Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

October 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2014


DEVICE: FLUOR PROTECTOR S
IVOCLAR VIVADENT AG               510(k) NO: K131487(Traditional)
ATTN: DONNA M HARTNETT            PHONE NO : 716 691-2260 
175 PINEVIEW DR.                  SE DECISION MADE: 08-OCT-14
AMHERST NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUPERNOVA C5 MRI SYSTEM
LIAONING KAMPO MEDICAL SYSTEM CO.,510(k) NO: K131737(Traditional)
ATTN: SHAO  KAI                   PHONE NO : 86 414 5555322 
NO. 9, YAODU STREET, BENXI ECONOMISE DECISION MADE: 23-OCT-14
BENXI, LIAONING  CN 117004        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS NOTA
H.S. HOSPITAL SERVICES S.P.A.     510(k) NO: K131925(Traditional)
ATTN: LUCIO  IMPROTA              PHONE NO : 561 477-1671 
10147 UMBERLAND PLACE             SE DECISION MADE: 10-OCT-14
BOCA RATON FL  33428              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIPULSE HOPLUS
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131987(Traditional)
ATTN: ANTJE  KATZER               PHONE NO : 004 936 417700309 
BRUESSELER STR. 10                SE DECISION MADE: 15-OCT-14
JENA, THURINGIA  DE 07747         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKORE AND MULTIPLE BRANDS
TTK PROTECTIVE DEVICES LIMITED (FO510(k) NO: K132490(Abbreviated)
ATTN: MANOJ  ZACHARIAS            PHONE NO : 630 270-2921 
2871, COASTAL DR                  SE DECISION MADE: 20-OCT-14
AURORA IL  60503                  510(k) STATEMENT
                                                    

DEVICE: FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
COOK, INC.                        510(k) NO: K132592(Traditional)
ATTN: DAVID  LEHR                 PHONE NO : 812 335-3575 
750 DANIELS WAY                   SE DECISION MADE: 09-OCT-14
Blmgtn IN  47404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
QINGDAO KINGSTON MEDICAL DEVICES L510(k) NO: K132771(Traditional)
ATTN: WU  HANHUA                  PHONE NO : 86 0532 86769190 
No.5 Seoul Road Free Trade Zone   SE DECISION MADE: 28-OCT-14
QINGDAO, SHANDONG  CN 266555      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVAPACS
NOVARAD CORP.                     510(k) NO: K132853(Traditional)
ATTN: AMY  HOFFMAN                PHONE NO : 801 642-1001 
752 E 1180 S Ste 200              SE DECISION MADE: 30-OCT-14
American Fork UT  84003           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED CURING LIGHT
MONITEX INDUSTRIAL CO., LTD.      510(k) NO: K133040(Traditional)
ATTN: SHU-LUNG  WANG              PHONE NO : 886 2 29993869 
6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 07-OCT-14
NEW TAIPEI CITY  TW 241 58        510(k) STATEMENT
                                                    

DEVICE: CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
CODENT TECHNICAL INDUSTRY CO., LTD510(k) NO: K133069(Traditional)
ATTN: CHIN-TING  WEN              PHONE NO : 886 769555 33 
5F., No.90, Luke 5th Rd., Luzhu DiSE DECISION MADE: 24-OCT-14
Kaohsiung City  TW 82151          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6"
MEDTRONIC, INC.                   510(k) NO: K133157(Traditional)
ATTN: JESSICA  SIXBERRY           PHONE NO : 763 514-9849 
7611 NORTHLAND DRIVE              SE DECISION MADE: 23-OCT-14
MINNEAPOLIS MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-FIT EF-1280 EMS MACHINE
FIT-PRO KFT LTD.                  510(k) NO: K133225(Traditional)
ATTN: RHONDA  ALEXANDER, M.S., M.PPHONE NO : 757 224-0177 
144 RESEARCH DRIVE                SE DECISION MADE: 24-OCT-14
HAMPTON VA  23666                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
GENESYS SPINE                     510(k) NO: K133245(Traditional)
ATTN: WILLIAM W SOWERS            PHONE NO : 512 381-7080 
1250 CAPITAL OF TEXAS HWY SOUTH BUSE DECISION MADE: 08-OCT-14
AUSTIN TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AERONEB SOLO; AERONEB SOLO ADAPTER
AEROGEN LTD                       510(k) NO: K133360(Traditional)
ATTN: MARTIN  CREHAN              PHONE NO : 353 91 540459 
IDA BUSINESS PARK, DANGAN         SE DECISION MADE: 17-OCT-14
GALWAY  IE GALWAY                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NDX DORSAL APPLIANCE
INSTITUTE FOR QUALITY RESOURCE MAN510(k) NO: K133390(Traditional)
ATTN: LEAH  AMIR, MS, MHA         PHONE NO : 877 997-3360 
1 CITY PLACE DRIVE, STE 285       SE DECISION MADE: 16-OCT-14
ST. LOUIS MO  63131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONESTEP CPR II MULTI-FUNCTION ELECTRODE
BIO-DETEK, INC.                   510(k) NO: K133441(Traditional)
ATTN: SHANNON  DUHAMEL            PHONE NO : 978 421-9574 
269 MILL ROAD                     SE DECISION MADE: 10-OCT-14
CHELMSFORD MA  01824-4105         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOMED
W & H DENTALWERK BUERMOOS GMBH    510(k) NO: K133488(Traditional)
ATTN: ANJA  LINDNER               PHONE NO : 43 627 46236297 
IGNAZ-GLASER-STRASSE 53           SE DECISION MADE: 16-OCT-14
BUERMOOS, SALZBURG  AT 5111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYNGO CT SINGLE SOURCE DUAL ENERGY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133677(Traditional)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448-4912 
51 VALLEY STREAM PKWY.            SE DECISION MADE: 16-OCT-14
MALVERN PA  19355-1406            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VC150 VITAL SIGNS MONITOR
INNOKAS YHTYMA                    510(k) NO: K133810(Traditional)
ATTN: TIINA  VETELAINEN           PHONE NO : 358 8 5623100 
TARJUSOJANTIE 12                  SE DECISION MADE: 30-OCT-14
KEMPELE, OULU  FI 90440           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VANTERA CLINICAL ANALYZER
LIPOSCIENCE                       510(k) NO: K133849(Special)
ATTN: SUZETTE  WARNER             PHONE NO : 919 256-1326 
2500 SUMMER BLVD.                 SE DECISION MADE: 22-OCT-14
RALEIGH NC  27616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MSA100 PEAK FLOW METER
BEIJING M&B ELECTRONIC INSTRUMENTS510(k) NO: K133975(Traditional)
ATTN: MIKE  GU                    PHONE NO : 86 20 62321333 
7TH FLOOR, JINGUI BUSINESS BUILDINSE DECISION MADE: 03-OCT-14
GUANGZHOU, GUANGDONG  CN 510420   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IEVA REHABILITATIVE POSITIONAL DEVICE
REMENDIUM LABS, LLC               510(k) NO: K133990(Traditional)
ATTN: YOLANDA  LORIE              PHONE NO : 386 717-4360 
340 EAST PARKER ROAD              SE DECISION MADE: 09-OCT-14
BATON ROUGE LA  70803             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
MEDTEK LIGHTING                   510(k) NO: K134009(Traditional)
ATTN: SUSAN  ANTHONEY-DE WET      PHONE NO : 865 982-5552 
2424 DEMPSTER DRIVE               SE DECISION MADE: 15-OCT-14
CORALVILLE IA  52241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
Terumo Cardiovascular Systems Corp510(k) NO: K140008(Traditional)
ATTN: GARRY  COURTNEY             PHONE NO : 800 262-3304 
125 BLUE BALL RD.                 SE DECISION MADE: 31-OCT-14
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYPERQ ACS-100 SYSTEM
BSP-BIIOLOGICAL SIGNAL PROCESSING,510(k) NO: K140020(Traditional)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002 
20 HATA' AS STR., SUITE 102       SE DECISION MADE: 28-OCT-14
KFAR SABA  IL 44425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
CORK MEDICAL PRODUCTS LLC         510(k) NO: K140022(Traditional)
ATTN: JON  SPEER                  PHONE NO : 765 315-2736 
PO BOX 1784                       SE DECISION MADE: 24-OCT-14
MARTINSVILLE IN  46151            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEVATION
PDG PRODUCT DESIGN GROUP, INC.    510(k) NO: K140023(Traditional)
ATTN: EDWARD A KROLL              PHONE NO : 440 546-9810 
5905 FAWN LANE                    SE DECISION MADE: 16-OCT-14
CLEVELAND OH  44141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
Pegavision Corporation            510(k) NO: K140025(Traditional)
ATTN: PENNY  NORTHCUTT            PHONE NO : 886 332 98808 
174 WATERCOLOR WAY, SUITE 103-403 SE DECISION MADE: 15-OCT-14
SANTA ROSA BEACH FL  32459        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KJ EXTERNAL IMPLANT SYSTEM
KJ MEDITECH CO., LTD.             510(k) NO: K140051(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 30-OCT-14
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: J2I IMPLANT SYSTEM
KJ MEDITECH CO., LTD.             510(k) NO: K140052(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 30-OCT-14
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
FSC LABORATORIES, INC.            510(k) NO: K140062(Traditional)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498-2155 
6000 Fairview Rd. Suite 600       SE DECISION MADE: 03-OCT-14
Charlotte NC  28210               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIC 10
BIOLASE, INC.                     510(k) NO: K140120(Traditional)
ATTN: COLLEEN  BOSWELL            PHONE NO : 949 226-8470 
