April 2014 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2014
TOTAL 510(k)s THIS PERIOD 268
TOTAL WITH SUMMARIES 250
TOTAL WITH STATEMENTS 18
DEVICE: OMNYX IDP FOR HER2 MANUAL APPLICATION
OMNYX, LLC 510(k) NO: K131140(TRADITIONAL)
ATTN: GAIL E RADCLIFFE PHONE NO : 508 835 1688
62 FOREST STREET, SUITE 300 SE DECISION MADE: 01-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A1C GEAR SYSTEM
SAKAE CORPORATION 510(k) NO: K130014(TRADITIONAL)
ATTN: ERICA B AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 04-APR-14
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTUS C. DIFFICILE QS-RGQ MDX KIT
QIAGEN, GMBH 510(k) NO: K133936(TRADITIONAL)
ATTN: KIMBERLY MAPP PHONE NO : 301 944 7817
1201 CLOPPER RD SE DECISION MADE: 04-APR-14
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WUNDER PREGNANCY TEST
JAMES NGUYEN 510(k) NO: K130456(TRADITIONAL)
ATTN: JAMES NGUYEN, M.D. PHONE NO : 408 569 5454
2231 FORTUNE DR, STE D SE DECISION MADE: 08-APR-14
SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K140089(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 08-APR-14
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
LK CONSULTING GROUP USA, INC. 510(k) NO: K133045(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-APR-14
FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN LAMBDA FREE KIT
THE BINDING SITE GROUP, LTD. 510(k) NO: K140396(TRADITIONAL)
ATTN: DOUG KURTH PHONE NO :
5889 OBDERLIN DR., STE 101 SE DECISION MADE: 16-APR-14
SAN DIEGO CA 92121 510(k) STATEMENT
DEVICE: ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD 510(k) NO: K132406(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 18-APR-14
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
THE BINDING SITE GROUP, LTD. 510(k) NO: K140664(TRADITIONAL)
ATTN: JON LAUDER PHONE NO : 44 121 4569500
8 CALTHORPE ROAD SE DECISION MADE: 16-APR-14
EDGBASTON UK B15 1QT 510(k) STATEMENT
DEVICE: EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K133537(SPECIAL)
ATTN: CYNTHIA HUNG PHONE NO : 886 36 686868X652
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 28-APR-14
HSINCHU CITY, TW 30077 510(k) STATEMENT
DEVICE: VUPAD
SONOMED, INC. 510(k) NO: K140199(TRADITIONAL)
ATTN: CHARLES C O’NEAL PHONE NO : 516 354 0900
1979 MARCUS AVE., SUITE 105C SE DECISION MADE: 01-APR-14
LAKE SUCCESS NY 11042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADO STEERABLE SHEATH
KALILA MEDICAL, INC. 510(k) NO: K140420(TRADITIONAL)
ATTN: CARRIE NEUBERGER PHONE NO : 415 640 3377
745 CAMDEN AVE, SUITE A SE DECISION MADE: 01-APR-14
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140541(ABBREVIATED)
ATTN: GARO MIMARYAN PHONE NO : 914 524 3270
511 BENEDICT AVE. SE DECISION MADE: 01-APR-14
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED DISTAL RADIUS PLATING SYSTEM
BIOMET 510(k) NO: K133939(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386
56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 01-APR-14
WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX CLAVICLE HOOK PLATE
STRYKER TRAUMA AG 510(k) NO: K140259(TRADITIONAL)
ATTN: ELIJAH N WREH PHONE NO : 201 831 5691
325 CORPORATE DRIVE SE DECISION MADE: 01-APR-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TABLET VIEWER SOFTWARE FOR IMAGE SUITE
CARESTREAM HEALTH, INC. 510(k) NO: K140271(TRADITIONAL)
ATTN: ALEXANDRA CHAMBERLAIN PHONE NO : 585 627 8790
150 VERONA STREET SE DECISION MADE: 01-APR-14
ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMBIBE NEEDLE
ORTHOVITA, INC. 510(k) NO: K140414(TRADITIONAL)
ATTN: JOHN URTZ PHONE NO : 610 407 7450
77 GREAT VALLEY PARKWAY SE DECISION MADE: 01-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
ARTHROCARE CORPORATION 510(k) NO: K133606(TRADITIONAL)
ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995
7000 West William Cannon Drive SE DECISION MADE: 01-APR-14
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNESIS PEEK CERVICAL CAGE
BK MEDITECH CO., LTD. 510(k) NO: K132483(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
PO BOX 560 SE DECISION MADE: 02-APR-14
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHP 300, EMERGENCY PORTABLE VENTILATOR
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K132021(TRADITIONAL)
ATTN: STEPHEN MUNDWILLER PHONE NO : 314 268 1661
1720 SUBLETTE AVE. SE DECISION MADE: 02-APR-14
Saint Louis MO 63110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNATURE PLANNER, SIGNATURE GUIDES
MATERIALISE N.V. 510(k) NO: K140257(TRADITIONAL)
ATTN: OLIVER CLEMENS PHONE NO : 321 674453 7
15 TECHNOLOGIELAAN SE DECISION MADE: 02-APR-14
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133933(SPECIAL)
ATTN: ASHLEY SANTOS PHONE NO : 508 683 4359
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 02-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
DIALYSIS MEDICAL SOLUTIONS, LLC 510(k) NO: K131202(TRADITIONAL)
ATTN: COURTNEY J MILLER PHONE NO : 614 719 2858
21 EAST STATE STREET SUITE 1700 SE DECISION MADE: 03-APR-14
COLUMBUS OH 43215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
SPENCER FILLMORE 510(k) NO: K130757(TRADITIONAL)
ATTN: CHRISTINA BERNSTEIN PHONE NO : 415 450 0515
2670 LEAVENWORTH ST. SE DECISION MADE: 03-APR-14
SAN FRANCISCO CA 94133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALCONNECT PLATFORM BY VITAL CONNECT INC.
VITAL CONNECTIONS, INC. 510(k) NO: K132447(TRADITIONAL)
ATTN: SAM MOSTAFAVI PHONE NO : 408 963 4620
900 E. HAMILTON AVE. STE # 500 SE DECISION MADE: 03-APR-14
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIZION ULTRA
VIZTEK LLC 510(k) NO: K133139(SPECIAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 03-APR-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIBLE COOAGEN NERVE CUFF
COLLAGEN MATRIX, INC. 510(k) NO: K131541(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201 405 1477
15 THORNTON ROAD SE DECISION MADE: 03-APR-14
OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUITY PRO LEAD DELIVERY SYSTEM
BOSTON SCIENTIFIC 510(k) NO: K132914(TRADITIONAL)
ATTN: HOLLY RAMIREZ PHONE NO : 763 494 2113
ONE SCIMED PLACE SE DECISION MADE: 03-APR-14
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL CODE WRITER
ZOLL MEDICAL CORPORATION 510(k) NO: K132488(TRADITIONAL)
ATTN: SHANNON DUHAMEL PHONE NO : 978 421 9574
269 MILL ROAD SE DECISION MADE: 03-APR-14
CHELMSFORD MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCLOT TOPICAL
CRYOLIFE, INC. 510(k) NO: K132105(TRADITIONAL)
ATTN: KIMBERLY DICONO PHONE NO : 770 419 3355
1655 ROBERTS BLVD., N.W. SE DECISION MADE: 03-APR-14
KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSOURCE IV ADMINISTRATION SET 72" MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K140402(SPECIAL)
ATTN: JENNIFER NESS PHONE NO : 952 241 8318
5346 SHORELINE DR. SE DECISION MADE: 03-APR-14
MOUND MN 55364 510(k) STATEMENT
DEVICE: COROENT SMALL INTERBODY SYSTEM
NUVASIVE, INC. 510(k) NO: K140003(TRADITIONAL)
ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549
7475 LUSK BLVD SE DECISION MADE: 03-APR-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEUTIAN IBF SYSTEM
K2M, INC. 510(k) NO: K133614(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR SE SE DECISION MADE: 03-APR-14
LEESBURG VA 22066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
MICROPORT ORTHOPEDICS INC. 510(k) NO: K140043(TRADITIONAL)
ATTN: MAX MORTENSEN PHONE NO : 901 485 1102
5677 AIRLINE RD SE DECISION MADE: 03-APR-14
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
