• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

October 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2011
 
 
DEVICE: CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
CHIENMAX VIETNAM CO. LTD          510(k) NO: K103675(TRADITIONAL)
ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 03-OCT-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXCELLAGEN
TISSUE REPAIR COMPANY             510(k) NO: K110318(TRADITIONAL)
ATTN: LOIS  CHANDLER              PHONE NO : 858 436 1012   
12255 EL CAMINO REAL SUITE 250    SE DECISION MADE: 03-OCT-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ETWO SKIN TREATMENT SYSTEM
SYNERON, LTD.                     510(k) NO: K110672(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 03-OCT-11
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
KWANG MYUNG DAICOM INC            510(k) NO: K111169(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 03-OCT-11
FULLERTON CA 92833                510(k) STATEMENT
 
DEVICE: PROSTHETIC SYSTEM
OSSTEM IMPLANT CO.,LTD            510(k) NO: K110308(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 03-OCT-11
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SILVER CARE ANITBACTERIAL TOOTHBRUSH
PIAVE SPAZZOLIFICIO S.P.A.        510(k) NO: K102871(TRADITIONAL)
ATTN: KEILA  LACOURT              PHONE NO : 917 674 0418   
212 W 91ST ST APT 812             SE DECISION MADE: 03-OCT-11
NEW YORK NY 10024                 510(k) STATEMENT
 
DEVICE: PINNACLE PRECISION ACCESS SYSTEM
TERUMO MEDICAL CORP.              510(k) NO: K111606(TRADITIONAL)
ATTN: DANIEL R PLONSKI            PHONE NO : 410 392 7395   
950 ELKTON BLVD.                  SE DECISION MADE: 03-OCT-11
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
STRAUMANN USA                     510(k) NO: K111357(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 03-OCT-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARMADA 35/35LL PTA CATHETER
ABBOTT VASCULAR                   510(k) NO: K111899(TRADITIONAL)
ATTN: LAARNI  RICAFORT            PHONE NO : 408 845 0688   
3200 LAKESIDE DRIVE               SE DECISION MADE: 03-OCT-11
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
ENCORE MEDICAL, L.P.              510(k) NO: K111735(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   
9800 METRIC BLVD.                 SE DECISION MADE: 03-OCT-11
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
BIOMERIEUX, INC.                  510(k) NO: K112228(TRADITIONAL)
ATTN: JENNIFER  CHIA-HSUAN LIN    PHONE NO : 314 731 8639   
595 ANGLUM RD.                    SE DECISION MADE: 03-OCT-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MOBICATH TRANSSEPTAL NEEDLE
GREATBATCH MEDICAL                510(k) NO: K111644(TRADITIONAL)
ATTN: KRISTI  FOX                 PHONE NO : 763 951 8181   
2300 BERKSHIRE LANE NORTH         SE DECISION MADE: 03-OCT-11
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K103487(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 04-OCT-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K110870(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DR. P.O. BOX 2068   SE DECISION MADE: 04-OCT-11
TUSTIN CA 92781 2068              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOVEREIGN SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K110063(TRADITIONAL)
ATTN: MIKE  SCOTT                 PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 04-OCT-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARDIOMED
CARDIO MEDICAL PRODUCTS, INC.     510(k) NO: K103651(TRADITIONAL)
ATTN: NICK  MENDISE               PHONE NO : 973 586 9500   
385 FRANKLIN AVE. STE. L          SE DECISION MADE: 04-OCT-11
ROCKAWAY NJ 07866                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TECO DIAGNOSTICS SALIVA ALCOHOL TEST
TECO DIAGNOSTICS                  510(k) NO: K111206(TRADITIONAL)
ATTN: JAMES  LI                   PHONE NO : 714 463 1111   
1268 NORTH LAKEVIEW AVE.          SE DECISION MADE: 04-OCT-11
ANAHEIM CA 92807                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OXIMETRY INTERFACE KIT
PHILIPS RESPIRONICS, INC          510(k) NO: K111378(TRADITIONAL)
ATTN: ELAINE  LARKIN              PHONE NO : 724 387 5350   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 04-OCT-11
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OEC(R) 9800, OEC(R) 9800 PLUS
GE OEC MEDICAL SYSTEMS, INC       510(k) NO: K111551(TRADITIONAL)
ATTN: GERALD  BUSS                PHONE NO : 801 517 6591   
384 WRIGHT BROTHERS DR.           SE DECISION MADE: 04-OCT-11
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHAKER DIGITAL THERMOMETER
MEASURE TECHNOLOGY CO. LTD.       510(k) NO: K112703(SPECIAL)
ATTN: RACK  YU                    PHONE NO : 886 285 122747
7F, NO 86, SEC. 1, KWANG FU RD    SE DECISION MADE: 04-OCT-11
SAN CHUNG CITY, TAIPEI HSIANG    T510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLAATZ 560
DRTECH CORP.                      510(k) NO: K111583(SPECIAL)
ATTN: CHOUL-WOO  SHIN             PHONE NO : 82 31 7306823
333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 04-OCT-11
SEONGNAM-SHI, GYEONGGI-DO    KS 46510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K111905(ABBREVIATED)
ATTN: MARKUS  STACHA              PHONE NO : 49 70 314632842
HEWLETT-PACKARD STR.2             SE DECISION MADE: 04-OCT-11
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
TELEFLEX MEDICAL, INC.            510(k) NO: K112456(SPECIAL)
ATTN: NATALIE  SMITH              PHONE NO : 919 433 8049   
2917 WECK DR.                     SE DECISION MADE: 04-OCT-11
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENOTRAIN CURAFLOW
BAUERFEIND AG                     510(k) NO: K111662(TRADITIONAL)
ATTN: INES  EXNER                 PHONE NO : 49 366 28661350
TRIEBESER STRASSE 16              SE DECISION MADE: 04-OCT-11
ZEULENRODA-TRIEBES    GM 07937    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL CLINICAL THERMOMETER MODEL V901US
AMPEROR-ELECTRONIC(SZ) CO., LTD   510(k) NO: K112116(SPECIAL)
ATTN: RAJ  KASBEKAR               PHONE NO : 508 490 7280   
250 TURNPIKE ROAD                 SE DECISION MADE: 04-OCT-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER PERIARTICULAR SCREWS
ZIMMER INC.                       510(k) NO: K111447(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 05-OCT-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SINGHMED ROOLIP MANIPULATOR
J.SINGH INSTRUMENTS               510(k) NO: K110819(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 WEST 5TH STREET 3RD FLOOR     SE DECISION MADE: 05-OCT-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
AMERIWATER                        510(k) NO: K111740(ABBREVIATED)
ATTN: BRIAN R BOWMAN              PHONE NO : 937 461 8833   
1303 STANLEY AVE.                 SE DECISION MADE: 05-OCT-11
DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXETER X3 RIMFIT ACETABULAR CUP
STRYKER CORP.                     510(k) NO: K111848(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461
325 CORPORATE DRIVE               SE DECISION MADE: 05-OCT-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPEACELABS MULTIGAS MODULE
SPACELABS HEALTHCARE              510(k) NO: K112173(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 05-OCT-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
BIOSENSE WEBSTER, INC.            510(k) NO: K112007(SPECIAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD            SE DECISION MADE: 05-OCT-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CANDELA GENTLEMAX FAMILY OF LASERS
CANDELA CORP.                     510(k) NO: K112715(TRADITIONAL)
ATTN: SAM  WADE                   PHONE NO : 508 358 7400   
530 BOSTON POST ROAD              SE DECISION MADE: 05-OCT-11
WAYLAND MA 01778                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
CHENG MEDICAL, CORPORATION        510(k) NO: K101592(TRADITIONAL)
ATTN: MARY P GALLUP               PHONE NO : 510 441 4017   
12945 SARATOGA AVE                SE DECISION MADE: 06-OCT-11
SARATOGA CA 95070                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SENOGRAPH DS, SENOGRAPH ESSENSTIAL
GENERAL ELECTRIC COMPANY          510(k) NO: K103485(TRADITIONAL)
ATTN: STEVEN  KACHELMEYER         PHONE NO : 262 548 2432   
3000 N. GRANDVIEW BLVD., W-709    SE DECISION MADE: 06-OCT-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOFLIP ECD
CROSPON, LTD.                     510(k) NO: K110531(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 06-OCT-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
ABBOTT LABORATORIES               510(k) NO: K110579(TRADITIONAL)
ATTN: DARLA  ABANO                PHONE NO : 847 937 3461   
100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 06-OCT-11
ABBOTT PARK IL 60064              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYLOCK OSTEOSYSTEM
TRIMED, INC.                      510(k) NO: K111266(TRADITIONAL)
ATTN: DOUG  STEINBERGER           PHONE NO : 661 255 7406   
27533 AVENUE HOPKINS              SE DECISION MADE: 06-OCT-11
SANTA CLARITA CA 91355            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
ASCOT TECHNOLOGIES, INC.          510(k) NO: K103643(ABBREVIATED)
ATTN: MARY E RANDALL              PHONE NO : 919 388 1776   
267 HOGANS VALLEY WAY             SE DECISION MADE: 06-OCT-11
CARY NC 27513                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DRYVIEW CHROMA IMAGING SYSTEM
CARESTREAM HEALTH,INC.            510(k) NO: K111566(TRADITIONAL)
ATTN: CHRISTINE  EHAMNN           PHONE NO : 585 627 6473   
150 VERONA STREET                 SE DECISION MADE: 06-OCT-11
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI)
K2M, INC.                         510(k) NO: K112037(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 06-OCT-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XL EXTRACTION CATHETER
VASCULAR SOLUTIONS, INC.          510(k) NO: K112571(SPECIAL)
ATTN: MATT  NIENSTEDT             PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 06-OCT-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
INOMED MEDIZINTECHNIK GMBH        510(k) NO: K111647(TRADITIONAL)
ATTN: SASCHKA  BUSCH              PHONE NO : 49 764 1941487
IM HAUSGRUEN 29                   SE DECISION MADE: 06-OCT-11
EMMENDINGEN    GM 79312           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
CROSSTEX INTERNATIONAL, INC.      510(k) NO: K111343(TRADITIONAL)
ATTN: RICHARD M ORMSBEE           PHONE NO : 763 551 2689   
14605 28TH AVENUE NORTH           SE DECISION MADE: 06-OCT-11
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K103625(TRADITIONAL)
ATTN: JOYCE  KILROY               PHONE NO : 215 660 2626   
3135 QUARRY RD.                   SE DECISION MADE: 06-OCT-11
TELFORD PA 18969                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K111371(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 MESA RIM RD.                SE DECISION MADE: 06-OCT-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
AVINGER, INC.                     510(k) NO: K112579(SPECIAL)
ATTN: SEVRINA  CIUCCI             PHONE NO : 650 241 7900   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 06-OCT-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
SIEMENS HEATLHCARE DIAGNOSTICS INC510(k) NO: K102772(TRADITIONAL)
ATTN: HELEN M LEE                 PHONE NO : 302 631 8706   
500 GBC DRIVE M/S 514             SE DECISION MADE: 07-OCT-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
ZIMMER GMBH                       510(k) NO: K110836(TRADITIONAL)
ATTN: DANIEL J WILLIMAN           PHONE NO : 574 371 8065   
P.O. BOX 708                      SE DECISION MADE: 07-OCT-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
ELITECH GROUP                     510(k) NO: K110780(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 825 5174   
21720 23RD DR S.E., SUITE 150     SE DECISION MADE: 07-OCT-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
BROADMASTER BIOTECH CORPORATION   510(k) NO: K102316(TRADITIONAL)
ATTN: ROGER  LAI                  PHONE NO : 886 266 375859
7F, NO. 168-2, LIANCHENG          SE DECISION MADE: 07-OCT-11
ZHONGHE CITY    TW 23553          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC.        510(k) NO: K111320(TRADITIONAL)
ATTN: JON  WARD                   PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 07-OCT-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BABI PLUS INFANT NASAL CANNULA SYSTEM
A PLUS MEDICAL                    510(k) NO: K110471(SPECIAL)
ATTN: THOMAS C LOESCHER           PHONE NO : 760 930 0425   
5431 AVENIDA ENCINAS SUITE G      SE DECISION MADE: 07-OCT-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTIPLE
LARSON MEDICAL PRODUCTS, INC.     510(k) NO: K112460(TRADITIONAL)
ATTN: PETER  LARSON               PHONE NO : 740 788 8107   
80 WESTGATE DRIVE                 SE DECISION MADE: 07-OCT-11
NEWARK OH 43055                   510(k) STATEMENT
 
