510(k) summaries or 510(k) statements for final decisions rendered during October 2013.
TOTAL 510(k)s THIS PERIOD264TOTAL WITH SUMMARIES254TOTAL WITH STATEMENTS10
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD October 2014
DEVICE: FLUOR PROTECTOR SIVOCLAR VIVADENT AG510(k) NO: K131487(Traditional)ATTN: DONNA M HARTNETTPHONE NO : 716 691-2260175 PINEVIEW DR.SE DECISION MADE: 08-OCT-14AMHERST NY14228510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERNOVA C5 MRI SYSTEMLIAONING KAMPO MEDICAL SYSTEM CO.,510(k) NO: K131737(Traditional)ATTN: SHAOKAI PHONE NO : 86 414 5555322NO. 9, YAODU STREET, BENXI ECONOMISE DECISION MADE: 23-OCT-14BENXI, LIAONINGCN 117004510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS NOTAH.S. HOSPITAL SERVICES S.P.A.510(k) NO: K131925(Traditional)ATTN: LUCIOIMPROTAPHONE NO : 561 477-167110147 UMBERLAND PLACE SE DECISION MADE: 10-OCT-14BOCA RATON FL33428510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPULSE HOPLUSASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131987(Traditional)ATTN: ANTJEKATZERPHONE NO : 004 936 417700309BRUESSELER STR. 10 SE DECISION MADE: 15-OCT-14JENA, THURINGIADE 07747510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKORE AND MULTIPLE BRANDSTTK PROTECTIVE DEVICES LIMITED (FO510(k) NO: K132490(Abbreviated)ATTN: MANOJZACHARIASPHONE NO : 630 270-29212871, COASTAL DRSE DECISION MADE: 20-OCT-14AURORA IL60503510(k) STATEMENT
DEVICE: FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SETCOOK, INC.510(k) NO: K132592(Traditional)ATTN: DAVIDLEHRPHONE NO : 812 335-3575750 DANIELS WAY SE DECISION MADE: 09-OCT-14Blmgtn IN47404510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTSQINGDAO KINGSTON MEDICAL DEVICES L510(k) NO: K132771(Traditional)ATTN: WUHANHUAPHONE NO : 86 0532 86769190No.5 Seoul Road Free Trade ZoneSE DECISION MADE: 28-OCT-14QINGDAO, SHANDONGCN 266555510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAPACSNOVARAD CORP.510(k) NO: K132853(Traditional)ATTN: AMYHOFFMAN PHONE NO : 801 642-1001752 E 1180 S Ste 200SE DECISION MADE: 30-OCT-14American Fork UT84003510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED CURING LIGHTMONITEX INDUSTRIAL CO., LTD.510(k) NO: K133040(Traditional)ATTN: SHU-LUNGWANGPHONE NO : 886 2 299938696F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 07-OCT-14NEW TAIPEI CITYTW 241 58510(k) STATEMENT
DEVICE: CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIESCODENT TECHNICAL INDUSTRY CO., LTD510(k) NO: K133069(Traditional)ATTN: CHIN-TINGWENPHONE NO : 886 769555 335F., No.90, Luke 5th Rd., Luzhu DiSE DECISION MADE: 24-OCT-14Kaohsiung CityTW 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: JESSICASIXBERRYPHONE NO : 763 514-98497611 NORTHLAND DRIVESE DECISION MADE: 23-OCT-14MINNEAPOLIS MN55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-FIT EF-1280 EMS MACHINEFIT-PRO KFT LTD.510(k) NO: K133225(Traditional)ATTN: RHONDAALEXANDER, M.S., M.PPHONE NO : 757 224-0177144 RESEARCH DRIVE SE DECISION MADE: 24-OCT-14HAMPTON VA23666510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEMGENESYS SPINE510(k) NO: K133245(Traditional)ATTN: WILLIAM W SOWERSPHONE NO : 512 381-70801250 CAPITAL OF TEXAS HWY SOUTH BUSE DECISION MADE: 08-OCT-14AUSTIN TX78746510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERONEB SOLO; AERONEB SOLO ADAPTERAEROGEN LTD510(k) NO: K133360(Traditional)ATTN: MARTINCREHANPHONE NO : 353 91 540459IDA BUSINESS PARK, DANGANSE DECISION MADE: 17-OCT-14GALWAYIE GALWAY510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDX DORSAL APPLIANCEINSTITUTE FOR QUALITY RESOURCE MAN510(k) NO: K133390(Traditional)ATTN: LEAHAMIR, MS, MHAPHONE NO : 877 997-33601 CITY PLACE DRIVE, STE 285 SE DECISION MADE: 16-OCT-14ST. LOUIS MO63131510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONESTEP CPR II MULTI-FUNCTION ELECTRODEBIO-DETEK, INC. 510(k) NO: K133441(Traditional)ATTN: SHANNONDUHAMELPHONE NO : 978 421-9574269 MILL ROADSE DECISION MADE: 10-OCT-14CHELMSFORD MA01824-4105510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOMEDW & H DENTALWERK BUERMOOS GMBH 510(k) NO: K133488(Traditional)ATTN: ANJALINDNERPHONE NO : 43 627 46236297IGNAZ-GLASER-STRASSE 53SE DECISION MADE: 16-OCT-14BUERMOOS, SALZBURGAT 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO CT SINGLE SOURCE DUAL ENERGYSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133677(Traditional)ATTN: KIMBERLYMANGUMPHONE NO : 610 448-491251 VALLEY STREAM PKWY.SE DECISION MADE: 16-OCT-14MALVERN PA19355-1406510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VC150 VITAL SIGNS MONITORINNOKAS YHTYMA510(k) NO: K133810(Traditional)ATTN: TIINAVETELAINENPHONE NO : 358 8 5623100TARJUSOJANTIE 12SE DECISION MADE: 30-OCT-14KEMPELE, OULUFI 90440510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTERA CLINICAL ANALYZERLIPOSCIENCE510(k) NO: K133849(Special)ATTN: SUZETTEWARNER PHONE NO : 919 256-13262500 SUMMER BLVD.SE DECISION MADE: 22-OCT-14RALEIGH NC27616510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSA100 PEAK FLOW METERBEIJING M&B ELECTRONIC INSTRUMENTS510(k) NO: K133975(Traditional)ATTN: MIKEGUPHONE NO : 86 20 623213337TH FLOOR, JINGUI BUSINESS BUILDINSE DECISION MADE: 03-OCT-14GUANGZHOU, GUANGDONGCN 510420510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IEVA REHABILITATIVE POSITIONAL DEVICEREMENDIUM LABS, LLC510(k) NO: K133990(Traditional)ATTN: YOLANDALORIEPHONE NO : 386 717-4360340 EAST PARKER ROADSE DECISION MADE: 09-OCT-14BATON ROUGE LA70803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONALMEDTEK LIGHTING 510(k) NO: K134009(Traditional)ATTN: SUSANANTHONEY-DE WETPHONE NO : 865 982-55522424 DEMPSTER DRIVESE DECISION MADE: 15-OCT-14CORALVILLE IA52241510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMTerumo Cardiovascular Systems Corp510(k) NO: K140008(Traditional)ATTN: GARRYCOURTNEY PHONE NO : 800 262-3304125 BLUE BALL RD.SE DECISION MADE: 31-OCT-14ELKTON MD21921510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERQ ACS-100 SYSTEMBSP-BIIOLOGICAL SIGNAL PROCESSING,510(k) NO: K140020(Traditional)ATTN: AHAVASTEIN PHONE NO : 972 976 7000220 HATA’ AS STR., SUITE 102 SE DECISION MADE: 28-OCT-14KFAR SABAIL 44425510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCTCORK MEDICAL PRODUCTS LLC510(k) NO: K140022(Traditional)ATTN: JONSPEERPHONE NO : 765 315-2736PO BOX 1784SE DECISION MADE: 24-OCT-14MARTINSVILLE IN46151510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEVATIONPDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K140023(Traditional)ATTN: EDWARD A KROLLPHONE NO : 440 546-98105905 FAWN LANESE DECISION MADE: 16-OCT-14CLEVELAND OH44141510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSESPegavision Corporation510(k) NO: K140025(Traditional)ATTN: PENNYNORTHCUTTPHONE NO : 886 332 98808174 WATERCOLOR WAY, SUITE 103-403 SE DECISION MADE: 15-OCT-14SANTA ROSA BEACH FL32459510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KJ EXTERNAL IMPLANT SYSTEMKJ MEDITECH CO., LTD. 510(k) NO: K140051(Traditional)ATTN: PriscillaChungPHONE NO : 714 202-57892651 E CHAPMAN AVE STE 110SE DECISION MADE: 30-OCT-14FULLERTON CA92831510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J2I IMPLANT SYSTEMKJ MEDITECH CO., LTD. 510(k) NO: K140052(Traditional)ATTN: PriscillaChungPHONE NO : 714 202-57892651 E CHAPMAN AVE STE 110SE DECISION MADE: 30-OCT-14FULLERTON CA92831510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBERFSC LABORATORIES, INC.510(k) NO: K140062(Traditional)ATTN: PAULDRYDEN PHONE NO : 239 498-21556000 Fairview Rd. Suite 600 SE DECISION MADE: 03-OCT-14Charlotte NC28210510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIC 10BIOLASE, INC.510(k) NO: K140120(Traditional)ATTN: COLLEENBOSWELLPHONE NO : 949 226-84704 CROMWELLSE DECISION MADE: 10-OCT-14IRVINE CA92618510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflex Medical, Inc.510(k) NO: K140197(Traditional)ATTN: HOLLYKORNEGAY PHONE NO : 919 433-49182917 WECK DR. PO BOX 12600SE DECISION MADE: 21-OCT-14RESEARCH TRIANGLE PARK NC27709510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflex Medical, Inc.510(k) NO: K140205(Traditional)ATTN: HOLLYKORNEGAY PHONE NO : 919 433-49182917 WECK DR. PO BOX 12600SE DECISION MADE: 23-OCT-14RESEARCH TRIANGLE PARK NC27709510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POPHADIA US INC.510(k) NO: K140225(Traditional)ATTN: MARTINMANN PHONE NO : 497 614 7805173MUNZINGER STRASSE 7SE DECISION MADE: 27-OCT-14FREIBURG IM BREISGAUDE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AILERON INTERSPINOUS FIXATION SYSTEMLIFE SPINE, INC 510(k) NO: K140236(Traditional)ATTN: RANDYLEWIS PHONE NO : 847 884-61172401 W. HASSELL RD SUITE 1535SE DECISION MADE: 20-OCT-14HOFFMAN ESTATES IL60169510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG PULSE ND: YAG LASER SYSTEMADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K140249(Traditional)ATTN: DianaHongPHONE NO : 86 21 22815850P.O. BOX 120-119SE DECISION MADE: 08-OCT-14SHANGHAICN 200120510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL DIGITAL INTERFACE 2, UDI 2MERIDIAN MEDICAL SYSTEMS, LLC510(k) NO: K140251(Traditional)ATTN: LARRYCORNELLPHONE NO : 440 287-6801325 HARRIS DRIVESE DECISION MADE: 22-OCT-14AURORA OH44202510(k) STATEMENT
DEVICE: SIMPLE T YOUTH NASAL MASKRESPIRONICS, INC.510(k) NO: K140268(Abbreviated)ATTN: COLLEENWITTPHONE NO : 724 387-47801001 MURRY RIDGE LN.SE DECISION MADE: 20-OCT-14MURRYSVILLE PA15668 510(k) STATEMENT
DEVICE: TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEMADIN DENTAL IMPLANTS SYSTEMS LTD. 510(k) NO: K140293(Traditional)ATTN: NISSIMSHAKEDPHONE NO : 972 491161 52ALON TAVOR INDUSTRIAL ZONESE DECISION MADE: 31-OCT-14POB 1128 AFULA ELITIL 1811101510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLY SLICK PERSONAL LUBRICATING LOTIONSIMPLY SOLUTIONS, LLC 510(k) NO: K140304(Third Party – Traditional)ATTN: JOHNGOEPFERTPHONE NO : 608 563-55552949 VENTURE DR., STE 170SE DECISION MADE: 07-OCT-14JANESVILLE WI53546-8501510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: CRANIOPLUGOSSDSIGN AB510(k) NO: K140309(Traditional)ATTN: DAVIDWEISSBURGPHONE NO : 608 770-0223808 WILLIAMSON ST. SUITE 402SE DECISION MADE: 03-OCT-14MADISON WI53703510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT TI-C SYSTEMNUVASIVE, INC.510(k) NO: K140319(Traditional)ATTN: JEREMYMARKOVICHPHONE NO : 858 309-37837475 LUSK BLVDSE DECISION MADE: 09-OCT-14SAN DIEGO CA92121510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOX2 TISSUE EXPANDERSSPECIALTY SURGICAL PRODUCTS, INC. 510(k) NO: K140383(Traditional)ATTN: SHERRYNULL PHONE NO : 406 961-01021123 NORTH U.S. HWY. 93SE DECISION MADE: 28-OCT-14VICTOR MT59875510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA EXTERNAL FIXATION SYSTEMASCENSION ORTHOPEDIC510(k) NO: K140463(Traditional)ATTN: STEVEBROWN PHONE NO : 435 7741535560 W. GOLF COURSE ROADSE DECISION MADE: 10-OCT-14PROVIDENCE UT84332510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZERSTERILUCENT, INC510(k) NO: K140464(Traditional)ATTN: PETERKALKBRENNER PHONE NO : 612 767-32531400 MARSHALL STREET NESE DECISION MADE: 31-OCT-14MINNEAPOLIS MN55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-MT +EMSI510(k) NO: K140467(Traditional)ATTN: CHERITAJAMESPHONE NO : 703 562-9800 257815 KING STREET STE 206SE DECISION MADE: 07-OCT-14ALEXANDRIA VA22314510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBEROBERON GMBH FIBER TECHNOLOGIES 510(k) NO: K140470(Traditional)ATTN: ARMINKAUSPHONE NO : 480 598-40907404 W. DETROIT STREET, STE 140SE DECISION MADE: 15-OCT-14CHANDLER AZ85226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONASTENT TRACHEAL / BRONCHIALENDOCHOICE, INC.510(k) NO: K140472(Traditional)ATTN: BosmatFriedmanPHONE NO : 647 975 39741208-12 ROCKFORD RD.SE DECISION MADE: 17-OCT-14TORONTO, ONCA M2R 3A2510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA SCL-70S IMMUNOASSAYPHADIA GMBH510(k) NO: K140493(Traditional)ATTN: MARTIN R MANNPHONE NO : 269 492-19574169 COMMERCIAL AVESE DECISION MADE: 30-OCT-14PORTAGE MI49002510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electro Auricular DeviceNAVIGANT CONSULTING, INC.510(k) NO: K140530(Traditional)ATTN: COLLEENHITTLE PHONE NO : 317 228-873030 S WACKER DRIVE SUITE 3100SE DECISION MADE: 02-OCT-14CHICAGO IL60606510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDEEASE HYDROPHILIC SHEATH INTRODUCERMERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140543(Traditional)ATTN: MICHAELARIVKOWICHPHONE NO : 801 208-41961600 WEST MERIT PKWY. SE DECISION MADE: 16-OCT-14SOUTH JORDAN UT84095510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNESIS PEEK TL CAGEBK MEDITECH CO., LTD. 510(k) NO: K140577(Traditional)ATTN: ELAINEDUNCANPHONE NO : 715 549-6035PO BOX 560SE DECISION MADE: 01-OCT-14STILLWATER MN55082510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORTCEDIC S.R.L. 510(k) NO: K140581(Traditional)ATTN: ROGERGRAYPHONE NO : 39 06 5782665PIAZZA ALBANIA, 10 SE DECISION MADE: 17-OCT-14ROMEIT 00153510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTROGLIDE SENSUAL STRAWBERRYBIOFILM, INC.510(k) NO: K140590(Traditional)ATTN: SherryCastelloPHONE NO : 760 72790303225 Executive Rdg SE DECISION MADE: 30-OCT-14VISTA CA92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERCDIMA ITALIA SRL 510(k) NO: K140598(Traditional)ATTN: DARIOBASCIUPHONE NO : 39 051568 857via Coriolano Vighi, 29SE DECISION MADE: 16-OCT-14BolognaIT 40133510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERCDIMA ITALIA SRL 510(k) NO: K140605(Traditional)ATTN: DARIOBASCIUPHONE NO : 39 051568 857via Coriolano Vighi, 29SE DECISION MADE: 03-OCT-14BolognaIT 40133510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECA XPRESSFISHADVANDX, INC.510(k) NO: K140619(Traditional)ATTN: RONEISENWINTERPHONE NO : 781 376-0009 1027400 TradeCenter Suite 6990SE DECISION MADE: 10-OCT-14WOBURN MA01801510(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: TinaIpPHONE NO : 416 593 4323439 UNIVERSITY AVE.SE DECISION MADE: 24-OCT-14TORONTO, ONTARIOCA M5G 1Y8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINPRO PROPHY POWDER3M DEUTSCHLAND GMBH510(k) NO: K140684(Traditional)ATTN: DESI W SOEGIARTOPHONE NO : 49 815 27001169ESPE PLATZSE DECISION MADE: 24-OCT-14SEEFELDDE D-82229510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPI – MOLECULAR PRECISION IMPLANT, CIP – CYLINDRICAL PRECISION IMPLANT, OPI – ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PRDITRON PRECISION LTD510(k) NO: K140728(Traditional)ATTN: TALIHAZANPHONE NO : 972 505 292304RAMOT NAFTALI M.P UPPER GALILLEESE DECISION MADE: 17-OCT-14RAMOT NAFTALIIL 13830510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEMCOOPER SURGICAL, INC. 510(k) NO: K140754(Traditional)ATTN: TIMLOHNESPHONE NO : 203 922-0105 821180 SHELTON TECHNOLOGY CENTERSE DECISION MADE: 23-OCT-14SHELTON CT06484510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO AMBULATORY INFUSION SYSTEMZYNO MEDICAL LLC.510(k) NO: K140783(Abbreviated)ATTN: MEIZHANGPHONE NO : 508 650-2008 205177 PINE STSE DECISION MADE: 17-OCT-14NATICK MA01760510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITCLAMP 50INNOVATIVE TRAUMA CARE INC510(k) NO: K140805(Traditional)ATTN: RICHARDWAITEPHONE NO : 210 582-5850 