MEDCOM GMBH 510(k) NO: K133914(ABBREVIATED)
ATTN: LUCA SALVATORE PHONE NO : 49 6151 9514718
RUNDETURMSTRASSE 12 SE DECISION MADE: 03-APR-14
DARMSTADT GM 64283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GLOBAL UNITE SHOULDER SYSTEM
DEPUY (IRELAND) 510(k) NO: K133834(TRADITIONAL)
ATTN: KELLIE MYERS PHONE NO : 574 372 7276
LOUGHBEG RINGASKIDDY SE DECISION MADE: 03-APR-14
CO. CORK EI IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
EMED TECHNOLOGIES CORPORATION 510(k) NO: K140131(SPECIAL)
ATTN: PETER KOLLINGS PHONE NO : 916 932 0071
1264 Hawks Flight Ct Ste 200 SE DECISION MADE: 03-APR-14
EL DORADO HILLS CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOTOP(R) SC
KITAZATO BIOPHARMA CO., LTD. 510(k) NO: K140072(TRADITIONAL)
ATTN: RICHARD VINCINS PHONE NO : 512 327 9997
816 CONGRESS AVE SUITE 1400 SE DECISION MADE: 03-APR-14
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACH LED 2SC
DR. MACH GMBH & CO. KG 510(k) NO: K140460(SPECIAL)
ATTN: GUDRUN BUSCH, PH.D. PHONE NO : 49 40 58979794
FEHMARNSTRASSE 31 SE DECISION MADE: 03-APR-14
NORDERSTEDT, SCHLESWIG-HOLSTEIN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACH LED 2MC
DR. MACH GMBH & CO. KG 510(k) NO: K140461(SPECIAL)
ATTN: GUDRUN BUSCH, PH.D. PHONE NO : 49 40 58979794
FEHMARNSTRASSE 31 SE DECISION MADE: 03-APR-14
NORDERSTEDT, SCHLESWIG-HOLSTEIN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX 2 SYSTEM
STRYKER TRAUMA AG 510(k) NO: K140376(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461
325 CORPORATE DRIVE SE DECISION MADE: 03-APR-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLOUDEKG
MAKROMED, INC. 510(k) NO: K130878(TRADITIONAL)
ATTN: BARRY V ASHAR PHONE NO : 603 890 3311
88 STILES ROAD SE DECISION MADE: 04-APR-14
SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
IN2BONES SAS 510(k) NO: K132911(TRADITIONAL)
ATTN: ERIC FOURCAULT PHONE NO :
28 CHEMIN DU PETIT BOIS 69130 ECULSE DECISION MADE: 04-APR-14
FRANCE FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
CLEARMRI SOLUTIONS, INC. 510(k) NO: K132381(TRADITIONAL)
ATTN: MARY ANN FERGUSON PHONE NO : 978 578 1196
W315 S3283 Harvest View Drive SE DECISION MADE: 04-APR-14
Waukesha WI 53189 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 8MP COLOR LCD MONITOR, RADIFORCE RX850
EIZO CORPORATION 510(k) NO: K140702(TRADITIONAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO SE DECISION MADE: 04-APR-14
HAKUSAN JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
NOBEL BIOCARE AB 510(k) NO: K133377(TRADITIONAL)
ATTN: PHUONG NGUYEN PHONE NO : 714 282 4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 04-APR-14
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORDICBRAINEX
NORDICNEUROLAB 510(k) NO: K133910(TRADITIONAL)
ATTN: CHANDANA GURUNG BHANDARI PHONE NO : 475 57 07095
MOLLENDALSVEIEN 65C SE DECISION MADE: 04-APR-14
BERGEN NO N-5009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US ENDOSCOPY DISTAL ATTACHMENT CAP
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K140315(TRADITIONAL)
ATTN: SAGAR D PIMPALWAR PHONE NO : 440 639 4494
5976 HEISLEY RD. SE DECISION MADE: 04-APR-14
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
BIOPLAX LIMITED 510(k) NO: K130959(TRADITIONAL)
ATTN: PAUL KETTERIDGE PHONE NO : 443 729 0836
472 S STATE STREET, #101 SE DECISION MADE: 04-APR-14
BELLINGHAM WA 98225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSP HIP FRACTURE PLATING SYSTEM
BIOMET, INC. 510(k) NO: K140018(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574 267 6639
56 EAST BELL DR. SE DECISION MADE: 04-APR-14
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
TORNIER, INC. 510(k) NO: K133777(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO :
10801 NESBITT AVENUE SOUTH SE DECISION MADE: 04-APR-14
BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIBALL INCENTIVE SPIROMETER
BESMED HEALTH BUSINESS CORP. 510(k) NO: K133873(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
NO.5, LANE116, WU-KONG 2ND RD SE DECISION MADE: 04-APR-14
NEW TAIPEI CITY, WU-KU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIA RADIATION THERAPY MANAGEMENT
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K133572(TRADITIONAL)
ATTN: PETER J CORONADO PHONE NO : 650 424 5731
3120 HANSEN WAY C-260 SE DECISION MADE: 04-APR-14
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD RITECATH INTERMITTENT CATHETER
C.R. BARD, INC. 510(k) NO: K133470(TRADITIONAL)
ATTN: MICHELE DAVIS PHONE NO : 770 784 6274
8195 INDUSTRIAL BLVD SE DECISION MADE: 04-APR-14
COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO DUAL ENERGY SOFTWARE PACKAGE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132902(TRADITIONAL)
ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912
51 VALLEY STREAM PKWY. SE DECISION MADE: 07-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROPHILIC COATED GUIDEWIRE
LAKE REGION MEDICAL 510(k) NO: K133155(TRADITIONAL)
ATTN: TRACY MEYER PHONE NO : 952 448 5111
340 LAKE HAZELTINE DRIVE SE DECISION MADE: 07-APR-14
CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THREADED PEEK K-WIRE
MTP SOLUTIONS LLC 510(k) NO: K133235(TRADITIONAL)
ATTN: ROBERT HOY PHONE NO : 614 448 6358
124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 07-APR-14
LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDINAUT KYPHOPLASTY SYSTEM
IMEDICOM 510(k) NO: K133669(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 922 5276
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 07-APR-14
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEED TRIAD
BIOMEDICAL ENT., INC. 510(k) NO: K133844(SPECIAL)
ATTN: JOE SOWARD PHONE NO : 210 677 0354
14785 OMICRON DR., SUITE 205 SE DECISION MADE: 07-APR-14
SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
MERETE MEDICAL GMBH 510(k) NO: K140069(TRADITIONAL)
ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 493 077998 0114
102 ALT LANKWITZ SE DECISION MADE: 07-APR-14
BERLIN GM D-12247 510(k) STATEMENT
DEVICE: FRAGMENT PLATE SYSTEM
SKELETAL DYNAMICS, LLC 510(k) NO: K140372(TRADITIONAL)
ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585
8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 07-APR-14
MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABACUS TM SPACER SYSTEM
SPINE WAVE, INC. 510(k) NO: K140007(TRADITIONAL)
ATTN: JOSEPH MERCADO PHONE NO : 203 944 9494
THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 07-APR-14
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXANO SURGICAL MIS SPINAL SYSTEM
BAXANO SURGICAL, INC. 510(k) NO: K133743(TRADITIONAL)
ATTN: KRISTEN ALLEN PHONE NO : 910 332 1733
301 Government Center Drive SE DECISION MADE: 07-APR-14
Wilmington NC 28403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFUSE
BAXTER HEALTHCARE CORP. 510(k) NO: K130531(TRADITIONAL)
ATTN: GRETCHEN MURRAY PHONE NO : 805 372 3065
ONE BAXTER WAY SE DECISION MADE: 08-APR-14
WESTLAKE VILLAGE CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLIGHT 60 VENTILATOR
FLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K130171(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092
1914 JN PEASE PLACE SE DECISION MADE: 08-APR-14
CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE GYNOCULAR
GYNIUS AB 510(k) NO: K132423(TRADITIONAL)
ATTN: MATTHEW VOLSKY PHONE NO : 46 700 237670
DOBELNSGATAN 23 SE DECISION MADE: 08-APR-14
STOCKHOLM SW 11140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANDREL GUIDEWIRE