DEVICE: HUIBAO BODY FAT SCALE
ZHONGSHAN HUIBAO WEIGHING APPARATU510(k) NO: K111404(TRADITIONAL)
ATTN: KEVIN  DENG                 PHONE NO : 867 602 3668989
CHANGAN ROAD, GUZHEN TOWN         SE DECISION MADE: 07-OCT-11
ZHONGSHAN CITY, GUANGDONG    CH 52510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
GALIL MEDICAL INC.                510(k) NO: K111859(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 651 287 5096   
63 CHICORY CT.                    SE DECISION MADE: 07-OCT-11
LAKE JACKSON TX 77566             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRECISION FLOW(R) - HELIOX
VAPOTHERM, INC.                   510(k) NO: K111640(TRADITIONAL)
ATTN: GREGORY A WHITNEY           PHONE NO : 410 604 0808   
198 LOG CANOE CIRCLE              SE DECISION MADE: 07-OCT-11
STEVENSVILLE MD 21666             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHOLOC(TM) BONE SCREWS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K112772(SPECIAL)
ATTN: KELLEN  HILLS               PHONE NO : 901 290 5816   
5677 AIRLINE RD.                  SE DECISION MADE: 07-OCT-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
KIMBERLY-CLARK CORP.              510(k) NO: K112635(SPECIAL)
ATTN: SWARNA  MUKUND              PHONE NO : 770 587 8083   
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 07-OCT-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
ACCLARENT, INC.                   510(k) NO: K110687(SPECIAL)
ATTN: DEAN  KNIGHT                PHONE NO : 650 687 4087   
1525-B O'BRIEN DR.                SE DECISION MADE: 07-OCT-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
INTUITIVE SURGICAL, INC.          510(k) NO: K112263(SPECIAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
950 KIFER RD.                     SE DECISION MADE: 07-OCT-11
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
ANTHOGYR SAS                      510(k) NO: K111532(TRADITIONAL)
ATTN: BRAYETTE  SABINE            PHONE NO : 334 505 80237
2237, AVENUE ANDRE LASQUIN        SE DECISION MADE: 07-OCT-11
SALLANCHES    FR 74700            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSTEOMED HAND FUSION SYSTEM
OSTEOMED L.P.                     510(k) NO: K111419(TRADITIONAL)
ATTN: SUZANNE  CHEANG             PHONE NO : 972 677 4779   
3885 ARAPAHO RD.                  SE DECISION MADE: 07-OCT-11
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
GLOBUS MEDICAL, INC.              510(k) NO: K112756(SPECIAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 07-OCT-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENUS SWAN SYSTEM
VENUS CONCEPT LTD                 510(k) NO: K111784(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST                     SE DECISION MADE: 07-OCT-11
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MECTACER BIOLOX(R) DELTA FEMORAL HEADS
MEDACTA USA, INC.                 510(k) NO: K112115(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 Calle Quetzal Unit B         SE DECISION MADE: 07-OCT-11
Camarillo CA 93012                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TOMOTHERAPY TREATMENT SYSTEM
TOMOTHERAPY INCORPORATED          510(k) NO: K112446(TRADITIONAL)
ATTN: GREG  BANGE                 PHONE NO : 608 830 3605   
1209 DEMING WAY                   SE DECISION MADE: 07-OCT-11
MADISON WI 53717                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CONCORDE BULLET SPINAL SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K110694(SPECIAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 508 880 8395   
325 PARAMOUNT DR.                 SE DECISION MADE: 11-OCT-11
RAYNHAM MA 02767 0151             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEALTH-E-CONNECT SYSTEM
ALR TECHNOLOGIES                  510(k) NO: K102063(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 11-OCT-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K112615(SPECIAL)
ATTN: BRAHIM  HADRI               PHONE NO : 781 249 8030   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 11-OCT-11
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RELIEVA SPIN SINUS DILATION SYSTEM
ACCLARENT, INC.                   510(k) NO: K111875(TRADITIONAL)
ATTN: KERI  YEN                   PHONE NO : 650 687 5874   
1525-B O'BRIEN DR.                SE DECISION MADE: 11-OCT-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAUMEDIC ICP MONITORING SYSTEM
RAUMEDIC AG                       510(k) NO: K112017(TRADITIONAL)
ATTN: REINER  THIEM               PHONE NO : 499 25 523592782
HERRMANN-STAUDINGER-STR. 2        SE DECISION MADE: 11-OCT-11
HELMBRECHTS    GM D 95233         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: APEX KIRSCHNER WIRES AND STEINMANN PINS
APEX TOOLS & ORTHOPEDICS CO.      510(k) NO: K112254(TRADITIONAL)
ATTN: SCOTT  LIANG                PHONE NO : 862 082 986918
25 YONGHUA, YONGHE, GETDD         SE DECISION MADE: 11-OCT-11
GUANGZHOU, GUANGDONG    CH CN-5113510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
SMITH & NEPHEW, INC.              510(k) NO: K111994(TRADITIONAL)
ATTN: MAUREEN  WHITSON            PHONE NO : 901 399 6845   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 11-OCT-11
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ONSET ACCESS CATHETER SYSTEM
ONSET MEDICAL CORPORATION         510(k) NO: K112629(TRADITIONAL)
ATTN: JOSEPH  BISHOP              PHONE NO : 949 716 1100   
13900 ALTON PARKWAY, SUITE 120    SE DECISION MADE: 11-OCT-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURESIGNS VS2+ -SURESIGNS VSI
PHILIPS MEDICAL SYSTEMS           510(k) NO: K112652(SPECIAL)
ATTN: MARY  KRUITWAGEN            PHONE NO : 978 659 2500   
3000 MINUTEMAN RD.                SE DECISION MADE: 11-OCT-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRODIGY DIABETES MANAGEMENT SOFTWARE
PRODIGY DIABETES CARE, LLC.       510(k) NO: K103115(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 12-OCT-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FEMCHEC PRESSURE MANAGEMET DEVICE
FEMASYS INC.                      510(k) NO: K110993(TRADITIONAL)
ATTN: LISA  PEACOCK               PHONE NO : 770 500 3910   
5000 RESEARCH COURT STE .100      SE DECISION MADE: 12-OCT-11
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SFC VERTEBRAL BODY REPLACEMENT
KONIGSEE IMPLANTATE GMBH          510(k) NO: K110153(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 12-OCT-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
GE HEALTHCARE                     510(k) NO: K111200(TRADITIONAL)
ATTN: CAROL  ALLOIAN              PHONE NO : 847 244 8327   
8200 WEST TOWER AVE               SE DECISION MADE: 12-OCT-11
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K111264(SPECIAL)
ATTN: REGINA  HOLMES              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 12-OCT-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
BEAM-MED LTD                      510(k) NO: K110646(ABBREVIATED)
ATTN: RITA  KOREMBLUM             PHONE NO : 972 392 36869
8 HALAPID STR.                    SE DECISION MADE: 12-OCT-11
PETACH TIKVA    IS 49170          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K111543(TRADITIONAL)
ATTN: INDU  LAKSHMAN              PHONE NO : 408 207 4200   
919 HERMOSA COURT                 SE DECISION MADE: 12-OCT-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BANTAM CATHETER (280MM BALLOON LENGTHS)
CLEAR STREAM TECHNOLOGIES, LTD.   510(k) NO: K112335(TRADITIONAL)
ATTN: FIONA  NI MHULLAIN          PHONE NO : 003 535 39237111
MOYNE UPPER, ENNISCORTHY          SE DECISION MADE: 12-OCT-11
COUNTY WEXFORD    EI              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
CORENTEC CO., LTD                 510(k) NO: K112019(TRADITIONAL)
ATTN: J.S.  DANIEL                PHONE NO : 82 234 455475
11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 12-OCT-11
SEOCHO GU, SEOUL    KS 137-040    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
BRONCUS TECHNOLOGIES, INC.        510(k) NO: K112051(SPECIAL)
ATTN: MAHTAB  FATEMI              PHONE NO : 650 428 1600   
1400N SHORELINE BLVD. BLDG. A, SUISE DECISION MADE: 12-OCT-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K112646(TRADITIONAL)
ATTN: KYEONG-MI  PARK             PHONE NO : 822 219 41373
1003 DAECHI-DONG, GANGNAM-GU      SE DECISION MADE: 12-OCT-11
SEOUL    KS 135-280               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: DISPOSABLE STIMULATING ELECTRODE
NUVASIVE, INC.                    510(k) NO: K111597(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 13-OCT-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
VYGON CORP.                       510(k) NO: K100163(TRADITIONAL)
ATTN: CINDY  VARUGHESE            PHONE NO : 215 390 2002   
103A PARK ROAD                    SE DECISION MADE: 13-OCT-11
MONTGOMERYVILLE PA 18936          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
GRIFOLS                           510(k) NO: K103757(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570 620 0198   
150 CHERRY LANE ROAD              SE DECISION MADE: 13-OCT-11
EAST STROUDSBURG PA 18301         510(k) STATEMENT
 
DEVICE: MTF NEW BONE VOID FILLER
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K110003(TRADITIONAL)
ATTN: NANCY  JOY                  PHONE NO : 732 661 2381   
125 MAY STREET                    SE DECISION MADE: 13-OCT-11
EDISON NJ 08837                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INVISIPORT
STEALTH THERAPEUTICS, INCORPORATED510(k) NO: K110407(TRADITIONAL)
ATTN: GARY J SYRING               PHONE NO : 608 877 2635   
800 LEVANGER LANE                 SE DECISION MADE: 13-OCT-11
STOUGHTON WI 53589                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
MATERIALISE N.V.                  510(k) NO: K111492(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 32 16 396280
TECHNOLOGIELAAN 15                SE DECISION MADE: 13-OCT-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3B FLEX-LITE
3B PRODUCTS, LLC                  510(k) NO: K103434(TRADITIONAL)
ATTN: ALBERT  ALEXANDER LUCIO     PHONE NO : 863 676 5948   
1142 N SCENIC HIGHWAY             SE DECISION MADE: 13-OCT-11
LAKE WALES FL 33853               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SULCUS BLUE
PRODUITS DENTAIRES PIERRE ROLLAND 510(k) NO: K111978(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 856 745 1146   
124 GAITHER DRIVE SUITE 140       SE DECISION MADE: 13-OCT-11
MT. LAUREL NJ 08054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
ALCON MANUFACTURING, LTD.         510(k) NO: K101774(TRADITIONAL)
ATTN: CATHERINE  GOBLE            PHONE NO : 817 551 6816   
6201 SOUTH FREEWAY                SE DECISION MADE: 13-OCT-11
FORT WORTH TX 76134 2099          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
ABBOT LABORATORIES                510(k) NO: K103627(TRADITIONAL)
ATTN: JUDITH R WALLACH            PHONE NO : 847 937 1132   
100 ABBOTT PARK RD. DEPT. 9V6, AP6SE DECISION MADE: 14-OCT-11
ABBOTT PARK IL 60064              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
BIOMERIEUX, INC.                  510(k) NO: K103752(TRADITIONAL)
ATTN: JOLYN  TENLLADO             PHONE NO : 314 731 8386   
595 ANGLUM RD.                    SE DECISION MADE: 14-OCT-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
TOTAL GLOVES SDN BHD              510(k) NO: K110250(TRADITIONAL)
ATTN: OOI  LOON SENG              PHONE NO : 605 829 5512
KAMUNTING INDUSTRIAL ESTATE KAMUNTSE DECISION MADE: 14-OCT-11
TAIPING, PERAK    MY 34600        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CSM SUBMERGED-R IMPLANT SYSTEM
CSMIMPLANT                        510(k) NO: K111120(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST. UNIT B          SE DECISION MADE: 14-OCT-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POLARCUP DUAL MOBILITY SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K110135(TRADITIONAL)
ATTN: THERESA  LEISTER            PHONE NO : 901 399 5899   
1450 EAST BROOKS RD.              SE DECISION MADE: 14-OCT-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANDOX DIGOXIN ASSAY
RANDOX LABORATORIES, LTD.         510(k) NO: K102346(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4452913
55 DIAMOND RD.                    SE DECISION MADE: 14-OCT-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) STATEMENT
 
DEVICE: ADVIA CENTAUR VITAMIN D TOTAL ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K110586(TRADITIONAL)
ATTN: NEIL  PARKER                PHONE NO : 914 524 2477   
511 BENEDICT AVENUE               SE DECISION MADE: 14-OCT-11
TARRYTOWN NY 10509                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRILOGY SERIES VENTILATOR WITH OXIMETRY
RESPIRONICS, INC.                 510(k) NO: K111610(ABBREVIATED)
ATTN: JOSEPH E OLSAVSKY           PHONE NO : 724 387 7562   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 14-OCT-11
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
BRENNEN MEDICAL, LLC              510(k) NO: K111436(TRADITIONAL)
ATTN: KENNETH B HERLAND           PHONE NO : 651 429 7413   
1290 HAMMOND RD.                  SE DECISION MADE: 14-OCT-11
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
WELLDOC, INC                      510(k) NO: K112370(SPECIAL)
ATTN: LAUREN  BRONICH-HALL        PHONE NO : 443 692 3100   
1501 SAINT PAUL STREET SUITE 118  SE DECISION MADE: 14-OCT-11
BALTIMORE MD 21202                510(k) STATEMENT
 
DEVICE: BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
SORIN GROUP ITALIA S.R.L.         510(k) NO: K112771(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 14-OCT-11
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GLADIATOR HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K111910(TRADITIONAL)
ATTN: MATT  PAUL                  PHONE NO : 901 867 4350   
5677 AIRLINE RD.                  SE DECISION MADE: 14-OCT-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
KURARAY MEDICAL INC.              510(k) NO: K111975(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 81 367 011706
OTE CENTER BLD 7F, 1-1-3, OTEMACHISE DECISION MADE: 14-OCT-11
CHIYODA-KU, TOKYO    JA 100-0004  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARFIL TRI-S BOND PLUS
KURARAY AMERICA, INC.             510(k) NO: K111980(TRADITIONAL)
ATTN: KIYOYUKI  ARIKAWA           PHONE NO : 212 986 2230   
600 LEXINGTON AVE. 26TH FLOOR     SE DECISION MADE: 14-OCT-11
NEW YORK NY 10022                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE ELECTRODE
SANIBEL SUPPLY                    510(k) NO: K111737(SPECIAL)
ATTN: ERIK  NIELSEN               PHONE NO : 456 371 3680
DREJERVAENGET 8                   SE DECISION MADE: 14-OCT-11
ASSENS    DA DK-5610              510(k) STATEMENT
 
DEVICE: NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC            510(k) NO: K112773(SPECIAL)
ATTN: DAVID M GAISSER             PHONE NO : 386 462 7661   
13631 PROGRESS BLVD SUITE 600     SE DECISION MADE: 14-OCT-11
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K112694(SPECIAL)
ATTN: SPENCER  WALKER             PHONE NO : 801 565 6103   
12050 LONE PEAK PKWY              SE DECISION MADE: 14-OCT-11
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDRAD MARK 7 ARTERION  (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
MEDRAD, INC.                      510(k) NO: K112086(SPECIAL)
ATTN: MIKE  BURNSIDE              PHONE NO : 763 717 1077   
ONE MEDRAD DR.                    SE DECISION MADE: 14-OCT-11
INDIANOLA PA 15051                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TETRIC EVOCERAM BULK FILL
IVOCLAR VIVADENT, INC.            510(k) NO: K111958(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 14-OCT-11
AMHERST NY 14228                  510(k) STATEMENT
 
DEVICE: PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K103598(TRADITIONAL)
ATTN: SARAH  HOLTGREWE            PHONE NO : 901 867 4476   
5677 AIRLINE RD.                  SE DECISION MADE: 17-OCT-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
ALCON RESEARCH, LTD.              510(k) NO: K110951(TRADITIONAL)
ATTN: MARTIN A KAUFMAN            PHONE NO : 949 753 6250   
15800 ALTON PARKWAY               SE DECISION MADE: 17-OCT-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CORONIS 5MP
BARCO NV                          510(k) NO: K111990(TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 17-OCT-11
KORTRIJK    BE 8500               510(k) STATEMENT
 
DEVICE: SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
OMISA INC. (SEGASIST TECHNOLOGIES)510(k) NO: K111311(TRADITIONAL)
ATTN: ALLISON  MANNERS            PHONE NO : 416 567 5176
1666 12TH LINE, RR #3             SE DECISION MADE: 17-OCT-11
LAKEFIELD, ONTARIO    CA K0L 2H0  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 8FR TURBO - TANDEM SYSTEM
SPECTRANETICS CORP.               510(k) NO: K112032(TRADITIONAL)
ATTN: SHELLEY  WILCOX             PHONE NO : 719 447 2414   
9965 FEDERAL DR.                  SE DECISION MADE: 17-OCT-11
COLORADO SPRINGS CO 80921         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K112710(SPECIAL)
ATTN: GERHARD  POLZER             PHONE NO : 498 072 313705219
SCHWENNINGER STRABE 13            SE DECISION MADE: 17-OCT-11
PFORZHEIM    GM D-75179           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K112439(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 17-OCT-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICROGARD II
CAREFUSION GERMANY 234 GMBH       510(k) NO: K111408(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 17-OCT-11
HOECHBERG, BAVARIA    GM 97204    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
GS MEDICAL CO., LTD.              510(k) NO: K111354(SPECIAL)
ATTN: DONALD W GUTHNER            PHONE NO : 646 460 2984   
111 HILL ROAD PO BOX 395          SE DECISION MADE: 17-OCT-11
DOUGLASSVILLE PA 19518            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K112156(TRADITIONAL)
ATTN: JOCELYN  RAPOSO             PHONE NO : 508 828 3421   
325 PARAMOUNT DRIVE               SE DECISION MADE: 17-OCT-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EZ VEIN INFLATABLE TOURNIQUET
DOMINION MEDICAL DEVICES, LLC     510(k) NO: K112874(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 17-OCT-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZYSTON STRAIGHT SPACER SYSTEM
BIOMET SPINE                      510(k) NO: K112014(TRADITIONAL)
ATTN: JULIE A RYAN                PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 17-OCT-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNIMAX TROCAR SYSTEM
ACMEBIOTECHS CO., LTD             510(k) NO: K112358(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 45, MINSHENG RD. DANSHUI TOWN SE DECISION MADE: 17-OCT-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVERYWAY LOW BACK PAIN RELIEF SYSTEM
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K110716(TRADITIONAL)
ATTN: ROBERT  TU                  PHONE NO : 886 226 620038
3FL. NO.5 LANE 155, SEC 3 PEISHEN SE DECISION MADE: 18-OCT-11
TAIPEI HSIEN    TW 222            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ABDOMINAL TOURNIQUET SYSTEM
COMPRESSION WORKS LLC             510(k) NO: K112384(TRADITIONAL)
ATTN: RUTH  FORSTADT              PHONE NO : 401 521 3294   
15 SARGENT AVE                    SE DECISION MADE: 18-OCT-11
PROVIDENCE RI 02906               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMARTLOC SPINAL FIXATION SYSTEM
A-SPINE ASIA, CO., LTD            510(k) NO: K111883(TRADITIONAL)
ATTN: FRANK  HSU                  PHONE NO : 886 226 272977
11F., NO. 1, ALY. 30, LN. 358 RUIGSE DECISION MADE: 18-OCT-11
TAIPEI, NEIHU DISTRICT    TW 11492510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APCLO PEDICLE SCREW SYSTEMS
ATLAS SPINE INC.                  510(k) NO: K112759(SPECIAL)
ATTN: THOMAS G SMITH              PHONE NO : 561 354 4318   
1555 JUPITER PARK DR., STE. 4     SE DECISION MADE: 18-OCT-11
JUPITER FL 33458                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K112586(TRADITIONAL)
ATTN: KATIE  COYLE                PHONE NO : 410 316 4975   
7 LOVETON CIRCLE MC 614           SE DECISION MADE: 18-OCT-11
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DASH HIP
BRAINLAB, AG                      510(k) NO: K110021(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 18-OCT-11
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RADIOACTIVE SEED LOCALIZATION NEEDLE
BIOCOMPATIBLES INC.               510(k) NO: K111979(TRADITIONAL)
ATTN: WAYNE  RICHARDSON           PHONE NO : 203 262 4194   
115 Hurley Rd                     SE DECISION MADE: 18-OCT-11
OXFORD CT 06478                   510(k) STATEMENT
 
DEVICE: CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
BAXTER HEALTHCARE CORPORATION     510(k) NO: K112893(SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 847 270 4871   
1620 WAUKEGAN RD.                 SE DECISION MADE: 18-OCT-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARDIA-CATH
MILLAR INSTRUMENTS, INC.          510(k) NO: K112323(SPECIAL)
ATTN: FATMA M ALI                 PHONE NO : 832 667 7000   
6001-A GULF FREEWAY               SE DECISION MADE: 18-OCT-11
HOUSTON TX 77023 5417             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
ARK DIAGNOSTICS,INC               510(k) NO: K111904(TRADITIONAL)
ATTN: KENNETH C KASPER            PHONE NO : 408 747 0708   
1190 BORDEAUX DRIVE               SE DECISION MADE: 18-OCT-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
BIOMERIEUX, INC.                  510(k) NO: K111909(TRADITIONAL)
ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666   
595 ANGLUM RD.                    SE DECISION MADE: 18-OCT-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECSYS T4 CALCHECK 5
ROCHE DIAGNOSTICS CORPORATION     510(k) NO: K112528(TRADITIONAL)
ATTN: MICHAEL  LEUTHER            PHONE NO : 317 521 3930   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 18-OCT-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: V-14 CONTROL WIRE GUIDEWIRE
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K112745(SPECIAL)
ATTN: SHANNON  PETTIT             PHONE NO : 
ONE SCIMED PLACE                  SE DECISION MADE: 18-OCT-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THERMOFLASH(TM) INFRARED THERMOMETER
VISIOMED GROUP SA                 510(k) NO: K112929(TRADITIONAL)
ATTN: ERIC  SEBBAN                PHONE NO : 331 406 70650
21, AVENUE VICTOR HUGE            SE DECISION MADE: 18-OCT-11
PARIS    FR 75116                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SCANVIEW SYSTEM
APPLIED SPECTRAL IMAGING          510(k) NO: K110345(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 482 46632
6 SIRENI                          SE DECISION MADE: 19-OCT-11
HAIFA    IS 10551                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMT G-J TUBE
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K110804(TRADITIONAL)
ATTN: JOSHUA D MEINKE             PHONE NO : 440 717 4000   
8000 KATHERINE BOULEVARD          SE DECISION MADE: 19-OCT-11
BRECKSVILLE OH 44141              510(k) STATEMENT
 
DEVICE: TBD
LENSAR, INC.                      510(k) NO: K112098(TRADITIONAL)
ATTN: SHIRLEY  MCGARVEY           PHONE NO : 702 524 3701   
2800 DISCOVERY DRIVE SUITE 100    SE DECISION MADE: 19-OCT-11
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
IDEV TECHNOLOGIES, INC.           510(k) NO: K111766(TRADITIONAL)
ATTN: DARENE  GARNER              PHONE NO : 281 525 2000   
253 MEDICAL CENTER BLVD           SE DECISION MADE: 19-OCT-11
WEBSTER TX 77598                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
ADVANCED MEDICAL PRODUCTS SDN BHD 510(k) NO: K110979(TRADITIONAL)
ATTN: ZAHARI  DARUS               PHONE NO : 605 672 7559
LOT 8961 & 8964, BATU 19 JALAN BRUSE DECISION MADE: 20-OCT-11
AYER TAWAR    MY 32400            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TIGER HEADLESS CANNULATED SCREWS
TRILLIANT SURGICAL LTD            510(k) NO: K112737(SPECIAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 20-OCT-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
NEXGEN MEDICAL SYSTEMS, INC.      510(k) NO: K110315(TRADITIONAL)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728 0126   
1050 W. NASA BLVD. SUITE 136      SE DECISION MADE: 20-OCT-11
MELBOURNE FL 32901                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XTRAFIX EXTERNAL FIXATION SYSTEM
EXTRAORTHO INC                    510(k) NO: K111155(TRADITIONAL)
ATTN: MARCOS  VELEZ-DURAN         PHONE NO : 703 562 9800   
901 KING ST SUITE 200             SE DECISION MADE: 20-OCT-11
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD GENEOHM VANR ASSAY
BD DIAGNOSTICS SCIENCE            510(k) NO: K102416(TRADITIONAL)
ATTN: RAYMOND  BOULE              PHONE NO : 410 316 4542   
7 LOVETON CIRCLE MAIL CODE 614    SE DECISION MADE: 20-OCT-11
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMART TOUCH UVTHERAPY MULTIPLE MACHINE
DAAVLIN DISTRIBUTING CO.          510(k) NO: K110912(TRADITIONAL)
ATTN: MICHELE  THIEL              PHONE NO : 419 636 6304   
205 WEST BEMENT ST.               SE DECISION MADE: 20-OCT-11
BRYAN OH 43506                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARESTREAM PACS
CARESTREAM HEALTH, INC.           510(k) NO: K110919(TRADITIONAL)
ATTN: LINDA  STEWART              PHONE NO : 972 517 1481   
150 VERONA STREET                 SE DECISION MADE: 20-OCT-11
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGIVIEW 250
KUB TECHNOLOGIES, INC             510(k) NO: K103348(TRADITIONAL)
ATTN: VIKRAM  BUTANI              PHONE NO : 203 364 8544   
270 ROWE AVENUE SUITE E           SE DECISION MADE: 20-OCT-11
MILFORD CT 06460                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES XRL
SYNTHES SPINE CO.LP               510(k) NO: K103320(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 20-OCT-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
LINDE HEALTHCARE AB               510(k) NO: K101286(TRADITIONAL)
ATTN: ANDERS  PALM                PHONE NO : 467 039 08875
AGAVAGEN 54                       SE DECISION MADE: 20-OCT-11
LIDINGO    SW SE 18181            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VISUCON-F FROZEN UNASSAYED NORMAL CONTROL PLASMA, VISUCON-F FROZEN UNASSAYED ABNORMAL CONTROL 1 PLASMA
AFFINITY BIOLOGICALS INC.         510(k) NO: K110432(TRADITIONAL)
ATTN: DENISE  FOULON              PHONE NO : 905 304 9896
1395 SANDHILL DRIVE               SE DECISION MADE: 20-OCT-11
ANCASTER, ONTARIO    CA L9G 4V5   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUADRA BLOC TENS PLUS
GRADIENT TECHNOLOGIES, LLC        510(k) NO: K102278(TRADITIONAL)
ATTN: JOHN  TOWNSEND              PHONE NO : 901 767 2384   
6070 POPLAR AVENUE SIXTH FLOOR    SE DECISION MADE: 20-OCT-11
MEMPHIS TN 38119                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VANISHPOINT BLOOD COLLECTION SET
RETRACTABLE TECHNOLOGIES, INC.    510(k) NO: K112512(TRADITIONAL)
ATTN: RHONDA  WELLS               PHONE NO : 972 294 1010   
511 LOBO LN.                      SE DECISION MADE: 20-OCT-11
LITTLE ELM TX 75068 0009          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
KIMBERLY-CLARK                    510(k) NO: K111402(ABBREVIATED)
ATTN: ANN  WATERHOUSE, RAC        PHONE NO : 678 352 6719   
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 20-OCT-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALERKAN SPIROMETRY FILTER
ALERKAN LTD                       510(k) NO: K111587(TRADITIONAL)
ATTN: GLEN  FEYE                  PHONE NO : 619 517 1762   
1340 WEST PENNSYLVANIA AVE.       SE DECISION MADE: 20-OCT-11
SAN DIEGO CA 92013                510(k) STATEMENT
 
DEVICE: THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
REGULATORY SPECIALISTS, INC.      510(k) NO: K112468(TRADITIONAL)
ATTN: GRACE  HOLLAND              PHONE NO : 949 262 0411   
3722 AVE SAUSALITO                SE DECISION MADE: 20-OCT-11
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIPSONIX(R) SYSTEM MODEL 2
MEDICIS TECHNOLOGIES CORPORATION  510(k) NO: K112626(SPECIAL)
ATTN: MICHAEL A HOFFMAN           PHONE NO : 425 420 2135   
11818 NORTH CREEK PARKWAY N.      SE DECISION MADE: 20-OCT-11
BOTHELL WA 98011                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASTLYTE NA/K/CA/PH
MEDICA CORP.                      510(k) NO: K112788(SPECIAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 20-OCT-11
BEDFORD MA 01730                  510(k) STATEMENT
 
DEVICE: NEUROLAC(R) NERVE GUIDE
POLYGANICS BV                     510(k) NO: K112267(SPECIAL)
ATTN: BETTY  IJMKER               PHONE NO : 31 50 5886598
ROZENBURGLAAN 15A                 SE DECISION MADE: 20-OCT-11
GRONINGEN    NL 9727-DL           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
OSTAR MEDITECH CORP.              510(k) NO: K112269(TRADITIONAL)
ATTN: STEVEN  CHANG               PHONE NO : 886 229 182390
5F, NO. 46-4, MIN-CHIUAN RD. SHINGSE DECISION MADE: 20-OCT-11
NEW TAIPEI CITY    TW 231         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DELTEX MEDICAL CARDIOQ EDM
DELTEX MEDICAL LIMITED            510(k) NO: K111542(TRADITIONAL)
ATTN: NEIL R ARMSTRONG            PHONE NO : 44 176 3222505
BIOPARK, BROADWATER ROAD WELWYN GASE DECISION MADE: 20-OCT-11
HERTSFORDSHIRE    UK AL7 3AX      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
CURVE DENTAL, INC.                510(k) NO: K112974(TRADITIONAL)
ATTN: GEORGE  STANTCHEV           PHONE NO : 888 910 4376   
424 W. 800 N. SUITE 202           SE DECISION MADE: 20-OCT-11
OREM UT 84057                     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K111772(TRADITIONAL)
ATTN: CHO SOW  FONG               PHONE NO : 603 33 927616
LOT 6129,JALAN HAJI ABDUL MANAN, OSE DECISION MADE: 20-OCT-11
KLANG, SELANGOR D.E.    MY 41050  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DURA BLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K112283(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAAN ROAD               SE DECISION MADE: 20-OCT-11
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: QUANTA FLASH (TM) DGP SCREEN
INOVA DIAGNOSTICS, INC.           510(k) NO: K111414(TRADITIONAL)
ATTN: RUFUS  BURLINGAME           PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 20-OCT-11
SAN DIEGO CA 92131 1638           510(k) STATEMENT
 
DEVICE: X-TRA BASE
VOCO GMBH                         510(k) NO: K112374(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 494 721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 20-OCT-11
CUXHAVEN    GM D-27472            510(k) STATEMENT
 
DEVICE: SAPIENS TIP CONFIRMATION SYSTEM
C.R. BARD, INC.                   510(k) NO: K112744(SPECIAL)
ATTN: HENRY  BOLAND               PHONE NO : 801 595 0700   
605 NORTH 5600 WEST               SE DECISION MADE: 20-OCT-11
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DURA BLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K112211(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAAN ROAD               SE DECISION MADE: 20-OCT-11
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: VIZION DR
VIZTEK LLC                        510(k) NO: K112661(SPECIAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT.                  SE DECISION MADE: 20-OCT-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VRESELECT CULTURE MEDIUM
BIO-RAD                           510(k) NO: K103684(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   
180 CABOT STREET                  SE DECISION MADE: 21-OCT-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENSPIRE DEBRIDER SYSTEM
SPINE VIEW, INC.                  510(k) NO: K110992(TRADITIONAL)
ATTN: MBITHI  MUTHINI             PHONE NO : 510 743 5090   
48810 KATO ROAD SUITE 100E        SE DECISION MADE: 21-OCT-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PHYSIOGLOVE ES WITH ECG ANALYSIS
COMMWELL LTD.                     510(k) NO: K103791(TRADITIONAL)
ATTN: IRVING  LEVY                PHONE NO : 972 976 68094
RECHOV YAD HARUTZIM 4             SE DECISION MADE: 21-OCT-11
KFAR SABA    IS 44641             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K111030(TRADITIONAL)
ATTN: JINYOUNG  LEE               PHONE NO : 
SUITE 1104 E&C VENTURE DREAM TOWERSE DECISION MADE: 21-OCT-11
GURO-GU , SEOUL    KS 152719      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: LIFECARE ARM & LEG PAIN RELIEF SYSTEM
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K112415(TRADITIONAL)
ATTN: ROBERT  TU                  PHONE NO : 886 226 620038
3FL. NO.5 LANE 155, SEC 3 PEISHEN SE DECISION MADE: 21-OCT-11
TAIPEI HSIEN    TW 222            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIOSLIMON IMPLANT SYSTEM
DIO CORPORATION                   510(k) NO: K112746(SPECIAL)
ATTN: TIMOTHY  LEE                PHONE NO : 213 365 2875   
3540 WILSHIRE BLVD. SUITE 1104    SE DECISION MADE: 21-OCT-11
LOS ANGELES CA 90010              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE            510(k) NO: K111639(SPECIAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 21-OCT-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
W AND R INVESTMENTS DBA LASER ENGI510(k) NO: K112166(TRADITIONAL)
ATTN: ROBERT I RUDKO              PHONE NO : 508 520 2552   
113 CEDAR STREET                  SE DECISION MADE: 21-OCT-11
MILFORD MA 01757                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K112292(TRADITIONAL)
ATTN: RAMONA  KULIK               PHONE NO : 480 763 2952   
5307 Great Oak Dr                 SE DECISION MADE: 21-OCT-11
LAKELAND FL 33815                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
ST. JUDE MEDICAL SYSTEMS AB       510(k) NO: K111854(TRADITIONAL)
ATTN: MIKAEL  SJOLANDER           PHONE NO : 46 181 61000
PALMBLADSGATAN 10                 SE DECISION MADE: 21-OCT-11
UPPSALA    SW SE-751 35           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K112473(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 301 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 21-OCT-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
INOVISE MEDICAL, INC.             510(k) NO: K110569(TRADITIONAL)
ATTN: EARL  ANDERSON              PHONE NO : 503 431 3800   
8770 SW NIMBUS AVENUE SUITE D     SE DECISION MADE: 24-OCT-11
BEAVERTON OR 97008 7196           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FRAMEWALKER
QUANTUM MEDICAL CONCEPTS, LLC.    510(k) NO: K111993(TRADITIONAL)
ATTN: ALICIA  BACH                PHONE NO : 503 233 3984   
3518 SE 21ST AVE.                 SE DECISION MADE: 24-OCT-11
PORTLAND OR 97202                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
L & K BIOMED CO., LTD             510(k) NO: K110783(TRADITIONAL)
ATTN: HEE  KYEONG JOO             PHONE NO : 822 262 41471
ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 24-OCT-11
SEOUL    KS 153803                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
MEDISCOPE MANUFACTURING, INC.     510(k) NO: K102387(TRADITIONAL)
ATTN: DIANE  SUDDUTH  MS, DVM, MPHPHONE NO : 561 305 5075   
8282 SHADOW WOOD BLVD             SE DECISION MADE: 24-OCT-11
POMPANO BEACH FL 33069            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NANOKNIFE SYSTEM
ANGIODYNAMICS, INC.               510(k) NO: K102329(TRADITIONAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 24-OCT-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K103513(TRADITIONAL)
ATTN: JULIE  GLENDRANGE           PHONE NO : 310 533 9966   
386 BEECH AVENUE UNIT B6          SE DECISION MADE: 24-OCT-11
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOFIA ANALYZER AND INFLUENZA A+B FIA
QUIDEL CORP.                      510(k) NO: K112177(TRADITIONAL)
ATTN: JOHN D TAMERIUS             PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 24-OCT-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PATIENT MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K112803(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 24-OCT-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WINGEATER V2
JMS NORTH AMERICA CORPORATION     510(k) NO: K111948(SPECIAL)
ATTN: E J SMITH                   PHONE NO : 410 451 0639   
1468 HARWELL AVE.                 SE DECISION MADE: 24-OCT-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
C.R. BARD, INC.                   510(k) NO: K112497(SPECIAL)
ATTN: JONI  CREAL                 PHONE NO : 480 638 2906   
1625 WEST 3RD ST.                 SE DECISION MADE: 24-OCT-11
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AFFIRM (TM) VCF SYSTEM
ALGEA THERAPIES                   510(k) NO: K110998(TRADITIONAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVENUE     SE DECISION MADE: 25-OCT-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
RESPIRONICS RESPIRATORY DRUG DELIV510(k) NO: K102454(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 25-OCT-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K111825(TRADITIONAL)
ATTN: FRANK  GIANELLI             PHONE NO : 203 492 5352   
60 Middletown Ave                 SE DECISION MADE: 25-OCT-11
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
SYNOVIS ORTHOPEDIC AND WOUNDCARE, 510(k) NO: K112786(SPECIAL)
ATTN: AMY  BOUCLY                 PHONE NO : 949 502 3240   
6 JENNER SUITE 150                SE DECISION MADE: 25-OCT-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHARGER BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K112701(SPECIAL)
ATTN: GLENN  JACQUES              PHONE NO : 763 494 1152   
ONE SCIMED PLACE                  SE DECISION MADE: 25-OCT-11
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REVIVE INTERMEDIATE CATHETER (REVIVE IC)
CODMAN & SHURTLEFF, INC.          510(k) NO: K112828(SPECIAL)
ATTN: CATHERINE  KILSHAW          PHONE NO : 508 828 3312   
325 PARAMOUNT DR.                 SE DECISION MADE: 25-OCT-11
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMS ELEVATE PC
AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K112842(SPECIAL)
ATTN: MATTHEW D STEPANEK          PHONE NO : 952 930 6000   
10700 BREN RD., WEST              SE DECISION MADE: 25-OCT-11
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEALIX KNOTLESS(TM) ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K112249(TRADITIONAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 25-OCT-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SKAFFOLD CIS
SKELETAL KINETICS, LLC            510(k) NO: K111538(TRADITIONAL)
ATTN: CHRISTINE  KUO              PHONE NO : 408 350 5842   
10201 BUBB RD.                    SE DECISION MADE: 25-OCT-11
CUPERTINO CA 95014 4167           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VUSION(R) OS
ORTHO DEVELOPMENT                 510(k) NO: K111965(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 S. BUSINESS PARK DR.        SE DECISION MADE: 25-OCT-11
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
BAUSCH & LOMB, INC.               510(k) NO: K112192(SPECIAL)
ATTN: TRICIA  GARRETT             PHONE NO : 585 338 6706   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 25-OCT-11
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXPEDIUM SPINE SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K110551(SPECIAL)
ATTN: FRANK  JURCZAK              PHONE NO : 508 828 3288   
325 PARAMOUNT DR.                 SE DECISION MADE: 26-OCT-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
DIAGNOSTICA STAGO, INC.           510(k) NO: K111822(TRADITIONAL)
ATTN: CARLO  D'ALESSANDRO         PHONE NO : 39 065 782665
PIAZZA ALBANIA, 10                SE DECISION MADE: 26-OCT-11
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
THOMPSON MIS INC                  510(k) NO: K111512(TRADITIONAL)
ATTN: FRANK  SULLIVAN             PHONE NO : 603 912 5306   
45 STILES RD SUITE 210            SE DECISION MADE: 26-OCT-11
SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTI-ANALYTE DETECTION SYSTEMS
BIO-RAD LABORATORIES              510(k) NO: K112810(SPECIAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 26-OCT-11
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
MASIMO CORPORATION                510(k) NO: K111621(TRADITIONAL)
ATTN: ANIL  BHALANI               PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 26-OCT-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITEK 2 STREPTOCOCCUS PENICILLIN
BIOMERIEUX, INC.                  510(k) NO: K112000(TRADITIONAL)
ATTN: JOLYN  TENLLADO             PHONE NO : 314 731 8386   
595 ANGLUM RD.                    SE DECISION MADE: 26-OCT-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NCB PERIPROSTHETIC FEMUR POLYASIAL LOCKING PLATE SYSTEM
ZIMMER, INC.                      510(k) NO: K112174(SPECIAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 26-OCT-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARSPLINT ES
ASTRON DENTAL CORPORATION         510(k) NO: K111828(TRADITIONAL)
ATTN: DOUGLAS S MULLER            PHONE NO : 847 726 8787   
815 OAKWOOD RD. UNIT G            SE DECISION MADE: 26-OCT-11
LAKE ZURICH IL 60047              510(k) STATEMENT
 
DEVICE: US-101L, US-103S
ITO CO., LTD.                     510(k) NO: K112520(TRADITIONAL)
ATTN: HARUHISA  OKADA             PHONE NO : 813 399 48996
3-3-3 TOYOTAMA-MINAMI NERIMA-KU   SE DECISION MADE: 26-OCT-11
TOKYO    JA 176-0014              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: IPC POWEREASE SYSTEM
MEDTRONIC XOMED, INC.             510(k) NO: K111520(TRADITIONAL)
ATTN: RISHI  SINHA                PHONE NO : 817 788 6685   
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 26-OCT-11
JACKSONVILLE FL 32216             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES STERNAL FIXATION SYSTEM
SYNTHES INC                       510(k) NO: K112689(SPECIAL)
ATTN: ELIZABETH  KIERZEK          PHONE NO : 610 719 6565   
1301 GOSHEN PARKWAY               SE DECISION MADE: 26-OCT-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPIDERFX EMBOLIC PROTECTION DEVICE
EV3 INC                           510(k) NO: K111010(TRADITIONAL)
ATTN: BRENDA  JOHNSON             PHONE NO : 763 398 7238   
3033 CAMPUS DRIVE                 SE DECISION MADE: 27-OCT-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSRAM ITOS
OSRAM SYLVANIA, INC.              510(k) NO: K110326(TRADITIONAL)
ATTN: MARIE A SCHROEDER           PHONE NO : 301 272 3286   
1801 ROCKVILLE PIKE SUITE 300     SE DECISION MADE: 27-OCT-11
ROCKVILLE MD 20852                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZOLL RESCUENETLINK
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K111296(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 27-OCT-11
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AESCULAP- MEITHKE SHUNT SYSTEM
AESCULAP, INC.                    510(k) NO: K110206(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 27-OCT-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 4MP COLOR LCD MONITOR, RADIFORCERX430
EIZO NANAO CORPORATION            510(k) NO: K112466(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627 42468
153 SHIMOKASHIWANO, HAKUSAN       SE DECISION MADE: 27-OCT-11
ISHIKAWA    JA 924-8566           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DX-D 600
AGFA HEALTHCARE N.V.              510(k) NO: K112670(TRADITIONAL)
ATTN: PHIL  CUSCUNA               PHONE NO : 416 240 7317   
10 S ACADEMY STREET               SE DECISION MADE: 27-OCT-11
GREENVILLE SC 29601               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
TOTOKU ELECTRIC CO., LTD          510(k) NO: K112604(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 812 582 46611
300 OYA                           SE DECISION MADE: 27-OCT-11
UEDA, NAGANO    JA 386-0192       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FIXATE TISSUE BAND
ANULEX TECHNOLOGIES, INC          510(k) NO: K112849(SPECIAL)
ATTN: RACHEL  KENNEDY             PHONE NO : 952 224 4000   
5600 ROWLAND ROAD, STE 280        SE DECISION MADE: 27-OCT-11
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REHASTIM 2, REHAMOVE 2
HASOMED GMBH                      510(k) NO: K112844(SPECIAL)
ATTN: MATTHIAS  WEBER             PHONE NO : 493 916 230112
PAUL-ECKE-STRASSE 1               SE DECISION MADE: 27-OCT-11
MAGDEBURG    GM 39114             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
GIOTTO USA, LLC                   510(k) NO: K111434(TRADITIONAL)
ATTN: PATRICK  MOONEY             PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 27-OCT-11
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K111796(TRADITIONAL)
ATTN: ELSA  LINKE                 PHONE NO : 952 830 6205   
7375 BUSH LAKE RD.                SE DECISION MADE: 27-OCT-11
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VSI GUIDEWIRE
VASCULAR SOLUTIONS, INC.          510(k) NO: K112631(TRADITIONAL)
ATTN: MELINDA  SWANSON            PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 27-OCT-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALCATRON AND / OR MULTIPLE BRAND
ALCATRON GLOVES FACTORY           510(k) NO: K112222(TRADITIONAL)
ATTN: SHUQIN  GAO                 PHONE NO : 86 536 2197155
NO. 12-1, XING'AN RD EAST LINQU, WSE DECISION MADE: 27-OCT-11
SHANDONG    CH 262600             510(k) STATEMENT
 
DEVICE: JMS APHERESIS NEEDLE SET "WINGEATER(R)" V2
JMS NORTH AMERICA CORPORATION     510(k) NO: K112178(SPECIAL)
ATTN: E.J.  SMITH                 PHONE NO : 410 451 0639   
1468 HARWELL AVE.                 SE DECISION MADE: 27-OCT-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112529(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 27-OCT-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FETAL DOPPLER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K112911(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 27-OCT-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
MEDTRONIC, INC.                   510(k) NO: K112917(SPECIAL)
ATTN: DEBORAH  KIDDER             PHONE NO : 763 526 3561   
8200 CORAL SEA STREET MS MVS11    SE DECISION MADE: 27-OCT-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
NORFOLK MEDICAL PRODUCTS, INC.    510(k) NO: K112713(SPECIAL)
ATTN: MICHAEL  DALTON             PHONE NO : 847 674 7075   
7350 NORTH RIDGEWAY               SE DECISION MADE: 27-OCT-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
EV3 INC                           510(k) NO: K111723(TRADITIONAL)
ATTN: BRENDA  JOHNSON             PHONE NO : 763 398 7000   
3033 CAMPUS DRIVE                 SE DECISION MADE: 27-OCT-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
MAHE MEDICAL GMBH                 510(k) NO: K110655(ABBREVIATED)
ATTN: ANDREA  PECSI               PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 27-OCT-11
TUTTLINGEN, BW    GR 78532        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
I-SENS, INC.                      510(k) NO: K103278(SPECIAL)
ATTN: HYUN JOON  OH               PHONE NO : 82 291 66191
465-6 WOLGYE-DONG, NOWON-GU       SE DECISION MADE: 28-OCT-11
SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DUOCENTRIC REVERSED
ASTON MEDICAL                     510(k) NO: K103251(TRADITIONAL)
ATTN: CATHERINE  GLOSTER          PHONE NO : 805 679 1258   
577 NORTH HOPE AVE                SE DECISION MADE: 28-OCT-11
SANTA BARBARA CA 93110            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K112277(TRADITIONAL)
ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 28-OCT-11
SAN DIEGO CA 92064                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MINI MASSEUSE
MJ SPECIALTY RETAIL               510(k) NO: K110057(TRADITIONAL)
ATTN: CHARLES  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 28-OCT-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
NIHON KOHDEN CORP.                510(k) NO: K110594(TRADITIONAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 28-OCT-11
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
PHILIPS MEDICAL SYSTEMS           510(k) NO: K111693(TRADITIONAL)
ATTN: TAMARA  YOUNT               PHONE NO : 206 664 5000   
2301 5TH AVENUE, SUITE 200        SE DECISION MADE: 28-OCT-11
SEATTLE WA 98121 1825             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUMO ACCESS AND TISSUE RESECTION SYSTEM
APOLLO ENDOSURGERY, INC.          510(k) NO: K103155(TRADITIONAL)
ATTN: GREG  MATHISON              PHONE NO : 512 328 9990   
7000 BEE CAVES RD. SUITE 350      SE DECISION MADE: 28-OCT-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
NEUROVIRTUAL USA, INC.            510(k) NO: K112107(TRADITIONAL)
ATTN: EDUARDO  FARIA              PHONE NO : 786 693 8200   
2315 NW 107TH AVE SUITE #1M27     SE DECISION MADE: 28-OCT-11
DORAL FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYRINGES AND NEEDLES
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K113091(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 28-OCT-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CHX=CHX PLUS
INTER-MED, INC.                   510(k) NO: K112250(TRADITIONAL)
ATTN: JOHN  BAETEN                PHONE NO : 262 636 9755   
2200 NORTHWESTERN AVE.            SE DECISION MADE: 28-OCT-11
RACINE WI 53404                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
NOBEL BIOCARE AB                  510(k) NO: K112259(SPECIAL)
ATTN: HERBERT  CRANE              PHONE NO : 714 282 4800   
22715 SAVI  RANCH PARKWAY         SE DECISION MADE: 28-OCT-11
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOFRELINER TOUGH S
TOKUYAMA DENTAL CORPORATION       510(k) NO: K112445(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET, N.W. SUITE 1100    SE DECISION MADE: 28-OCT-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISTAL VOLAR RADIUS PLATING SYSTEMS
MEDOS INTERNATIONAL SARL          510(k) NO: K112345(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 31-OCT-11
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLIGHT 60 VENTILATOR
FLIGHT MEDICAL INNOVATIONS LTD.   510(k) NO: K111683(TRADITIONAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 704 899 0092   
1914 JN PEASE PLACE               SE DECISION MADE: 31-OCT-11
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLO-SURPLUS P.A.D.
SCION CARDIO-VASCULAR, INC.       510(k) NO: K112961(SPECIAL)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728 0125   
1050 W NASA BLVD # 136            SE DECISION MADE: 31-OCT-11
MELBOURNE FL 32901                510(k) SUMMARY AVAILABLE FROM FDA
 
 
                                                 TOTAL 510(k)s THIS PERIOD   252                                     
                                                 TOTAL WITH SUMMARIES        235                                     
                                                 TOTAL WITH STATEMENTS        17