19323463 MAGIC DR. SUITE 120 SE DECISION MADE: 09-OCT-14SAN ANTONIO TX78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUGGERKNOT MINI SOFT ANCHORBIOMET SPORTS MEDICINE510(k) NO: K140908(Traditional)ATTN: GARYBAKERPHONE NO : 574 371108856 EAST BELL DRIVE SE DECISION MADE: 02-OCT-14WARSAW IN46582510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL NAVIGATION INSTRUMENTSMEDOS INTERNATIONAL SARL 510(k) NO: K140927(Traditional)ATTN: KIRSTENLEHMULLER PHONE NO : 508 828-3291325 Paramount DriveSE DECISION MADE: 24-OCT-14Raynham MA02767510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z1 CPAP SYSTEMHUMAN DESIGN MEDICAL, LLC510(k) NO: K140929(Traditional)ATTN: MAUREENO’CONNELL PHONE NO : 978 207-12455 TIMBER LANESE DECISION MADE: 17-OCT-14NORTH READING MA01864510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTOM-I ALERT11 HEALTH AND TECHNOLOGIES LLC 510(k) NO: K140938(Traditional)ATTN: E J SMITH PHONE NO : 888 729-96741468 Harwell AvenueSE DECISION MADE: 10-OCT-14Crofton MD21114510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCESS INDICATOR TAPE FOR STEAM STERILIZATIONCANADIAN TECHNICAL TAPE, LTD.510(k) NO: K140940(Traditional)ATTN: GARYSOCOLA PHONE NO : 505 743-1935125 HIGHPOWER ROAD SE DECISION MADE: 27-OCT-14ROCHESTER NY14623510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IONOSTAR MOLARVOCO GMBH 510(k) NO: K140993(Traditional)ATTN: TGERKENSMEIER PHONE NO : 494 721 719200ANTON-FLETTNER-STRASSE 1-3SE DECISION MADE: 20-OCT-14CUXHAVENDE D-27472510(k) STATEMENT
DEVICE: FRONTIER DEVICES FUSIO SCREW FUZE SYSTEMFOLSOM METAL PRODUCTS, INC. DBA FR510(k) NO: K141106(Traditional)ATTN: KEVINETHERIDGEPHONE NO : 205 733-0901153ACAHABA VALLEY PARKWAY SE DECISION MADE: 10-OCT-14PELHAM AL35124510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEHANDPIECE HEADQUARTERS510(k) NO: K141125(Traditional)ATTN: TINASTEFFANIE-OAKPHONE NO : 717 335-7230 4150620 S. PLACENTIA AVE. SE DECISION MADE: 23-OCT-14PLACENTIA CA92870510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLEUNISIS CORP. 510(k) NO: K141126(Traditional)ATTN: DIANERUTHERFORDPHONE NO : 972 480-95541201 RICHARDSON DRIVE, SUITE 280SE DECISION MADE: 31-OCT-14RICHARDSON TX75080510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERZOLL CIRCULATION510(k) NO: K141139(Traditional)ATTN: SUSANNORIEGAPHONE NO : 408 419-29882000 Ringwood AveSE DECISION MADE: 03-OCT-14San Jose CA95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGESTEVENSON INDUSTRIES, INC.510(k) NO: K141152(Traditional)ATTN: SERRAHNAMINIPHONE NO : 805 426-3544780 CHAMBERS LANE SUITE 200 SE DECISION MADE: 17-OCT-14SIMI VALLEY CA93065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITORA & D CO., LTD. 510(k) NO: K141160(Special)ATTN: JERRYWANGPHONE NO : 408 518-51131756 AUTOMATION PARKWAYSE DECISION MADE: 07-OCT-14SAN JOSE CA95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIXWAVE MMF SYSTEMSYNTHES (USA) PRODUCTS LLC510(k) NO: K141165(Traditional)ATTN: DamonLeesPHONE NO : 610 718-56081302 WRIGHTS LANE EASTSE DECISION MADE: 17-OCT-14WEST CHESTER PA19380510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVOCATH RC120RENOVORX, INC.510(k) NO: K141175(Traditional)ATTN: RON S WARREN PHONE NO : 408 400-08567775 N. MATHILDA AVE, STE 100SE DECISION MADE: 24-OCT-14SUNNYVALE CA94085510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADI-LOCKPADI-LOCK, LLC510(k) NO: K141200(Traditional)ATTN: MARIAGRIFFINPHONE NO : 516 482-900155 NORTHERN BLVD, STE 200SE DECISION MADE: 02-OCT-14GREAT NECK NY11021510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITORA & D CO., LTD. 510(k) NO: K141201(Special)ATTN: JERRYWANGPHONE NO : 408 518-51131756 AUTOMATION PARKWAYSE DECISION MADE: 08-OCT-14SAN JOSE CA95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE BIOACTIVE STRIPNovaBone Products, LLC510(k) NO: K141207(Traditional)ATTN: LisaSimpsonPHONE NO : 386 462-7661 21613510 NW US Highway 441SE DECISION MADE: 31-OCT-14Alachua FL32615510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTSPRISMATIK DENTALCRAFT, INC. 510(k) NO: K141211(Traditional)ATTN: MARIAHATEGANPHONE NO : 949 225-12412212 DUPONT DRIVE, SUITE PSE DECISION MADE: 22-OCT-14IRVINE CA92612510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PRLARES RESEARCH, INC.510(k) NO: K141221(Abbreviated)ATTN: JASONORGAINPHONE NO : 530 345-1767295 LOCKHEED AVE.SE DECISION MADE: 28-OCT-14CHICO CA95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLIDE DEVICEHOME SKINOVATIONS LTD.510(k) NO: K141242(Traditional)ATTN: AHAVASTEIN PHONE NO : 972 976 7000220 HATA’AS STR., SUITE 102SE DECISION MADE: 17-OCT-14KFAR SABAIL 44425510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORUM GLAUCOMA WORKPLACECARL ZEISS MEDITEC AG 510(k) NO: K141297(Traditional)ATTN: MANDYAMBRECHT PHONE NO : 925 557-45615160 HACIENDA DRIVESE DECISION MADE: 03-OCT-14DUBLIN CA94568510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILUCENT PROCESS CHALLENGE DEVICESTERILUCENT, INC510(k) NO: K141312(Traditional)ATTN: PETERKALKBRENNER PHONE NO : 612 767-32531400 MARSHALL STREET NESE DECISION MADE: 31-OCT-14MINNEAPOLIS MN55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERATOPCON CORP. 510(k) NO: K141325(Traditional)ATTN: MAUREENO’CONNELL PHONE NO : 978 207-12455 TIMBER LANESE DECISION MADE: 23-OCT-14NORTH READING MA01864510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)BIOMET, INC. 510(k) NO: K141331(Traditional)ATTN: TRACYBICKEL JOHNSON PHONE NO : 574 372-176156 EAST BELL DRIVE PO BOX 587SE DECISION MADE: 27-OCT-14WARSAW IN46581510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEL APD DRAINAGE CATHETER SYSTEMBOSTON SCIENTIFIC CORP.510(k) NO: K141335(Traditional)ATTN: MATTBEAUCHANE PHONE NO : 763 494-1789ONE SCIMED PLACESE DECISION MADE: 17-OCT-14MAPLE GROVE MN55311-1566510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIREASAHI INTECC CO., LTD.510(k) NO: K141339(Traditional)ATTN: CANDACECEDERMANPHONE NO : 410 674-20605523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 23-OCT-14BALTIMORE MD21228510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEMBOSTON SCIENTIFIC CORP.510(k) NO: K141344(Traditional)ATTN: MATTBEAUCHANE PHONE NO : 763 494-1789ONE SCIMED PLACESE DECISION MADE: 17-OCT-14MAPLE GROVE MN55311-1566510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL IM NAIL SYSTEMEMERGE MEDICAL510(k) NO: K141347(Traditional)ATTN: MICHELLEPOTVINPHONE NO : 720 459-6392720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 02-OCT-14DENVER CO80246510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDC INTERLOCKING DETACHABLE COILBoston Scientific Corporation510(k) NO: K141378(Traditional)ATTN: LIZJOHNSTONPHONE NO : 763 494-1676ONE SCIMED PLACESE DECISION MADE: 08-OCT-14MAPLE GROVE MN55311-1566510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMSTIMWAVE TECHNOLOGIES INCORPORATED510(k) NO: K141399(Traditional)ATTN: ElizabethGreenePHONE NO : 800 965-5134420 Lincoln Rd Suite 365 SE DECISION MADE: 10-OCT-14Miami Beach FL33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIALBIOMET, INC. 510(k) NO: K141407(Traditional)ATTN: JULIEGANTENBERG, M.S.PHONE NO : 574 377-813356 EAST BELL DR. BOX 587 SE DECISION MADE: 27-OCT-14WARSAW IN46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITORSHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K141416(Traditional)ATTN: XIEQIONGYU PHONE NO : 086 075526 7107952/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 09-OCT-14NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS FOLATE IIIRoche Diagnostics510(k) NO: K141426(Traditional)ATTN: KELLITURNERPHONE NO : 317 521-45159115 HAGUE ROAD SE DECISION MADE: 