LAKE REGION MEDICAL 510(k) NO: K140482(SPECIAL)
ATTN: MATHEW PEXA PHONE NO : 952 488 5111
340 LAKE HAZELTINE DRIVE SE DECISION MADE: 08-APR-14
CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
TOP CALIBRE SDN BHD 510(k) NO: K133949(TRADITIONAL)
ATTN: ROSNITA MAODIN PHONE NO : 603 329105 16
Lot 13726, Jalan Haji Salleh, BatuSE DECISION MADE: 08-APR-14
KLANG, SELANGOR MY 41050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL LIGHT HANDLE COVER
MICROTEK MEDICAL, INC. AN ECOLAB C510(k) NO: K133554(SPECIAL)
ATTN: ANDY ROLLER PHONE NO : 651 293 2080
370 WABASHA STREET N SE DECISION MADE: 08-APR-14
ST. PAUL MN 55102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHROS POSTERIOR STABILIZATION SYSTEM
CAMBER SPINE 510(k) NO: K133366(TRADITIONAL)
ATTN: DANIEL A PONTECORVO PHONE NO : 484 420 4671
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 08-APR-14
NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
COVIDIEN 510(k) NO: K123555(TRADITIONAL)
ATTN: JIM WELSH PHONE NO : 508 261 8532
15 HAMPSHIRE STREET SE DECISION MADE: 09-APR-14
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA ISQ
OSSTELL AB 510(k) NO: K132401(SPECIAL)
ATTN: CHERITA JAMES PHONE NO : 703 562 9800
901 KING STREET SUITE 101 SE DECISION MADE: 09-APR-14
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZELTIQ COOLSCULPTING SYSTEM
ZELTIQ AESTHETICS, INC. 510(k) NO: K133212(TRADITIONAL)
ATTN: SHRUTI JAYAKUMAR PHONE NO : 925 621 2516
4698 Willow Road SE DECISION MADE: 09-APR-14
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
OPUS KSD, INC. 510(k) NO: K131563(TRADITIONAL)
ATTN: ROSINA ROBINSON, RN, MED, RPHONE NO : 508 247 7244
62 FOREST STREET SUITE 300 SE DECISION MADE: 09-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER TEMPORARY CONDYLAR PROSTHESIS
STRYKER 510(k) NO: K133285(TRADITIONAL)
ATTN: JAMSHED BADARPURA PHONE NO : 269 389 4260
750 TRADE CENTRE WAY STE 200 SE DECISION MADE: 09-APR-14
PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HTFX-222
GC AMERICA, INC. 510(k) NO: K133182(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 597 0900
3737 WEST 127TH ST. SE DECISION MADE: 09-APR-14
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX VIDEO COLONOSCOPES (EC FAMILY)
PENTAX MEDICAL COMPANY 510(k) NO: K131855(TRADITIONAL)
ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880
3 Paragon Drive SE DECISION MADE: 09-APR-14
MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD-FLEX HEAVY BODY
META BIOMED, INC. 510(k) NO: K134008(TRADITIONAL)
ATTN: BLIX WINSTON PHONE NO : 301 607 9185
2600 MULLINIX MILL ROAD SE DECISION MADE: 09-APR-14
MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K132009(TRADITIONAL)
ATTN: PAMELA PAPINEAU, RAC PHONE NO : 978 772 3552
5 WHITCOMB AVE. SE DECISION MADE: 09-APR-14
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEXICONTURE MECHANICAL DILATOR SHEATH SET
SPECTRANETICS CORP. 510(k) NO: K140047(TRADITIONAL)
ATTN: PHAROAH GARMA PHONE NO : 719 447 2385
9665 FEDERAL DRIVE SE DECISION MADE: 09-APR-14
COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRC-PASTE
KM CORPORATION 510(k) NO: K133716(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E. KATELLA AVE UNIT 2115 SE DECISION MADE: 09-APR-14
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIORA V-TOTAL
VIORA LTD. 510(k) NO: K133837(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 4 6388837
31 HAAVODA ST. SE DECISION MADE: 09-APR-14
BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
COVIDIEN 510(k) NO: K140609(SPECIAL)
ATTN: CLARE SANTULLI PHONE NO : 203 492 7635
60 MIDDLETOWN AVE SE DECISION MADE: 09-APR-14
NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIX SELECT DR
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K132934(TRADITIONAL)
ATTN: PATRICIA D JONES PHONE NO : 610 448 3536
51 VALLEY STREAM PARKWAY SE DECISION MADE: 10-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IEEG
JORDAN NEUROSCIENCE, INC. 510(k) NO: K131944(TRADITIONAL)
ATTN: ANNE PERRY PHONE NO : 909 881 2694
1660 PLUM LANE SE DECISION MADE: 10-APR-14
REDLANDS CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
PENTAX MEDICAL COMPANY 510(k) NO: K131902(TRADITIONAL)
ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880
3 Paragon Drive SE DECISION MADE: 10-APR-14
MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR I V3.1 SYSTEM
SYNERON MEDICAL LTD 510(k) NO: K133238(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 10-APR-14
PHILADELPHIA PA 19103 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
MATERIALISE N.V. 510(k) NO: K132290(TRADITIONAL)
ATTN: OLIVER CLEMENS PHONE NO : 32 16 744537
TECHNOLOGIELAAN 15 SE DECISION MADE: 10-APR-14
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA NEO CLINICAL THERAPY SYSTEM
DJO, LLC 510(k) NO: K132284(TRADITIONAL)
ATTN: MARIA PRONINA PHONE NO : 760 734 5599
1430 Decision St SE DECISION MADE: 10-APR-14
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STREAMLINE TL SPINAL FIXATION SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K140696(SPECIAL)
ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861
375 RIVER PARK CIRCLE SE DECISION MADE: 10-APR-14
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUALGUARD
FLEXICARE MEDICAL LTD. 510(k) NO: K140473(TRADITIONAL)
ATTN: CHRISTOPHER WATKINS PHONE NO : 441 44 3471593
CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 10-APR-14
MID GLAMORGAN UK CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIO-PROBE TRANSDUCER (ADULT)
MEDTRONIC INC. 510(k) NO: K133903(TRADITIONAL)
ATTN: RAHUL SHAH PHONE NO : 763 514 9846
8200 CORAL SEA STREET NE SE DECISION MADE: 10-APR-14
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
PENTAX MEDICAL COMPANY 510(k) NO: K131028(TRADITIONAL)
ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880
3 Paragon Drive SE DECISION MADE: 10-APR-14
MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROMTA-ORTHOMTA II
BIOMTA 510(k) NO: K132825(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-APR-14
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
STRYKER SUSTAINABILITY SOLUTIONS 510(k) NO: K133578(TRADITIONAL)
ATTN: JILL CLARK PHONE NO : 480 763 5300
1810 WEST DRAKE DRIVE SE DECISION MADE: 10-APR-14
TEMPE AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN 510(k) NO: K140339(TRADITIONAL)
ATTN: BRIANNA REYNOLDS PHONE NO : 303 305 2728
6135 GUNBARREL AVE. SE DECISION MADE: 10-APR-14
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
TOSOH BIOSCIENCE, INC. 510(k) NO: K140648(ABBREVIATED)
ATTN: ROBERT L WICK PHONE NO : 650 636 8117
6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 10-APR-14
SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
LEMAITRE VASCULAR, INC. 510(k) NO: K140042(TRADITIONAL)
ATTN: BRYAN COWELL PHONE NO : 781 425 1727
63 SECOND AVENUE SE DECISION MADE: 10-APR-14
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTEX AND OTHERS PROPRIETARY NAMES
ONTEX BVBA 510(k) NO: K132208(TRADITIONAL)
ATTN: RACHEL PAUL PHONE NO : 317 034585 70
PRINSESSEGRACHT 20 SE DECISION MADE: 10-APR-14
THE HAGUE NL 2514AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL EXAMINATION GLOVES
SHU TONG XINGHUA CO., LTD. 510(k) NO: K122176(TRADITIONAL)
ATTN: SU SONG SHI PHONE NO : 008 652 383495619
WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14
XINGHUA CH 225700 510(k) STATEMENT
DEVICE: POWDER FREE VINYL EXAMINATION GLOVES
SHU TONG XINGHUA CO., LTD. 510(k) NO: K122377(TRADITIONAL)
