprehensive teeth cleaning treatment plans we use restorative and cosmetic practices to help our patients receive the smile they are proud of.
TOTAL 510(k)s THIS PERIOD 284
TOTAL WITH SUMMARIES 280
TOTAL WITH STATEMENTS 4
DEVICE: HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
SHENZHEN MINDRAY BIO-MEIDCAL ELECT510(k) NO: K132036(ABBREVIATED)
ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391
800 MACARTHUR BLVD. SE DECISION MADE: 01-JUL-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN OCT SPINAL SYSTEM
K2M, INC. 510(k) NO: K133288(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 01-JUL-14
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRE VENTURA
DRE MEDICAL, INC. 510(k) NO: K132903(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
1800 WILLIAMSON CT. SE DECISION MADE: 01-JUL-14
LOUISVILLE KY 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESARA BLUE OV, DESARA BLUE SS
CALDERA MEDICAL 510(k) NO: K140843(SPECIAL)
ATTN: VICKI GAIL PHONE NO : 818 483 7602
5171 Clareton Dr SE DECISION MADE: 01-JUL-14
Agoura Hills CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
STRYKER CORPORATION 510(k) NO: K140400(TRADITIONAL)
ATTN: SORAYA KING PHONE NO : 201 760 8296
2 PEARL COURT SE DECISION MADE: 01-JUL-14
ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
BIOSENSE WEBSTER, INC. 510(k) NO: K133916(TRADITIONAL)
ATTN: WAYNE R HOHMAN PHONE NO : 909 839 8597
3333 DIAMOND CANYON RD SE DECISION MADE: 01-JUL-14
DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA BIG BOY CONDOM
OKAMOTO U.S.A., INC. 510(k) NO: K140379(ABBREVIATED)
ATTN: JEFFREY N GIBBS PHONE NO : 202 737 4288
700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 01-JUL-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTERA SPACER
GLOBUS MEDICAL INC. 510(k) NO: K140411(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 01-JUL-14
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
IMMUNALYSIS CORPORATION 510(k) NO: K141406(TRADITIONAL)
ATTN: JOSEPH GINETE PHONE NO : 909 482 0840
829 TOWNE CENTER DR. SE DECISION MADE: 01-JUL-14
POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODISSEY TISSUE OXIMETER
VIOPTIX, INC. 510(k) NO: K141234(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949 262 0411
3722 AVE. SAUSALITO SE DECISION MADE: 01-JUL-14
IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
FOCUS DIAGNOSTICS 510(k) NO: K141458(SPECIAL)
ATTN: SHARON YOUNG PHONE NO : 562 240 6680
11331 VALLEY VIEW STREET SE DECISION MADE: 01-JUL-14
CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
COOK VASCULAR, INC. 510(k) NO: K141148(TRADITIONAL)
ATTN: THOMAS J KARDOS PHONE NO : 724 845 8621
1186 MONTGOMERY LANE SE DECISION MADE: 01-JUL-14
VANDERGRIFT PA 15690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
CANON, INC. 510(k) NO: K133693(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE, STE 280 SE DECISION MADE: 01-JUL-14
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133110(TRADITIONAL)
ATTN: RENEE MITCHELL PHONE NO : 763 494 1405
ONE SCIMED PLACE SE DECISION MADE: 02-JUL-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
ENDOSEC CORPORATION 510(k) NO: K132384(TRADITIONAL)
ATTN: PIN YU PHONE NO : 650 397 5174
4546 EL CAMINO REAL, STE 215 SE DECISION MADE: 02-JUL-14
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOW-NAIL
FLOW-FX, LLC 510(k) NO: K140601(TRADITIONAL)
ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800
1331 H STREET NW, 12TH FLOOR REGULSE DECISION MADE: 02-JUL-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIO
BLUE BELT TECHNOLOGIES, INC. 510(k) NO: K140596(TRADITIONAL)
ATTN: RICHARD G CONFER PHONE NO : 412 683 3844
2828 LIBERTY AVENUE SUITE 100 SE DECISION MADE: 02-JUL-14
PITTSBURGH PA 15222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K141369(TRADITIONAL)
ATTN: SARASWATHI DEORA PHONE NO :
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 02-JUL-14
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: X-REPAIRSL
SYNTHASOME, INC. 510(k) NO: K141499(SPECIAL)
ATTN: ANTHONY RATCLIFFE PHONE NO : 858 490 9400
3030 BUNKER HILL ST. SUITE 308 SE DECISION MADE: 02-JUL-14
SAN DIEGO CA 92109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW GPSCATH BALLOON DILATATION CATHETER
HOTSPUR TECHNOLOGIES,INC SUBSIDIAR510(k) NO: K140351(TRADITIONAL)
ATTN: ERIC ANKERUD, JD PHONE NO : 978 302 9467
880 Maude Ave Ste A SE DECISION MADE: 02-JUL-14
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCKESSON RADIOLOGY
MCKESSON MEDICAL IMAGING COMPANY 510(k) NO: K140909(TRADITIONAL)
ATTN: PAUL SUMNER PHONE NO : 404 338 3556
5995 WINWARD PARKWAY SE DECISION MADE: 02-JUL-14
ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
ICU MEDICAL, INC. 510(k) NO: K140129(TRADITIONAL)
ATTN: KRISTIN CASPER PHONE NO : 801 264 1313
4455 ATHERTON DRIVE SE DECISION MADE: 02-JUL-14
SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ANDON HEALTH CO., LTD 510(k) NO: K140121(SPECIAL)
ATTN: LIU YI PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 02-JUL-14
TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
SYBRONENDO 510(k) NO: K140685(TRADITIONAL)
ATTN: COURTNEY CLARK PHONE NO : 714 516 7426
1717 W.COLLINS AVENUE SE DECISION MADE: 02-JUL-14
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AP EXPANDABLE XLIF SYSTEM
NUVASIVE, INC. 510(k) NO: K140162(TRADITIONAL)
ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549
7475 LUSK BLVD SE DECISION MADE: 02-JUL-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOSEED
ECKERT & ZIEGLER BEBIG GMBH 510(k) NO: K140849(ABBREVIATED)
ATTN: SVEN LANGER PHONE NO : 49 30 941084734
ROBERT-ROSSLE STR.10 SE DECISION MADE: 02-JUL-14
BERLIN GM 13125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
JUNO DENTISTRY LP 510(k) NO: K140512(TRADITIONAL)
ATTN: ROGER MASTRONY PHONE NO : 203 298 0438
848-1/2 DERBY AVE SE DECISION MADE: 02-JUL-14
ORANGE CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKYHAWK LATERAL PLATE SYSTEM
ORTHOFIX INC. 510(k) NO: K140260(TRADITIONAL)
ATTN: TROY BROOKS PHONE NO : 214 937 2047
3451 PLANO PARKWAY SE DECISION MADE: 02-JUL-14
LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
TITAN SPINE, LLC 510(k) NO: K140055(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901 831 8035
3416 ROXEE RUN COVE SE DECISION MADE: 02-JUL-14
BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS80A DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD 510(k) NO: K141620(TRADITIONAL)
ATTN: PARK KYEONG-MI PHONE NO :
42, TEHERAN-RO 108-GIL SE DECISION MADE: 02-JUL-14
GANGNAM-GU, SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AVREO INTERWORKS SYSTEM
AVREO, INC. 510(k) NO: K141556(SPECIAL)
ATTN: ALISON MCKEE PHONE NO : 866 286 8082
4050 Azalea Dr SE DECISION MADE: 02-JUL-14
N Charleston SC 29405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHYGMOMANOMETER
SUZHOU JJ METER CO., LTD. 510(k) NO: K141392(TRADITIONAL)
ATTN: LONG YANG PHONE NO : 86 755 86664986
R1508, EAST BLDG, YIHAI PLAZA CHUASE DECISION MADE: 02-JUL-14
SHENZHEN, GUANGDONG CH 518054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K140572(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 02-JUL-14
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM
OSTIAL CORPORATION 510(k) NO: K133861(TRADITIONAL)
ATTN: JAKE WOLENBERG PHONE NO : 650 903 9100
1221 INNSBRUCK DRIVE SE DECISION MADE: 02-JUL-14
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
JEIL MEDICAL CORPORATION 510(k) NO: K141452(SPECIAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 02-JUL-14
FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
GALIL MEDICAL LTD. 510(k) NO: K141485(SPECIAL)
ATTN: LYNN DAVIES PHONE NO : 651 287 5098
4364 ROUND LAKE ROAD SE DECISION MADE: 02-JUL-14
ARDEN HILLS MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