17-OCT-14INDIANAPOLIS IN46250-0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE FIAGON NAVIGATION – EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLFIAGON GMBH510(k) NO: K141456(Traditional)ATTN: DIRKMUCHAPHONE NO : 49 3302 2012124NEUENDORFSTRASSE 23BSE DECISION MADE: 08-OCT-14HENNIGSDORFDE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141459(Traditional)ATTN: ORLANDOTADEOPHONE NO : 714 669-74592441 MICHELLE DRIVESE DECISION MADE: 28-OCT-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITAIRE 2 REVASCULARIZATION DEVICEMICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K141491(Traditional)ATTN: LARRYBOUCHERPHONE NO : 948 837-37009775 TOLEDO WAY SE DECISION MADE: 22-OCT-14IRVINE CA92618510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTYORTHOCON, INC.510(k) NO: K141502(Traditional)ATTN: HowardSchrayerPHONE NO : 914 357-26001 Bridge St Ste 121SE DECISION MADE: 03-OCT-14Irvington NY10533510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)ECO MEDI GLOVE SDN. BHD510(k) NO: K141510(Traditional)ATTN: SURESHKUMARPHONE NO : 603 602 83033LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14TAIPINGMY 34600510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESAPEX MEDICAL CORP. 510(k) NO: K141522(Traditional)ATTN: ALANCHANGPHONE NO : 886 2 22685568NO. 9, MIN SHENG ST., TU-CHENG,SE DECISION MADE: 06-OCT-14NEW TAIPEI CITYTW 23679510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KUBTEC X250KUB TECHNOLOGIES, INC 510(k) NO: K141539(Traditional)ATTN: VIKRAMBUTANIPHONE NO : 203 364-8544270 ROWE AVENUE, UNIT ESE DECISION MADE: 29-OCT-14MILFORD CT06461510(k) STATEMENT
DEVICE: NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )Covidien LLC 510(k) NO: K141542(Traditional)ATTN: MIA M WAREPHONE NO : 303 305-27506135 Gunbarrel Ave SE DECISION MADE: 02-OCT-14BOULDER CO80301510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEMZIMMER DENTAL INC. 510(k) NO: K141544(Traditional)ATTN: CHRISTINABOYDSTONPHONE NO : 760 929-43001900 ASTON AVE. SE DECISION MADE: 22-OCT-14CARLSBAD CA92008-7308510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICEETHICON, INC.510(k) NO: K141560(Traditional)ATTN: SUSANLINPHONE NO : 908 218-2256P.O. BOX 151 ROUTE 22 WESTSE DECISION MADE: 23-OCT-14SOMERVILLE NJ08876-0151510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "OPTON PRO"ZIMMER MEDIZINSYSTEMS GMBH510(k) NO: K141564(Third Party – Traditional)ATTN: ARMINPETRASCHKAPHONE NO : 497 319761 140JUNKERSSTRASSE 9SE DECISION MADE: 24-OCT-14NEU-ULMDE 89231510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: IMPLANT STUDIO3SHAPE MEDICAL A/S 510(k) NO: K141570(Traditional)ATTN: HANNENIELSENPHONE NO : 457 027262 0HOLMENS KANAL 7 SE DECISION MADE: 31-OCT-14COPENHAGEN KDK DK-1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREEECO MEDI GLOVE SDN. BHD510(k) NO: K141579(Traditional)ATTN: SURESHKUMARPHONE NO : 603 602 83033LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 17-OCT-14TAIPING, PERAKMY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEMBoston Scientific Corporation510(k) NO: K141584(Traditional)ATTN: THOMASHIRTEPHONE NO : 508 683-4454100 BOSTON SCIENTIFIC WAYSE DECISION MADE: 16-OCT-14MARLBOROUGH MA01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KITPIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K141600(Traditional)ATTN: SARAHMCINTYRE PHONE NO : 916 225-5861375 RIVER PARK CIRCLE SE DECISION MADE: 17-OCT-14MARQUETTE MI49855510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra Silver DressingsMILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K141603(Special)ATTN: GORDONMACFARLANE PHONE NO : 919 873-896262 FOREST STREET,SUITE300SE DECISION MADE: 22-OCT-14MARLBOROUGH MA01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141604(Traditional)ATTN: LILAJOE PHONE NO : 800 39631338761800 PYRAMID PLACE SE DECISION MADE: 21-OCT-14MEMPHIS TN38132510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIMECO MEDI GLOVE SDN BHD510(k) NO: K141623(Traditional)ATTN: SURESHKUMARPHONE NO : 603 602 83033LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14TAIPINGMY 34600510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE SUSCEPTIBILITY PLATESThermo Fisher Scientific 510(k) NO: K141651(Traditional)ATTN: CynthiaKnappPHONE NO : 800 871-8909 41171 Thermo Fisher WaySE DECISION MADE: 21-OCT-14Oakwood Village OH44146510(k) STATEMENT
DEVICE: LIGHT SCALPELLIGHT SCALPEL LLC510(k) NO: K141658(Traditional)ATTN: DAVIDWALTERSPHONE NO : 425 368-158816932 WOODINIVILLE-REDMOND RD NE, SE DECISION MADE: 22-OCT-14WOODINIVILLE WA98072510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISM ZIRCONIA, ST-98A & D DENTAL INNOVATIONS 510(k) NO: K141659(Traditional)ATTN: YOONHOJUNPHONE NO : 888 374-51349308 EVENING PRIMROSE PATHSE DECISION MADE: 09-OCT-14AUSTIN TX78750510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAWALUTION SKIN AND WOUND CLEANSERNAWA HEILMITTEL GMBH510(k) NO: K141660(Traditional)ATTN: ALLYSON B MULLENPHONE NO : 202 737-9639700 THIRTEENTH ST, N.W.SE DECISION MADE: 31-OCT-14WASHINGTON DC20005510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE’N’SOUND STAKED PASSIVE DELIVERY SYSTEM – CONE VERSIONREXAM HEALTHCARE510(k) NO: K141664(Abbreviated)ATTN: BEATRICEGRAND DEMARSPHONE NO : 334 7495 291520 AVENUE DE LA GARESE DECISION MADE: 02-OCT-14LA VERPILLIEREFR 38292 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODYSMITH MEDICAL ASD, INC.510(k) NO: K141686(Traditional)ATTN: JIMJOHNSON PHONE NO : 651 628-72641265 GREY FOX ROAD SE DECISION MADE: 28-OCT-14ST. PAUL MN55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSEN COLORVASSEN CO., LTD.510(k) NO: K141699(Traditional)ATTN: BRETANDREPHONE NO : 503 372-5226474 NE 61ST PL. SE DECISION MADE: 07-OCT-14HILLSBORO OR97124510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGENORAY CO., LTD.510(k) NO: K141700(Traditional)ATTN: KAITLYNNMINPHONE NO : 714 289-80203002 DOW AVENUE, SUITE 420SE DECISION MADE: 31-OCT-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVASHIELD INJECTABLE NASAL PACKING AND STENTMEDTRONIC INC.510(k) NO: K141704(Traditional)ATTN: RISHISINHA PHONE NO : 269 903-43736743 SOUTHPOINT DRIVE NORTH SE DECISION MADE: 06-OCT-14JACKSONVILLE FL32259510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASHAPE SYSTEMSYNERON MEDICAL LTD.510(k) NO: K141708(Traditional)ATTN: JANICE M HOGANPHONE NO : 617 863-55201835 MARKET ST, 29TH FLOORSE DECISION MADE: 06-OCT-14PHILADELPHIA PA19103510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTGRAFT 200 SYSTEMINGENERON, INC. 510(k) NO: K141713(Traditional)ATTN: ANITAKADALAPHONE NO : 713 440-99008205 El Rio StSE DECISION MADE: 28-OCT-14Houston TX77054510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.510(k) NO: K141714(Traditional)ATTN: VALMYLESPHONE NO : 901 290-51621023 CHERRY ROADSE DECISION MADE: 24-OCT-14MEMPHIS TN38117510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPCERA COLORING LIQUID (I AND II )LIAONING UPCERA CO.,LTD510(k) NO: K141723(Traditional)ATTN: CHARLESSHENPHONE NO : 608 217-9358853 DORCHESTER LN, SUITE-BSE DECISION MADE: 22-OCT-14NEW MILFORD NJ07646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKLIAONING UPCERA CO.,LTD510(k) NO: K141724(Traditional)ATTN: CHARLESSHENPHONE NO : 608 217-9358853 DORCHESTER LN, SUITE-BSE DECISION MADE: 22-OCT-14NEW MILFORD NJ07646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEPHROS DSU-H, NEPHROS SSU-HNEPHROS, INC.510(k) NO: K141731(Traditional)ATTN: JAMESSUMMERTONPHONE NO : 201 343-520241 GRAND AVE SE DECISION MADE: 24-OCT-14River Edge NJ07661510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESIDUAL LIMB