ATTN: SU SONG SHI PHONE NO : 008 652383 495619
WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14
XINGHUA CH 225700 510(k) STATEMENT
DEVICE: RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K132312(TRADITIONAL)
ATTN: SHARYN ORTON, PH.D. PHONE NO : 401 330 8264
200 HOMER AVE SE DECISION MADE: 11-APR-14
ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPOSED OPTIMUS
CUSTOM SPINE, INC. 510(k) NO: K132596(TRADITIONAL)
ATTN: HANAA SHAHIN PHONE NO : 973 808 0019
9 Campus Dr SE DECISION MADE: 11-APR-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
SATELEC-ACTEON GROUP 510(k) NO: K131906(ABBREVIATED)
ATTN: RICK ROSATI PHONE NO : 800 289 6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 11-APR-14
MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL-BOND UNIVERSAL SC (NOT FINALIZED)
BISCO, INC. 510(k) NO: K131734(TRADITIONAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 11-APR-14
SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
INOVISE MEDICAL, INC. 510(k) NO: K131883(TRADITIONAL)
ATTN: EARL ANDERSON PHONE NO : 503 431 3800
8770 SW NIMBUS AVENUE SUITE D SE DECISION MADE: 11-APR-14
BEAVERTON OR 97008 7196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR-FLOW HANDY 3.0
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132478(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919 859 4207
62 FOREST ST., STE 300 SE DECISION MADE: 11-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K132138(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222
1140 FIRST STREET SOUTH SE DECISION MADE: 11-APR-14
COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEEL ENDOSCOPIC RETRACTOR
RETRACTION LIMITED 510(k) NO: K133345(TRADITIONAL)
ATTN: STUART MORAN PHONE NO : 852 311 06011
UNIT F, 2/F, HONG KONG INDUSTRIAL SE DECISION MADE: 11-APR-14
SAI WAN, HONG KONG CH 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION FREEDOMPIN
INION OY 510(k) NO: K133932(TRADITIONAL)
ATTN: KATI MARTTINEN PHONE NO : 358 108306 600
LAAKARINKATU 2 SE DECISION MADE: 11-APR-14
TAMPERE FI 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K134047(TRADITIONAL)
ATTN: RUTHANNE VENDY PHONE NO : 717 840 3527
589 DAVIES DRIVE SE DECISION MADE: 11-APR-14
YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEWORKS ANTERIOR LUMBAR DEVICE
SPINEWORKS, LLC 510(k) NO: K133340(TRADITIONAL)
ATTN: ROBERT POGGIE, PHD PHONE NO : 973 738 6097
815 IRIS LANE SE DECISION MADE: 11-APR-14
VERO BEACH FL 32963 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DECLIPSESPECT LAPAROSCOPY
SURGICEYE GMBH 510(k) NO: K133781(TRADITIONAL)
ATTN: MORITZ HOYER PHONE NO : 49 895499 89024
FRIEDENSTRASSE 18A SE DECISION MADE: 11-APR-14
MUNICH, BAVARIA GM 81671 510(k) STATEMENT
DEVICE: REVOLUTION CT
GE MEDICAL SYSTEMS, LLC 510(k) NO: K133705(TRADITIONAL)
ATTN: HELEN PENG PHONE NO : 262 424 8222
3000 N GRANDVIEW BLVD. SE DECISION MADE: 11-APR-14
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-PM-DISC
MERZ DENTAL GMBH 510(k) NO: K134015(TRADITIONAL)
ATTN: RICHARD G HUNTER PHONE NO : 505 400 4992
5616 MARIOLA PL NE SE DECISION MADE: 11-APR-14
ALBUQUERQUE NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
REFLECTANCE MEDICAL INC 510(k) NO: K133923(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 781 710 5378
116 FLAUNDERS ROAD, SUITE 1000 SE DECISION MADE: 11-APR-14
WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIBRALT ROD-TO-ROD CROSS CONNECTORS
EXACTECH SARASOTA 510(k) NO: K140645(SPECIAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
7455 16th Street East Suite 105 SE DECISION MADE: 11-APR-14
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
RAYENCE CO., LTD 510(k) NO: K140646(SPECIAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
8310 BUFFALO SPEEDWAY SE DECISION MADE: 11-APR-14
HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZE PHOENIX SOFTWARE
AZE, LTD. 510(k) NO: K133521(TRADITIONAL)
ATTN: KARL DIEDRICH, AZE PHONE NO : 617 475 1502
1-8-1 MARUNOUCHI, CHIYODA-KU SE DECISION MADE: 11-APR-14
TOKYO JA 100-0005 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ERCHONIA ALLAY
ERCHONIA MEDICAL, INC. 510(k) NO: K132940(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412
33 GOLDEN EAGLE LANE SE DECISION MADE: 14-APR-14
LITTLETON CO 80127 510(k) STATEMENT
DEVICE: DISCOSCOPES, CERVICAL ENDOSCOPES
RZ MEDIZINTECHNIK GMBH 510(k) NO: K130778(TRADITIONAL)
ATTN: ANDRE WEINGREL PHONE NO : 49 7463 99540
GRIESWEG 47 SE DECISION MADE: 14-APR-14
MUEHLHEIM, BADEN-WUERTTEMBERG G510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVANCE® FOAM ABDOMINAL DRESSING KIT
MOLNLYCKE HEALTHCARE 510(k) NO: K130852(TRADITIONAL)
ATTN: ANGELA L BUNN PHONE NO : 678 250 7930
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 14-APR-14
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERVICAL STAND ALONE SYSTEM
ORTHOFIX INC. 510(k) NO: K132999(TRADITIONAL)
ATTN: NATALIA VOLOSEN PHONE NO : 214 937 2145
3451 PLANO PARKWAY SE DECISION MADE: 14-APR-14
LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYHEALTHPOINT TELEHEALTH MANAGER
ENTRA HEALTH SYSTEMS 510(k) NO: K132930(TRADITIONAL)
ATTN: RICHARD STROBRIDGE PHONE NO : 877 458 2646
3111 Camino Del Rio North Suite 10SE DECISION MADE: 14-APR-14
San Diego CA 92108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICASSO II MIS SPINAL SYSTEM
ACCEL SPINE 510(k) NO: K140219(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512 507 0746
14001 HUNTERS PASS SE DECISION MADE: 14-APR-14
AUSTIN TX 78734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
GALEMED CORP. 510(k) NO: K133957(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498215 5
AMOY EXPORT PROCESSING ZONE, 39 SESE DECISION MADE: 14-APR-14
XIAMEN, FUJIAN CH 361000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CABOCHON SYSTEM
CABOCHON AESTHETICS, INC. 510(k) NO: K134010(TRADITIONAL)
ATTN: BEN F BRIAN, PH.D. PHONE NO : 650 543 7110
127 INDEPENDENCE DRIVE SE DECISION MADE: 14-APR-14
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELISIO-H HEMODIALYZER
NIPRO MEDICAL CORPORATION 510(k) NO: K140191(SPECIAL)
ATTN: CAROLYN GEORGE PHONE NO : 305 599 7174
3150 NW 107 AVE., SE DECISION MADE: 14-APR-14
MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAMIC RCS SYRINGE
NAVILYST MEDICAL, INC. 510(k) NO: K140194(ABBREVIATED)
ATTN: BRANDON M BRACKETT PHONE NO : 508 658 7984
26 FOREST STREET SE DECISION MADE: 14-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COGENT MED-LIF
COGENT SPINE LLC 510(k) NO: K132738(TRADITIONAL)
ATTN: JUDE PAGANELLI PHONE NO : 858 774 7891
101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 15-APR-14
SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
CAREFUSION 510(k) NO: K140831(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO :
10020 PACIFIC MESA BLVD SE DECISION MADE: 15-APR-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
BOSTON SCIENTIFIC 510(k) NO: K140503(TRADITIONAL)
ATTN: JEANNE O’TOOLE PHONE NO : 508 683 4271
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 15-APR-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 6200 / 6250 ULTRASOUND SYSTEM
ESAOTE S.P.A. 510(k) NO: K133905(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 228 8719
9001 WESLEYAN ROAD, SUITE 200 SE DECISION MADE: 15-APR-14
INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K133389(SPECIAL)
ATTN: CYNTHIA HUNG PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 15-APR-14