4 CROMWELL                        SE DECISION MADE: 10-OCT-14
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflex Medical, Inc.            510(k) NO: K140197(Traditional)
ATTN: HOLLY  KORNEGAY             PHONE NO : 919 433-4918 
2917 WECK DR. PO BOX 12600        SE DECISION MADE: 21-OCT-14
RESEARCH TRIANGLE PARK NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflex Medical, Inc.            510(k) NO: K140205(Traditional)
ATTN: HOLLY  KORNEGAY             PHONE NO : 919 433-4918 
2917 WECK DR. PO BOX 12600        SE DECISION MADE: 23-OCT-14
RESEARCH TRIANGLE PARK NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
PHADIA US INC.                    510(k) NO: K140225(Traditional)
ATTN: MARTIN  MANN                PHONE NO : 497 614 7805173 
MUNZINGER STRASSE 7               SE DECISION MADE: 27-OCT-14
FREIBURG IM BREISGAU  DE 79111    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AILERON INTERSPINOUS FIXATION SYSTEM
LIFE SPINE, INC                   510(k) NO: K140236(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 884-6117 
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 20-OCT-14
HOFFMAN ESTATES IL  60169         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LONG PULSE ND: YAG LASER SYSTEM
ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K140249(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
P.O. BOX 120-119                  SE DECISION MADE: 08-OCT-14
SHANGHAI  CN 200120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIVERSAL DIGITAL INTERFACE 2, UDI 2
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K140251(Traditional)
ATTN: LARRY  CORNELL              PHONE NO : 440 287-6801 
325 HARRIS DRIVE                  SE DECISION MADE: 22-OCT-14
AURORA OH  44202                  510(k) STATEMENT
                                                    

DEVICE: SIMPLE T YOUTH NASAL MASK
RESPIRONICS, INC.                 510(k) NO: K140268(Abbreviated)
ATTN: COLLEEN  WITT               PHONE NO : 724 387-4780 
1001 MURRY RIDGE LN.              SE DECISION MADE: 20-OCT-14
MURRYSVILLE PA  15668             510(k) STATEMENT
                                                    

DEVICE: TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
ADIN DENTAL IMPLANTS SYSTEMS LTD. 510(k) NO: K140293(Traditional)
ATTN: NISSIM  SHAKED              PHONE NO : 972 491161 52 
ALON TAVOR INDUSTRIAL ZONE        SE DECISION MADE: 31-OCT-14
POB 1128 AFULA ELIT  IL 1811101   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIMPLY SLICK PERSONAL LUBRICATING LOTION
SIMPLY SOLUTIONS, LLC             510(k) NO: K140304(Third Party - Traditional)
ATTN: JOHN  GOEPFERT              PHONE NO : 608 563-5555 
2949 VENTURE DR., STE 170         SE DECISION MADE: 07-OCT-14
JANESVILLE WI  53546-8501         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CRANIOPLUG
OSSDSIGN AB                       510(k) NO: K140309(Traditional)
ATTN: DAVID  WEISSBURG            PHONE NO : 608 770-0223 
808 WILLIAMSON ST. SUITE 402      SE DECISION MADE: 03-OCT-14
MADISON WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COROENT TI-C SYSTEM
NUVASIVE, INC.                    510(k) NO: K140319(Traditional)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309-3783 
7475 LUSK BLVD                    SE DECISION MADE: 09-OCT-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLOX2 TISSUE EXPANDERS
SPECIALTY SURGICAL PRODUCTS, INC. 510(k) NO: K140383(Traditional)
ATTN: SHERRY  NULL                PHONE NO : 406 961-0102 
1123 NORTH U.S. HWY. 93           SE DECISION MADE: 28-OCT-14
VICTOR MT  59875                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTEGRA EXTERNAL FIXATION SYSTEM
ASCENSION ORTHOPEDIC              510(k) NO: K140463(Traditional)
ATTN: STEVE  BROWN                PHONE NO : 435 7741535 
560 W. GOLF COURSE ROAD           SE DECISION MADE: 10-OCT-14
PROVIDENCE UT  84332              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
STERILUCENT, INC                  510(k) NO: K140464(Traditional)
ATTN: PETER  KALKBRENNER          PHONE NO : 612 767-3253 
1400 MARSHALL STREET NE           SE DECISION MADE: 31-OCT-14
MINNEAPOLIS MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX-MT +
EMSI                              510(k) NO: K140467(Traditional)
ATTN: CHERITA  JAMES              PHONE NO : 703 562-9800 257
815 KING STREET STE 206           SE DECISION MADE: 07-OCT-14
ALEXANDRIA VA  22314              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
OBERON GMBH FIBER TECHNOLOGIES    510(k) NO: K140470(Traditional)
ATTN: ARMIN  KAUS                 PHONE NO : 480 598-4090 
7404 W. DETROIT STREET, STE 140   SE DECISION MADE: 15-OCT-14
CHANDLER AZ  85226                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BONASTENT TRACHEAL / BRONCHIAL
ENDOCHOICE, INC.                  510(k) NO: K140472(Traditional)
ATTN: Bosmat  Friedman            PHONE NO : 647 975 3974 
1208-12 ROCKFORD RD.              SE DECISION MADE: 17-OCT-14
TORONTO, ON  CA M2R 3A2           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELIA SCL-70S IMMUNOASSAY
PHADIA GMBH                       510(k) NO: K140493(Traditional)
ATTN: MARTIN R MANN               PHONE NO : 269 492-1957 
4169 COMMERCIAL AVE               SE DECISION MADE: 30-OCT-14
PORTAGE MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electro Auricular Device
NAVIGANT CONSULTING, INC.         510(k) NO: K140530(Traditional)
ATTN: COLLEEN  HITTLE             PHONE NO : 317 228-8730 
30 S WACKER DRIVE SUITE 3100      SE DECISION MADE: 02-OCT-14
CHICAGO IL  60606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K140543(Traditional)
ATTN: MICHAELA  RIVKOWICH         PHONE NO : 801 208-4196 
1600 WEST MERIT PKWY.             SE DECISION MADE: 16-OCT-14
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNESIS PEEK TL CAGE
BK MEDITECH CO., LTD.             510(k) NO: K140577(Traditional)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549-6035 
PO BOX 560                        SE DECISION MADE: 01-OCT-14
STILLWATER MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
CEDIC S.R.L.                      510(k) NO: K140581(Traditional)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665 
PIAZZA ALBANIA, 10                SE DECISION MADE: 17-OCT-14
ROME  IT 00153                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASTROGLIDE SENSUAL STRAWBERRY
BIOFILM, INC.                     510(k) NO: K140590(Traditional)
ATTN: Sherry  Castello            PHONE NO : 760 7279030 
3225 Executive Rdg                SE DECISION MADE: 30-OCT-14
VISTA CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
DIMA ITALIA SRL                   510(k) NO: K140598(Traditional)
ATTN: DARIO  BASCIU               PHONE NO : 39 051568 857 
via Coriolano Vighi, 29           SE DECISION MADE: 16-OCT-14
Bologna  IT 40133                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
DIMA ITALIA SRL                   510(k) NO: K140605(Traditional)
ATTN: DARIO  BASCIU               PHONE NO : 39 051568 857 
via Coriolano Vighi, 29           SE DECISION MADE: 03-OCT-14
Bologna  IT 40133                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MECA XPRESSFISH
ADVANDX, INC.                     510(k) NO: K140619(Traditional)
ATTN: RON  EISENWINTER            PHONE NO : 781 376-0009 1027
400 TradeCenter Suite 6990        SE DECISION MADE: 10-OCT-14
WOBURN MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K140647(Traditional)
ATTN: Tina  Ip                    PHONE NO : 416 593 4323 
439 UNIVERSITY AVE.               SE DECISION MADE: 24-OCT-14
TORONTO, ONTARIO  CA M5G 1Y8      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLINPRO PROPHY POWDER
3M DEUTSCHLAND GMBH               510(k) NO: K140684(Traditional)
ATTN: DESI W SOEGIARTO            PHONE NO : 49 815 27001169 
ESPE PLATZ                        SE DECISION MADE: 24-OCT-14
SEEFELD  DE D-82229               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPI - MOLECULAR PRECISION IMPLANT, CIP - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR
DITRON PRECISION LTD              510(k) NO: K140728(Traditional)
ATTN: TALI  HAZAN                 PHONE NO : 972 505 292304 
RAMOT NAFTALI M.P UPPER GALILLEE  SE DECISION MADE: 17-OCT-14
RAMOT NAFTALI  IL 13830           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
COOPER SURGICAL, INC.             510(k) NO: K140754(Traditional)
ATTN: TIM  LOHNES                 PHONE NO : 203 922-0105 8211
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 23-OCT-14
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALO AMBULATORY INFUSION SYSTEM
ZYNO MEDICAL LLC.                 510(k) NO: K140783(Abbreviated)
ATTN: MEI  ZHANG                  PHONE NO : 508 650-2008 205
177 PINE ST                       SE DECISION MADE: 17-OCT-14
NATICK MA  01760                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ITCLAMP 50
INNOVATIVE TRAUMA CARE INC        510(k) NO: K140805(Traditional)
ATTN: RICHARD  WAITE              PHONE NO : 210 582-5850 1932