LENGTHENING SYSTEMELLIPSE TECHNOLOGIES INC.510(k) NO: K141739(Traditional)ATTN: REBECCASHELBURNE PHONE NO : 949 837-360013900 ALTON PKWY STE 123 SE DECISION MADE: 07-OCT-14IRVINE CA92618-0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARDO CARUM AND CALYPSO POWERED BREAST PUMPSARDO MEDICAL AG 510(k) NO: K141742(Traditional)ATTN: YARMELAPAVLOVICPHONE NO : 267 675-46011835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 17-OCT-14PHILADELPHIA PA19103510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KITRADIOLOGY SOLUTIONS LLC510(k) NO: K141743(Traditional)ATTN: DANIELKAMM, P.E. PHONE NO : 239 234-17358870 RAVELLO CT.SE DECISION MADE: 03-OCT-14NAPLES FL34114510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQQA-BODYIMAGING SOFTWAREEDDA TECHNOLOGY 510(k) NO: K141745(Traditional)ATTN: DANIELKAMM PHONE NO : 239 234-17355 Independence Way SE DECISION MADE: 31-OCT-14Princeton NJ08540510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUS NASAL FEEDING TUBEDEGANIA SILICONE, LTD.510(k) NO: K141753(Traditional)ATTN: ZOYALEE PHONE NO : 972 467 55122DEGANIA BETSE DECISION MADE: 16-OCT-14EMEK HAYARDENIL 15130510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE, INC.510(k) NO: K141758(Traditional)ATTN: JANICEHOGANPHONE NO : 267 675-46001835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 31-OCT-14PHILADELPHIA PA19103510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERSOAK RIDGE PRODUCTS, LLC510(k) NO: K141759(Third Party – Traditional)ATTN: CONOR J O’MALLEYPHONE NO : 888 650-74444612 Century Ct SE DECISION MADE: 24-OCT-14McHenry IL60050510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEMFUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K141765(Traditional)ATTN: KATHERINE Y CHOIPHONE NO : 203 602-3568419 WEST AVENUE SE DECISION MADE: 03-OCT-14STAMFORD CT06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICESETHICON, INC.510(k) NO: K141776(Traditional)ATTN: PETERCECCHINI PHONE NO : 908 218-2457ROUTE 22 WESTSE DECISION MADE: 15-OCT-14SOMERVILLE NJ08876-0151510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET FUSION SYSTEMBIOMET SPINE 510(k) NO: K141791(Traditional)ATTN: TEDKUHN PHONE NO : 303 501-8549310 INTERLOCKEN PARKWAYSE DECISION MADE: 09-OCT-14BROOMFIELD CO80021510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMCOVIDIEN, LLC510(k) NO: K141801(Traditional)ATTN: JULIEUNDERDAHLPHONE NO : 763 398-70003033 CAMPUS DRIVESE DECISION MADE: 16-OCT-14PLYMOUTH MN55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDEFIBTECH, LLC510(k) NO: K141809(Traditional)ATTN: EdHortonPHONE NO : 203 453-6654741 BOSTON POST ROADSE DECISION MADE: 27-OCT-14GUILFORD CT06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOPOREPolyganics BV510(k) NO: K141816(Traditional)ATTN: BETTYIJMKERPHONE NO : 31 50 5886588ROZENBURGLAAN 15ASE DECISION MADE: 23-OCT-14GRONINGENNL 9727DL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAGWIRE HIGH PERFORMANCE GUIDWIREBOSTON SCIENTIFIC CORP.510(k) NO: K141820(Traditional)ATTN: ALLISONBAILLIEPHONE NO : 508 683-4942100 BOSTON SCIENTIFIC WAYSE DECISION MADE: 21-OCT-14MARLBOROUGH MA01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARBAND, STARLIGHTORTHOMERICA PRODUCTS, INC.510(k) NO: K141842(Traditional)ATTN: DAVID C KERR PHONE NO : 407 290-65926333 N Orange Blossom TrlSE DECISION MADE: 06-OCT-14ORLANDO FL32810510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOSPINE PEDICLE SCREW SYSTEMFLOSPINE510(k) NO: K141850(Traditional)ATTN: RICHJANSEN PHONE NO : 612 281-550511821 BRAMBLE COVE DRIVE SE DECISION MADE: 27-OCT-14FT. MYERS FL33905510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSTATIONRAYSEARCH LABORATORIES AB510(k) NO: K141860(Traditional)ATTN: DAVIDHEDFORSPHONE NO : 46 722 366110SVEAV 25, PLAN 9SE DECISION MADE: 23-OCT-14STOCKHOLMSE 111 34510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANAANTHROTRONIX, INC510(k) NO: K141865(Traditional)ATTN: CORINA E LATHAN, PHD, PE PHONE NO : 240 498-94718737 COLESVILLE ROAD SUITE L-203SE DECISION MADE: 15-OCT-14SILVER SPRING MD20910510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITHEMEDEX INCORPORATED510(k) NO: K141869(Traditional)ATTN: DEANHONKONENPHONE NO : 617 577-1759222 3rd St Suite 0123 SE DECISION MADE: 10-OCT-14CAMBRIDGE MA02142510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDRESULTSRAMSOFT, INC.510(k) NO: K141881(Traditional)ATTN: LELYLAM-HONGPHONE NO : 416 674134 7 EXT 213243 COLLEGE ST.,SUITE 100SE DECISION MADE: 31-OCT-14TORONTO, ONCA M5T 1R5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARKCORE FINE NEEDLE BIOPSY SYSTEMCOVIDIEN LLC (FORMERLY BEACON ENDO510(k) NO: K141894(Traditional)ATTN: SaketBhatt PHONE NO : 408 328-73572000 COMMONWEALTH AVE. SUITE 110SE DECISION MADE: 06-OCT-14AUBURNDALE MA02466-2008510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIORA V-TOUCHVIORA LTD.510(k) NO: K141904(Traditional)ATTN: YORAMLEVYPHONE NO : 972 463 8883731 HAAVODA ST.SE DECISION MADE: 21-OCT-14BINYAMINAIL 30500510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL SWITCHLASER ENGINEERING, INC.510(k) NO: K141908(Special)ATTN: LAURIEDOBBSPHONE NO : 615 739-5418475 METROPLEX DR. SUITE 401 SE DECISION MADE: 22-OCT-14NASHVILLE TN37211510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BONADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141912(Traditional)ATTN: ANNAHWANGPHONE NO : 310 533-99663203 KASHIWA STREETSE DECISION MADE: 29-OCT-14TORRANCE CA90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEARUNICON OPTICAL CO., LTD. 510(k) NO: K141917(Traditional)ATTN: MICHAELLEE PHONE NO : 886 228 096995NO. 45, MINGSHENG RD., DANSHUI DISSE DECISION MADE: 17-OCT-14NEW TAIPEITW 251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA PARAINFLUENZA VIRUS ASSAYQUIDEL CORPORATION 510(k) NO: K141927(Traditional)ATTN: Ronald H Lollar PHONE NO : 740 589-33732005 E State St Suite 100SE DECISION MADE: 09-OCT-14ATHENS OH45701510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA ADENOVIRUS ASSAYQUIDEL CORPORATION 510(k) NO: K141931(Traditional)ATTN: Ronald H Lollar PHONE NO : 750 589-33732005 E State St Suite 100SE DECISION MADE: 09-OCT-14ATHENS OH45701510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP3D 3.0-ENABLE, SPINEMAP3D 3.0-SALES DSTRYKER CORPORATE510(k) NO: K141941(Traditional)ATTN: LILIANECKERTPHONE NO : 497 614 512117BOETZINGER STR.41SE DECISION MADE: 31-OCT-14FREIBURG, BADEN-WUERTTEMBERGDE 7510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLTITAN SPINE, LLC510(k) NO: K141953(Traditional)ATTN: CHRISTINESCIFERT PHONE NO : 901 831-80533416 ROXEE RUN COVESE DECISION MADE: 27-OCT-14BARTLETT TN38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCEL 455 SLIT LAMPREICHERT, INC.510(k) NO: K141954(Special)ATTN: THOMAS M HECKMANNPHONE NO : 716 686-45003362 WALDEN AVE.SE DECISION MADE: 15-OCT-14DEPEW NY14043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLASSIC HD ACETABULAR INSERT WITH E-LINK POLYTOTAL JOINT ORTHOPEDICS, INC.510(k) NO: K141972(Traditional)ATTN: CHRISWEABERPHONE NO : 801 486-60701567 E. Stratford Avenue SE DECISION MADE: 09-OCT-14Salt Lake City UT84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODE LASER HAIR REMOVAL SYSTEMBEIJING ANCHORFREE TECHNOLOGY CO.,510(k) NO: K141973(Traditional)ATTN: DianaHongPHONE NO : 86 21 22815850P.O.BOX 237-023 SE DECISION MADE: 06-OCT-14SHANGHAICN 200030510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDR D-EVO II FLAT PANEL DETECTOR SYSTEMFUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K142003(Traditional)ATTN: KATHERINE Y CHOIPHONE NO : 203 602-3568419 WEST AVE.SE DECISION MADE: 21-OCT-14STAMFORD