TECHLINK INTERNATIONAL 510(k) NO: K131923(TRADITIONAL)
ATTN: TARA CONRAD PHONE NO : 305 377 0077
PO BOX 694125 SE DECISION MADE: 03-JUL-14
MIAMI FL 33269 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPUNCTURE INTRODUCER SET
COOK INCORPORATED 510(k) NO: K133114(TRADITIONAL)
ATTN: DAVID LEHR, RAC PHONE NO : 812 335 3575
750 DANIELS WAY SE DECISION MADE: 03-JUL-14
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5C
Z-SYSTEMS AG 510(k) NO: K132881(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235
12264 EL CAMINO REAL STE. 400 SE DECISION MADE: 03-JUL-14
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA FUNDUS CAMERA
C.S.O. S.R.L. 510(k) NO: K132987(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630
110 EAST GRANADA BLVD, STE 209 SE DECISION MADE: 03-JUL-14
ORMOND BEACH FL 32716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT INCUBATOR
BISTOS CO., LTD. 510(k) NO: K132543(TRADITIONAL)
ATTN: YOUNG CHI PHONE NO : 973 278 5222
27 NEW ENGLAND DRIVE SE DECISION MADE: 03-JUL-14
RAMSEY NJ 07446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS TRANSFEMORAL BALLOON CATHETER
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K140241(TRADITIONAL)
ATTN: ERIC CARRIER PHONE NO : 949 250 6443
ONE EDWARDS WAY SE DECISION MADE: 03-JUL-14
IRVINE CA 92663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
ARTHROSURFACE, INC. 510(k) NO: K133835(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003
28 FORGE PARKWAY SE DECISION MADE: 03-JUL-14
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H&H EMERGENCY CRICOTHYROTOMY KIT
H&H MEDICAL CORPORATION 510(k) NO: K133528(TRADITIONAL)
ATTN: J. LAWRENCE STEVENS PHONE NO : 508 926 8330
290 TURNPIKE RD. SUITE 200 SE DECISION MADE: 03-JUL-14
WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
BIOMET, INC. 510(k) NO: K140902(TRADITIONAL)
ATTN: AMY L WALRIVEN PHONE NO : 574 372 6660
56 EAST BELL DR. BOX 587 SE DECISION MADE: 03-JUL-14
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K133689(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 626 13000 7134
JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 03-JUL-14
MEDAN, NORTH SUMATERA ID 20362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
CERAGEM MEDISYS INC. 510(k) NO: K140141(SPECIAL)
ATTN: DANA MOON PHONE NO : 82 41 5298427
16 JEONGIAL-GIL, SEONGGEO-EUP, SEOSE DECISION MADE: 03-JUL-14
CHEONAN, CHUNGCHEONGNAM-DO KS 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS COATED COMPREHENSIVE FRACTURE STEMS
BIOMET MANUFACTURING CORP. 510(k) NO: K140652(TRADITIONAL)
ATTN: BRIAN KINCAID PHONE NO : 574 267 6639
56 EAST BELL DRIVE SE DECISION MADE: 03-JUL-14
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POD SYSTEM
PENUMBRA, INC. 510(k) NO: K141134(SPECIAL)
ATTN: CHARLES DENAULT PHONE NO : 510 748 3302
1351 Harbor Bay Parkway SE DECISION MADE: 03-JUL-14
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND
NEUROMETRIX, INC. 510(k) NO: K140333(TRADITIONAL)
ATTN: RAINER MAAS PHONE NO : 781 314 2781
62 FOURTH AVE. SE DECISION MADE: 03-JUL-14
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED VARIO SUBTALAR SCREW
NORMED NEDIZIN TECHNIK GMBH 510(k) NO: K140962(TRADITIONAL)
ATTN: DAVID FURR PHONE NO : 512 906 9654
8708 CAPEHART COVE SE DECISION MADE: 03-JUL-14
AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K140641(TRADITIONAL)
ATTN: KURTIS HUNSBERGER PHONE NO : 763 494 1204
ONE SCIMED PLACE SE DECISION MADE: 03-JUL-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCAS I
GP&P CO., LTD. 510(k) NO: K140869(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931 625 4938
12226 WASHINGTON LANE SE DECISION MADE: 03-JUL-14
PARKER AZ 85344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
QUBYX LIMITED 510(k) NO: K131601(TRADITIONAL)
ATTN: ALICE KOTYLARENKO PHONE NO : 33 01 80963820
80, RUE MARECHAL JOFFRE SE DECISION MADE: 07-JUL-14
NICE FR 06000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
HAGER & MEISINGER GMBH 510(k) NO: K132214(TRADITIONAL)
ATTN: WIEBKE STOLTEN PHONE NO : 004 92 1312012388
HANSEMANNSTRASSE 10 SE DECISION MADE: 07-JUL-14
NEUSS GM D-41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAB ‘N GO PLUS, GRAB ‘N GO DIGITAL
PRAXAIR HEALTHCARE SERVICES 510(k) NO: K132778(TRADITIONAL)
ATTN: TINA WU, PH.D. PHONE NO : 443 352 3909
62 FOREST STREET, STE 300 SE DECISION MADE: 07-JUL-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
FRESENIUS MEDICAL CARE, NORTH AMER510(k) NO: K133299(TRADITIONAL)
ATTN: DENISE M OPPERMANN PHONE NO : 781 699 4044
920 WINTER ST. SE DECISION MADE: 07-JUL-14
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO, CT DUAL ENERGY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133648(TRADITIONAL)
ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912
51 VALLEY STREAM PKWY. SE DECISION MADE: 07-JUL-14
MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
ARROW INTERNATIONAL, INC. 510(k) NO: K141051(SPECIAL)
ATTN: FRANK PELC PHONE NO : 610 378 0131
2400 BERNVILLE RD. SE DECISION MADE: 07-JUL-14
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140324(TRADITIONAL)
ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541
325 PARAMOUNT DRIVE SE DECISION MADE: 07-JUL-14
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K133784(TRADITIONAL)
ATTN: JUDITH ROSEN PHONE NO : 973 576 0032
10 POMEROY RD. SE DECISION MADE: 07-JUL-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K140785(TRADITIONAL)
ATTN: BRODIE PEDERSEN PHONE NO : 763 577 3180
13700 1ST AVE, NORTH SE DECISION MADE: 07-JUL-14
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
MAQUET CARDIOPULMONARY AG 510(k) NO: K141432(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 49 747199730
KEHLER STRASSE 31 SE DECISION MADE: 07-JUL-14
RASTATT GM 76437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRELESS THERMOMETER
RAIING MEDICAL COMPANY 510(k) NO: K132761(TRADITIONAL)
ATTN: WU WEI PHONE NO : 86 106411 8658
21 Huoju St SE DECISION MADE: 08-JUL-14
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
BETTER CARE PLASTIC TECHNOLOGY CO.510(k) NO: K140816(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611
3973 SCHAEFER AVE SE DECISION MADE: 08-JUL-14
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT MIDLINE
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K141151(TRADITIONAL)
ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201
1499 DELP DR. SE DECISION MADE: 08-JUL-14
HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141228(TRADITIONAL)
ATTN: ANNA HWANG PHONE NO : 310 533 9966
3203 KASHIWA STREET SE DECISION MADE: 08-JUL-14
TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENDA WEDGE
CENTRIX, INC. 510(k) NO: K140144(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203 567 7444
770 RIVER RD. SE DECISION MADE: 08-JUL-14
SHELTON CT 06484 5458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
HOSPIRA, INC. 510(k) NO: K141102(SPECIAL)
ATTN: TOM GUTIERREZ PHONE NO : 858 391 1142
275 NORTH FIELD DR. SE DECISION MADE: 08-JUL-14
LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORIS POROUS PARTIAL KNEE SYSTEM
MAKO SURGICAL CORP. 510(k) NO: K133811(TRADITIONAL)
ATTN: TERRY POWELL PHONE NO : 703 562 9800
575 EIGHTH AVE, SUITE 1212 SE DECISION MADE: 08-JUL-14
NEW YORK NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140643(TRADITIONAL)
ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541
325 PARAMOUNT DRIVE SE DECISION MADE: 08-JUL-14
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO INTRAOSSEOUS INFUSION SYSTEM
VIDACARE LLC 510(k) NO: K141117(TRADITIONAL)
ATTN: DIANA F MONTEZ, BSN, RN PHONE NO : 210 375 8500
4350 LOCKHILL SELMA RD. SE DECISION MADE: 08-JUL-14
SHAVANO PARK TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
WELLDOC, INC 510(k) NO: K141273(SPECIAL)
ATTN: DIVYA KALLAMADI PHONE NO : 443 692 3100
1501 SAINT PAUL STREET SUITE 118 SE DECISION MADE: 08-JUL-14
BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
ARROW INTERNATIONAL, INC (SUBSIDIA510(k) NO: K141618(SPECIAL)
ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131
2400 BERNVILLE ROAD SE DECISION MADE: 08-JUL-14
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FRACTURE PLATES AND SCREWS
ARTHREX, INC. 510(k) NO: K141478(SPECIAL)
ATTN: DAVID L ROGERS PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 08-JUL-14
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER, MODEL ADELANTE MAGNUM
OSCOR INC. 510(k) NO: K140917(TRADITIONAL)
ATTN: LAURA SOBRIN PHONE NO : 727 937 2511
3816 DE SOTO BLVD. SE DECISION MADE: 09-JUL-14
PALM HARBOR FL 34683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEX MIXING AND DELIVERY SYSTEM
ETEX CORPORATION 510(k) NO: K141245(TRADITIONAL)
ATTN: ANDY SOMAN PHONE NO : 617 871 6342
675 MASSACHUSETTS AVE 12TH FLOOR SE DECISION MADE: 09-JUL-14
CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLENTS PLASTIC EYE WASH CUP
APOTHECARY PRODUCTS, INC. 510(k) NO: K140409(TRADITIONAL)
ATTN: JAMES JENKINS PHONE NO : 952 808 8364
11750 12TH AVE. SOUTH SE DECISION MADE: 09-JUL-14
BURNSVILLE MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K141444(ABBREVIATED)
ATTN: DONNA VELASQUEZ PHONE NO : 310 645 8200
5210 PACIFIC CONCOURSE DRIVE SE DECISION MADE: 09-JUL-14
LOS ANGELES CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFOAM BONE WEDGE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K140531(TRADITIONAL)
ATTN: VAL MYLES PHONE NO : 901 290 5162
1023 CHERRY ROAD SE DECISION MADE: 09-JUL-14
MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K141417(SPECIAL)
ATTN: LESLIE FITCH PHONE NO : 901 867 4120
1023 CHERRY ROAD SE DECISION MADE: 09-JUL-14
MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIROCAM CAPSULE ENDOSCOPE SYSTEM
INTROMEDIC CO., LTD 510(k) NO: K134005(TRADITIONAL)
ATTN: JINYOUNG LEE PHONE NO : 82 2 8019300
STE 1104, E&C VENTURE DREAM TOWER SE DECISION MADE: 09-JUL-14
GURO-GU , SEOUL KS 152-719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K140417(TRADITIONAL)
ATTN: SHWETA SHARMA PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 09-JUL-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT SAFETY INTRODUCER NEEDLE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140513(TRADITIONAL)
ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789
1600 WEST MERIT PKWY. SE DECISION MADE: 09-JUL-14
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GANTRY BEAM LINE
ION BEAM APPLICATIONS S.A. 510(k) NO: K132919(TRADITIONAL)
ATTN: BRUCE D ARMON PHONE NO : 215 972 7985
1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 10-JUL-14
PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOSSOM SALINE DELIVERY ASSIST DEVICE
MARZ MEDICAL, INC 510(k) NO: K131692(TRADITIONAL)
ATTN: MARY PASCUAL GALLUP PHONE NO : 510 441 4017
2500 HOSPITAL DRIVE BUILDING 9 SE DECISION MADE: 10-JUL-14
MOUNTAIN VIEW CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARATHON NO STING LIQUID SKIN PROTECTANT
ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K133443(TRADITIONAL)
ATTN: ROSE GUANG PHONE NO : 44 416068 63500
WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 10-JUL-14
PLYMOUTH, DEVON UK PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
CONMED CORPORATION 510(k) NO: K140658(TRADITIONAL)
ATTN: SANDY LECLAIR PHONE NO : 315 624 3435
525 FRENCH RD. SE DECISION MADE: 10-JUL-14
UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
IMPLANTECH ASSOCIATES INC. 510(k) NO: K141027(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805 339 9415
6025 NICOLLE ST., SUITE B SE DECISION MADE: 10-JUL-14
VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANGE/MESA/DENALI SPINAL SYSTEM
K2M, INC. 510(k) NO: K140765(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 10-JUL-14
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MELUNA CLASSIC/SPORT MENSTRUAL CUP
MELUNA 510(k) NO: K140626(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 888 729 9674
1468 HARWELL AVE SE DECISION MADE: 10-JUL-14
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERADIUS
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133819(ABBREVIATED)
ATTN: RUOJUAN ZHANG PHONE NO : 310 6316 85825
VEENPLUIS 4-6 SE DECISION MADE: 10-JUL-14
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
ABMEDICA SAS 510(k) NO: K140101(TRADITIONAL)
ATTN: DANIEL DONOVAN PHONE NO : 203 799 2400
333 QUARRY ROAD SE DECISION MADE: 10-JUL-14
MILFORD CT 06460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENADEN FLOW
KM CORPORATION 510(k) NO: K140976(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-JUL-14
FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIMOVE
DORSA VI PTY. LTD 510(k) NO: K131094(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 430 8695
1914 J N PEASE PLACE SE DECISION MADE: 11-JUL-14
CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
RITM OKB ZAO 510(k) NO: K131513(TRADITIONAL)
ATTN: LARISA SHPUNGINA PHONE NO : 7 8634 623179
99, PETROVSKAYA SE DECISION MADE: 11-JUL-14
TAGANROG RS 347900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
FOTONA D.D. 510(k) NO: K132806(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 1 5009100
STEGNE 7, SE DECISION MADE: 11-JUL-14
LJUBLJANA SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
QUALITY ELECTRODYNAMICS, LLC. 510(k) NO: K140998(TRADITIONAL)
ATTN: KATHLEEN ARAS PHONE NO : 440 484 2964
700 BETA DRIVE STE 100 SE DECISION MADE: 11-JUL-14
MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESIE APPS SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141554(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650 694 5988
685 East Middlefield Road SE DECISION MADE: 11-JUL-14
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INSTAFIX SHAPE MEMORY FIXATION SYSTEM
OT MEDICAL 510(k) NO: K141550(SPECIAL)
ATTN: WILLIAM RHODA PHONE NO : 484 588 2063
1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 11-JUL-14
KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
CONMED CORPORATION 510(k) NO: K140459(TRADITIONAL)
ATTN: LISA ANDERSON PHONE NO : 315 624 3371
525 FRENCH RD. SE DECISION MADE: 11-JUL-14
UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
WELCH ALLYN 510(k) NO: K141582(SPECIAL)
ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609
4341 STATE STREET ROAD SE DECISION MADE: 11-JUL-14
SKANEATELES FALLS NY 13153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA MICRO ALB CONTROL L/H
HORIBA ABX SAS 510(k) NO: K133676(ABBREVIATED)
ATTN: CAROLINE FERRER PHONE NO : 33 46714 1843
PARC EUROMEDECINE RUE DU CADUCEE SE DECISION MADE: 11-JUL-14
MONTPELLIER FR 34184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXAMINATION GLOVES
HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K140316(TRADITIONAL)
ATTN: NOORZALIZA AHMAD PHONE NO : 606 481 108788
LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 11-JUL-14
KUALA PILAH, NEGERI SEMBILAN MY510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPACE BURR HOLE COVER
NEUROPACE INC 510(k) NO: K141368(SPECIAL)
ATTN: ISABELLA R ABATI PHONE NO : 650 237 2700
455 N. BERNARDO AVE SE DECISION MADE: 11-JUL-14
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLABSIX ULTRASOUND SYSTEM
ESAOTE EUROPE B.V. 510(k) NO: K141486(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 228 8719
PHILIPSWEG 1 SE DECISION MADE: 11-JUL-14
MAASTRICHT NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
KEELER LIMITED 510(k) NO: K140451(TRADITIONAL)
ATTN: EUGENE VAN ARSDALE PHONE NO : 610 353 4350
456 PARKWAY SE DECISION MADE: 11-JUL-14
BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K141301(TRADITIONAL)
ATTN: BRIAN HOCKETT PHONE NO : 330 869 9562
1065 Medina Rd. SUITE 500 SE DECISION MADE: 11-JUL-14
Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
SURGICAL SPECIALTIES CORP. 510(k) NO: K141558(SPECIAL)
ATTN: KIRSTEN STOWELL FRANCO PHONE NO : 610 404 3367
100 DENNIS DR. SE DECISION MADE: 11-JUL-14
READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE STORK OTC
RINOVUM WOMEN’S HEALTH, INC 510(k) NO: K140186(TRADITIONAL)
ATTN: ANDREW ZELTWANGER PHONE NO : 724 241 8934
300 Oxford Dr Suite 330 SE DECISION MADE: 11-JUL-14
Monroeville PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRT REVISION KNEE
ENCORE MEDICAL, L.P. 510(k) NO: K140830(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255
9800 METRIC BLVD. SE DECISION MADE: 11-JUL-14
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM CALIBRATER
BECKMAN COULTER IRELAND INC 510(k) NO: K141388(ABBREVIATED)
ATTN: DAVID G DAVIS PHONE NO : 469 236 8180
250 S. KRAEMER BLVD. E1.SE.01 SE DECISION MADE: 11-JUL-14
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE GUIDE
KOELIS 510(k) NO: K141334(TRADITIONAL)
ATTN: LAETITIA GERVAIS PHONE NO : 334 766375 87
5 AVENUE DU GRAND SABLON SE DECISION MADE: 11-JUL-14
LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PFX SPINOUS PROCESS FIXATION SYSTEM
INNOVASIS, INC. 510(k) NO: K132765(TRADITIONAL)
ATTN: MARSHALL MCCARTY PHONE NO : 801 261 2236
614 EAST 3900 SOUTH SE DECISION MADE: 14-JUL-14
SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K141532(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 14-JUL-14
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS VITALITE TIBIAL INSERT
CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K133919(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 916 355 7100
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 14-JUL-14
EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141605(SPECIAL)
ATTN: MICHAEL SCOTT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 14-JUL-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K140829(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714 961 4517
250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 14-JUL-14
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY POWER WHEELCHAIR
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K132856(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 423580 357
NO. 6 ROAD 25 TAICHUNG INDUSTRIAL SE DECISION MADE: 15-JUL-14
TAICHUNG CITY, TAIWAN TW R.O.C.510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILESTONE SPINAL SYSTEM
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K133053(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
PO BOX 120-119 SE DECISION MADE: 15-JUL-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
COVIDIEN 510(k) NO: K140813(TRADITIONAL)
ATTN: DANIEL CAMPION PHONE NO : 508 452 4135
15 HAMPSHIRE STREET SE DECISION MADE: 15-JUL-14
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTUS FEMTOSECOND LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH 510(k) NO: K140615(TRADITIONAL)
ATTN: BETTY M JOHNSON PHONE NO : 714 273 8254
PO BOX 17190 SE DECISION MADE: 15-JUL-14
ANAHEIM CA 92817 7190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
EXPANDING ORTHOPEDICS, INC. 510(k) NO: K133813(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 337 7579
4628 NORTHPARK DRIVE SE DECISION MADE: 15-JUL-14
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORMATRIX ECM FOR VASCULAR REPAIR
CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K140789(TRADITIONAL)
ATTN: BRYAN BROSSEAU PHONE NO : 470 514 4036
1100 OLD ELLIS ROAD SE DECISION MADE: 15-JUL-14
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
MEDIVATORS 510(k) NO: K140753(SPECIAL)
ATTN: KINNARI SHAH PHONE NO : 763 553 3369
14605 28TH AVE. N. SE DECISION MADE: 15-JUL-14
MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP OPTILENE NONABSORBABLE SUTURE
AESCULAP, INC. 510(k) NO: K133890(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291
3773 CORPORATE PARKWAY SE DECISION MADE: 15-JUL-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK SPHERE EXTENSION
MEDACTA INTERNATIONAL 510(k) NO: K140826(TRADITIONAL)
ATTN: ADAM GROSS PHONE NO : 805 910 6511
1556 W CARROLL AVE. SE DECISION MADE: 15-JUL-14
CHICAGO IL 60607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSTAR LOGIX PUMP
ALBAHEALTH LLC 510(k) NO: K141609(SPECIAL)
ATTN: SHANE BRUCE PHONE NO : 865 354 0410
425 N GATEWAY AVE. SE DECISION MADE: 15-JUL-14
ROCKWOOD TN 37854 510(k) STATEMENT
DEVICE: LINSCAN 808, LINSCAN 980
GME (GERMAN MEDICAL ENGINEERING) G510(k) NO: K141063(TRADITIONAL)
ATTN: MIKE JOHNSON, M.D. PHONE NO : 406 209 3039
PO BOX 106 SE DECISION MADE: 15-JUL-14
WILLOW CREEK MT 59760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
SYNERGY BIOMEDICAL, INC. 510(k) NO: K140844(TRADITIONAL)
ATTN: RANDY PREBULA PHONE NO : 202 637 6548
555 THIRTEENTH ST, N.W. SE DECISION MADE: 16-JUL-14
WASHINGTON DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
RAYENCE CO., LTD 510(k) NO: K141563(SPECIAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
8310 BUFFALO SPEEDWAY SE DECISION MADE: 16-JUL-14
HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORCINE ANORGANIC BONE MINERAL
COLLAGEN MATRIX, INC. 510(k) NO: K140714(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201 405 1477
15 THORNTON ROAD SE DECISION MADE: 16-JUL-14
OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCTIGARD
ACCESS PHARMACEUTICALS, INC 510(k) NO: K140558(TRADITIONAL)
ATTN: JEFFREY B DAVIS PHONE NO : 212 786 6205
1325 AVENUE OF THE AMERICA, 27TH FSE DECISION MADE: 16-JUL-14
NEW YORK NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC 510(k) NO: K141112(SPECIAL)
ATTN: CAROL TIFFANY PHONE NO : 763 494 1106
ONE SCIMED PLACE SE DECISION MADE: 16-JUL-14
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-TL
VITROLIFE, INC. 510(k) NO: K133568(TRADITIONAL)
ATTN: MARK LARMAN PHONE NO : 303 762 1933
3601 SOUTH INCA ST. SE DECISION MADE: 16-JUL-14
ENGLEWOOD CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
CHOICE SPINE, LP 510(k) NO: K140142(TRADITIONAL)
ATTN: KIM FINCH PHONE NO : 865 246 3333
306 ERIN DRIVE SE DECISION MADE: 16-JUL-14
KNOXVILLE TN 37919 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
RAYENCE CO., LTD 510(k) NO: K141566(SPECIAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
8310 BUFFALO SPEEDWAY SE DECISION MADE: 16-JUL-14
HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF TL AND PL CAGE
STRYKER CORPORATION 510(k) NO: K141217(SPECIAL)
ATTN: KRISTEN MEANY PHONE NO : 201 760 8070
2 PEARL COURT SE DECISION MADE: 16-JUL-14
ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE SUSCEPTIBILITY PLATES
THERMO FISHER SCIENTIFIC 510(k) NO: K141000(TRADITIONAL)
ATTN: CYNTHIA KNAPP PHONE NO : 800 871 8909
1 THERMO FISHER WAY SE DECISION MADE: 16-JUL-14
OAKWOOD VILLAGE OH 44146 510(k) STATEMENT
DEVICE: TATTOOSTAR EFFECT COMBO
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131757(TRADITIONAL)
ATTN: ANTJE KATZER PHONE NO : 493 641 7700309
BRUESSELER STR. 10 SE DECISION MADE: 17-JUL-14
JENA GM 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
HEALGEN SCIENTIFIC, LLC 510(k) NO: K141647(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 301 505 7880
504 EAST DIAMNOND AVE. SUITE F SE DECISION MADE: 17-JUL-14
GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVIS ARTHROSCOPE
INTEGRATED ENDOSCOPY, INC. 510(k) NO: K140903(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949 777 6749
23141 ARROYO VISTA, STE 100 SE DECISION MADE: 17-JUL-14
RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGERTIP PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K140682(TRADITIONAL)
ATTN: LEI CHEN PHONE NO : 86 10 88798300
NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 17-JUL-14
BEIJING CH 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
STERIS CORPORATION 510(k) NO: K140499(TRADITIONAL)
ATTN: BILL BRODBECK PHONE NO : 440 392 7690
5960 HEISLEY ROAD SE DECISION MADE: 17-JUL-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
STERIS CORPORATION 510(k) NO: K140515(ABBREVIATED)
ATTN: BILL BRODBECK PHONE NO : 440 392 7695
5960 HEISLEY ROAD SE DECISION MADE: 17-JUL-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELWORKS DR SYSTEM
DEL MEDICAL, INC. 510(k) NO: K140825(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 17-JUL-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D2 HEMOSTANTIC DRESSING
Z-MEDICA, LLC 510(k) NO: K140757(TRADITIONAL)
ATTN: SHEILA WALLIN PHONE NO : 203 294 0000
4 FAIRFIELD BLVD. SE DECISION MADE: 17-JUL-14
Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
ROCHE DIAGNOSTICS 510(k) NO: K141143(TRADITIONAL)
ATTN: KHOA TRAN PHONE NO : 317 521 3409
9115 HAGUE ROAD SE DECISION MADE: 17-JUL-14
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
VASCULAR PATHWAYS, INC. 510(k) NO: K140504(TRADITIONAL)
ATTN: BILL BOLD PHONE NO :
1847 Trade Center Way SE DECISION MADE: 17-JUL-14
Naples FL 34109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHILLA GROWTH GUIDANCE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140750(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 17-JUL-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
PJUR GROUP LUXEMBOURG SA 510(k) NO: K133233(TRADITIONAL)
ATTN: CANDACE CEDERMAN PHONE NO : 503 201 2485
722 ARJEAN DRIVE SE DECISION MADE: 18-JUL-14
WILMINGTON NC 28411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX PIP DART
ARTHREX, INC. 510(k) NO: K141577(SPECIAL)
ATTN: DAVID L ROGERS PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 18-JUL-14
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALMA DIODE TABLETOP LASER
ALMA LASERS LTD. 510(k) NO: K140005(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 352 586 3113
26 REBECCA CT SE DECISION MADE: 18-JUL-14
HOMOSASSA FL 34446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
BIOMET MANUFACTURING CORP. 510(k) NO: K141219(TRADITIONAL)
ATTN: JARED COOPER PHONE NO : 574 372 1941
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 18-JUL-14
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
TORNIER SAS 510(k) NO: K140082(TRADITIONAL)
ATTN: AYMEN AZAIEZ PHONE NO : 33 476613 500
161 RUE LAVOISIER SE DECISION MADE: 18-JUL-14
MONTBONNOT SAINT MARTIN FR 3833510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILITE C1 INACTIVATOR KIT
THE BINDING SITE GROUP LTD 510(k) NO: K141100(TRADITIONAL)
ATTN: MARIANNE SENDER PHONE NO : 440 121456 9500
8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 18-JUL-14
BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT
DEVICE: ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K133551(TRADITIONAL)
ATTN: MELISSA BURBAGE PHONE NO : 760 929 4110
1900 ASTON AVE. SE DECISION MADE: 18-JUL-14
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
EV3 INC 510(k) NO: K141118(SPECIAL)
ATTN: LAURA J LIND PHONE NO : 763 398 7247
3033 CAMPUS DRIVE SUITE N550 SE DECISION MADE: 18-JUL-14
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
ZONARE MEDICAL SYSTEMS, INC. 510(k) NO: K141641(TRADITIONAL)
ATTN: DAN BRADFORD PHONE NO : 650 316 3113
420 NORTH BERNARDO AVENUE SE DECISION MADE: 18-JUL-14
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
PT. SMART GLOVE INDONESIA 510(k) NO: K133699(TRADITIONAL)
ATTN: KHON PU FOO PHONE NO : 616 17 940100
JL. PELITA RAUYA NO. 5-7,KIM STAR,SE DECISION MADE: 18-JUL-14
MEDAN, NORTH SUMATER ID 20362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVO TINNITUS MASKING SOFTWARE DEVICE
OTOHARMONICS CORP 510(k) NO: K140845(TRADITIONAL)
ATTN: YARMELA PAVLOVIC PHONE NO : 267 675 4618
1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 18-JUL-14
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYSYN SURGICAL SUTURE
SURGICAL SPECIALTIES CORP. 510(k) NO: K141625(SPECIAL)
ATTN: PAUL AMUDALA PHONE NO : 610 404 3367
100 DENNIS DR. SE DECISION MADE: 18-JUL-14
READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
NEUROINVENT INC. 510(k) NO: K140200(TRADITIONAL)
ATTN: CHAO-SHENT CHAO PHONE NO : 886 227935 961
5F,NO.123,ANMEI ST.,NEIHU DISTRICTSE DECISION MADE: 18-JUL-14
TAIPEI CITY TW 11484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BELMONT RAPID INFUSER
BELMONT INSTRUMENT CORPORATION 510(k) NO: K141654(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978 663 0212
780 BOSTON ROAD SE DECISION MADE: 18-JUL-14
BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON S6, VOLUSON S8
GE HEALTHCARE 510(k) NO: K141639(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 INNOVATION DRIVE SE DECISION MADE: 18-JUL-14
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
ELITECHGROUP 510(k) NO: K141265(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 18-JUL-14
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
GEISTLICH PHARMA AG 510(k) NO: K140518(TRADITIONAL)
ATTN: DANIEL A KRACOV PHONE NO : 202 942 5120
555 TWELFTH STREET, NW SE DECISION MADE: 18-JUL-14
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
SEINOH OPTICAL CO. LTD. 510(k) NO: K141280(ABBREVIATED)
ATTN: JENNIFER TING PHONE NO : 886 282823 192
6F, NO. 39, LN 224, JIXIAN RD, LUZSE DECISION MADE: 18-JUL-14
NEW TAIPEI CITY TW 247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX DISTAL RADIUS PLATING SYSTEM
STRYKER LEIBINGER GMBH & CO. KG 510(k) NO: K141430(TRADITIONAL)
ATTN: ELIJA WREH PHONE NO : 201 831 5691
325 CORPORATE DRIVE SE DECISION MADE: 18-JUL-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140897(TRADITIONAL)
ATTN: CORDELL L FIELDS, ESQ. PHONE NO : 610 219 8518
51 VALLEY STREAM PARKWAY SE DECISION MADE: 18-JUL-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSURE HEALICOIL PK INTERFERENCE SCREW
SMITH & NEPHEW, INC 510(k) NO: K140879(TRADITIONAL)
ATTN: VIVEK MUKHATYAR PHONE NO : 978 749 1043
150 MINUTEMAN DR. SE DECISION MADE: 21-JUL-14
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCIA TOTAL HIP SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K140915(SPECIAL)
ATTN: JULIE T WING PHONE NO : 610 984 9147
3773 CORPORATE PARKWAY SE DECISION MADE: 21-JUL-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUL PERSONAL LUBRICANT
CHURCH & DWIGHT CO., INC. 510(k) NO: K141034(TRADITIONAL)
ATTN: JOSEPH CICONE PHONE NO : 609 806 1994
500 CHARLES EWING BLVD SE DECISION MADE: 21-JUL-14
EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYMEG BIOMAGNETOMETER SYSTEM
TRISTAN TECHNOLOGIES INC 510(k) NO: K133419(TRADITIONAL)
ATTN: EUGENE HIRSCHKOFF PHONE NO : 619 992 6301
3365 CALLE MARGARITA SE DECISION MADE: 21-JUL-14
ENCINITAS CA 92024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K134031(TRADITIONAL)
ATTN: VICKY L HAGENS PHONE NO : 763 494 1522
ONE SCIMED PLACE SE DECISION MADE: 21-JUL-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES – BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES – BOX 5, CAPTIV
BOSTON SCIENTIFIC CORP. 510(k) NO: K140726(TRADITIONAL)
ATTN: TARA PAUL PHONE NO : 508 683 4296
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 21-JUL-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
AMERICAN MEDICAL MANUFACTURING, IN510(k) NO: K130097(TRADITIONAL)
ATTN: MIKE HOFTMAN PHONE NO : 818 701 7171
8741 SHIRLEY AVE SE DECISION MADE: 22-JUL-14
NORTHRIDGE CA 91324 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
COMED MEDICAL SYSTEMS CO., LTD 510(k) NO: K131721(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832 675 9281
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 22-JUL-14
HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEVA DISH (WITH 12 MICROWELLS)
AUXOGYN, INC. 510(k) NO: K141663(SPECIAL)
ATTN: JULIA S ANASTAS PHONE NO : 650 763 3875
1490 O’BRIEN DRIVE, SUITE A SE DECISION MADE: 22-JUL-14
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOXTM INTERBODY FUSION SYSTEM
U&I CORP. 510(k) NO: K140864(TRADITIONAL)
ATTN: JI YEA LEE PHONE NO : 82 318520 102
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 22-JUL-14
Uijeongbu-si KR 480-859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-CONNEKT WOUND MATRIX
MLM BIOLOGICS, INC. 510(k) NO: K140456(TRADITIONAL)
ATTN: GREGG RITTER PHONE NO : 352 494 2122
12085 RESEARCH DRIVE SE DECISION MADE: 22-JUL-14
ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
ICON ORTHOPEDIC CONCEPTS, LLC DBA 510(k) NO: K140876(TRADITIONAL)
ATTN: JAN TRIANI PHONE NO : 201 543 9388
6 MARS COURT, UNIT 6-3 SE DECISION MADE: 22-JUL-14
BOONTON NJ 07005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOSURE WORKSTATION
CYNOSURE, INC. 510(k) NO: K133364(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 781 993 2414
5 CARLISLE ROAD SE DECISION MADE: 22-JUL-14
WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
CEDARS-SINAI MEDICAL CENTER 510(k) NO: K141652(SPECIAL)
ATTN: GEOFF POLLARD PHONE NO : 310 423 4663
8700 BEVERLY BOULEVARD SE DECISION MADE: 22-JUL-14
LOS ANGELES CA 90048 1869 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OARTRAC SYSTEM
RADIADYNE 510(k) NO: K141154(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997
816 CONGRESS AVE. SUITE 1400 SE DECISION MADE: 22-JUL-14
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
SIGNATURE ORTHOPAEDICS PTY LIMITED510(k) NO: K133370(TRADITIONAL)
ATTN: DECLAN BRAZIL PHONE NO : 61 2 94285181
7 Sirius Road LANE COVE SE DECISION MADE: 22-JUL-14
NSW AS 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUALIZER OCCLUSION BALLOON CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K140273(TRADITIONAL)
ATTN: DIANE NELSON PHONE NO :
ONE SCIMED PLACE SE DECISION MADE: 22-JUL-14
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
ABBOTT VASCULAR 510(k) NO: K141678(SPECIAL)
ATTN: JESSICA KAO PHONE NO : 408 845 0696
3200 LAKESIDE DRIVE SE DECISION MADE: 22-JUL-14
SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX ELBOW PLATING SYSTEM
STRYKER TRAUMA AG 510(k) NO: K141677(TRADITIONAL)
ATTN: ELIJAH N WREH PHONE NO : 201 831 5691
325 CORPORATE DRIVE SE DECISION MADE: 22-JUL-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
SHASER, INC. 510(k) NO: K141583(SPECIAL)
ATTN: ANTHONY BURNS PHONE NO : 339 927 2599
10 Maguire Rd Ste 120 BUILDING 1 SE DECISION MADE: 22-JUL-14
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
STERIS CORPORATION 510(k) NO: K140487(TRADITIONAL)
ATTN: TONY PIOTRKOWSKI PHONE NO : 440 392 7437
5960 HEISLEY ROAD SE DECISION MADE: 22-JUL-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS HERNIA GRAFT
COOK BIOTECH, INC. 510(k) NO: K133306(TRADITIONAL)
ATTN: PERRY W GUINN PHONE NO : 765 497 3355
1425 INNOVATION PLACE SE DECISION MADE: 23-JUL-14
West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
SPECTRANETICS CORPORATION 510(k) NO: K140775(TRADITIONAL)
ATTN: AMANDA JOHNSON PHONE NO : 719 477 2000
9965 FEDERAL DRIVE SE DECISION MADE: 23-JUL-14
COLORADO SPRINGS CO 80921 3617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADWELL SPIKE AND SEIZURE DETECTOR
CADWELL 510(k) NO: K140552(TRADITIONAL)
ATTN: JINESH JAIN PHONE NO : 509 735 6481
909 N. KELLOGG ST. SE DECISION MADE: 23-JUL-14
KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROSCOPIC ENERGY SYSTEM
CONMED CORPORATION 510(k) NO: K140578(TRADITIONAL)
ATTN: DIONNE SANDERS PHONE NO : 727 399 5564
525 FRENCH RD. SE DECISION MADE: 23-JUL-14
UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFX-8000V, V5.30
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133535(TRADITIONAL)
ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896
2441 MICHELLE DRIVE SE DECISION MADE: 23-JUL-14
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
VILEX, INC. 510(k) NO: K132820(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 941 373 3987
7214 LAKE FOREST GLEN SE DECISION MADE: 23-JUL-14
LAKEWOOD RANCH FL 34202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO SOLUTIONS ULTOS PLATING SYSTEM
ORTHO SOLUTIONS LIMITED 510(k) NO: K141784(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858
3150 EAST 200TH STREET SE DECISION MADE: 23-JUL-14
PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIJOINT HIP
INTELLIJOINT SURGICAL INC. 510(k) NO: K133759(TRADITIONAL)
ATTN: BRANDON GINGRICH PHONE NO : 519 342 3178 X2104
60 BATHURST DR. SE DECISION MADE: 23-JUL-14
WATERLOO ONTARIO CA N2V 2A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC. 510(k) NO: K141049(TRADITIONAL)
ATTN: ROXANNE DUBOIS PHONE NO : 408 207 0700
3055 OLIN AVE SUITE 2200 SE DECISION MADE: 23-JUL-14
SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OKAMOTO STUDDED CONDOM
OKAMOTO U.S.A., INC. 510(k) NO: K141256(ABBREVIATED)
ATTN: JOSEPH W CORMIER, JD, PHD PHONE NO : 202 737 7553
700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 23-JUL-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN SPINAL SYSTEM
K2M, INC. 510(k) NO: K141284(SPECIAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 23-JUL-14
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC NEUROSCREENING DEVICE
PROSENEX 510(k) NO: K141208(TRADITIONAL)
ATTN: WILLIAM G MCLAIN PHONE NO : 717 656 9656
342 E. MAIN ST. SUITE 207 SE DECISION MADE: 23-JUL-14
LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAPROBE LED LIGHT SOURCE
NOVAPROBE INCORPORATED 510(k) NO: K131226(TRADITIONAL)
ATTN: MANISH INGLE PHONE NO : 215 259 3673
2333W. MAIN STREET SUITE 210 SE DECISION MADE: 24-JUL-14
LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLIF LITE AND TLIF LITE
SINTEA PLUSTEK 510(k) NO: K132907(TRADITIONAL)
ATTN: RICH JANSEN PHONE NO : 612 281 5505
11821 BRAMBLE COVE DRIVE SE DECISION MADE: 24-JUL-14
FT. MYERS FL 33905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PJUR SILICONE GEL, PJUR BASIC, PJUR LIGHT, PJUR ANALYSE ME, PJUR BACKDOOR, PJUR MED PREMIUM GLIDE
PJUR GROUP,LUXEMBOURG S.A. 510(k) NO: K133336(TRADITIONAL)
ATTN: CANDACE CEDERMAN PHONE NO : 503 201 2485
722 ARJEAN DR. SE DECISION MADE: 24-JUL-14
WILMINGTON NC 28411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELPROCERA OVERDENTURE BAR
NOBEL BIOCARE USA, LLC 510(k) NO: K132749(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714 282 4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 24-JUL-14
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-JAWS CERVICAL COMPRESSIVE STAPLE
MEDICREA INTERNATIONAL 510(k) NO: K133906(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202 637 3638
555 THIRTEENTH STREET NW SE DECISION MADE: 24-JUL-14
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONGLIDE LUBRICANT
PEDIATRIC PHARMACEUTICALS INC. 510(k) NO: K141028(SPECIAL)
ATTN: ROBERT M HARRIS PHONE NO : 732 739 2018
2137 ROUTE 35 SE DECISION MADE: 24-JUL-14
HOLMDEL NJ 07733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
INFOPIA CO., LTD 510(k) NO: K141750(SPECIAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 24-JUL-14
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
COLOPLAST A/S 510(k) NO: K140523(SPECIAL)
ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987
1601 WEST RIVER ROAD N SE DECISION MADE: 24-JUL-14
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
PONTIS ORTHOPAEEICS, LLC 510(k) NO: K141711(SPECIAL)
ATTN: LEONARD GORDON PHONE NO : 415 567 8935
2299 POST STREET, SUITE 103 SE DECISION MADE: 24-JUL-14
SAN FRANCISCO CA 94115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
HMICRO, INC. 510(k) NO: K140096(TRADITIONAL)
ATTN: KIM TOMPKINS PHONE NO : 408 981 4889
4984 EL CAMINO REAL #200 SE DECISION MADE: 24-JUL-14
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
NEOCOIL, LLC 510(k) NO: K133670(ABBREVIATED)
ATTN: MICHEAL LEIGH PHONE NO : 262 374 1250
N27 W23910A PAUL RD. SE DECISION MADE: 24-JUL-14
PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINOS MOH HAND PLATING SYSTEM
KLS MARTIN L.P. 510(k) NO: K141489(SPECIAL)
ATTN: JENNIFER DAMATO PHONE NO : 800 625 1557
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 24-JUL-14
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLIVUE GAS ASSAY
QUIDEL CORPORATION 510(k) NO: K141173(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3373
2005 E State St Suite 100 SE DECISION MADE: 24-JUL-14
ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133156(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914 524 2443
511 BENEDICT AVE. SE DECISION MADE: 24-JUL-14
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICR02 OSA DEVICE
MICRODENTAL, INC. 510(k) NO: K133683(TRADITIONAL)
ATTN: LAURA SHEPPARD PHONE NO : 925 803 8643
5601 ARNOLD RD. SE DECISION MADE: 24-JUL-14
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
HARTALEGA NGC SDN. BHD. 510(k) NO: K140890(TRADITIONAL)
ATTN: NURUL AISYAH KONG PHONE NO : 603 3280 3888
DATARAN SD PJU 9 SE DECISION MADE: 24-JUL-14
BANDAR SRI DAMANSARA, KUALA LUMPUR510(k) STATEMENT
DEVICE: BNA ANALYSIS SYSTEM
EIMINDA LTD. 510(k) NO: K121119(TRADITIONAL)
ATTN: DALIA DICKMAN PHONE NO : 972 995164 76
16 HAMINHARA ST. BEIT BACHAR SE DECISION MADE: 25-JUL-14
HERZLIYA IS 46586 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIVOX SELF ADHESIVE ELECTRODE GEL PADS
HIVOX BIOTEK, INC. 510(k) NO: K131720(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 2 85112668
8 F., NO. 98, SHINDE RD, SANCHONG SE DECISION MADE: 25-JUL-14
NEW TAIPEI CITY TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON P6, VOLUSON P8
GE HEALTHCARE 510(k) NO: K141675(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 INNOVATION DRIVE SE DECISION MADE: 25-JUL-14
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
MAUNA KEA TECHNOLOGIES 510(k) NO: K133466(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415 407 0223
8 SNOWBERRY COURT SE DECISION MADE: 25-JUL-14
ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
3M HEALTH CARE 510(k) NO: K140250(TRADITIONAL)
ATTN: KRISTIN TOTUSHEK PHONE NO : 651 736 6117
3M CENTER, 2510 CONWAY AVE. BLDG 2SE DECISION MADE: 25-JUL-14
ST. PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELTER BLOOD PRESSURE METER
SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K134029(TRADITIONAL)
ATTN: PANG MING PHONE NO : 86 755 61869839
702, 704 BLOCK C, TSINGHUA UNIS SCSE DECISION MADE: 25-JUL-14
SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
BECTON, DICKINSON AND COMPANY 510(k) NO: K141311(SPECIAL)
ATTN: JUMA HOSHINO PHONE NO : 201 847 4260
1 BECTON DRIVE SE DECISION MADE: 25-JUL-14
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO STERILIZATION TRAY/ STERILIZATION MAT
STERIS CORPORATION 510(k) NO: K140494(TRADITIONAL)
ATTN: TONY PIOTRKOWSKI PHONE NO : 440 392 7437
5960 HEISLEY ROAD SE DECISION MADE: 25-JUL-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDI BLOOD PARAMETER MONITORING SYSTEM 500
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K133658(TRADITIONAL)
ATTN: KEVIN KONG PHONE NO : 734 663 4145
6200 JACKSON RD. SE DECISION MADE: 25-JUL-14
ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
REGULATORY TECHNOLOGY SERVICES LLC510(k) NO: K141838(TRADITIONAL)
ATTN: MARK JOB PHONE NO : 763 682 4139
1394 25TH STREET NW SE DECISION MADE: 25-JUL-14
BUFFALO MN 55313 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HARD PACK SYRINGE
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K141359(SPECIAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 25-JUL-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
PHILIPS MEDICAL SYSTEMS DMC GMBH 510(k) NO: K141736(SPECIAL)
ATTN: GEROLD SCHWARZ PHONE NO : 49 405078 1116
ROENTGENSTRASSE 24-26 SE DECISION MADE: 25-JUL-14
HAMBURG GM 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZQUIET-SA
SLEEPING WELL, LLC 510(k) NO: K140777(TRADITIONAL)
ATTN: WILLIAM MCLAIN PHONE NO : 717 656 9656
342 E. MAIN STREET, STE 207 SE DECISION MADE: 25-JUL-14
LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON XL ANALYZER
DIASORIN, INC. 510(k) NO: K141116(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651 351 5635
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 25-JUL-14
STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
SMITHS MEDICAL ASD, INC. 510(k) NO: K141193(TRADITIONAL)
ATTN: TOM BLISS PHONE NO : 651 628 7145
1265 GREY FOX ROAD SE DECISION MADE: 25-JUL-14
ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MLX – MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
NUVASIVE, INCORPORATED 510(k) NO: K140770(TRADITIONAL)
ATTN: OLGA LEWIS PHONE NO : 858 320 5257
7475 LUSK BLVD SE DECISION MADE: 25-JUL-14
SAN DIEGO CA 92121 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
MEDTRONIC NAVIGATION, INC. 510(k) NO: K133444(TRADITIONAL)
ATTN: KAYE WAITE PHONE NO : 720 890 2182
826 COAL CREEK CIR. SE DECISION MADE: 25-JUL-14
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
TOUCHSTONE INTERNATIONAL MEDICAL S510(k) NO: K141367(TRADITIONAL)
ATTN: JO QIAO PHONE NO : 86 512 62991985
21A SCIENCE PLAZA, INTRENATIONAL SSE DECISION MADE: 25-JUL-14
SUZHOU, JIANGSU CH 215021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
INTUITIVE SURGICAL, INC. 510(k) NO: K140553(TRADITIONAL)
ATTN: DAWN CHANG PHONE NO : 408 523 2347
1266 KIFER RD SE DECISION MADE: 25-JUL-14
SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCOON CONVECTIVE WARMING SYSTEM
CARE ESSENTIALS PTY LTD 510(k) NO: K140635(TRADITIONAL)
ATTN: BIBIANA FRANCO PHONE NO : 618 7231 0324
SUITE 2/ 36-38 GLEN OSMOND ROAD SE DECISION MADE: 25-JUL-14
PARKSIDE, SOUTH AUSTRALIA AS 50510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDS COMBO-RINSE
ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K140846(TRADITIONAL)
ATTN: JEFFREY WAN PHONE NO : 201 487 9090
89 LEUNING STREET SUITE 8 SE DECISION MADE: 25-JUL-14
SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMELOCK II CEMENTED SHOULDER SYSTEM
FX SOLUTIONS 510(k) NO: K140071(TRADITIONAL)
ATTN: JEAN-JACQUES MARTIN PHONE NO : 33 474 553555
1663 rue de Majornas SE DECISION MADE: 28-JUL-14
Viriat FR 01440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
GENERICA MEDICAL INTERNATIONAL, IN510(k) NO: K133077(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 949 433 3058
1910 D ST. SE DECISION MADE: 28-JUL-14
LAVERNE CA 91750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT SMALL INTERBODY SYSTEM
NUVASIVE, INCORPORATED 510(k) NO: K140921(TRADITIONAL)
ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549
7475 LUSK BOULEVARD SE DECISION MADE: 28-JUL-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR SYRINGE DUAL PACK
COEUR, INC. 510(k) NO: K140469(TRADITIONAL)
ATTN: ERIN RHEINSCHELD PHONE NO : 615 547 7923
100 PHYSICIANS WAY SUITE 200 SE DECISION MADE: 28-JUL-14
LEBANON TN 37090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT XL-F SYSTEM
NUVASIVE, INCORPORATED 510(k) NO: K140479(TRADITIONAL)
ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549
7475 LUSK BLVD SE DECISION MADE: 28-JUL-14
SAN DIEGO CA 92121 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
OXFORD PERFORMANCE MATERIALS 510(k) NO: K133809(TRADITIONAL)
ATTN: LEIGH AYRES PHONE NO : 860 698 9300
30 South Satellite Road SE DECISION MADE: 28-JUL-14
South Windsor CT 06074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUS EXTENSION FEEDING SET
DEGANIA SILICONE, LTD. 510(k) NO: K141631(SPECIAL)
ATTN: ZOYA LEE PHONE NO : 972 467 55122
KIBBUTZ DEGANIA BET SE DECISION MADE: 28-JUL-14
EMEK HAYARDEN IS 1513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
COAG MEDICAL LLC 510(k) NO: K140313(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 231 1761
4486 TIMBERLINE CT. SE DECISION MADE: 28-JUL-14
VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP
KIMBERLY-CLARK HEALTH CARE 510(k) NO: K141071(TRADITIONAL)
ATTN: THOMAS KOZMA, PH.D. PHONE NO : 770 587 8393
1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 28-JUL-14
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE CALIBRATOR
SENTINEL CH. SPA 510(k) NO: K141728(ABBREVIATED)
ATTN: PATRICIA DUPE PHONE NO : 39 02 34551496
VIA ROBERT KOCH, 2 SE DECISION MADE: 28-JUL-14
MILANO IT 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMERA ENABLED PROBE
TRICE MEDICAL, INC. 510(k) NO: K141119(TRADITIONAL)
ATTN: TIFFINI DIAGE PHONE NO : 707 799 6732
1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 29-JUL-14
KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDILOC FRAGMENT SYSTEM
ORTHOPEDIATRICS, CORP. 510(k) NO: K140431(TRADITIONAL)
ATTN: MARK FOX PHONE NO : 574 268 6379
2850 FRONTIER DRIVE SE DECISION MADE: 29-JUL-14
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
FACET TECHNOLOGIES, LLC 510(k) NO: K141749(SPECIAL)
ATTN: JENNIFER REGISTER PHONE NO : 770 590 6455
112 TOWN PARK DR. SUITE 300 SE DECISION MADE: 29-JUL-14
KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
VITAL CONNECT INC. 510(k) NO: K141167(TRADITIONAL)
ATTN: SAM MOSTAFAVI PHONE NO : 408 963 4620
900 E. HAMILTON AVE., SUITE 500 SE DECISION MADE: 29-JUL-14
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT
LEONHARD LANG GMBH 510(k) NO: K140500(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
P.O. BOX 560 SE DECISION MADE: 29-JUL-14
STILLWATER MN 55082 0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
X-SPINE SYSTEMS, INC 510(k) NO: K133947(TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8410
452 Alexandersville Rd SE DECISION MADE: 29-JUL-14
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K141120(TRADITIONAL)
ATTN: MELISSA BURBAGE PHONE NO : 760 929 4110
1900 ASTON AVE. SE DECISION MADE: 29-JUL-14
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KANGLI
SUZHOU KANGLI ORTHOPAEDICS INSTRUM510(k) NO: K133840(TRADITIONAL)
ATTN: ALICE GONG PHONE NO : 86 21 64957283
503 ROOM, 8 BUILDING, 600 LIU ZHOUSE DECISION MADE: 29-JUL-14
SHANGHAI CH 200233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTEON 6.5MM BONE SCREWS
EXACTECH, INC. 510(k) NO: K141797(SPECIAL)
ATTN: THOMAS MCNAMARA PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 29-JUL-14
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXIPROBE E (OXIPROBE)
BIO MEDICAL TECHNOLOGIES CO., LTD 510(k) NO: K132516(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
P.O. BOX 560 SE DECISION MADE: 30-JUL-14
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
IN2BONES SAS 510(k) NO: K132912(TRADITIONAL)
ATTN: NORMAN F ESTRIN, PH.D. PHONE NO : 301 279 2899
9109 COPENHAVER DR. SE DECISION MADE: 30-JUL-14
POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCTION LIPOPLASTY ACCESSORIES
INEX 510(k) NO: K132353(TRADITIONAL)
ATTN: RAYMOND PATEL PHONE NO : 330 344 741995
ZA LA GOBETTE 60540 PUISEUX LE HAUSE DECISION MADE: 30-JUL-14
PUISEUX LE HAUBERGER FR 60540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
VR MEDICAL 510(k) NO: K132709(TRADITIONAL)
ATTN: LEE PAN, PHD PHONE NO : 86 137 88975958
90 GAOXIN ROAD, ZHOUZHUANG SE DECISION MADE: 30-JUL-14
KUN SHAN, JIANGSU CH 215325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOLED
OLYMPUS WINTER & IBE GMBH 510(k) NO: K133311(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 484 986 3147
3500 CORPORATE PARKWAY SE DECISION MADE: 30-JUL-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L’DISQ
U & I CORPORATION 510(k) NO: K132797(TRADITIONAL)
ATTN: GYEONG-JE KWON PHONE NO : 82 318520 102
20, SANDAN-RO, 76BEON-GIL (RD) SE DECISION MADE: 30-JUL-14
UIJEONGBU-SI, GYEONGGI-DO KS 48510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPINE HIP STEM; ALPINE HA HIP STEM
ORTHO DEVELOPMENT 510(k) NO: K141001(TRADITIONAL)
ATTN: MIKE ENSIGN PHONE NO : 801 553 9991
12187 S. BUSINESS PARK DR. SE DECISION MADE: 30-JUL-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
EXACTECH, INC. 510(k) NO: K140302(TRADITIONAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 30-JUL-14
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORPORATION 510(k) NO: K141778(SPECIAL)
ATTN: KIRSTEN STOWELL FRANCO PHONE NO : 610 404 3367
100 DENNIS DRIVE SE DECISION MADE: 30-JUL-14
READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEADERFLEX
VYGON 510(k) NO: K141026(TRADITIONAL)
ATTN: JILLIAN MIKOVICH PHONE NO : 800 473 5414
2750 MORRIS ROAD, SUITE A200 SE DECISION MADE: 30-JUL-14
LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOMPASS
PANORAMIC CORP. 510(k) NO: K141130(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 30-JUL-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPEN FMSEALER
DOMAIN SURGICAL, INC. 510(k) NO: K141484(TRADITIONAL)
ATTN: CURTIS JENSEN PHONE NO : 801 924 4950
1370 SOUTH 2100 EAST SE DECISION MADE: 30-JUL-14
SALT LAKE SITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2M MODULAR HOOKS
K2M, INC. 510(k) NO: K133402(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
PO BOX 566 SE DECISION MADE: 30-JUL-14
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCAM STOPCOCKS AND MANIFOLDS
ELCAM MEDICAL ACAL 510(k) NO: K141254(SPECIAL)
ATTN: NATASHA BRANZBURG PHONE NO : 972 772568 625
KIBBUTZ BARAM SE DECISION MADE: 30-JUL-14
MP MEROM HAGALIL IS 1386000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY PDX CYCLER
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K141145(TRADITIONAL)
ATTN: DENISE M OPPERMANN PHONE NO : 781 699 4479
920 WINTER STREET SE DECISION MADE: 30-JUL-14
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
BIOMET, INC. 510(k) NO: K140883(TRADITIONAL)
ATTN: JOHN HECKAMAN PHONE NO : 574 371 3707
56 EAST BELL DR. BOX 587 SE DECISION MADE: 30-JUL-14
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K141011(TRADITIONAL)
ATTN: DMITRI FALKNER PHONE NO : 901 290 5883
1023 CHERRY ROAD SE DECISION MADE: 30-JUL-14
MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVER DENTAL ARREST
COOLEY CONSULTING, INC. 510(k) NO: K102973(TRADITIONAL)
ATTN: WILLIAM COOLEY PHONE NO : 513 522 3797
531 CHISHOLM TRAIL SE DECISION MADE: 31-JUL-14
WYOMING OH 45215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYVEK RADIAL BAND
MARINE POLYMER TECHNOLOGIES 510(k) NO: K132293(TRADITIONAL)
ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781 270 3200
107 WATER STREET SE DECISION MADE: 31-JUL-14
DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSIZE
THERENVA SAS 510(k) NO: K141475(TRADITIONAL)
ATTN: CEMIL GOKSU PHONE NO : 33 299 283751
2 RUE HENRI LE GUILLOUX SE DECISION MADE: 31-JUL-14
RENNES FR 35000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARGEN PMMA
THE ARGEN CORPORATION 510(k) NO: K140894(TRADITIONAL)
ATTN: CRAIG JOLICOEUR PHONE NO : 858 455 7900
5855 OBERLIN DRIVE SE DECISION MADE: 31-JUL-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSILIGHT MINI
EL GLOBAL TRADE LTD. 510(k) NO: K140527(TRADITIONAL)
ATTN: SHLOMIT SEGMAN PHONE NO : 972 9788 9069
TZORAN 4TH ST. SE DECISION MADE: 31-JUL-14
NETANYA IS 42504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIARC 100AU+
BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K141672(SPECIAL)
ATTN: JUNE LI PHONE NO : 861 067892 3558968
B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 31-JUL-14
BEIJING CH 100023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S9 GREENHILLS
RESMED LTD. 510(k) NO: K140279(TRADITIONAL)
ATTN: JIM CASSI PHONE NO : 858 836 6081
9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 31-JUL-14
SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
SAPHENA MEDICAL, INC. 510(k) NO: K140603(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949 285 3517
27392 CAPRICHO SE DECISION MADE: 31-JUL-14
MISSION VIEJO CA 92692 510(k) SUMMARY AVAILABLE FROM FDA