HSINCHU CITY, TW 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
PAN MEDICAL LTD 510(k) NO: K132620(TRADITIONAL)
ATTN: JENNIE BUDDING PHONE NO : 44 1452 621621
BARNETT WAY, BARNWOOD SE DECISION MADE: 16-APR-14
GLOUCESTER, GLOUCESTERSHIRE UK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
STERNGOLD DENTAL LLC 510(k) NO: K133791(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508 556 5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 16-APR-14
ATTLEBORO MA 02703 0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
CURRIE MEDICAL SPECIALTIES, INC. 510(k) NO: K140092(TRADITIONAL)
ATTN: OWEN J BRY PHONE NO : 909 912 0900
8758 Hellman Ave SE DECISION MADE: 16-APR-14
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
AMERIWATER 510(k) NO: K133783(TRADITIONAL)
ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833
1303 STANLEY AVE. SE DECISION MADE: 16-APR-14
DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTATING ADAPTERS
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140475(TRADITIONAL)
ATTN: CORY MARSH PHONE NO : 801 316 3690
1600 WEST MERIT PKWY. SE DECISION MADE: 16-APR-14
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSERTION TOOL
BOSTON SCIENTIFIC CORP. 510(k) NO: K140673(SPECIAL)
ATTN: LISA MEE PHONE NO : 763 494 1185
ONE SCIMED PLACE SE DECISION MADE: 16-APR-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTESS CERVICAL CAGE SYSTEM
KALITEC DIRECT, LLC 510(k) NO: K133815(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199
1001 OAKWOOD BLVD SE DECISION MADE: 16-APR-14
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEPATH CTO DEVICE
BOSTON SCIENTIFIC CORP. 510(k) NO: K140288(SPECIAL)
ATTN: CAROL TIFFANY PHONE NO :
ONE SCIMED PLACE SE DECISION MADE: 16-APR-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
ORIGIO A/S 510(k) NO: K133707(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 45 4679 0200
Knardrupvej 2 SE DECISION MADE: 16-APR-14
Maaloev DA 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
HITACHI ALOKA MEDICAL, LTD. 510(k) NO: K140639(TRADITIONAL)
ATTN: ANGELA VANARSDALE PHONE NO : 203 269 5088
10 FAIRFIELD BLVD. SE DECISION MADE: 16-APR-14
WALLINGFORD CT CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVMED DDR 2430T
PORTAVISION MEDICAL LLC 510(k) NO: K133524(TRADITIONAL)
ATTN: TERRY ANCAR PHONE NO : 866 783 4133
5401 COCOS PLUMOSAS DRIVE SE DECISION MADE: 16-APR-14
KENNER LA 70065 510(k) STATEMENT
DEVICE: ADVATX
ADVALIGHT APS 510(k) NO: K132976(TRADITIONAL)
ATTN: MAUREEN O’CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 17-APR-14
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOV DIODE LASER FAMILY
G.N.S NEOLASER LTD. 510(k) NO: K133006(TRADITIONAL)
ATTN: GIL SHAPIRA PHONE NO : 972 467 79919
7 HA’ESHEL STR SE DECISION MADE: 17-APR-14
CAESAREA IS 38900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART (SMART-D, SMART-DX)
BTS SPA 510(k) NO: K131660(TRADITIONAL)
ATTN: ENRICO BISSON PHONE NO : 39 049981 5500
VIA CROCE ROSSA, 11 SE DECISION MADE: 17-APR-14
PADOVA IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HC-1 AND HC-1 CLASSIC
TRANSCENDENCIAS COMERCIALES SL TRA510(k) NO: K131852(TRADITIONAL)
ATTN: RAMON ECHEVARRIA PHONE NO : 34 943 224360
C/ZUBIBERRI 31- PLANTA BAJA LOCAL SE DECISION MADE: 17-APR-14
SAN SEBASTIAN, GUIPUZCOA SP 200510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
MONARCH MEDICAL TECHNOLOGIES 510(k) NO: K132547(ABBREVIATED)
ATTN: ANN A GRAHAM PHONE NO : 240 476 3477
3457 CHISWICK COURT SE DECISION MADE: 17-APR-14
SILVER SPRING MD 20906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-STATION
PHILIPS ULTRASOUND, INC. 510(k) NO: K140808(TRADITIONAL)
ATTN: PENNY GRECO PHONE NO :
3000 MINUTEMAN RD. SE DECISION MADE: 17-APR-14
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
BECKMAN COULTER, INC. 510(k) NO: K131189(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 714 307 3469
250 S. KRAEMER ST SE DECISION MADE: 17-APR-14
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
BOSTON SCIENTIFIC CORP. 510(k) NO: K140495(TRADITIONAL)
ATTN: MATT BEAUCHANE PHONE NO : 763 494 1789
ONE SCIMED PLACE SE DECISION MADE: 17-APR-14
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESTINO TWIST, STEERABLE GUIDING SHEATH
OSCOR INC. 510(k) NO: K140406(SPECIAL)
ATTN: TINA STRICKLAND PHONE NO : 727 937 2511
3816 DE SOTO BLVD. SE DECISION MADE: 17-APR-14
PALM HARBOR FL 34683 510(k) STATEMENT
DEVICE: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
STRAUMANN USA, LLC 510(k) NO: K133421(TRADITIONAL)
ATTN: CHARLOTTE RINGLEB PHONE NO : 978 747 2552
60 MINUTEMAN ROAD SE DECISION MADE: 17-APR-14
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIS MODULIFT VBR SYSTEM
AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K133802(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610 984 9274
3773 CORPORATE PWKY. SE DECISION MADE: 17-APR-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALOCK PLATING SYSTEM / TUFFNEK SCREW
PARAGON 28 510(k) NO: K140397(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
P O BOX 566 SE DECISION MADE: 17-APR-14
CHESTERLAND OH 44026 0566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLIP INTRODUCER ACCESS KIT
VASCULAR SOLUTIONS, INC. 510(k) NO: K132789(TRADITIONAL)
ATTN: ELLIE GILLESPIE PHONE NO : 763 656 4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 17-APR-14
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX 2 SYSTEM
STRYKER TRAUMA AG 510(k) NO: K140769(SPECIAL)
ATTN: ELIJAH N WREH PHONE NO : 201 831 5691
325 CORPORATE ARIVE SE DECISION MADE: 17-APR-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
BIONIME COPORATION 510(k) NO: K133522(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 949 951 3046
2700 LA PAZ ROAD SUITE 266B SE DECISION MADE: 17-APR-14
MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM FORCE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133589(TRADITIONAL)
ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912
51 VALLEY STREAM PKWY. SE DECISION MADE: 17-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INITARY BETTER BLADDER-PEDIATRIC
CIRCULATORY TECHNOLOGY, INC. 510(k) NO: K140321(SPECIAL)
ATTN: YEHUDA TAMARI PHONE NO : 516 624 2424
21 SINGWORTH ST. SE DECISION MADE: 17-APR-14
OYSTER BAY NY 11771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM
AURORA SPINE, INC. 510(k) NO: K140715(SPECIAL)
ATTN: JUSTI N EGGLETON PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 17-APR-14
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUFACE MINI DEVICE
CAROL COLE COMPANY 510(k) NO: K133823(ABBREVIATED)
ATTN: RAND DAOUD PHONE NO : 760 734 4545
1325 Sycamore Ave Ste A SE DECISION MADE: 17-APR-14
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGONOMIC PRODUCTS WORKSTATION
ERGONOMIC PRODUCTS, INC. 510(k) NO: K132315(TRADITIONAL)
ATTN: RENEE GOULD PHONE NO : 401 651 6513
240 ANNETTE AVE SE DECISION MADE: 18-APR-14
WOONSOCKET RI 02895 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
GS MEDICAL CO., LTD. 510(k) NO: K131612(TRADITIONAL)
ATTN: DONALD W GUTHNER PHONE NO : 646 460 2984
111 HILL ROAD SE DECISION MADE: 18-APR-14
DOUGLASSVILLE PA 19518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
MINDRAY NORTH AMERICA 510(k) NO: K132075(ABBREVIATED)
ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391
800 MACARTHUR BLVD SE DECISION MADE: 18-APR-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPASS CT, COMPASS CT PORT
