FDA 510(k) Decisions During June, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K140695 06/12/2014 COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE MEDTRONIC INC. NISARG SHAH
K140602 06/05/2014 FLASH PENTA MB QUICK, FLASH MB QUICK 3M ESPE AG RUEDIGER FRANKE
K141179 06/27/2014 A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. JERRY WANG
K133096 06/18/2014 ABB VIE J ABBVIE INC. KATHERINE WORTLEY
K133129 06/19/2014 ABBVIE NJ ABBVIE INC. KATHERINE WORTLEY
K133087 06/19/2014 ABBVIE PEG ABBVIE INC. KATHERINE WORTLEY
K132833 06/17/2014 ULTRA RENEW PLUS ACCORD MEDIA MICHAEL CHIBBARO
K140683 06/03/2014 0180 INTUITION, 0072 PRECISION ACROMA AB DANIEL KAMM
K141383 06/13/2014 ACUMED HAND FRACTURE SYSTEM ACUMED, LLC MARIAH KNIGHT
K130755 06/27/2014 HICUT HIGHSPEED INSTRUMENT ADEOR MEDICAL AG FABIO VON ZEPPELIN
K132354 06/30/2014 POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE ADVANCED HEALTH PRODUCTS, LOT 60 & 61 FRANCIS V
K141192 06/06/2014 DR 400 AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K141104 06/25/2014 TRUKLEAR BRACKET AJW TECHNOLOGY CONSULTANTS, INC. TANYA O'BRIEN
K141520 06/13/2014 ALERE I INFLUENZA A & B, ALERE I INSTRUMENT, ALERE I INFLUENZA A & B CONTROL SWAB KIT ALERE SCARBOROUGH, INC D/B/A BINAX, INC. ANGELA DRYSDALE
K140435 06/26/2014 MEDLEY GOLD AMERICAN DENTAL SLEEP MEDICINE, IP, LLC PAUL DRYDEN
K140679 06/20/2014 SUREFLEX LITHOTRIPSY LASER FIBERS AMERICAN MEDICAL SYSTEMS JOSH CLARIN
K133770 06/10/2014 A.I.M. KNOTLESS MENISCAL REPAIR DEVICE ANCHOR INNOVATION MEDICAL (A.I.M.) KAREN M BECKER, PH.D.
K132003 06/13/2014 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
DEN130034 06/26/2014 REWALK ARGO MEDICAL TECHNOLOGIES, INC. JOHN V HAMILTON
K131798 06/26/2014 REWALK ARGO MEDICAL TECHNOLOGIES, INC. JOHN V HAMILTON
K124021 06/30/2014 ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. LONNA M DENDOOVEN
K140871 06/06/2014 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. GRACE LI
K140992 06/16/2014 ARTHROCARE NASASTENT CMC NASAL DRESSING ARTHROCARE CORPORATION MITCHELL DHORITY
K140521 06/10/2014 TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH ARTHROCARE CORPORATION MITCHELL A DHORITY
K133297 06/10/2014 QUADROSTARPROGREEN, QUADROSTARPROYELLOW ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
DEN120015 06/06/2014 EEVA 2.0 AUXOGYN, INC. CINDY DOMECUS
K120427 06/06/2014 EEVA 2.0 AUXOGYN, INC. CINDY DOMECUS
K140955 06/11/2014 MTA2.1 MATERIAL AVALON BIOMED INC. CAROLYN PRIMUS
K133632 06/27/2014 PERICAN ULTRA B.BRAUN MEDICAL, INC LISA GIAQUINTO
K141428 06/27/2014 MDMC-12133 BARCO N.V. LIEVEN DE WANDEL
K130265 06/23/2014 CONTOUR NEXT EZ BLOOD GLUCOSE METER BAYER HEALTHCARE LLC JENNIFER GREGORY
K141374 06/30/2014 BICARBONATE CALIBRATOR BECKMAN COULTER IRELAND INC DAVID G DAVIS
K140468 06/02/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) BECTON, DICKINSON AND COMPANY MONICA E GIGUERE
K131183 06/03/2014 MED-RX ORAL/ENTERAL SYRINGE BENLAN, INC. CHERYL BROWN
K130733 06/18/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) BENTENG PLASTIC CO., LTD. CHU XIAOAN
K140370 06/19/2014 DISPOSABLE PRESSURE MANOMETER BESMED HEALTH BUSINESS CORP. PAUL DRYDEN
K140788 06/27/2014 P-STIM BIEGLER GMBH PAUL DRYDEN
K133774 06/06/2014 ATOVEN BIO-MED U.S.A., INC. YOUNG CHI
K141073 06/23/2014 LIQUICHEK TUMOR MARKER CONTROL BIO-RAD LABORATORIES SUZANNE PARSONS
K140801 06/25/2014 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM BIO-RAD LABORATORIES, INC. EBONY MCKINNIES
K133884 06/13/2014 BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM BIODENTA SWISS AG DAVID EILER
K141149 06/20/2014 VITEK 2 AST GP CEFTAROLINE BIOMERIEUX, INC. CHARLENE FERRAND
K140891 06/03/2014 BIOMET CANNULATED SCREW SYSTEM BIOMET, INC. VICTORIA SCHEITLIN
K132960 06/06/2014 BIOMONITOR BIOTRONIK, INC. JON BRUMBAUGH
K141185 06/06/2014 V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM BOSTON SCIENTIFIC CORP. ROBIN MULVEY
K133147 06/20/2014 BRACCO INJEENERING TRANSFER SET BRACCO INJENEERING S.A. THOMAS KROENKE
K141199 06/20/2014 QUENTRY DOSE REVIEW BRAINLAB AG ALEXANDER SCHWIERSCH
K141413 06/27/2014 CRC PC WITH SMART CHAMBER CAPINTEC, INC. MARY ANNE YUSKO
K140155 06/20/2014 SECURE-GARD SURGICAL AND PROCEDURE FACE MASK CARDINAL HEALTH 200, LLC LAVENIA FORD
K140430 06/13/2014 740 SELECT CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K140364 06/02/2014 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K140215 06/16/2014 ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD CO-INNOVATION BIOTECH CO., LTD. HONG FENG
K132585 06/04/2014 ZIBONE CERAMIC DENTAL IMPLANT SYSTEM COHO TECHNOLOGY CO., LTD JENNIFER REICH
K140481 06/05/2014 COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH COLGATE-PALMOLIVE COMPANY CHARLES IRELAND
K140833 06/30/2014 ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K133465 06/26/2014 CONSURE STOOL MANAGEMENT SYSTEM CONSURE MEDICAL PVT LTD. ALAN DONALD
K140930 06/09/2014 VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES CONVIDA HEALTHCARE & SYSTEMS CORPORATION SHARON LEE
K133011 06/20/2014 DIAPHRAGMATIC HERNIA GRAFT COOK BIOTECH, INC. MARY A FADERAN PH.D., RAC
K133843 06/27/2014 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER CORDIS CORPORATION KIM FONDA
K133258 06/19/2014 TRUFREEZE SYSTEM CSA MEDICAL, INC. ELLEN SHEETS, MD, MBA
K133098 06/13/2014 SENYINT PACS DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD. LEON LU
K140358 06/02/2014 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K141259 06/10/2014 GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K140662 06/11/2014 FLEX ENDOSCOPIC INSTRUMENTS DESIGN STANDARDS CORP. MICHELE LUCEY
K141578 06/27/2014 DEVON CIRONA 6200 DVT DEVON MEDICAL RUTH WU
K133083 06/24/2014 DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET DIAZYME LABORATORIES ABHIJIT DATTA
K133105 06/24/2014 BREEZE NEBULIZER (NBR-10X) DIGIO2 INTERNATIONAL CO., LTD MICHAEL LEE
K140809 06/23/2014 CLIQ DV-300 ASPIRATOR DING HWA CO., LTD. JANNA BABSON
K141006 06/05/2014 RSP HUMERAL SOCKET INSERT DJO GLOBAL CHRISTINE CHESNUTT
K133886 06/20/2014 PERSEUS A500 DRAEGER MEDICAL GMBH BETH ZIS
K133661 06/13/2014 CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K131323 06/09/2014 ECLERIS SINUSCOPE ECLERIS USA RAYMOND J KELLY, IV
K132491 06/30/2014 MUELLER HINTON AGAR EDGE BIOLOGICALS, INC. TED A PEARSON
K140312 06/13/2014 EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM EDWARDS LIFESCIENCES, LLC. RENATE A MACLAREN
K141447 06/30/2014 PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. REBECCA SHELBURNE
K140675 06/10/2014 EMERGE EXTERNAL FIXATION SYSTEM EMERGE MEDICAL, INC. MICHELLE POTVIN
K133194 06/26/2014 DIAMOND RATTLESNAKE SYSTEM EMINENT SPINE LINDA BRADDON
K140006 06/16/2014 ENDOSHIELD BURN PROTECTION SYSTEM ENCISION INC. MIKE BIGGS
K140760 06/16/2014 BONASTENT BILIARY ENDOCHOICE, INC. BOSMAT FRIEDMAN
K132195 06/27/2014 EUROIMMUN ANTI-PLA2R ELISA (IGG) EUROIMMUN US INC MICHAEL LOCKE
K140674 06/30/2014 EXACTECH TAPERED WEDGE FEMORAL STEM EXACTECH, INC. SHING JEN TAI, PHD
K140242 06/12/2014 FEIYUE FEIYUE GLOVE CO., LTD. CHU XIAOAN
K141019 06/10/2014 AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED FENWAL, INC. KIM FORCH
K133403 06/11/2014 FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS FIRESTONE OPTICS, INC. MARTIN DALSING
K133872 06/02/2014 ARIA WIFI SMART SCALE FITBIT, INC. DIANE HORWITZ
K141261 06/05/2014 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE BRYAN BEHN
K132289 06/16/2014 GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM GEMSS MEDICAL SYSTEMS COL, LTD HARVEY KNAUSS
K140996 06/11/2014 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-GEM IMAGIN JOSE MONTES
K132375 06/12/2014 GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG GENICON KATLYN TISSUE
K140583 06/18/2014 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K131858 06/11/2014 DIGITAL ELECTROCARDIOGRAPH GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131762 06/06/2014 HANDHELD MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K140924 06/05/2014 STARCERAM H.C. STARCK CERAMICS GMBH MAUREEN O'CONNELL
K140610 06/20/2014 NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) HARTALEGA NGC SDN. BHD. NURUL AISYAH KONG
K140546 06/06/2014 HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST HEALGEN SCIENTIFIC, LLC JOE SHIA
K133848 06/25/2014 RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK HEARTVISTA, INC. JAMES J ROGERS
K140434 06/05/2014 MEDICAD CLASSIC HECTEC GMBH THOMAS WENGENMAYER
K140422 06/05/2014 HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM HET SYSTEMS, LLC HOWARD L SCHRAYER
K140854 06/11/2014 INTRA-OPERATIVE ULTRASOUND TRANSDUCER HITACHI ALOKA MEDICAL, LTD. ANGELA VANARSDALE
K140443 06/16/2014 ARIETTA 60/ARIETTAS60/ARIETTAV60 HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL AMERICA) ANGELA VANARSDALE
K140650 06/27/2014 HIVOX ELECTRIC STIMULATOR OTC TENS HIVOX BIOTEK, INC. KE-MIN JEN
K140960 06/13/2014 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K132869 06/19/2014 SILDENT HRS CO., LTD. JAE-HYEON CHOI
K132180 06/25/2014 IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM IDEAL LIFE INC. DAINE HORWITZ
K133062 06/20/2014 DISCOVERY SYSTEM INNOVATIVE VISUAL SYSTEMS DONALD R SANDERS, M.D. PH.D
K132489 06/20/2014 INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) INOGEN, INC. MARA KORSUNSKY
K132205 06/06/2014 ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM INOVA LABS, INC. PAMELA M BUCKMAN
K140967 06/10/2014 FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK INSIGHTRA MEDICAL LISA MALONEY
K132143 06/04/2014 EXHALATION VALVE INTERSURGICAL INCORPORATED MICHAEL ZALEWSKI
K140751 06/30/2014 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD JINYOUNG LEE
K140189 06/05/2014 ENDOWRIST VESSEL SEALER INTUITIVE SURGICAL, INC. NADINE NASR
K132557 06/03/2014 EWNL SAFETY SYRINGE WITH NEEDLE JIAMEI-UN CO., LTD. YU-HONG CHEN
K140239 06/12/2014 JIAWANG JIAWANG GLOVE CO., LTD. CHU XIAOAN
K133494 06/10/2014 CHESAPEAKE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K141147 06/03/2014 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K140678 06/19/2014 COSMOLOCK PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC J.D. WEBB
K141250 06/11/2014 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K140450 06/17/2014 KEELER KAPTURE SOFTWARE KEELER LIMITED EUGENE VAN ARSDALE
K140539 06/09/2014 AERO BLUE PERFORMANCE SURGICAL GOWN KIMBERLY-CLARK CORPORATION DAVID M LEE
K140026 06/03/2014 COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST LACRIMEDICS, INC. REBECCA DUTTON
K140562 06/16/2014 WIJAY EZ-VOID EXTERNAL CATHETER VALVE LEOMED, LLC BANDULA WIJAY
K141395 06/30/2014 DELTA TT ACETABULAR SYSTEM LIMACORPORATE S.P.A. STEPHEN J PEOPLES
K140975 06/10/2014 MASTERSL FEMORAL STEM LIMACORPORATE S.P.A. STEPHEN PEOPLES
K133349 06/03/2014 SMR TT METAL BACK GLENOID LIMACORPORATE S.P.A. STEPHEN PEOPLES
K141055 06/13/2014 LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K130694 06/19/2014 JR IMPLANT SYSTEM LK CONSULTING GROUP USA, INC. PRISCILLA CHUNG
K123149 06/20/2014 SERVO-I VENTILATOR SYSTEM MAQUET CRITICAL CARE AB WHITNEY TORNING
K140188 06/25/2014 MASIMO ROOT MONITORING SYSTEM MASIMO CORPORATION MARGUERITE THOMLINSON
K141045 06/30/2014 MBD PLATE SYSTEM MBD MEDICAL, LLC JENNIFER A DAUDELIN
K140361 06/12/2014 META-C CERVICAL PLATE MEDACTA INTERNATIONAL ADAM GROSS
K141232 06/23/2014 APTUS ULNA SHORTENING 2.5 MEDARTIS AG KEVIN A THOMAS
K140799 06/13/2014 CELERITY SYSYEM MEDCOMP (MEDICAL COMPONENTS, INC.) LORRAINE M HANLEY
K140730 06/12/2014 VIAL2BAG DIRECT CONNECT MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K140759 06/13/2014 BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL MEDOS INTERNATIONAL, SARL LINDA BERNIER
K132333 06/25/2014 BONDILOXS TOPICAL HEMOSTATIC DRESSING MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K140374 06/10/2014 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK USA, INC. KELLY ANGLIN
K141233 06/12/2014 AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE MEDTRONIC, INC. JESSICA SIXBERRY
K140972 06/06/2014 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING MEDTRONIC, INC. DEBRA TAITAGUE
K140564 06/05/2014 BN LUMBAR CAGE SYSTEM MEDYSSEY USA, INC. RICH JANSEN, PHARM D.
K140642 06/10/2014 PCD 737A MEGO AFEK AC LTD AHARON COHEN
K140519 06/16/2014 RECOVERY PUMP 737R MEGO AFEK AC LTD AHARON COHEN
K133295 06/18/2014 SPERM SORTER QUALIS MENICON CO., LTD. NEW BUSINESS DIVISION JULIE BULVER
K141363 06/18/2014 CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K131416 06/23/2014 NOVOPRESS MILKA, LLC JONATHAN KAHAN
K140510 06/19/2014 MIROMATRIX WOUND MATRIX MIROMATRIX MEDICAL INC. STEPHEN RHODES
K140660 06/24/2014 MOBIUS3D MOBIUS MEDICAL SYSTEMS, LP STAN ESHELMAN
K140083 06/20/2014 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) NANOSPHERE, INC TERESA RAICH
K133189 06/30/2014 DUAL SHOT ALPHA 7 NEMOTO KYORINDO CO., LTD. KEN WAKABAYASHI
K141376 06/26/2014 INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS NEXXT SPINE LLC KAREN E WARDEN
K133132 06/11/2014 OPTICAL BIOMETER AL-SCAN NIDEK CO., LTD. DARLENE CROCKETT-BILLIG
K140701 06/27/2014 NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG NOVOSOURCE INC ALLISON SCOTT, RAC
K140803 06/26/2014 LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM NUCLETRON B.V. RUDOLF VOS
K132816 06/13/2014 ONCENTRA BRACHY NUCLETRON B.V. LU ANNE JOHNSON
K140659 06/26/2014 COROENT THORACOLUMBAR IMPLANTS NUVASIVE, INCORPORATED OLGA LEWIS
K140623 06/16/2014 NXSTAGE EXPRESS FLUID WARMER NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K141060 06/06/2014 CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT ON-X LIFE TECHNOLOGIES, INC. JOHN ELY
K140317 06/16/2014 EMBRYOGEN ORIGIO A/S TOVE KJAER
K140331 06/10/2014 ORTHALIGN PLUS SYSTEM ORTHALIGN, INC DAVID VANCELETTE
K132697 06/20/2014 ENCOMPASS 10/12 HIP STEM ORTHO DEVELOPMENT CORP. TOM HAUETER
K140353 06/06/2014 STARBAND AND STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID L HOOPER
K140357 06/09/2014 OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM ORTHOPAEDIC IMPLANT COMPANY DOUGLAS FULTON
K140868 06/05/2014 STRYKER KWIC NEEDLE ORTHOVITA, INC. JOHN URTZ
K140425 06/11/2014 CONTRAST MODULATION SYSTEM OSPREY MEDICAL, INC. JILL MUNSINGER
K140937 06/19/2014 OSSEOFLEX SB OSSEON LLC KEITH BURGER
K140644 06/19/2014 PROCEM OTOTRONIX, LLC BERNARD HORWATH
K123795 06/03/2014 AXON-BUS PROSTHETIC SYSTEM OTTO BOCK AUSTRIA REINHARD WOLKERSTORFER
K132670 06/04/2014 PANPAC INFLATABLE DOCUT PESSARY PANPAC MEDICAL CORPORATION YEN-MING PAN
K140711 06/20/2014 COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, PARAGON BIOTECK, INC. LAUREN M-C BLUETT
K133901 06/27/2014 PARI-PATH SURGICAL NAVIGATION SYSTEM PARITIC INC KEVIN BARRETT
K132115 06/25/2014 ABSOLUTE DENTIN 2 PARKELL, INC. ROBERT BURKE
K133012 06/09/2014 SENTIERO PATH MEDICAL GMBH JOHANN OSWALD
K141381 06/12/2014 DURADIAGNOST PHILIPS HEALTHCARE (SUZHOU) CO., LTD. GORDON SHU
K132524 06/13/2014 CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION PHILIPS MEDICAL SYSTEMS SUSAN QUICK
K133961 06/26/2014 SURESIGNS VS3, SURESIGNS VS4 PHILIPS MEDICAL SYSTEMS GREG LI
K140138 06/10/2014 HEARTNAVIGATOR RELEASE 2.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MICHAEL DAYTON
K140666 06/13/2014 MR ELASTOGRAPHY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SUSAN QUICK
K140713 06/16/2014 PLANMECA ROMEXIS PLANMECA OY LARS MORING
K133579 06/26/2014 MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS PONTIS ORTHOPAEDICS, LLC LEONARD GORDON
K140437 06/13/2014 SU-POR SURGICAL IMPLANT PORIFEROUS, LLC. AARON NOBLE
K141397 06/26/2014 SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM PRECISION SPINE, INC. MICHAEL C DAWSON
K133850 06/04/2014 CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K140441 06/17/2014 BI-FLEX URETERAL ACCESS SHEATH PROMEPLA SAM MOHAMED REKIK
K140067 06/18/2014 QARDIOARM QARDIO, INC. JEN KE-MIN
K140336 06/25/2014 OPTIMUS FUSION: SLT, YAG AND YAG/SLT QUANTEL MEDICAL MAUREEN O'CONNELL
K141323 06/04/2014 VTI SUCTION IRRIGATION SYSTEM REGULATORY TECHNOLOGY SERVICES LLC MARK JOB
K131080 06/13/2014 PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE REIMERS AND JANSSEN GMBH JOSEPHUS JANSSEN
K132901 06/09/2014 AIRSOFT F15 RESMED LTD. JIM CASSI
K133868 06/04/2014 ASTRAL VENTILATOR RESMED LTD. JIM CASSI
K140159 06/17/2014 S9 WANDA VPAP ST RESMED LTD. JIM CASSI
K141072 06/23/2014 SUPOLENE RESORBA MEDICAL GMBH KARL-JOSEF BECK
K133635 06/17/2014 EASYPOINT NEEDLE RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K141313 06/18/2014 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM REVERSE MEDICAL CORPORATION JANE METCALF
K140542 06/27/2014 NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER RHINOSYSTEMS, INC. MARTIN R HOKE
K133193 06/23/2014 RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. SURESH KUMAR
K140112 06/06/2014 CA 125 II CALSET II ROCHE DIAGNOSTICS JANE ELLEN PHILLIPS
K140802 06/04/2014 STERISPINE PS SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K133682 06/02/2014 SCHOELLY ARTHROSCOPE SCHOLLY FIBEROPTIC GMBH PAMELA PAPINEAU, RAC
K140226 06/03/2014 OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 SCIENCE FOR BIOMATERIALS DENIS CLEMENT
K140132 06/27/2014 BIODENTINE SEPTODONT CORA BRACHO-TROCONIS
K132978 06/13/2014 IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST SEQUENOM, INC. ROBIN WEINER
K140322 06/12/2014 WHITE VINYL EXAM GLOVES POWDER FREE SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. SOPHIE HAO
K123126 06/04/2014 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) SHANGHAI MOTEX HEALTHCARE CO., LTD. JEN KE-MIN
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K133816 06/24/2014 IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS INC. ERNEST JOSEPH
K133646 06/20/2014 ADMIRE SIEMENS MEDICAL SYSTEMS, INC. KIMBERLY MANGUM
K141252 06/09/2014 GUARDIAN URETHRAL SHEATH SOLACE THERAPEUTICS ADAM HEROUX
K140278 06/20/2014 SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX SOMNOMED INC. KATHRYN A JAYNE
K141454 06/26/2014 SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD SONY ELECTRONICS, INC. JOANNE BRONIKOWSKI
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K134022 06/11/2014 BASE IT SPIDENT CO., LTD. LENA PAK
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K140337 06/02/2014 BRIGHTMATTER PLANNING SOFTWARE SYNAPTIVE MEDICAL INC. CAMERON PIRON
K140462 06/13/2014 MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) SYNTHES (USA) PRODUCTS LLC ALAN T HALEY
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K133280 06/12/2014 TERUMO SURFLO I.V. CATHETER TERUMO (PHILIPPINES) CORPORATION PHILLIP LESTER
K140774 06/02/2014 TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORPORATION EILEEN DORSEY
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