CT06902-6300510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA DISTAL ACCESS CATHETERMICROVENTION, INC. 510(k) NO: K142014(Special)ATTN: NaomiGongPHONE NO : 714 247-80551311 VALENCIA AVESE DECISION MADE: 10-OCT-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICESPINEFRONTIER, INC.510(k) NO: K142026(Traditional)ATTN: MEREDITHMAYPHONE NO : 719 337-75794628 NORTHPARK DRIVESE DECISION MADE: 20-OCT-14COLORADO SPRINGS CO80918510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 888 WNLE POWERED WHEELCHAIRPIHSIANG MACHINERY MFG. CO., LTD. 510(k) NO: K142027(Third Party – Traditional)ATTN: DAVIDLINPHONE NO : 310 328-8866 10221184 FIGUEROA ST. SE DECISION MADE: 07-OCT-14CARSON CA90745510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)NANOSPERE,INC.510(k) NO: K142033(Traditional)ATTN: NOAHLERMER PHONE NO : 847 400-90004088 COMMERCIAL AVESE DECISION MADE: 10-OCT-14NORTHBROOK IL60062510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTRAHOLOGIC, INC.510(k) NO: K142037(Traditional)ATTN: CATHERINEWILLIAMSPHONE NO : 408 352-02012585 AUGUSTINE DRSE DECISION MADE: 10-OCT-14SANTA CLARA CA95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERCHONIA SHLERCHONIA CORPORATION510(k) NO: K142042(Traditional)ATTN: KevinWalls PHONE NO : 720 962-541233 Golden Eagle LaneSE DECISION MADE: 21-OCT-14Littleton CO80127510(k) STATEMENT
DEVICE: NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEMNUVASIVE, INCORPORATED510(k) NO: K142050(Traditional)ATTN: MICHELLECHEUNGPHONE NO : 858 909-33607475 LUSK BLVD. SE DECISION MADE: 29-OCT-14SAN DIEGO CA92121510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL CLAMP SPINAL FIXATION SYSTEMZIMMER SPINE, INC. 510(k) NO: K142053(Traditional)ATTN: HOLLYSEPPANEN PHONE NO : 952 830-62407375 BUSH LAKE RD. SE DECISION MADE: 29-OCT-14MINNEAPOLIS MN55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: #8C RENEGADE DENTAL HANDPIECEHANDPIECE CLUB, LLC510(k) NO: K142063(Traditional)ATTN: TINAWUPHONE NO : 443 352-390962 FOREST STREET, SUITE 300 SE DECISION MADE: 28-OCT-14MARLBOROUGH MA01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMISRTI SURGICAL, INC. 510(k) NO: K142070(Traditional)ATTN: KRISTINAHALLPHONE NO : 386 418-8888 451111621 Research Cir SE DECISION MADE: 27-OCT-14ALACHUA FL32615510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELASII THERAPY LASER SYSTEMASPEN LASER SYSTEMS, LLC 510(k) NO: K142078(Traditional)ATTN: A. BRAUNHENDERSONPHONE NO : 303 751-2055970 SOUTH DAWSON WAY #14 SE DECISION MADE: 30-OCT-14AURORA CO80012510(k) STATEMENT
DEVICE: STALIF CTI, STALIF CCENTINEL SPINE, INC.510(k) NO: K142079(Traditional)ATTN: JUSTINEGGLETONPHONE NO : 202 552-58001331 H STREET NW, 12TH FLOORSE DECISION MADE: 24-OCT-14WASHINGTON DC20005510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTZIMMER DENTAL INC. 510(k) NO: K142082(Traditional)ATTN: CHRISTINABOYDSON PHONE NO : 760 919-41101900 ASTON AVE. SE DECISION MADE: 28-OCT-14CARLSBAD CA92008-7308510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNCONTACT SURGICAL, INC.510(k) NO: K142084(Traditional)ATTN: JANERICUPEROPHONE NO : 919 655-13551001AVIATION PARKWAY, SUITE 400SE DECISION MADE: 28-OCT-14MORRISVILLE NC27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIESGRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K142088(Traditional)ATTN: PATRICKCHOWPHONE NO : 008 522 8516789BLOCK 6 AND 7, ZHU KENG INDUSTRIALSE DECISION MADE: 31-OCT-14GUANG DONGCN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBOSSISORTHOREBIRTH CO., LTD.510(k) NO: K142090(Traditional)ATTN: KEVINA.THOMAS PHONE NO : 858 792-123512264 El Camino Real, Suite 400SE DECISION MADE: 29-OCT-14San Diego CA92130510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETENE MACROPOROUS MESHSOFRADIM PRODUCTION510(k) NO: K142091(Traditional)ATTN: JENNIFERBRENNANPHONE NO : 203 492-534660 MIDDLETOWN AVENUESE DECISION MADE: 17-OCT-14NORTH HAVEN CT06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, Inc510(k) NO: K142095(Special)ATTN: SharynOrtonPHONE NO : 401 330-8264200 HOMER AVE.SE DECISION MADE: 15-OCT-14ASHLAND MA01721510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-PIECE RESUSCITATORMERCURY MEDICAL 510(k) NO: K142096(Traditional)ATTN: PAULDRYDEN PHONE NO : 239 498-215524301 WOODSAGE DRIVESE DECISION MADE: 17-OCT-14BONITA SPRINGS FL34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABACUS (TM) SPACER SYSTEMSPINE WAVE, INC.510(k) NO: K142101(Traditional)ATTN: ROAIDAJOHNSON PHONE NO : 203 944-94943 ENTERPRISE DRIVE, SUITE 210SE DECISION MADE: 23-OCT-14SHELTON CT06484510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA 4.5 SPINAL SYSTEMSTRYKER CORPORATION510(k) NO: K142114(Traditional)ATTN: GARRY T HAYECK, PH.D. PHONE NO : 201 760-80432 PEARL COURTSE DECISION MADE: 27-OCT-14ALLENDALE NJ07401510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMRoche Diagnostics510(k) NO: K142133(Traditional)ATTN: SarahBaumannPHONE NO : 317 521-39529155 HAGUE RD.SE DECISION MADE: 24-OCT-14INDIANAPOLIS IN46250510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISO-GARD MASKTeleflex Medical, Inc.510(k) NO: K142138(Traditional)ATTN: BRIANGALLPHONE NO : 919 544-80002917 WECK DR.SE DECISION MADE: 30-OCT-14RESEARCH TRIANGLE PARK NC27709510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIS MODULIFT VBR SYSTEMAESCULAP IMPLANT SYSTEM, INC.510(k) NO: K142150(Traditional)ATTN: LISA M BOYLE PHONE NO : 610 984-92743773 Corporate ParkwaySE DECISION MADE: 29-OCT-14Center Valley PA18034510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMGE HEALTHCARE510(k) NO: K142160(Traditional)ATTN: BRYANBEHNPHONE NO : 414 721-42149900 INNOVATION DR.SE DECISION MADE: 10-OCT-14WAUWATOSA WI53226510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM – TIGECYCLINE (0.313-4UG/ML) GPBecton, Dickinson and Company510(k) NO: K142170(Traditional)ATTN: MONICA E GIGUEREPHONE NO : 410 316-42877 Loveton Cir., MC 694SE DECISION MADE: 28-OCT-14Sparks MD21152510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX-D IMAGING PACKAGEAGFA HEALTHCARE N.V.510(k) NO: K142184(Traditional)ATTN: SHAEANNCAVANAGHPHONE NO : 864 421-176610 SOUTH ACADEMY ST.SE DECISION MADE: 16-OCT-14GREENVILLE SC29601510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COGENT MED-LIF XLCOGENT SPINE LLC510(k) NO: K142193(Special)ATTN: JUDEPAGANELLI PHONE NO : 858 774 7891101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 15-OCT-14SOLANA BEACH CA92075510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNX Fine Needle Aspiration SystemCovidien LLC 510(k) NO: K142198(Traditional)ATTN: SaketBhatt PHONE NO : 1 408 32873572000 Commonwealth Ave Suite 110SE DECISION MADE: 08-OCT-14Auburndale MA02466510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ascendra Balloon Aortic Valvaloplasty CatheterEDWARDS LIFESCIENCES510(k) NO: K142199(Traditional)ATTN: SusanReynoldsPHONE NO : 949 7564518ONE EDWARDS WAY SE DECISION MADE: 29-OCT-14IRVINE CA92614510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)NOVA BIOMEDICAL CORPORATION 510(k) NO: K142220(Traditional)ATTN: PaulW.MacDonaldPHONE NO : 781 8940800200 PROSPECT ST.SE DECISION MADE: 17-OCT-14WALTHAM MA02454510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiAccess SystemEpieP, Inc.510(k) NO: K142245(Traditional)ATTN: PamelaBunesPHONE NO : 864 4232526142 Temple Street, Suite 206SE DECISION MADE: 29-OCT-14New Haven CT06510510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XprESS Multi-Sinus Dilation ToolENTELLUS MEDICAL, INC.510(k) NO: K142252(Special)ATTN: KarenE.PetersonPHONE NO : 763 46370663600 Holly Lane North, Suite 40SE DECISION MADE: 17-OCT-14PlymouthMN55447510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock 3CG Tip Positioning System StyletC.R.Bard, Inc.510(k) NO: K142267(Traditional)ATTN: BryanStone PHONE NO : 1 801 5225876605 North 5600 WestSE DECISION MADE: 17-OCT-14Salt Lake City UT84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian Verification System (VVS)VARIAN MEDICAL SYSTEMS, INC.510(k) NO: K142268(Traditional)ATTN: Peter J. CoronadoPHONE NO : 650 42463203100 HANSEN WAY SE DECISION MADE: 02-OCT-14PALO ALTO CA94304510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensNEO VISION CO., LTD.510(k) NO: K142275(Traditional)ATTN: Kyung Hwa KimPHONE NO : 82 31 88920401029 YEONGDOEK-DONG, GIHENUNG-GU YSE DECISION MADE: 07-OCT-14GYEONGGI-DOKR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIET POSPINEART510(k) NO: K142277(Traditional)ATTN: FranckPennesi PHONE NO : 41 22 5701246INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 14-OCT-14GENEVACH 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 LLC510(k) NO: K142280(Traditional)ATTN: JianqiuFangPHONE NO : 1 713 73380885213 MAPLE STREETSE DECISION MADE: 16-OCT-14BELLAIRE TX77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEMZIMMER, INC. 510(k) NO: K142281(Traditional)ATTN: PATRICKMCCULLAGHPHONE NO : 574 272 4656P.O. BOX 708 SE DECISION MADE: 22-OCT-14WARSAW IN46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NS3000 Holmium Laser SystemNew Star Lasers, Inc. 510(k) NO: K142286(Special)ATTN: NatalieVollrathPHONE NO : 1 916 67719009085 Foothills Blvd.SE DECISION MADE: 31-OCT-14Roseville CA95747510(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 SystemPolymer Technology Systems, Inc.510(k) NO: K142302(Traditional)ATTN: JackRogers PHONE NO : 1 317 8705610 10647736 Zionsville Rd.SE DECISION MADE: 02-OCT-14Indianapolis IN46268510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viberect Penile Vibratory Stimulation DeviceREFLEXONIC, LLC 510(k) NO: K142304(Traditional)ATTN: KambizTajkarimiPHONE NO : 301 3788433915 Toll House Avenue, Suite 205SE DECISION MADE: 03-OCT-14Frederick MD21701510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGE MEDICAL SYSTEMS ISRAEL LTD. 510(k) NO: K142323(Traditional)ATTN: BryanBehn PHONE NO : 972 4 85196194 Etgar StreetSE DECISION MADE: 10-OCT-14Tirat CarmelIL 39120510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland Inc.510(k) NO: K142346(Traditional)ATTN: Anne-MarieShinePHONE NO : 353 65 6831138Lismeehan, O’Callaghan’s Mills SE DECISION MADE: 15-OCT-14Co. ClareIE510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestW.H.P.M., Inc.510(k) NO: K142353(Traditional)ATTN: JohnWan PHONE NO : 1 626 44384805358 Irwindale Ave SE DECISION MADE: 07-OCT-14Irwindale CA91706510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vasc Band hemostatLepu Medical Technology (Beijing) 510(k) NO: K142359(Traditional)ATTN: KimXiangdanPHONE NO :No. 37 Chaoqian RoadSE DECISION MADE: 23-OCT-14BeijingCN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrx RFA Self Sizing Balloon CatheterCovidien llc 510(k) NO: K142364(Special)ATTN: RachelSilvaPHONE NO : 1 408 328735915 Hampshire StreetSE DECISION MADE: 01-OCT-14Mansfield MA02048510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pico Way Laser SystemCANDELA CORPATION510(k) NO: K142372(Traditional)ATTN: RuthieAmir PHONE NO : 508 3587400 330530 BOSTON POST ROADSE DECISION MADE: 30-OCT-14WAYLAND MA01778510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xia 3 Spinal SystemSTRYKER CORP.510(k) NO: K142381(Traditional)ATTN: GARRY T HAYECKPHONE NO : 201 76080432 PEARL COURTSE DECISION MADE: 21-OCT-14ALLENDALE NJ07401510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsChemtron Biotech, Inc.510(k) NO: K142396(Traditional)ATTN: JaneZhangPHONE NO : 858 45000449245 Brown Deer RoadSE DECISION MADE: 09-OCT-14San Diego CA92121510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miltex N-Tralig Intraligamentary SyringeINTEGRA LIFESCIENCES CORPORATION510(k) NO: K142414(Special)ATTN: JudithE.O’GradyPHONE NO : 609 2750500311 ENTERPRISE DR. SE DECISION MADE: 30-OCT-14PLAINSBORO NJ08536510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroflowmeterBE TECHNOLOGIES, INC. 510(k) NO: K142425(Traditional)ATTN: EdwardBelotserkovskyPHONE NO : 415 30785312939 20th AvenueSE DECISION MADE: 27-OCT-14San Francisco CA94132510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cryoICE croablation probeATRICURE, INC.510(k) NO: K142441(Special)ATTN: JonathanMcElweePHONE NO : 513 64442496217 CENTER PARK DRIVESE DECISION MADE: 29-OCT-14WEST CHESTER OH45069510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEMZIMMER, INC. 510(k) NO: K142442(Traditional)ATTN: PATRICKMCCULLAGH PHONE NO : 574 3724656P.O. BOX 708 SE DECISION MADE: 03-OCT-14WARSAW IN46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc510(k) NO: K142443(Traditional)ATTN: KerrieHamblin PHONE NO : 801 5224909605 North 5600 WestSE DECISION MADE: 30-OCT-14Salt Lake City UT84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVERGENCE Anterior Cervical Fusion SystemMEDTRONIC SOFAMOR DANEK USA, INC510(k) NO: K142450(Special)ATTN: ShwetaSharmaPHONE NO : 901 39631331800 PYRAMID PLACE SE DECISION MADE: 01-OCT-14MEMPHIS TN38132510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM Spine System/Synapse SystemJOHNSON AND JOHNSON510(k) NO: K142460(Special)ATTN: JaclynPorsolt PHONE NO : 1 508 8283269325 PARAMOUNT DR.SE DECISION MADE: 01-OCT-14RAYNHAM MA02767510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGEO PT60A Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD 510(k) NO: K142466(Third Party – Traditional)ATTN: PARKKYEONG-MI PHONE NO : 822 2194 137342, TEHERAN-RO 108-GIL,SE DECISION MADE: 03-OCT-14GANGNAM-GUKR510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: Sternal Closure SystemJACE Medical LLC510(k) NO: K142484(Traditional)ATTN: JustinMayPHONE NO : 574 5271663536 East 200 North SE DECISION MADE: 31-OCT-14Warsaw IN46582510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Combi Suite Neurosurgery for the MAGNETOMAera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM SkyraSiemens Medical Solutions USA, Inc510(k) NO: K142515(Special)ATTN: CordellL. Fields PHONE NO : 1 610 219851851 Valley Stream Parkway, MailcodeSE DECISION MADE: 08-OCT-14Malvern PA19355510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SolfVueDELPHINUS MEDICAL TECHNOLOGIES, IN510(k) NO: K142517(Traditional)ATTN: Andrea N Wallen-GerdingPHONE NO : 1 734 233308846701 COMMERCE CENTER DRIVE SE DECISION MADE: 31-OCT-14PLYMOUTH MI48170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyProCure IIGraham Medical Technologies, L.L.C510(k) NO: K142534(Traditional)ATTN: ANGELARECCHIA PHONE NO : 586 677960016137 LEONE DRIVESE DECISION MADE: 03-OCT-14MACOMB MI48042510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)JVC KENWOOD CORPORATION510(k) NO: K142536(Traditional)ATTN: TSUKASATASHIROPHONE NO : 81 258 2466113-12, MORIYACHO, KANAGAWA-KUSE DECISION MADE: 03-OCT-14YOKOHAMA-SHIJP 221-0022510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiNA SafeAir Smoke PencilLINA MEDICAL APS510(k) NO: K142538(Special)ATTN: LouisaMemborg PHONE NO : 454 329 6652FORMERVAGEN 5SE DECISION MADE: 06-OCT-14GLOSTRUPDK 2600510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)JVC KENWOOD CORPORATION510(k) NO: K142540(Traditional)ATTN: TsukasaTashiroPHONE NO : 81 258 2466113-12, MORIYA-CHO, KANAGAWA-KUSE DECISION MADE: 03-OCT-14YOKOHAMA-SHIJP 221-0022510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Video-Uretero-Choledochoscope SystemKARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K142556(Traditional)ATTN: MikeSamuelsPHONE NO : 424 21882882151 E. GRAND AVENUESE DECISION MADE: 23-OCT-14EL SEGUNDO CA90245510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well Lead PVC Urethral CatheterWELL LEAD MEDICAL CO., LTD. 510(k) NO: K142563(Traditional)ATTN: Han Guang YuanPHONE NO : 86 20 84758878C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 28-OCT-14GuangzhouCN 511434510(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: TRACEYHANNONPHONE NO : 508 8808033325 PARAMOUNT DR.SE DECISION MADE: 24-OCT-14RAYNHAM MA02767510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. 510(k) NO: K142575(Traditional)ATTN: MicheleDavisPHONE NO : 770 78462748195 Industrial BlvdSE DECISION MADE: 31-OCT-14Covington GA30014510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Periarticular Plating SystemZIMMER, INC. 510(k) NO: K142579(Traditional)ATTN: PatrickMcCullagh PHONE NO : 574 3724656P.O. BOX 708 SE DECISION MADE: 22-OCT-14WARSAW IN46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLTITAN SPINE, LLC510(k) NO: K142589(Special)ATTN: JaneRoddPHONE NO : 262 24278016140 WEST EXECUTIVE DRIVE, SUITE ASE DECISION MADE: 17-OCT-14MEQUON WI53092510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALOR Hindfoot Fusion Nail SystemWRIGHT MEDICAL TECHNOLOGY, INC.510(k) NO: K142602(Special)ATTN: VALMYLESPHONE NO : 1 901 29051621023 CHERRY ROADSE DECISION MADE: 22-OCT-14MEMPHIS TN38117510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Precision HD Camera SystemStryker Endoscopy510(k) NO: K142603(Third Party – Traditional)ATTN: AngelaWong PHONE NO : 1 408 75420005900 Optical Court SE DECISION MADE: 23-OCT-14San Jose CA95138 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: AngioDynamics VenaCure EVLT Tre? Sheath and VenaCure EVLT NeverTouch Procedure KitsAngioDynamics, Inc.510(k) NO: K142614(Special)ATTN: TeriJuckettPHONE NO : 518 7951142603 Queensbury Avenue SE DECISION MADE: 10-OCT-14Queensbury NY12804510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICC Maximal Barrier Nursing KitNAVILYST MEDICAL, INC.510(k) NO: K142616(Special)ATTN: WANDACARPINELLLA PHONE NO : 508 658792926 FOREST STREETSE DECISION MADE: 14-OCT-14MARLBOROUGH MA01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound SystemHitachi Aloka Medical America, Inc510(k) NO: K142618(Special)ATTN: AngelaVan ArsdalePHONE NO : 203 269508810 Fairfield BlvdSE DECISION MADE: 16-OCT-14Wallingford CT06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuson SC2000 Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS, INC.510(k) NO: K142628(Third Party – Traditional)ATTN: KevinKongPHONE NO : 650 9699112685 EAST MIDDLEFIELD RD. SE DECISION MADE: 10-OCT-14MOUNTAIN VIEW CA94043510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: Merit 10mL SyringeMerit Medical Systems, Inc. 510(k) NO: K142636(Special)ATTN: MridiKumathePHONE NO : 1 801 20847121600 W Merit ParkwaySE DECISION MADE: 17-OCT-14South Jordan UT84095510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporatio510(k) NO: K142653(Special)ATTN: TomerAlonPHONE NO : 972 4 9858400D.N. AshratSE DECISION MADE: 16-OCT-14Kibbutz GaatonIL 25130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortex 0.035 OTW PTA Balloon CatheterCovidien LLC 510(k) NO: K142654(Third Party – Traditional)ATTN: RupaliGuptaPHONE NO : 1 763 39870003033 Campus DriveSE DECISION MADE: 28-OCT-14Plymouth MN55441 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc.510(k) NO: K142660(Special)ATTN: Xiang (Vic) ZhangPHONE NO : 781 2212266 10263 Second AvenueSE DECISION MADE: 17-OCT-14Burlington MA01803510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vericore Zirconia BlanksWHIP MIX CORPORATION510(k) NO: K142670(Special)ATTN: JOHNWATERS PHONE NO : 502 6371451361 FARMINGTON AVE SE DECISION MADE: 22-OCT-14LOUISVILLE KY40217510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinElmer, Inc510(k) NO: K142698(Special)ATTN: DawnSpoonerPHONE NO : 781 6636071940 Winter StreetSE DECISION MADE: 23-OCT-14Waltham MA02451510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERADIUS UNITYPHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K142708(Abbreviated)ATTN: JeanetteBeckerPHONE NO : 31 06113 86380VEENPLUIS 4-6SE DECISION MADE: 22-OCT-14BESTNL 5684 PC510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossCLIP Implant SystemOrthoDiscovery Group LLC(D.B.A. Cr510(k) NO: K142727(Traditional)ATTN: VernonHartdegenPHONE NO : 1 901 2218406458 DISTRIBUTION PKWY SE DECISION MADE: 24-OCT-14COLLIERVILLE TN38017510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 5ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142733(Traditional)ATTN: DONGHWANKIMPHONE NO : 82 70 746520681, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14SEOULKR 152-848510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Siemens 3.0 Blanket Array CoilRESONANCE INNOVATIONS LLC510(k) NO: K142755(Traditional)ATTN: RandallJonesPHONE NO : 1 402 93426509840 S. 140TH ST., STE 8 SE DECISION MADE: 23-OCT-14OMAHA NE68138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiNA PowerBlade Plus HCLiNA Medical ApS510(k) NO: K142757(Special)ATTN: LouisaMemborg PHONE NO : 454 3296652Formervangen 5SE DECISION MADE: 23-OCT-14GlostrupDK 2600510(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 SurfaceMedtronic, Inc510(k) NO: K142784(Special)ATTN: LisaStonePHONE NO : 1 763 51498668200 Coral Sea Street NE SE DECISION MADE: 24-OCT-14Mounds View MN55112 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: AshaGartlandPHONE NO : 914 5243257511 Benedict AvenueSE DECISION MADE: 29-OCT-14Tarrytown NY10591510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K142847(Traditional)ATTN: LAVEEDALEFLOREPHONE NO : 1 901 34631331800 PYRAMID PLACE SE DECISION MADE: 27-OCT-14MEMPHIS TN38132510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact LensUnilens Corp., USA 510(k) NO: K142851(Special)ATTN: Alan J. FrazerPHONE NO : 727 544253110431 72nd Street NorthSE DECISION MADE: 30-OCT-14Largo FL33777 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: FatimaPacheco PHONE NO : 1 914 5242450511 BENEDICT AVENUESE DECISION MADE: 29-OCT-14TARRYTOWN NY10591510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premium Surgiclip IIICOVIDIEN510(k) NO: K142869(Special)ATTN: MichaelKoczocikPHONE NO : 1 203 492631260 Middletown AvenueSE DECISION MADE: 30-OCT-14North Haven CT06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142876(Third Party – Traditional)ATTN: NANCYBURKE PHONE NO : 1 425 2958665685 East Middlefield RoadSE DECISION MADE: 23-OCT-14Mountain CA94043 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW
DEVICE: IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification MaterialSIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142878(Abbreviated)ATTN: DonnaVelasquezPHONE NO : 1 310 6458200 74035210 Pacific Concourse DriveSE DECISION MADE: 30-OCT-14Los Angeles CA90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 12ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142884(Traditional)ATTN: DonghwanKimPHONE NO : 82 70 746520681, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14SEOULKR 152-848510(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 MeshSOFRADIM PRODUCTION510(k) NO: K142900(Special)ATTN: EricJaguePHONE NO : 33 4 74089000116 AVENUE DU FORMANS SE DECISION MADE: 28-OCT-14TREVOUXFR 01600510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leo MinorSUNNEX, INC. 510(k) NO: K142984(Third Party – Traditional)ATTN: TISHMENDICKPHONE NO : 402 85094859319 FORSYTH PARK DRIVESE DECISION MADE: 29-OCT-14CHARLOTTE NC28273510(k) STATEMENTTHIRD PARTY REVIEW