MIRADOR BIOMEDICAL 510(k) NO: K133624(TRADITIONAL)
ATTN: JUSTIN HULVERSHORN PHONE NO : 206 295 3372
2815 EASTLAKE AVE E SUITE 220 SE DECISION MADE: 18-APR-14
SEATTLE WA 98102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT PUTTY, MASTERGRAFT STRIP
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140375(TRADITIONAL)
ATTN: KELLY ANGLIN PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 18-APR-14
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MITEK ARTHROSCOPES
MEDOS INTERNATIONAL SARL 510(k) NO: K133941(TRADITIONAL)
ATTN: SUSAN KAGAN PHONE NO : 508 880 8097
CHEMIN-BLANC 38, CASE POSTALE SE DECISION MADE: 18-APR-14
LE LOCLE SZ CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLECARE AR APPLICATOR
GC MEDTECH, LLC 510(k) NO: K133922(TRADITIONAL)
ATTN: GREGORY MATHISON PHONE NO : 218 387 1559
3924 CASCADE BEACH ROAD SE DECISION MADE: 18-APR-14
LUTSEN MN 55612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
ANGIOSCORE, INC. 510(k) NO: K133998(TRADITIONAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989
5055 BRANDIN COURT SE DECISION MADE: 18-APR-14
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY CO2 LASER SYSTEM
BEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K133915(TRADITIONAL)
ATTN: ZHANG XIAOSONG PHONE NO : 86 106435 4759
EAST 3RD FL, BLDG M7 # 1 JIUXIANQISE DECISION MADE: 18-APR-14
CHAOYANG DISTRICT, BEIJING CH 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSORB LS
BIOMET, INC. 510(k) NO: K140625(TRADITIONAL)
ATTN: VICTORIA SCHEITLIN PHONE NO : 574 372 6801
56 EAST BELL DR. SE DECISION MADE: 18-APR-14
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIET OL
SPINEART 510(k) NO: K140474(TRADITIONAL)
ATTN: FRANK PENNESI PHONE NO : 41 22 7994025
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 18-APR-14
GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
COOK, INC. 510(k) NO: K133597(TRADITIONAL)
ATTN: SEAN SPENCE PHONE NO : 812 335 3575
750 DANIELS WAY SE DECISION MADE: 18-APR-14
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P-POD
P-POD 510(k) NO: K133397(TRADITIONAL)
ATTN: LINDA BRADDON PHONE NO : 770 837 2681
7828 HICKORY FLAT HWY. SUITE 120 SE DECISION MADE: 18-APR-14
WOODSTOCK GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCKESSON CARDIOLOGY ECG MOBILE
MCKESSON ISRAEL LTD. 510(k) NO: K133534(TRADITIONAL)
ATTN: PAUL SUMNER PHONE NO : 404 338 3556
5995 WINDWARD PARKWAY SE DECISION MADE: 18-APR-14
ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY GUIDING CATHETER
CODMAN & SHURTLEFF, INC. 510(k) NO: K140307(SPECIAL)
ATTN: HANNAH FOLEY PHONE NO : 305 265 6810
325 PARAMOUNT DR. SE DECISION MADE: 21-APR-14
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALAMO T
ALLIANCE PARTNERS, LLC. 510(k) NO: K140303(SPECIAL)
ATTN: KELLEN HILLS PHONE NO : 901 433 1990
4600 E SHELBY DR SE DECISION MADE: 21-APR-14
MEMPHIS TN 38118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
CAREFUSION 2200 INC. 510(k) NO: K140761(SPECIAL)
ATTN: JANE WEBER PHONE NO : 847 362 8094
72 N. FAIRWAY DRIVE SE DECISION MADE: 21-APR-14
VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTINCT; PLAIN, DOTTED, ULTRA THIN
PROFILATEX, S.A. DE C.V. 510(k) NO: K132390(ABBREVIATED)
ATTN: JUAN ERNESTO DE LA PUENTE PHONE NO : 52 555975 6060
FEBRERO DE 1917 #4 COL. CIPRESES SE DECISION MADE: 22-APR-14
CHALCO MX 56600 510(k) STATEMENT
DEVICE: HEPATIC VCAR
GE MEDICAL SYSTEMS SCS 510(k) NO: K133649(TRADITIONAL)
ATTN: HUY DOAN PHONE NO : 262 312 7751
3000 N. GRANDVIEW SE DECISION MADE: 22-APR-14
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133761(TRADITIONAL)
ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896
2441 MICHELLE DRIVE SE DECISION MADE: 22-APR-14
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSOURCE SELECTABLE IV SET
MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K140442(SPECIAL)
ATTN: JENNIFER NESS PHONE NO : 952 241 8318
5346 SHORELINE DR. SE DECISION MADE: 22-APR-14
MOUND MN 55364 510(k) STATEMENT
DEVICE: ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
ETHICON ENDO-SURGERY, LLC 510(k) NO: K140560(TRADITIONAL)
ATTN: ASIFA VONHOF PHONE NO : 513 337 3118
4545 CREEK ROAD SE DECISION MADE: 22-APR-14
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
BIO-MEDICAL CARBON TECHNOLOGY CO.,510(k) NO: K140147(TRADITIONAL)
ATTN: DIANE SUDDUTH PHONE NO : 512 327 9997
816 CONGRESS AVE. STE 1400 SE DECISION MADE: 22-APR-14
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
VIVONIC GMBH 510(k) NO: K133829(TRADITIONAL)
ATTN: ANDREAS HESSBERGER PHONE NO : 49 6093 971311
KURFUERST-EPPSTEIN-RING 4 SE DECISION MADE: 22-APR-14
SAILAUF GM 63877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTIP COVER
ACCUTOME, INC. 510(k) NO: K132549(TRADITIONAL)
ATTN: ADAM PICKHOLTZ PHONE NO : 610 889 0200
3222 PHOENIXVILLE PIKE SE DECISION MADE: 23-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
ONTEX BVBA 510(k) NO: K132595(TRADITIONAL)
ATTN: RACHEL PAUL PHONE NO : 31 70 3458570
PRINSESSEGRACHT 20 SE DECISION MADE: 23-APR-14
THE HAGUE NL 2514AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUM 100PRO
PROMEDIC, INC. 510(k) NO: K131889(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DR SE DECISION MADE: 23-APR-14
BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL MASK, NASAL MASK, FULL FACE MASK
BMC MEDICAL CO., LTD 510(k) NO: K133009(TRADITIONAL)
ATTN: MS. JINJING PHONE NO :
5/F Main Building No.19 Gucheng StSE DECISION MADE: 23-APR-14
Beijing CN 100043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTERVUE MACULAR INTEGRITY ASSESSMENT
CENTERVUE SPA 510(k) NO: K133758(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10 SE DECISION MADE: 23-APR-14
ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XQ-1 INCUBATOR
AT MEDICAL UAB 510(k) NO: K133742(TRADITIONAL)
ATTN: THOMAS PEDERSEN PHONE NO : 004 526340 702
DRAUGYSTES G.19 SE DECISION MADE: 23-APR-14
KAUNAS LH 51230 510(k) STATEMENT
DEVICE: DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
IMAGING SCIENCES INTERNATIONAL, LL510(k) NO: K140445(SPECIAL)
ATTN: SANJAY AHUJA PHONE NO : 267 954 1463
1910 NORTH PENN RD. SE DECISION MADE: 23-APR-14
HATFIELD PA 19440 510(k) STATEMENT
DEVICE: AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
XLUMENA, INC. 510(k) NO: K140561(SPECIAL)
ATTN: JANE BEGGS PHONE NO : 650 961 9900
453 RAVENDALE DRIVE. SUITE H SE DECISION MADE: 23-APR-14
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTRESS PEDICLE SCREW SYSTEM
SPINEOLOGY, INC. 510(k) NO: K140010(TRADITIONAL)
ATTN: KAREN ROCHE PHONE NO : 651 256 8513
7800 3RD ST NORTH SUITE 600 SE DECISION MADE: 23-APR-14
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
INFRAREDX, INC. 510(k) NO: K133897(TRADITIONAL)
ATTN: STEVEN J CHARTIER PHONE NO : 781 345 9593
34 THIRD AVE SE DECISION MADE: 23-APR-14
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY IGS 740
GE MEDICAL SYSTEMS SCS 510(k) NO: K133278(TRADITIONAL)
ATTN: MICHEL GENUER PHONE NO : 33 13070 4741
283 RUE DE LA MINIERE SE DECISION MADE: 24-APR-14
BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
DEFIBTECH, LLC 510(k) NO: K131525(TRADITIONAL)
ATTN: ED HORTON PHONE NO : 203 453 6654
741 BOSTON POST ROAD,SUITE 201 SE DECISION MADE: 24-APR-14
GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURAGEN 3D
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K130557(TRADITIONAL)
ATTN: STEPHEN H BEIER PHONE NO : 609 936 5436
311 ENTERPRISE DR. SE DECISION MADE: 24-APR-14
PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINOOK MASSAGER
PINOOK USA 510(k) NO: K132563(TRADITIONAL)
ATTN: TEJAS SHAH PHONE NO : 858 657 9226
5703 OBERLIN DRIVE STE 306 SE DECISION MADE: 24-APR-14
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODE LASER FOR HIAR REMOVAL
BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131838(TRADITIONAL)
ATTN: MIKE GU PHONE NO : 86 206232 1333
7TH FL. JINGGUI BUSINESS BLDG NO. SE DECISION MADE: 24-APR-14
GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC BREAST PUMP
SHANTOU XINGHE ELECTRICAL APPARATU510(k) NO: K132882(TRADITIONAL)
ATTN: MIKE GU PHONE NO : 86 206232 1333
7TH FLOOR, JINGUI BUSINESS BLDG, NSE DECISION MADE: 24-APR-14
GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX3000-L
DEXCOWIN CO., LTD 510(k) NO: K133007(SPECIAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 0450
110 EAST GRANADA BLVD. SUITE 207 SE DECISION MADE: 24-APR-14
ORMOND BEACH FL 32176 510(k) STATEMENT
DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC. 510(k) NO: K132433(TRADITIONAL)
ATTN: JAMES PATRICK GARVEY II PHONE NO : 650 687 4807
1525-B OBRIEN DR. SE DECISION MADE: 24-APR-14
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK RELAX PRO
HEALTHCARE INNOVATIONS, LLC 510(k) NO: K131956(TRADITIONAL)
ATTN: SHEPARD G BENTLEY, RAC PHONE NO : 949 374 9187
28241 CROWN VALLEY PKWY, STE 510(KSE DECISION MADE: 24-APR-14
LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
CODMAN & SHURTLEFF, INC. 510(k) NO: K140080(SPECIAL)
ATTN: HANNAH FOLEY PHONE NO : 305 265 6810
325 PARAMOUNT DR. SE DECISION MADE: 24-APR-14
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
EBI, LLC 510(k) NO: K140123(TRADITIONAL)
ATTN: MIKE MEDINA PHONE NO : 303 501 8548
399 Jefferson Rd SE DECISION MADE: 24-APR-14
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUID LEVEL MONITOR
COLEMAN LABORATORIES 510(k) NO: K133870(TRADITIONAL)
ATTN: LE-JUN YIN PHONE NO : 484 727 8812
1150 FIRST AVENUE, SUITE 501 SE DECISION MADE: 24-APR-14
KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOFILAMENT POLYPECTOMY SNARE
UNITED STATES ENDOSCOPY 510(k) NO: K140763(SPECIAL)
ATTN: SAGAR D PIMPALWAR PHONE NO : 440 358 6265
5976 HEISLEY ROAD SE DECISION MADE: 24-APR-14
MENTOR OH 44060 510(k) STATEMENT
DEVICE: LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
BIO-RAD LABORATORIES 510(k) NO: K134013(TRADITIONAL)
ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467
9500 JERONIMO RD. SE DECISION MADE: 24-APR-14
IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COUNTER OTC TENS DEVICE
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K132993(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 24-APR-14
BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
PENTAX MEDICAL COMPANY 510(k) NO: K131946(TRADITIONAL)
ATTN: KRISHNA GOVINDARAJAN PHONE NO : 800 431 5880
3 Paragon Drive SE DECISION MADE: 25-APR-14
MONTVALE NJ 07645 1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCTANE ELEVATE SPINAL IMPLANT SYSTEM
EXACTECH, INC. 510(k) NO: K123607(TRADITIONAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 25-APR-14
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEL-BEAD EMBOLIZATION SPHERES
VASCULAR SOLUTIONS, INC. 510(k) NO: K133237(TRADITIONAL)
ATTN: ELLIE GILLESPIE PHONE NO : 763 656 4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 25-APR-14
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE MOSES ELITE APPLIANCE
ALLEN J. MOSES, DDS, LTD. 510(k) NO: K132933(SPECIAL)
ATTN: ALLEN J MOSES, DDS PHONE NO : 312 993 0430
233 S. WACKER DR. SE DECISION MADE: 25-APR-14
CHICAGO IL 60606 510(k) STATEMENT
DEVICE: MTA FILLAPEX
ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K140247(SPECIAL)
ATTN: TARA CONRAD PHONE NO : 305 377 0077
18851 NE 29TH AVE 720 SE DECISION MADE: 25-APR-14
AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K134045(TRADITIONAL)
ATTN: JULIE LAMOTHE PHONE NO : 760 929 4300
1900 ASTON AVE. SE DECISION MADE: 25-APR-14
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTTOUCH
NEXUS6, LTD. 510(k) NO: K133951(TRADITIONAL)
ATTN: GARTH SUTHERLAND PHONE NO : 64 930727 71
8 COMMERCE STREET SUITE 205 SE DECISION MADE: 25-APR-14
AUCKLAND NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140851(SPECIAL)
ATTN: CDR YON YU, PHARM.D. PHONE NO : 404 639 3046
1600 CLIFTON ROAD, MAILSTOP D-30 SE DECISION MADE: 25-APR-14
ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140857(SPECIAL)
ATTN: CDR YON YU, PHARM.D. PHONE NO : 404 639 3046
1600 CLIFTON ROAD, MS-C18 SE DECISION MADE: 25-APR-14
ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY GO VAC
PRECISION MEDICAL, INC. 510(k) NO: K140179(SPECIAL)
ATTN: JAMES PARKER PHONE NO : 610 262 6090
300 HELD DR. SE DECISION MADE: 25-APR-14
NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINIT SMALL BONE FUSION SYSTEM
ARTHROSURFACE, INC. 510(k) NO: K140617(SPECIAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003
28 FORGE PARKWAY SE DECISION MADE: 25-APR-14
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
BIO-RAD LABORATORIES 510(k) NO: K140764(TRADITIONAL)
ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467
9500 JERONIMO RD. SE DECISION MADE: 25-APR-14
IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS ELEVA WORKSPOT
PHILIPS MEDICAL SYSTEMS DMC GMBH 510(k) NO: K140771(SPECIAL)
ATTN: GEROLD SCHWARZ PHONE NO : 49 405078 1116
ROENTGENSTRASSE 24-26 SE DECISION MADE: 25-APR-14
HAMBURG GM 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE ANTERIOR CERVICAL PLATE
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K140742(SPECIAL)
ATTN: BRET M BERRY PHONE NO : 801 295 3280
P.O. BOX 1693 SE DECISION MADE: 25-APR-14
BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY TOTAL ANKLE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K140749(SPECIAL)
ATTN: JEANINE REDDEN PHONE NO : 901 867 4522
1023 CHERRY ROAD SE DECISION MADE: 25-APR-14
MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2300 SERIES MGO PORTABLE OXYGEN
ULTRA ELECTRONICS LIMITED PRECISIO510(k) NO: K134023(TRADITIONAL)
ATTN: ANDY CHILTON PHONE NO : 441 242713 585
ARLE COURT HATHERLEY LANE SE DECISION MADE: 25-APR-14
CHELTENHAM, GLOUCESTERSHIRE UK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA CARE BLOOD PRESSURE MONITORING SYSTEM
FORA CARE INC. 510(k) NO: K133588(TRADITIONAL)
ATTN: SHARON PENG PHONE NO : 886 266258 188
6F, NO.127, WUGONG 2ND RD WUGU DISSE DECISION MADE: 25-APR-14
NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERASON USMART3400 ULTRASOUND SYSTEM
TERATECH CORP. 510(k) NO: K140834(TRADITIONAL)
ATTN: BEN CHIAMPA PHONE NO : 781 270 4143
77-79 TERRACE HALL AVE. SE DECISION MADE: 25-APR-14
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACESSA GUIDANCE HANDPIECE
HALT MEDICAL INC 510(k) NO: K132184(TRADITIONAL)
ATTN: CLARISA TATE PHONE NO : 925 271 0626
131 SAND CREEK RD STE., B SE DECISION MADE: 28-APR-14
BRENTWOOD CA 94513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARASYS
ION GENIUS INC 510(k) NO: K132179(TRADITIONAL)
ATTN: XANYA SOFRA-WEISS, PH.D PHONE NO : 808 395 0656
1833 KALAKAUA AVE. SE DECISION MADE: 28-APR-14
HONOLULU HI 96801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTEO, VIDEOGRAPH HD
OWANDY 510(k) NO: K133271(SPECIAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 0450
110 EAST GRANADA BLVD, SUITE 207 SE DECISION MADE: 28-APR-14
ORMOND BEACH FL 32176 32176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