3463 MAGIC DR. SUITE 120          SE DECISION MADE: 09-OCT-14
SAN ANTONIO TX  78229             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUGGERKNOT MINI SOFT ANCHOR
BIOMET SPORTS MEDICINE            510(k) NO: K140908(Traditional)
ATTN: GARY  BAKER                 PHONE NO : 574 3711088 
56 EAST BELL DRIVE                SE DECISION MADE: 02-OCT-14
WARSAW IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIVERSAL NAVIGATION INSTRUMENTS
MEDOS INTERNATIONAL SARL          510(k) NO: K140927(Traditional)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828-3291 
325 Paramount Drive               SE DECISION MADE: 24-OCT-14
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z1 CPAP SYSTEM
HUMAN DESIGN MEDICAL, LLC         510(k) NO: K140929(Traditional)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207-1245 
5 TIMBER LANE                     SE DECISION MADE: 17-OCT-14
NORTH READING MA  01864           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSTOM-I ALERT
11 HEALTH AND TECHNOLOGIES LLC    510(k) NO: K140938(Traditional)
ATTN: E J SMITH                   PHONE NO : 888 729-9674 
1468 Harwell Avenue               SE DECISION MADE: 10-OCT-14
Crofton MD  21114                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
CANADIAN TECHNICAL TAPE, LTD.     510(k) NO: K140940(Traditional)
ATTN: GARY  SOCOLA                PHONE NO : 505 743-1935 
125 HIGHPOWER ROAD                SE DECISION MADE: 27-OCT-14
ROCHESTER NY  14623               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IONOSTAR MOLAR
VOCO GMBH                         510(k) NO: K140993(Traditional)
ATTN: T  GERKENSMEIER             PHONE NO : 494 721 719200 
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 20-OCT-14
CUXHAVEN  DE D-27472              510(k) STATEMENT
                                                    

DEVICE: FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
FOLSOM METAL PRODUCTS, INC. DBA FR510(k) NO: K141106(Traditional)
ATTN: KEVIN  ETHERIDGE            PHONE NO : 205 733-0901 
153A  CAHABA VALLEY PARKWAY       SE DECISION MADE: 10-OCT-14
PELHAM AL  35124                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
HANDPIECE HEADQUARTERS            510(k) NO: K141125(Traditional)
ATTN: TINA  STEFFANIE-OAK         PHONE NO : 717 335-7230 4150
620 S. PLACENTIA AVE.             SE DECISION MADE: 23-OCT-14
PLACENTIA CA  92870               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
UNISIS CORP.                      510(k) NO: K141126(Traditional)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480-9554 
1201 RICHARDSON DRIVE, SUITE 280  SE DECISION MADE: 31-OCT-14
RICHARDSON TX  75080              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
ZOLL CIRCULATION                  510(k) NO: K141139(Traditional)
ATTN: SUSAN  NORIEGA              PHONE NO : 408 419-2988 
2000 Ringwood Ave                 SE DECISION MADE: 03-OCT-14
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVANTAGE
STEVENSON INDUSTRIES, INC.        510(k) NO: K141152(Traditional)
ATTN: SERRAH  NAMINI              PHONE NO : 805 426-3544 
780 CHAMBERS LANE SUITE 200       SE DECISION MADE: 17-OCT-14
SIMI VALLEY CA  93065             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
A & D CO., LTD.                   510(k) NO: K141160(Special)
ATTN: JERRY  WANG                 PHONE NO : 408 518-5113 
1756 AUTOMATION PARKWAY           SE DECISION MADE: 07-OCT-14
SAN JOSE CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATRIXWAVE MMF SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K141165(Traditional)
ATTN: Damon  Lees                 PHONE NO : 610 718-5608 
1302 WRIGHTS LANE EAST            SE DECISION MADE: 17-OCT-14
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RENOVOCATH RC120
RENOVORX, INC.                    510(k) NO: K141175(Traditional)
ATTN: RON S WARREN                PHONE NO : 408 400-0856 
7775 N. MATHILDA AVE, STE 100     SE DECISION MADE: 24-OCT-14
SUNNYVALE CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PADI-LOCK
PADI-LOCK, LLC                    510(k) NO: K141200(Traditional)
ATTN: MARIA  GRIFFIN              PHONE NO : 516 482-9001 
55 NORTHERN BLVD, STE 200         SE DECISION MADE: 02-OCT-14
GREAT NECK NY  11021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
A & D CO., LTD.                   510(k) NO: K141201(Special)
ATTN: JERRY  WANG                 PHONE NO : 408 518-5113 
1756 AUTOMATION PARKWAY           SE DECISION MADE: 08-OCT-14
SAN JOSE CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVABONE BIOACTIVE STRIP
NovaBone Products, LLC            510(k) NO: K141207(Traditional)
ATTN: Lisa  Simpson               PHONE NO : 386 462-7661 216
13510 NW US Highway 441           SE DECISION MADE: 31-OCT-14
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K141211(Traditional)
ATTN: MARIA  HATEGAN              PHONE NO : 949 225-1241 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 22-OCT-14
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
LARES RESEARCH, INC.              510(k) NO: K141221(Abbreviated)
ATTN: JASON  ORGAIN               PHONE NO : 530 345-1767 
295 LOCKHEED AVE.                 SE DECISION MADE: 28-OCT-14
CHICO CA  95973                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLIDE DEVICE
HOME SKINOVATIONS LTD.            510(k) NO: K141242(Traditional)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002 
20 HATA'AS STR., SUITE 102        SE DECISION MADE: 17-OCT-14
KFAR SABA  IL 44425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORUM GLAUCOMA WORKPLACE
CARL ZEISS MEDITEC AG             510(k) NO: K141297(Traditional)
ATTN: MANDY  AMBRECHT             PHONE NO : 925 557-4561 
5160 HACIENDA DRIVE               SE DECISION MADE: 03-OCT-14
DUBLIN CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERILUCENT PROCESS CHALLENGE DEVICE
STERILUCENT, INC                  510(k) NO: K141312(Traditional)
ATTN: PETER  KALKBRENNER          PHONE NO : 612 767-3253 
1400 MARSHALL STREET NE           SE DECISION MADE: 31-OCT-14
MINNEAPOLIS MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
TOPCON CORP.                      510(k) NO: K141325(Traditional)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207-1245 
5 TIMBER LANE                     SE DECISION MADE: 23-OCT-14
NORTH READING MA  01864           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
BIOMET, INC.                      510(k) NO: K141331(Traditional)
ATTN: TRACY  BICKEL JOHNSON       PHONE NO : 574 372-1761 
56 EAST BELL DRIVE PO BOX 587     SE DECISION MADE: 27-OCT-14
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPEL APD DRAINAGE CATHETER SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K141335(Traditional)
ATTN: MATT  BEAUCHANE             PHONE NO : 763 494-1789 
ONE SCIMED PLACE                  SE DECISION MADE: 17-OCT-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
ASAHI INTECC CO., LTD.            510(k) NO: K141339(Traditional)
ATTN: CANDACE  CEDERMAN           PHONE NO : 410 674-2060 
5523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 23-OCT-14
BALTIMORE MD  21228               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K141344(Traditional)
ATTN: MATT  BEAUCHANE             PHONE NO : 763 494-1789 
ONE SCIMED PLACE                  SE DECISION MADE: 17-OCT-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMERGE MEDICAL IM NAIL SYSTEM
EMERGE MEDICAL                    510(k) NO: K141347(Traditional)
ATTN: MICHELLE  POTVIN            PHONE NO : 720 459-6392 
720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 02-OCT-14
DENVER CO  80246                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDC INTERLOCKING DETACHABLE COIL
Boston Scientific Corporation     510(k) NO: K141378(Traditional)
ATTN: LIZ  JOHNSTON               PHONE NO : 763 494-1676 
ONE SCIMED PLACE                  SE DECISION MADE: 08-OCT-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
STIMWAVE TECHNOLOGIES INCORPORATED510(k) NO: K141399(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 800 965-5134 
420 Lincoln Rd Suite 365          SE DECISION MADE: 10-OCT-14
Miami Beach FL  33139             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
BIOMET, INC.                      510(k) NO: K141407(Traditional)
ATTN: JULIE  GANTENBERG, M.S.     PHONE NO : 574 377-8133 
56 EAST BELL DR. BOX 587          SE DECISION MADE: 27-OCT-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLOOD PRESSURE MONITOR
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K141416(Traditional)
ATTN: XIE  QIONGYU                PHONE NO : 086 075526 710795 
2/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 09-OCT-14
NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELECSYS FOLATE III
Roche Diagnostics                 510(k) NO: K141426(Traditional)
ATTN: KELLI  TURNER               PHONE NO : 317 521-4515 
9115 HAGUE ROAD                   SE DECISION MADE: 17-OCT-14
INDIANAPOLIS IN  46250-0416       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
FIAGON GMBH                       510(k) NO: K141456(Traditional)
ATTN: DIRK  MUCHA                 PHONE NO : 49 3302 2012124 
NEUENDORFSTRASSE 23B              SE DECISION MADE: 08-OCT-14
HENNIGSDORF  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141459(Traditional)
ATTN: ORLANDO  TADEO              PHONE NO : 714 669-7459 
2441 MICHELLE DRIVE               SE DECISION MADE: 28-OCT-14
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLITAIRE 2 REVASCULARIZATION DEVICE
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K141491(Traditional)
ATTN: LARRY  BOUCHER              PHONE NO : 948 837-3700 
9775 TOLEDO WAY                   SE DECISION MADE: 22-OCT-14
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC.                    510(k) NO: K141502(Traditional)
ATTN: Howard  Schrayer            PHONE NO : 914 357-2600 
1 Bridge St Ste 121               SE DECISION MADE: 03-OCT-14
Irvington NY  10533               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
ECO MEDI GLOVE SDN. BHD           510(k) NO: K141510(Traditional)
ATTN: SURESH  KUMAR               PHONE NO : 603 602 83033 
LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14
TAIPING  MY 34600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
APEX MEDICAL CORP.                510(k) NO: K141522(Traditional)
ATTN: ALAN  CHANG                 PHONE NO : 886 2 22685568 
NO. 9, MIN SHENG ST., TU-CHENG,   SE DECISION MADE: 06-OCT-14
NEW TAIPEI CITY  TW 23679         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KUBTEC X250
KUB TECHNOLOGIES, INC             510(k) NO: K141539(Traditional)
ATTN: VIKRAM  BUTANI              PHONE NO : 203 364-8544 
270 ROWE AVENUE, UNIT E           SE DECISION MADE: 29-OCT-14
MILFORD CT  06461                 510(k) STATEMENT
                                                    

DEVICE: NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
Covidien LLC                      510(k) NO: K141542(Traditional)
ATTN: MIA M WARE                  PHONE NO : 303 305-2750 
6135 Gunbarrel Ave                SE DECISION MADE: 02-OCT-14
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K141544(Traditional)
ATTN: CHRISTINA  BOYDSTON         PHONE NO : 760 929-4300 
1900 ASTON AVE.                   SE DECISION MADE: 22-OCT-14
CARLSBAD CA  92008-7308           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
ETHICON, INC.                     510(k) NO: K141560(Traditional)
ATTN: SUSAN  LIN                  PHONE NO : 908 218-2256 
P.O. BOX 151 ROUTE 22 WEST        SE DECISION MADE: 23-OCT-14
SOMERVILLE NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: "OPTON PRO"
ZIMMER MEDIZINSYSTEMS GMBH        510(k) NO: K141564(Third Party - Traditional)
ATTN: ARMIN  PETRASCHKA           PHONE NO : 497 319761 140 
JUNKERSSTRASSE 9                  SE DECISION MADE: 24-OCT-14
NEU-ULM  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IMPLANT STUDIO
3SHAPE MEDICAL A/S                510(k) NO: K141570(Traditional)
ATTN: HANNE  NIELSEN              PHONE NO : 457 027262 0 
HOLMENS KANAL 7                   SE DECISION MADE: 31-OCT-14
COPENHAGEN K  DK DK-1060          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
ECO MEDI GLOVE SDN. BHD           510(k) NO: K141579(Traditional)
ATTN: SURESH  KUMAR               PHONE NO : 603 602 83033 
LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 17-OCT-14
TAIPING, PERAK  MY 34600          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
Boston Scientific Corporation     510(k) NO: K141584(Traditional)
ATTN: THOMAS  HIRTE               PHONE NO : 508 683-4454 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 16-OCT-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K141600(Traditional)
ATTN: SARAH  MCINTYRE             PHONE NO : 916 225-5861 
375 RIVER PARK CIRCLE             SE DECISION MADE: 17-OCT-14
MARQUETTE MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra Silver Dressings
MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K141603(Special)
ATTN: GORDON  MACFARLANE          PHONE NO : 919 873-8962 
62 FOREST STREET,SUITE300         SE DECISION MADE: 22-OCT-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141604(Traditional)
ATTN: LILA  JOE                   PHONE NO : 800 3963133876 
1800 PYRAMID PLACE                SE DECISION MADE: 21-OCT-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
ECO MEDI GLOVE SDN BHD            510(k) NO: K141623(Traditional)
ATTN: SURESH  KUMAR               PHONE NO : 603 602 83033 
LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14
TAIPING  MY 34600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENSITITRE SUSCEPTIBILITY PLATES
Thermo Fisher Scientific          510(k) NO: K141651(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 871-8909 4117
1 Thermo Fisher Way               SE DECISION MADE: 21-OCT-14
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: LIGHT SCALPEL
LIGHT SCALPEL LLC                 510(k) NO: K141658(Traditional)
ATTN: DAVID  WALTERS              PHONE NO : 425 368-1588 
16932 WOODINIVILLE-REDMOND RD NE, SE DECISION MADE: 22-OCT-14
WOODINIVILLE WA  98072            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRISM ZIRCONIA, ST-98
A & D DENTAL INNOVATIONS          510(k) NO: K141659(Traditional)
ATTN: YOONHO  JUN                 PHONE NO : 888 374-5134 
9308 EVENING PRIMROSE PATH        SE DECISION MADE: 09-OCT-14
AUSTIN TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAWALUTION SKIN AND WOUND CLEANSER
NAWA HEILMITTEL GMBH              510(k) NO: K141660(Traditional)
ATTN: ALLYSON B MULLEN            PHONE NO : 202 737-9639 
700 THIRTEENTH ST, N.W.           SE DECISION MADE: 31-OCT-14
WASHINGTON DC  20005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
REXAM HEALTHCARE                  510(k) NO: K141664(Abbreviated)
ATTN: BEATRICE  GRAND DEMARS      PHONE NO : 334 7495 2915 
20 AVENUE DE LA GARE              SE DECISION MADE: 02-OCT-14
LA VERPILLIERE  FR 38292          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
SMITH MEDICAL ASD, INC.           510(k) NO: K141686(Traditional)
ATTN: JIM  JOHNSON                PHONE NO : 651 628-7264 
1265 GREY FOX ROAD                SE DECISION MADE: 28-OCT-14
ST. PAUL MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASSEN COLOR
VASSEN CO., LTD.                  510(k) NO: K141699(Traditional)
ATTN: BRET  ANDRE                 PHONE NO : 503 372-5226 
474 NE 61ST PL.                   SE DECISION MADE: 07-OCT-14
HILLSBORO OR  97124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
GENORAY CO., LTD.                 510(k) NO: K141700(Traditional)
ATTN: KAITLYNN  MIN               PHONE NO : 714 289-8020 
3002 DOW AVENUE, SUITE 420        SE DECISION MADE: 31-OCT-14
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVASHIELD INJECTABLE NASAL PACKING AND STENT
MEDTRONIC INC.                    510(k) NO: K141704(Traditional)
ATTN: RISHI  SINHA                PHONE NO : 269 903-4373 
6743 SOUTHPOINT DRIVE NORTH       SE DECISION MADE: 06-OCT-14
JACKSONVILLE FL  32259            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRASHAPE SYSTEM
SYNERON MEDICAL LTD.              510(k) NO: K141708(Traditional)
ATTN: JANICE M HOGAN              PHONE NO : 617 863-5520 
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 06-OCT-14
PHILADELPHIA PA  19103            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMARTGRAFT 200 SYSTEM
INGENERON, INC.                   510(k) NO: K141713(Traditional)
ATTN: ANITA  KADALA               PHONE NO : 713 440-9900 
8205 El Rio St                    SE DECISION MADE: 28-OCT-14
Houston TX  77054                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K141714(Traditional)
ATTN: VAL  MYLES                  PHONE NO : 901 290-5162 
1023 CHERRY ROAD                  SE DECISION MADE: 24-OCT-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UPCERA COLORING LIQUID (I AND II )
LIAONING UPCERA CO.,LTD           510(k) NO: K141723(Traditional)
ATTN: CHARLES  SHEN               PHONE NO : 608 217-9358 
853 DORCHESTER LN, SUITE-B        SE DECISION MADE: 22-OCT-14
NEW MILFORD NJ  07646             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
LIAONING UPCERA CO.,LTD           510(k) NO: K141724(Traditional)
ATTN: CHARLES  SHEN               PHONE NO : 608 217-9358 
853 DORCHESTER LN, SUITE-B        SE DECISION MADE: 22-OCT-14
NEW MILFORD NJ  07646             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEPHROS DSU-H, NEPHROS SSU-H
NEPHROS, INC.                     510(k) NO: K141731(Traditional)
ATTN: JAMES  SUMMERTON            PHONE NO : 201 343-5202 
41 GRAND AVE                      SE DECISION MADE: 24-OCT-14
River Edge NJ  07661              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RESIDUAL LIMB LENGTHENING SYSTEM
ELLIPSE TECHNOLOGIES INC.         510(k) NO: K141739(Traditional)
ATTN: REBECCA  SHELBURNE          PHONE NO : 949 837-3600 
13900 ALTON PKWY STE 123          SE DECISION MADE: 07-OCT-14
IRVINE CA  92618-0000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
ARDO MEDICAL AG                   510(k) NO: K141742(Traditional)
ATTN: YARMELA  PAVLOVIC           PHONE NO : 267 675-4601 
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 17-OCT-14
PHILADELPHIA PA  19103            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
RADIOLOGY SOLUTIONS LLC           510(k) NO: K141743(Traditional)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234-1735 
8870 RAVELLO CT.                  SE DECISION MADE: 03-OCT-14
NAPLES FL  34114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQQA-BODYIMAGING SOFTWARE
EDDA TECHNOLOGY                   510(k) NO: K141745(Traditional)
ATTN: DANIEL  KAMM                PHONE NO : 239 234-1735 
5 Independence Way                SE DECISION MADE: 31-OCT-14
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQUARIUS NASAL FEEDING TUBE
DEGANIA SILICONE, LTD.            510(k) NO: K141753(Traditional)
ATTN: ZOYA  LEE                   PHONE NO : 972 467 55122 
DEGANIA BET                       SE DECISION MADE: 16-OCT-14
EMEK HAYARDEN  IL 15130           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T:SLIM INSULIN DELIVERY SYSTEM
TANDEM DIABETES CARE, INC.        510(k) NO: K141758(Traditional)
ATTN: JANICE  HOGAN               PHONE NO : 267 675-4600 
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 31-OCT-14
PHILADELPHIA PA  19103            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
OAK RIDGE PRODUCTS, LLC           510(k) NO: K141759(Third Party - Traditional)
ATTN: CONOR J O'MALLEY            PHONE NO : 888 650-7444 
4612 Century Ct                   SE DECISION MADE: 24-OCT-14
McHenry IL  60050                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEM
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K141765(Traditional)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602-3568 
419 WEST AVENUE                   SE DECISION MADE: 03-OCT-14
STAMFORD CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
ETHICON, INC.                     510(k) NO: K141776(Traditional)
ATTN: PETER  CECCHINI             PHONE NO : 908 218-2457 
ROUTE 22 WEST                     SE DECISION MADE: 15-OCT-14
SOMERVILLE NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOMET FUSION SYSTEM
BIOMET SPINE                      510(k) NO: K141791(Traditional)
ATTN: TED  KUHN                   PHONE NO : 303 501-8549 
310 INTERLOCKEN PARKWAY           SE DECISION MADE: 09-OCT-14
BROOMFIELD CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
COVIDIEN, LLC                     510(k) NO: K141801(Traditional)
ATTN: JULIE  UNDERDAHL            PHONE NO : 763 398-7000 
3033 CAMPUS DRIVE                 SE DECISION MADE: 16-OCT-14
PLYMOUTH MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
DEFIBTECH, LLC                    510(k) NO: K141809(Traditional)
ATTN: Ed  Horton                  PHONE NO : 203 453-6654 
741 BOSTON POST ROAD              SE DECISION MADE: 27-OCT-14
GUILFORD CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMOPORE
Polyganics BV                     510(k) NO: K141816(Traditional)
ATTN: BETTY  IJMKER               PHONE NO : 31 50 5886588 
ROZENBURGLAAN 15A                 SE DECISION MADE: 23-OCT-14
GRONINGEN  NL 9727DL              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAGWIRE HIGH PERFORMANCE GUIDWIRE
BOSTON SCIENTIFIC CORP.           510(k) NO: K141820(Traditional)
ATTN: ALLISON  BAILLIE            PHONE NO : 508 683-4942 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 21-OCT-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STARBAND, STARLIGHT
ORTHOMERICA PRODUCTS, INC.        510(k) NO: K141842(Traditional)
ATTN: DAVID C KERR                PHONE NO : 407 290-6592 
6333 N Orange Blossom Trl         SE DECISION MADE: 06-OCT-14
ORLANDO FL  32810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLOSPINE PEDICLE SCREW SYSTEM
FLOSPINE                          510(k) NO: K141850(Traditional)
ATTN: RICH  JANSEN                PHONE NO : 612 281-5505 
11821 BRAMBLE COVE DRIVE          SE DECISION MADE: 27-OCT-14
FT. MYERS FL  33905               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAYSTATION
RAYSEARCH LABORATORIES AB         510(k) NO: K141860(Traditional)
ATTN: DAVID  HEDFORS              PHONE NO : 46 722 366110 
SVEAV 25, PLAN 9                  SE DECISION MADE: 23-OCT-14
STOCKHOLM  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DANA
ANTHROTRONIX, INC                 510(k) NO: K141865(Traditional)
ATTN: CORINA E LATHAN, PHD, PE    PHONE NO : 240 498-9471 
8737 COLESVILLE ROAD SUITE L-203  SE DECISION MADE: 15-OCT-14
SILVER SPRING MD  20910           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
HEMEDEX INCORPORATED              510(k) NO: K141869(Traditional)
ATTN: DEAN  HONKONEN              PHONE NO : 617 577-1759 
222 3rd St Suite 0123             SE DECISION MADE: 10-OCT-14
CAMBRIDGE MA  02142               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAPIDRESULTS
RAMSOFT, INC.                     510(k) NO: K141881(Traditional)
ATTN: LELY  LAM-HONG              PHONE NO : 416 674134 7 EXT 213 
243 COLLEGE ST.,SUITE 100         SE DECISION MADE: 31-OCT-14
TORONTO, ON  CA M5T 1R5           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHARKCORE FINE NEEDLE BIOPSY SYSTEM
COVIDIEN LLC (FORMERLY BEACON ENDO510(k) NO: K141894(Traditional)
ATTN: Saket  Bhatt                PHONE NO : 408 328-7357 
2000 COMMONWEALTH AVE. SUITE 110  SE DECISION MADE: 06-OCT-14
AUBURNDALE MA  02466-2008         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIORA V-TOUCH
VIORA LTD.                        510(k) NO: K141904(Traditional)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837 
31 HAAVODA ST.                    SE DECISION MADE: 21-OCT-14
BINYAMINA  IL 30500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DUAL SWITCH
LASER ENGINEERING, INC.           510(k) NO: K141908(Special)
ATTN: LAURIE  DOBBS               PHONE NO : 615 739-5418 
475 METROPLEX DR. SUITE 401       SE DECISION MADE: 22-OCT-14
NASHVILLE TN  37211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141912(Traditional)
ATTN: ANNA  HWANG                 PHONE NO : 310 533-9966 
3203 KASHIWA STREET               SE DECISION MADE: 29-OCT-14
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
UNICON OPTICAL CO., LTD.          510(k) NO: K141917(Traditional)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995 
NO. 45, MINGSHENG RD., DANSHUI DISSE DECISION MADE: 17-OCT-14
NEW TAIPEI  TW 251                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LYRA PARAINFLUENZA VIRUS ASSAY
QUIDEL CORPORATION                510(k) NO: K141927(Traditional)
ATTN: Ronald H Lollar             PHONE NO : 740 589-3373 
2005 E State St Suite 100         SE DECISION MADE: 09-OCT-14
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LYRA ADENOVIRUS ASSAY
QUIDEL CORPORATION                510(k) NO: K141931(Traditional)
ATTN: Ronald H Lollar             PHONE NO : 750 589-3373 
2005 E State St Suite 100         SE DECISION MADE: 09-OCT-14
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP  3D 3.0-ENABLE, SPINEMAP  3D 3.0-SALES D
STRYKER CORPORATE                 510(k) NO: K141941(Traditional)
ATTN: LILIAN  ECKERT              PHONE NO : 497 614 512117 
BOETZINGER STR.41                 SE DECISION MADE: 31-OCT-14
FREIBURG, BADEN-WUERTTEMBERG  DE 7510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
TITAN SPINE, LLC                  510(k) NO: K141953(Traditional)
ATTN: CHRISTINE  SCIFERT          PHONE NO : 901 831-8053 
3416 ROXEE RUN COVE               SE DECISION MADE: 27-OCT-14
BARTLETT TN  38133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XCEL 455 SLIT LAMP
REICHERT, INC.                    510(k) NO: K141954(Special)
ATTN: THOMAS M HECKMANN           PHONE NO : 716 686-4500 
3362 WALDEN AVE.                  SE DECISION MADE: 15-OCT-14
DEPEW NY  14043                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K141972(Traditional)
ATTN: CHRIS  WEABER               PHONE NO : 801 486-6070 
1567 E. Stratford Avenue          SE DECISION MADE: 09-OCT-14
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIODE LASER HAIR REMOVAL SYSTEM
BEIJING ANCHORFREE TECHNOLOGY CO.,510(k) NO: K141973(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
P.O.BOX 237-023                   SE DECISION MADE: 06-OCT-14
SHANGHAI  CN 200030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K142003(Traditional)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602-3568 
419 WEST AVE.                     SE DECISION MADE: 21-OCT-14
STAMFORD CT  06902-6300           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFIA DISTAL ACCESS CATHETER
MICROVENTION, INC.                510(k) NO: K142014(Special)
ATTN: Naomi  Gong                 PHONE NO : 714 247-8055 
1311 VALENCIA AVE                 SE DECISION MADE: 10-OCT-14
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
SPINEFRONTIER, INC.               510(k) NO: K142026(Traditional)
ATTN: MEREDITH  MAY               PHONE NO : 719 337-7579 
4628 NORTHPARK DRIVE              SE DECISION MADE: 20-OCT-14
COLORADO SPRINGS CO  80918        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 888 WNLE POWERED WHEELCHAIR
PIHSIANG MACHINERY MFG. CO., LTD. 510(k) NO: K142027(Third Party - Traditional)
ATTN: DAVID  LIN                  PHONE NO : 310 328-8866 102
21184 FIGUEROA ST.                SE DECISION MADE: 07-OCT-14
CARSON CA  90745                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
NANOSPERE,INC.                    510(k) NO: K142033(Traditional)
ATTN: NOAH  LERMER                PHONE NO : 847 400-9000 
4088 COMMERCIAL AVE               SE DECISION MADE: 10-OCT-14
NORTHBROOK IL  60062              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTRA
HOLOGIC, INC.                     510(k) NO: K142037(Traditional)
ATTN: CATHERINE  WILLIAMS         PHONE NO : 408 352-0201 
2585 AUGUSTINE DR                 SE DECISION MADE: 10-OCT-14
SANTA CLARA CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERCHONIA SHL
ERCHONIA CORPORATION              510(k) NO: K142042(Traditional)
ATTN: Kevin  Walls                PHONE NO : 720 962-5412 
33 Golden Eagle Lane              SE DECISION MADE: 21-OCT-14
Littleton CO  80127               510(k) STATEMENT
                                                    

DEVICE: NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K142050(Traditional)
ATTN: MICHELLE  CHEUNG            PHONE NO : 858 909-3360 
7475 LUSK BLVD.                   SE DECISION MADE: 29-OCT-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K142053(Traditional)
ATTN: HOLLY  SEPPANEN             PHONE NO : 952 830-6240 
7375 BUSH LAKE RD.                SE DECISION MADE: 29-OCT-14
MINNEAPOLIS MN  55439             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: #8C RENEGADE DENTAL HANDPIECE
HANDPIECE CLUB, LLC               510(k) NO: K142063(Traditional)
ATTN: TINA  WU                    PHONE NO : 443 352-3909 
62 FOREST STREET, SUITE 300       SE DECISION MADE: 28-OCT-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
RTI SURGICAL, INC.                510(k) NO: K142070(Traditional)
ATTN: KRISTINA  HALL              PHONE NO : 386 418-8888 4511
11621 Research Cir                SE DECISION MADE: 27-OCT-14
ALACHUA FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VELASII THERAPY LASER SYSTEM
ASPEN LASER SYSTEMS, LLC          510(k) NO: K142078(Traditional)
ATTN: A. BRAUN  HENDERSON         PHONE NO : 303 751-2055 
970 SOUTH DAWSON WAY #14          SE DECISION MADE: 30-OCT-14
AURORA CO  80012                  510(k) STATEMENT
                                                    

DEVICE: STALIF CTI, STALIF C
CENTINEL SPINE, INC.              510(k) NO: K142079(Traditional)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552-5800 
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 24-OCT-14
WASHINGTON DC  20005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT
ZIMMER DENTAL INC.                510(k) NO: K142082(Traditional)
ATTN: CHRISTINA  BOYDSON          PHONE NO : 760 919-4110 
1900 ASTON AVE.                   SE DECISION MADE: 28-OCT-14
CARLSBAD CA  92008-7308           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
NCONTACT SURGICAL, INC.           510(k) NO: K142084(Traditional)
ATTN: JANE  RICUPERO              PHONE NO : 919 655-1355 
1001AVIATION PARKWAY, SUITE 400   SE DECISION MADE: 28-OCT-14
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K142088(Traditional)
ATTN: PATRICK  CHOW               PHONE NO : 008 522 8516789 
BLOCK 6 AND 7, ZHU KENG INDUSTRIALSE DECISION MADE: 31-OCT-14
GUANG DONG  CN                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REBOSSIS
ORTHOREBIRTH CO., LTD.            510(k) NO: K142090(Traditional)
ATTN: KEVIN  A.THOMAS             PHONE NO : 858 792-1235 
12264 El Camino Real, Suite 400   SE DECISION MADE: 29-OCT-14
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PARIETENE MACROPOROUS MESH
SOFRADIM PRODUCTION               510(k) NO: K142091(Traditional)
ATTN: JENNIFER  BRENNAN           PHONE NO : 203 492-5346 
60 MIDDLETOWN AVENUE              SE DECISION MADE: 17-OCT-14
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Renovis Surgical Technologies, Inc510(k) NO: K142095(Special)
ATTN: Sharyn  Orton               PHONE NO : 401 330-8264 
200 HOMER AVE.                    SE DECISION MADE: 15-OCT-14
ASHLAND MA  01721                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-PIECE RESUSCITATOR
MERCURY MEDICAL                   510(k) NO: K142096(Traditional)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498-2155 
24301 WOODSAGE DRIVE              SE DECISION MADE: 17-OCT-14
BONITA SPRINGS FL  34134          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABACUS (TM) SPACER SYSTEM
SPINE WAVE, INC.                  510(k) NO: K142101(Traditional)
ATTN: ROAIDA  JOHNSON             PHONE NO : 203 944-9494 
3 ENTERPRISE DRIVE, SUITE 210     SE DECISION MADE: 23-OCT-14
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIA 4.5 SPINAL SYSTEM
STRYKER CORPORATION               510(k) NO: K142114(Traditional)
ATTN: GARRY T HAYECK, PH.D.       PHONE NO : 201 760-8043 
2 PEARL COURT                     SE DECISION MADE: 27-OCT-14
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
Roche Diagnostics                 510(k) NO: K142133(Traditional)
ATTN: Sarah  Baumann              PHONE NO : 317 521-3952 
9155 HAGUE RD.                    SE DECISION MADE: 24-OCT-14
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISO-GARD MASK
Teleflex Medical, Inc.            510(k) NO: K142138(Traditional)
ATTN: BRIAN  GALL                 PHONE NO : 919 544-8000 
2917 WECK DR.                     SE DECISION MADE: 30-OCT-14
RESEARCH TRIANGLE PARK NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIS MODULIFT VBR SYSTEM
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K142150(Traditional)
ATTN: LISA M BOYLE                PHONE NO : 610 984-9274 
3773 Corporate Parkway            SE DECISION MADE: 29-OCT-14
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
GE HEALTHCARE                     510(k) NO: K142160(Traditional)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721-4214 
9900 INNOVATION DR.               SE DECISION MADE: 10-OCT-14
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
Becton, Dickinson and Company     510(k) NO: K142170(Traditional)
ATTN: MONICA E GIGUERE            PHONE NO : 410 316-4287 
7 Loveton Cir., MC 694            SE DECISION MADE: 28-OCT-14
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DX-D IMAGING PACKAGE
AGFA HEALTHCARE N.V.              510(k) NO: K142184(Traditional)
ATTN: SHAEANN  CAVANAGH           PHONE NO : 864 421-1766 
10 SOUTH ACADEMY ST.              SE DECISION MADE: 16-OCT-14
GREENVILLE SC  29601              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COGENT MED-LIF XL
COGENT SPINE LLC                  510(k) NO: K142193(Special)
ATTN: JUDE  PAGANELLI             PHONE NO : 858 774 7891 
101 N. ACACIA AVE SUITE 106       SE DECISION MADE: 15-OCT-14
SOLANA BEACH CA  92075            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BNX Fine Needle Aspiration System
Covidien LLC                      510(k) NO: K142198(Traditional)
ATTN: Saket  Bhatt                PHONE NO : 1 408 3287357 
2000 Commonwealth Ave Suite 110   SE DECISION MADE: 08-OCT-14
Auburndale MA  02466              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ascendra Balloon Aortic Valvaloplasty Catheter
EDWARDS LIFESCIENCES              510(k) NO: K142199(Traditional)
ATTN: Susan   Reynolds            PHONE NO : 949 7564518 
ONE EDWARDS WAY                   SE DECISION MADE: 29-OCT-14
IRVINE CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
NOVA BIOMEDICAL CORPORATION       510(k) NO: K142220(Traditional)
ATTN: Paul  W.  MacDonald         PHONE NO : 781 8940800 
200 PROSPECT ST.                  SE DECISION MADE: 17-OCT-14
WALTHAM MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EpiAccess System
EpieP, Inc.                       510(k) NO: K142245(Traditional)
ATTN: Pamela  Bunes               PHONE NO : 864 4232526 
142 Temple Street, Suite 206      SE DECISION MADE: 29-OCT-14
New Haven CT  06510               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XprESS Multi-Sinus Dilation Tool 
ENTELLUS MEDICAL, INC.            510(k) NO: K142252(Special)
ATTN: Karen  E.  Peterson         PHONE NO : 763 4637066 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 17-OCT-14
Plymouth  MN  55447               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sherlock 3CG Tip Positioning System Stylet
C.R.Bard, Inc.                    510(k) NO: K142267(Traditional)
ATTN: Bryan  Stone                PHONE NO : 1 801 5225876 
605 North 5600 West               SE DECISION MADE: 17-OCT-14
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varian Verification System (VVS)
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K142268(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 HANSEN WAY                   SE DECISION MADE: 02-OCT-14
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
NEO VISION CO., LTD.              510(k) NO: K142275(Traditional)
ATTN: Kyung Hwa Kim               PHONE NO : 82 31 8892040 
1029 YEONGDOEK-DONG, GIHENUNG-GU YSE DECISION MADE: 07-OCT-14
GYEONGGI-DO  KR                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JULIET PO
SPINEART                          510(k) NO: K142277(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701246 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 14-OCT-14
GENEVA  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
HEALGEN SCIENTIFIC LLC            510(k) NO: K142280(Traditional)
ATTN: Jianqiu  Fang               PHONE NO : 1 713 7338088 
5213 MAPLE STREET                 SE DECISION MADE: 16-OCT-14
BELLAIRE TX  77401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
ZIMMER, INC.                      510(k) NO: K142281(Traditional)
ATTN: PATRICK   MCCULLAGH         PHONE NO : 574 272 4656 
P.O. BOX 708                      SE DECISION MADE: 22-OCT-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NS3000 Holmium Laser System
New Star Lasers, Inc.             510(k) NO: K142286(Special)
ATTN: Natalie  Vollrath           PHONE NO : 1 916 6771900 
9085 Foothills Blvd.              SE DECISION MADE: 31-OCT-14
Roseville CA  95747               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System  
Polymer Technology Systems, Inc.  510(k) NO: K142302(Traditional)
ATTN: Jack  Rogers                PHONE NO : 1 317 8705610 1064
7736 Zionsville Rd.               SE DECISION MADE: 02-OCT-14
Indianapolis IN  46268            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viberect Penile Vibratory Stimulation Device
REFLEXONIC, LLC                   510(k) NO: K142304(Traditional)
ATTN: Kambiz  Tajkarimi           PHONE NO : 301 3788433 
915 Toll House Avenue, Suite 205  SE DECISION MADE: 03-OCT-14
Frederick MD  21701               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
GE MEDICAL SYSTEMS ISRAEL LTD.    510(k) NO: K142323(Traditional)
ATTN: Bryan   Behn                PHONE NO : 972 4 8519619 
4 Etgar Street                    SE DECISION MADE: 10-OCT-14
Tirat Carmel  IL 39120            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urine/CSF Albumin, Urine/CSF Albumin Calibrator
Beckman Coulter Ireland Inc.      510(k) NO: K142346(Traditional)
ATTN: Anne-Marie  Shine           PHONE NO : 353 65 6831138 
Lismeehan, O'Callaghan's Mills    SE DECISION MADE: 15-OCT-14
Co. Clare  IE                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
W.H.P.M., Inc.                    510(k) NO: K142353(Traditional)
ATTN: John  Wan                   PHONE NO : 1 626 4438480 
5358 Irwindale Ave                SE DECISION MADE: 07-OCT-14
Irwindale CA  91706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vasc Band hemostat
Lepu Medical Technology (Beijing) 510(k) NO: K142359(Traditional)
ATTN: Kim  Xiangdan               PHONE NO : 
No. 37 Chaoqian Road              SE DECISION MADE: 23-OCT-14
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrx RFA Self Sizing Balloon Catheter
Covidien llc                      510(k) NO: K142364(Special)
ATTN: Rachel  Silva               PHONE NO : 1 408 3287359 
15 Hampshire Street               SE DECISION MADE: 01-OCT-14
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pico Way Laser System
CANDELA CORPATION                 510(k) NO: K142372(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 508 3587400 330
530 BOSTON POST ROAD              SE DECISION MADE: 30-OCT-14
WAYLAND MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xia 3 Spinal System
STRYKER CORP.                     510(k) NO: K142381(Traditional)
ATTN: GARRY T HAYECK              PHONE NO : 201 7608043 
2 PEARL COURT                     SE DECISION MADE: 21-OCT-14
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Chemtron Biotech, Inc.            510(k) NO: K142396(Traditional)
ATTN: Jane  Zhang                 PHONE NO : 858 4500044 
9245 Brown Deer Road              SE DECISION MADE: 09-OCT-14
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Miltex N-Tralig Intraligamentary Syringe
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K142414(Special)
ATTN: Judith  E.  O'Grady         PHONE NO : 609 2750500 
311 ENTERPRISE DR.                SE DECISION MADE: 30-OCT-14
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uroflowmeter
BE TECHNOLOGIES, INC.             510(k) NO: K142425(Traditional)
ATTN: Edward  Belotserkovsky      PHONE NO : 415 3078531 
2939 20th Avenue                  SE DECISION MADE: 27-OCT-14
San Francisco CA  94132           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cryoICE croablation probe
ATRICURE, INC.                    510(k) NO: K142441(Special)
ATTN: Jonathan  McElwee           PHONE NO : 513 6444249 
6217 CENTER PARK DRIVE            SE DECISION MADE: 29-OCT-14
WEST CHESTER OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
ZIMMER, INC.                      510(k) NO: K142442(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 03-OCT-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Site-Rite 6 Ultrasound System with Pinpoint GT Technology
C.R. Bard, Inc                    510(k) NO: K142443(Traditional)
ATTN: Kerrie  Hamblin             PHONE NO : 801 5224909 
605 North 5600 West               SE DECISION MADE: 30-OCT-14
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIVERGENCE Anterior Cervical Fusion System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K142450(Special)
ATTN: Shweta  Sharma              PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 01-OCT-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPEDIUM Spine System/Synapse System
JOHNSON AND JOHNSON               510(k) NO: K142460(Special)
ATTN: Jaclyn  Porsolt             PHONE NO : 1 508 8283269 
325 PARAMOUNT DR.                 SE DECISION MADE: 01-OCT-14
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UGEO PT60A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD          510(k) NO: K142466(Third Party - Traditional)
ATTN: PARK  KYEONG-MI             PHONE NO : 822 2194 1373 
42, TEHERAN-RO 108-GIL,           SE DECISION MADE: 03-OCT-14
GANGNAM-GU  KR                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sternal Closure System
JACE Medical LLC                  510(k) NO: K142484(Traditional)
ATTN: Justin  May                 PHONE NO : 574 5271663 
536 East 200 North                SE DECISION MADE: 31-OCT-14
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Combi Suite Neurosurgery for the MAGNETOM  Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
Siemens Medical Solutions USA, Inc510(k) NO: K142515(Special)
ATTN: Cordell  L. Fields          PHONE NO : 1 610 2198518 
51 Valley Stream Parkway, MailcodeSE DECISION MADE: 08-OCT-14
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SolfVue
DELPHINUS MEDICAL TECHNOLOGIES, IN510(k) NO: K142517(Traditional)
ATTN: Andrea N Wallen-Gerding     PHONE NO : 1 734 2333088 
46701 COMMERCE CENTER DRIVE       SE DECISION MADE: 31-OCT-14
PLYMOUTH MI  48170                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyProCure II
Graham Medical Technologies, L.L.C510(k) NO: K142534(Traditional)
ATTN: ANGELA  RECCHIA             PHONE NO : 586 6779600 
16137 LEONE DRIVE                 SE DECISION MADE: 03-OCT-14
MACOMB MI  48042                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
JVC KENWOOD CORPORATION           510(k) NO: K142536(Traditional)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258 246611 
3-12, MORIYACHO, KANAGAWA-KU      SE DECISION MADE: 03-OCT-14
YOKOHAMA-SHI  JP 221-0022         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiNA SafeAir Smoke Pencil
LINA MEDICAL APS                  510(k) NO: K142538(Special)
ATTN: Louisa  Memborg             PHONE NO : 454 329 6652 
FORMERVAGEN 5                     SE DECISION MADE: 06-OCT-14
GLOSTRUP  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
JVC KENWOOD CORPORATION           510(k) NO: K142540(Traditional)
ATTN: Tsukasa  Tashiro            PHONE NO : 81 258 246611 
3-12, MORIYA-CHO, KANAGAWA-KU     SE DECISION MADE: 03-OCT-14
YOKOHAMA-SHI  JP 221-0022         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Video-Uretero-Choledochoscope System
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K142556(Traditional)
ATTN: Mike  Samuels               PHONE NO : 424 2188288 
2151 E. GRAND AVENUE              SE DECISION MADE: 23-OCT-14
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well Lead PVC Urethral Catheter
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K142563(Traditional)
ATTN: Han Guang Yuan              PHONE NO : 86 20 84758878 
C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 28-OCT-14
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,  
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K142574(Special)
ATTN: TRACEY  HANNON              PHONE NO : 508 8808033 
325 PARAMOUNT DR.                 SE DECISION MADE: 24-OCT-14
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bard RiteCath Intermittent Urinary Catheter
C.R. Bard, Inc.                   510(k) NO: K142575(Traditional)
ATTN: Michele  Davis              PHONE NO : 770 7846274 
8195 Industrial Blvd              SE DECISION MADE: 31-OCT-14
Covington GA  30014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Periarticular Plating System
ZIMMER, INC.                      510(k) NO: K142579(Traditional)
ATTN: Patrick  McCullagh          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 22-OCT-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
TITAN SPINE, LLC                  510(k) NO: K142589(Special)
ATTN: Jane  Rodd                  PHONE NO : 262 2427801 
6140 WEST EXECUTIVE DRIVE, SUITE ASE DECISION MADE: 17-OCT-14
MEQUON WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALOR Hindfoot Fusion Nail System
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K142602(Special)
ATTN: VAL  MYLES                  PHONE NO : 1 901 2905162 
1023 CHERRY ROAD                  SE DECISION MADE: 22-OCT-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Precision HD Camera System
Stryker Endoscopy                 510(k) NO: K142603(Third Party - Traditional)
ATTN: Angela  Wong                PHONE NO : 1 408 7542000 
5900 Optical Court                SE DECISION MADE: 23-OCT-14
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AngioDynamics VenaCure EVLT Tre? Sheath and VenaCure EVLT NeverTouch Procedure Kits
AngioDynamics, Inc.               510(k) NO: K142614(Special)
ATTN: Teri  Juckett               PHONE NO : 518 7951142 
603 Queensbury Avenue             SE DECISION MADE: 10-OCT-14
Queensbury NY  12804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICC Maximal Barrier Nursing Kit
NAVILYST MEDICAL, INC.            510(k) NO: K142616(Special)
ATTN: WANDA  CARPINELLLA          PHONE NO : 508 6587929 
26 FOREST STREET                  SE DECISION MADE: 14-OCT-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
Hitachi Aloka Medical America, Inc510(k) NO: K142618(Special)
ATTN: Angela  Van Arsdale         PHONE NO : 203 2695088 
10 Fairfield Blvd                 SE DECISION MADE: 16-OCT-14
Wallingford CT  06492             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuson SC2000 Diagnostic Ultrasound System
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K142628(Third Party - Traditional)
ATTN: Kevin  Kong                 PHONE NO : 650 9699112 
685 EAST MIDDLEFIELD RD.          SE DECISION MADE: 10-OCT-14
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Merit 10mL Syringe
Merit Medical Systems, Inc.       510(k) NO: K142636(Special)
ATTN: Mridi  Kumathe              PHONE NO : 1 801 2084712 
1600 W Merit Parkway              SE DECISION MADE: 17-OCT-14
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-Lok and G-Lok XL Extender
T.A.G. Medical Products Corporatio510(k) NO: K142653(Special)
ATTN: Tomer  Alon                 PHONE NO : 972 4 9858400 
D.N. Ashrat                       SE DECISION MADE: 16-OCT-14
Kibbutz Gaaton  IL 25130          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortex 0.035 OTW PTA Balloon Catheter
Covidien LLC                      510(k) NO: K142654(Third Party - Traditional)
ATTN: Rupali  Gupta               PHONE NO : 1 763 3987000 
3033 Campus Drive                 SE DECISION MADE: 28-OCT-14
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Antegrade LeMills Valvulotome
LeMaitre Vascular, Inc.           510(k) NO: K142660(Special)
ATTN: Xiang (Vic) Zhang           PHONE NO : 781 2212266 102
63 Second Avenue                  SE DECISION MADE: 17-OCT-14
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vericore Zirconia Blanks
WHIP MIX CORPORATION              510(k) NO: K142670(Special)
ATTN: JOHN  WATERS                PHONE NO : 502 6371451 
361 FARMINGTON AVE                SE DECISION MADE: 22-OCT-14
LOUISVILLE KY  40217              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PerkinElmer, XRpad 4343 F MED Flat Panel Detector
PerkinElmer, Inc                  510(k) NO: K142698(Special)
ATTN: Dawn  Spooner               PHONE NO : 781 6636071 
940 Winter Street                 SE DECISION MADE: 23-OCT-14
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERADIUS UNITY 
PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K142708(Abbreviated)
ATTN: Jeanette  Becker            PHONE NO : 31 06113 86380 
VEENPLUIS 4-6                     SE DECISION MADE: 22-OCT-14
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossCLIP Implant System
OrthoDiscovery Group LLC(D.B.A. Cr510(k) NO: K142727(Traditional)
ATTN: Vernon  Hartdegen           PHONE NO : 1 901 2218406 
458 DISTRIBUTION PKWY             SE DECISION MADE: 24-OCT-14
COLLIERVILLE TN  38017            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-CUBE 5
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142733(Traditional)
ATTN: DONGHWAN  KIM               PHONE NO : 82 70 74652068 
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14
SEOUL  KR 152-848                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Siemens 3.0 Blanket Array Coil
RESONANCE INNOVATIONS LLC         510(k) NO: K142755(Traditional)
ATTN: Randall  Jones              PHONE NO : 1 402 9342650 
9840 S. 140TH ST., STE 8          SE DECISION MADE: 23-OCT-14
OMAHA NE  68138                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiNA PowerBlade Plus HC
LiNA Medical ApS                  510(k) NO: K142757(Special)
ATTN: Louisa  Memborg             PHONE NO : 454 3296652 
Formervangen 5                    SE DECISION MADE: 23-OCT-14
Glostrup  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
Medtronic, Inc                    510(k) NO: K142784(Special)
ATTN: Lisa  Stone                 PHONE NO : 1 763 5149866 
8200 Coral Sea Street NE          SE DECISION MADE: 24-OCT-14
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
Siemens Healthcare Diagnostics Inc510(k) NO: K142811(Traditional)
ATTN: Asha  Gartland              PHONE NO : 914 5243257 
511 Benedict Avenue               SE DECISION MADE: 29-OCT-14
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON Spinal System
MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K142847(Traditional)
ATTN: LAVEEDA  LEFLORE            PHONE NO : 1 901 3463133 
1800 PYRAMID PLACE                SE DECISION MADE: 27-OCT-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
Unilens Corp., USA                510(k) NO: K142851(Special)
ATTN: Alan J. Frazer              PHONE NO : 727 5442531 
10431 72nd Street North           SE DECISION MADE: 30-OCT-14
Largo FL  33777                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142864(Traditional)
ATTN: Fatima  Pacheco             PHONE NO : 1 914 5242450 
511 BENEDICT AVENUE               SE DECISION MADE: 29-OCT-14
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premium Surgiclip III
COVIDIEN                          510(k) NO: K142869(Special)
ATTN: Michael  Koczocik           PHONE NO : 1 203 4926312 
60 Middletown Avenue              SE DECISION MADE: 30-OCT-14
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142876(Third Party - Traditional)
ATTN: NANCY  BURKE                PHONE NO : 1 425 2958665 
685 East Middlefield Road         SE DECISION MADE: 23-OCT-14
Mountain CA  94043                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142878(Abbreviated)
ATTN: Donna  Velasquez            PHONE NO : 1 310 6458200 7403
5210 Pacific Concourse Drive      SE DECISION MADE: 30-OCT-14
Los Angeles CA  90045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-CUBE 12
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142884(Traditional)
ATTN: Donghwan  Kim               PHONE NO : 82 70 74652068 
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14
SEOUL  KR 152-848                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
SOFRADIM PRODUCTION               510(k) NO: K142900(Special)
ATTN: Eric  Jague                 PHONE NO : 33 4 74089000 
116 AVENUE DU FORMANS             SE DECISION MADE: 28-OCT-14
TREVOUX  FR 01600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leo Minor 
SUNNEX, INC.                      510(k) NO: K142984(Third Party - Traditional)
ATTN: TISH  MENDICK               PHONE NO : 402 8509485 
9319 FORSYTH PARK DRIVE           SE DECISION MADE: 29-OCT-14
CHARLOTTE NC  28273               510(k) STATEMENT
                                  THIRD PARTY REVIEW


                                  TOTAL 510(k)s THIS PERIOD   264                                     
                                  TOTAL WITH SUMMARIES        254                                     
                                  TOTAL WITH STATEMENTS        10
                                      

 

Page Last Updated: 01/26/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.