X6D, LTD. 510(k) NO: K132042(TRADITIONAL)
ATTN: KAREL VAN GORP PHONE NO : 386 1520 5622
21 HANAFA STREET SE DECISION MADE: 28-APR-14
ZUR- MOSHE IS 42810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K140733(TRADITIONAL)
ATTN: MICHELLE ROEDING PHONE NO : 408 935 3400
150 BAYTECH DRIVE SE DECISION MADE: 28-APR-14
SAN JOSE CA 95124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAIMAN SEAL AND CUT TECHNOLOGY
AESCULAP, INC. 510(k) NO: K140839(SPECIAL)
ATTN: DENISE ADAMS PHONE NO : 610 984 9076
3773 CORPORATE PARKWAY SE DECISION MADE: 28-APR-14
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133653(TRADITIONAL)
ATTN: JULIE BASSETT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 28-APR-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSP NEONATAL TOTAL GALACTOSE KIT
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K133652(TRADITIONAL)
ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781 663 6025
940 WINTER STREET SE DECISION MADE: 28-APR-14
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS ONE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133580(TRADITIONAL)
ATTN: PATRICIA D JONES PHONE NO : 610 448 3536
51 VALLEY STREAM PKWY. SE DECISION MADE: 28-APR-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRELLA-SPEC(TM) VAGINAL SPECULUM
PROA MEDICAL, INC. 510(k) NO: K133857(TRADITIONAL)
ATTN: VICTORIA NADERSHAHI PHONE NO : 310 717 5822
2512 Artesia Blvd Ste 305C SE DECISION MADE: 28-APR-14
Redondo Beach CA 90278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURACYN PLUS SKIN AND WOUND
INNOVACYN, INC. 510(k) NO: K133542(TRADITIONAL)
ATTN: FRED L MA PHONE NO : 909 349 3370
3546 N. RIVERSIDE AVE. SE DECISION MADE: 28-APR-14
RIALTO CA 92377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPRINT ABLATION SYSTEM
COVIDIEN LLC 510(k) NO: K133821(TRADITIONAL)
ATTN: HEATHER V NIGRO PHONE NO : 508 452 1936
15 HAMPSHIRE ST SE DECISION MADE: 28-APR-14
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCTION PUMP
DING HWA CO., LTD 510(k) NO: K140031(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 716 440 7362
1083 DELAWARE AVE. SE DECISION MADE: 28-APR-14
BUFFALO NY 14223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENMATRIX SURGICAL GRAFT
C.R. BARD 510(k) NO: K140501(SPECIAL)
ATTN: GINA CASSIDY PHONE NO : 401 825 8697
100 CROSSINGS BOULEVARD SE DECISION MADE: 28-APR-14
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURODYN COMPACT, NEURODYN II
IBRAMED EQUIPAMENTOS MEDICOS 510(k) NO: K131917(TRADITIONAL)
ATTN: TARA CONRAD PHONE NO : 305 377 0077
18851 NE 29TH AVE 720 SE DECISION MADE: 29-APR-14
AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC HANDPIECE SYSTEM
TTBIO CORP. 510(k) NO: K132570(ABBREVIATED)
ATTN: SHU-CHING LEE PHONE NO : 886 4 23595958
2F, NO.7, 6TH ROAD INDUSTRY PARK SE DECISION MADE: 29-APR-14
TAICHUNG, ROC TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROMATE FRAMELESS GEN II
RENISHAW MAYFIELD SARL 510(k) NO: K132755(TRADITIONAL)
ATTN: STEPHANE VINOT PHONE NO : 011 33 437238900
31, RUE AMPERE SE DECISION MADE: 29-APR-14
CHASSIEU FR 69680 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW STETIC DENTAL AMALGAM ALLOY
NEW STETIC 510(k) NO: K140125(TRADITIONAL)
ATTN: JOHN O’BRIEN PHONE NO : 813 645 2855
445 APOLLO BEACH BLVD SE DECISION MADE: 29-APR-14
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMILY OF DISPOSABLE LENSES
SENSOR MEDICAL TECHNOLOGY, LLC 510(k) NO: K140368(TRADITIONAL)
ATTN: MAUREEN O’CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 29-APR-14
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK AVIVA PLUS SYSTEM
ROCHE DIAGNOSTICS CORPORATION 510(k) NO: K133862(SPECIAL)
ATTN: KHONE SAYSANA PHONE NO : 317 521 7593
9115 HAGUE ROAD SE DECISION MADE: 29-APR-14
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL SPINAL SYSTEM
TIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K140229(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 29-APR-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTSOFT SOFT DENTURE LINER SYSTEM
WHIP MIX CORP. 510(k) NO: K140146(TRADITIONAL)
ATTN: JOHN WATERS PHONE NO : 502 634 5357
361 FARMINGTON AVE SE DECISION MADE: 29-APR-14
LOUISVILLE KY 40217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
ORIGIO A/S 510(k) NO: K133387(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 45 4679 0220
KNARDRUPVEJ 2 SE DECISION MADE: 29-APR-14
MALOV DA 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
CAS MEDICAL SYSTEMS, INC. 510(k) NO: K133879(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203 488 6056
44 EAST INDUSTRIAL RD. SE DECISION MADE: 29-APR-14
BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
BIOSONIC TECHNOLOGIES, LLC 510(k) NO: K130065(TRADITIONAL)
ATTN: SHEPARD G BENTLEY PHONE NO : 949 374 9187
28241 CROWN VALLEY PARKWAY SUITE 5SE DECISION MADE: 30-APR-14
LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSTDI DENTAL IMPLANT SYSTEM
MOSTDI INNOVATIONS SDN BHD 510(k) NO: K132178(TRADITIONAL)
ATTN: SUSAN PARK PHONE NO : 714 525 0114
325 N. PUENTE ST UNIT B SE DECISION MADE: 30-APR-14
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC INPUT PS INTRODUCER
MEDTRONIC, INC. 510(k) NO: K132617(TRADITIONAL)
ATTN: NISARG SHAH PHONE NO : 978 739 6632
37A CHERRY HILL DRIVE SE DECISION MADE: 30-APR-14
DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
MAR COR PURIFICATION, INC. 510(k) NO: K133149(TRADITIONAL)
ATTN: KINNARI SHAH PHONE NO : 763 553 3369
14605 28TH AVENUE NORTH SE DECISION MADE: 30-APR-14
MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140959(TRADITIONAL)
ATTN: CHRISTINE DUNN PHONE NO : 425 785 1617
685 EAST MIDDLEFIELD ROAD SE DECISION MADE: 30-APR-14
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FIAGON NAVIGATION SYSTEM
FIAGON GMBH 510(k) NO: K133573(TRADITIONAL)
ATTN: DIRK MUCHA PHONE NO : 49 330220 12124
NEUENDORFSTRASSE 23B SE DECISION MADE: 30-APR-14
HENNIGSDORF GM 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM PERSPECTIVE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133590(TRADITIONAL)
ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912
51 VALLEY STREAM PARKWAY SE DECISION MADE: 30-APR-14
MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
COEUR, INC. 510(k) NO: K133600(TRADITIONAL)
ATTN: DEBRA F MANNING PHONE NO : 615 547 7923
100 PHYSICIANS WAY SUITE 200 SE DECISION MADE: 30-APR-14
LEBANON TN 37090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
FLEXICARE 510(k) NO: K133516(TRADITIONAL)
ATTN: CHRISTOPHER WATKINS PHONE NO : 441 443474 560
CYNON VALLEY BUSINESS PARK MOUNTAISE DECISION MADE: 30-APR-14
MID GLAM UK CF454ER 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K133882(TRADITIONAL)
ATTN: ROBERT CASARSA PHONE NO : 414 362 3063
8200 WEST TOWER AVE. SE DECISION MADE: 30-APR-14
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE 26 ADVANTAGE KIT
BOSTON SCIENTIFIC CORP. 510(k) NO: K140745(SPECIAL)
ATTN: LISA MEE PHONE NO :
ONE SCIMED PLACE SE DECISION MADE: 17-APR-14
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPLIT CATH RG
MEDCOMP 510(k) NO: K130889(TRADITIONAL)
ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201
1499 DELP DR. SE DECISION MADE: 28-APR-14
HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
INTUITIVE SURGICAL, INC. 510(k) NO: K131962(TRADITIONAL)
ATTN: MIKE YRAMATEGUI PHONE NO : 408 523 2100
1266 KIFER ROAD SE DECISION MADE: 17-APR-14
SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA