| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K140250 |
07/25/2014 |
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE |
3M HEALTH CARE |
KRISTIN TOTUSHEK |
| K141678 |
07/22/2014 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
Abbott Vascular |
JESSICA KAO |
| K140101 |
07/10/2014 |
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS |
ABMEDICA SAS |
DANIEL DONOVAN |
| K140558 |
07/16/2014 |
PROCTIGARD |
ACCESS PHARMACEUTICALS, INC |
JEFFREY B DAVIS |
| K133443 |
07/10/2014 |
MARATHON NO STING LIQUID SKIN PROTECTANT |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
ROSE GUANG |
| K141228 |
07/08/2014 |
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ANNA HWANG |
| K140915 |
07/21/2014 |
EXCIA TOTAL HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
JULIE T WING |
| K133890 |
07/15/2014 |
AESCULAP OPTILENE NONABSORBABLE SUTURE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K141609 |
07/15/2014 |
PULSTAR LOGIX PUMP |
ALBAHEALTH LLC |
SHANE BRUCE |
| K140005 |
07/18/2014 |
ALMA DIODE TABLETOP LASER |
ALMA LASERS LTD. |
KATHY MAYNOR |
| K130097 |
07/22/2014 |
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS |
AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED |
MIKE HOFTMAN |
| K140121 |
07/02/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
| K140409 |
07/09/2014 |
FLENTS PLASTIC EYE WASH CUP |
APOTHECARY PRODUCTS, INC. |
JAMES JENKINS |
| K141618 |
07/08/2014 |
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS |
ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I |
ELIZABETH DUNCAN |
| K141051 |
07/07/2014 |
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU |
ARROW INTERNATIONAL, INC. |
FRANK PELC |
| K141478 |
07/08/2014 |
ARTHREX FRACTURE PLATES AND SCREWS |
ARTHREX, INC. |
DAVID L ROGERS |
| K141577 |
07/18/2014 |
ARTHREX PIP DART |
ARTHREX, INC. |
DAVID L ROGERS |
| K133835 |
07/03/2014 |
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K131757 |
07/17/2014 |
TATTOOSTAR EFFECT COMBO |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K141663 |
07/22/2014 |
EEVA DISH (WITH 12 MICROWELLS) |
AUXOGYN, INC. |
JULIA S ANASTAS |
| K141556 |
07/02/2014 |
AVREO INTERWORKS SYSTEM |
AVREO, INC. |
ALISON MCKEE |
| K141388 |
07/11/2014 |
SYSTEM CALIBRATER |
BECKMAN COULTER IRELAND INC |
DAVID G DAVIS |
| K140829 |
07/14/2014 |
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K141311 |
07/25/2014 |
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE |
Becton, Dickinson and Company |
JUMA HOSHINO |
| K140682 |
07/17/2014 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K141672 |
07/31/2014 |
DIGIARC 100AU+ |
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. |
JUNE LI |
| K141654 |
07/18/2014 |
THE BELMONT RAPID INFUSER |
BELMONT INSTRUMENT CORPORATION |
URAIWAN P LABADINI |
| K140816 |
07/08/2014 |
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
BETTER CARE PLASTIC TECHNOLOGY CO., LTD. |
KATHY LIU |
| K132516 |
07/30/2014 |
OXIPROBE E (OXIPROBE) |
BIO MEDICAL TECHNOLOGIES CO., LTD |
ELAINE DUNCAN |
| K141219 |
07/18/2014 |
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS |
BIOMET MANUFACTURING CORP. |
JARED COOPER |
| K140652 |
07/03/2014 |
POROUS COATED COMPREHENSIVE FRACTURE STEMS |
BIOMET MANUFACTURING CORP. |
BRIAN KINCAID |
| K140902 |
07/03/2014 |
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG |
BIOMET, INC. |
AMY L WALRIVEN |
| K140883 |
07/30/2014 |
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT |
BIOMET, INC. |
JOHN HECKAMAN |
| K133916 |
07/01/2014 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K132543 |
07/03/2014 |
INFANT INCUBATOR |
BISTOS CO., LTD. |
YOUNG CHI |
| K140596 |
07/02/2014 |
NAVIO |
BLUE BELT TECHNOLOGIES, INC. |
RICHARD G CONFER |
| K141112 |
07/16/2014 |
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC |
CAROL TIFFANY |
| K140726 |
07/21/2014 |
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV |
BOSTON SCIENTIFIC CORP. |
TARA PAUL |
| K140273 |
07/22/2014 |
EQUALIZER OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
DIANE NELSON |
| K133110 |
07/02/2014 |
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM |
Boston Scientific Corporation |
RENEE MITCHELL |
| K134031 |
07/21/2014 |
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER |
Boston Scientific Corporation |
VICKY L HAGENS |
| K140641 |
07/03/2014 |
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA |
Boston Scientific Corporation |
KURTIS HUNSBERGER |
| K132987 |
07/03/2014 |
COBRA FUNDUS CAMERA |
C.S.O. S.R.L. |
Claude Berthoin |
| K140552 |
07/23/2014 |
CADWELL SPIKE AND SEIZURE DETECTOR |
CADWELL |
JINESH JAIN |
| K140843 |
07/01/2014 |
DESARA BLUE OV, DESARA BLUE SS |
CALDERA MEDICAL |
VICKI GAIL |
| K133693 |
07/01/2014 |
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS |
CANON, INC. |
DIANE RUTHERFORD |
| K140635 |
07/25/2014 |
COCOON CONVECTIVE WARMING SYSTEM |
CARE ESSENTIALS PTY LTD |
BIBIANA FRANCO |
| K141652 |
07/22/2014 |
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE |
CEDARS-SINAI MEDICAL CENTER |
GEOFF POLLARD |
| K140144 |
07/08/2014 |
BENDA WEDGE |
CENTRIX, INC. |
GREG MOREAU |
| K140141 |
07/03/2014 |
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM |
CERAGEM MEDISYS INC. |
DANA MOON |
| K140142 |
07/16/2014 |
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) |
CHOICE SPINE, LP |
KIM FINCH |
| K141034 |
07/21/2014 |
AZUL PERSONAL LUBRICANT |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICONE |
| K140313 |
07/28/2014 |
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM |
COAG MEDICAL LLC |
BERNARD HORWATH |
| K140469 |
07/28/2014 |
MR SYRINGE DUAL PACK |
COEUR, INC. |
ERIN RHEINSCHELD |
| K140714 |
07/16/2014 |
PORCINE ANORGANIC BONE MINERAL |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K140523 |
07/24/2014 |
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K131721 |
07/22/2014 |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 |
COMED MEDICAL SYSTEMS CO., LTD |
J. HARVEY KNAUSS |
| K140459 |
07/11/2014 |
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM |
CONMED CORPORATION |
LISA ANDERSON |
| K140578 |
07/23/2014 |
ARTHROSCOPIC ENERGY SYSTEM |
CONMED CORPORATION |
DIONNE SANDERS |
| K140658 |
07/10/2014 |
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES |
CONMED CORPORATION |
SANDY LECLAIR |
| K133919 |
07/14/2014 |
CONSENSUS VITALITE TIBIAL INSERT |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K133306 |
07/23/2014 |
SIS HERNIA GRAFT |
COOK BIOTECH, INC. |
PERRY W GUINN |
| K133114 |
07/03/2014 |
MICROPUNCTURE INTRODUCER SET |
COOK INCORPORATED |
DAVID LEHR, RAC |
| K141148 |
07/01/2014 |
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
| K102973 |
07/31/2014 |
SILVER DENTAL ARREST |
COOLEY CONSULTING, INC. |
WILLIAM COOLEY |
| K140789 |
07/15/2014 |
CORMATRIX ECM FOR VASCULAR REPAIR |
CORMATRIX CARDIOVASCULAR, INC. |
BRYAN BROSSEAU |
| K140813 |
07/15/2014 |
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES |
COVIDIEN |
Daniel Campion |
| K133364 |
07/22/2014 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
Connie Hoy |
| K141631 |
07/28/2014 |
AQUARIUS EXTENSION FEEDING SET |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K140825 |
07/17/2014 |
DELWORKS DR SYSTEM |
DEL MEDICAL, INC. |
DANIEL KAMM |
| K140643 |
07/08/2014 |
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY |
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY |
YAYOI FUJIMAKI |
| K140324 |
07/07/2014 |
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL |
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY |
YAYOI FUJIMAKI |
| K141116 |
07/25/2014 |
LIAISON XL ANALYZER |
DIASORIN, INC. |
Mari Meyer |
| K141484 |
07/30/2014 |
OPEN FMSEALER |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K131094 |
07/11/2014 |
VIMOVE |
DORSA VI PTY. LTD |
SHOSHANA FRIEDMAN |
| K132903 |
07/01/2014 |
DRE VENTURA |
DRE MEDICAL, INC. |
PAUL DRYDEN |
| K140849 |
07/02/2014 |
ISOSEED |
ECKERT & ZIEGLER BEBIG GMBH |
SVEN LANGER |
| K140241 |
07/03/2014 |
EDWARDS TRANSFEMORAL BALLOON CATHETER |
EDWARDS LIFESCIENCES, LLC. |
ERIC CARRIER |
| K121119 |
07/25/2014 |
BNA ANALYSIS SYSTEM |
EIMINDA LTD. |
DALIA DICKMAN |
| K140527 |
07/31/2014 |
SENSILIGHT MINI |
EL GLOBAL TRADE LTD. |
SHLOMIT SEGMAN |
| K141254 |
07/30/2014 |
ELCAM STOPCOCKS AND MANIFOLDS |
ELCAM MEDICAL ACAL |
NATASHA BRANZBURG |
| K141265 |
07/18/2014 |
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT |
ELITECHGROUP |
DEBRA K HUTSON |
| K140830 |
07/11/2014 |
EXPRT REVISION KNEE |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K132384 |
07/02/2014 |
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA |
ENDOSEC CORPORATION |
PIN YU |
| K140281 |
07/24/2014 |
FLEXI-LUME LED SYSTEM |
EPIC MEDICAL CONCEPTS & INNOVATIONS |
ALEX WALLER |
| K141486 |
07/11/2014 |
MYLABSIX ULTRASOUND SYSTEM |
ESAOTE EUROPE B.V. |
Allison Scott |
| K140846 |
07/25/2014 |
EDS COMBO-RINSE |
ESSENTIAL DENTAL SYSTEMS, INC. |
JEFFREY WAN |
| K141245 |
07/09/2014 |
ETEX MIXING AND DELIVERY SYSTEM |
ETEX CORPORATION |
ANDY SOMAN |
| K141118 |
07/18/2014 |
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER |
EV3 INC |
LAURA J LIND |
| K141797 |
07/29/2014 |
ALTEON 6.5MM BONE SCREWS |
EXACTECH, INC. |
THOMAS MCNAMARA |
| K140302 |
07/30/2014 |
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS |
EXACTECH, INC. |
PATRICK HUGHES |
| K133813 |
07/15/2014 |
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE |
EXPANDING ORTHOPEDICS, INC. |
MEREDITH MAY |
| K141749 |
07/29/2014 |
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT |
FACET TECHNOLOGIES, LLC |
JENNIFER REGISTER |
| K140601 |
07/02/2014 |
FLOW-NAIL |
FLOW-FX, LLC |
MICHELLE MCDONOUGH |
| K141458 |
07/01/2014 |
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| K132806 |
07/11/2014 |
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE |
FOTONA D.D. |
STOJAN TROST |
| K141145 |
07/30/2014 |
LIBERTY PDX CYCLER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE M OPPERMANN |
| K133299 |
07/07/2014 |
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY |
FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER |
DENISE M OPPERMANN |
| K140071 |
07/28/2014 |
HUMELOCK II CEMENTED SHOULDER SYSTEM |
FX SOLUTIONS |
JEAN-JACQUES MARTIN |
| K141485 |
07/02/2014 |
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE |
GALIL MEDICAL LTD. |
LYNN DAVIES |
| K141675 |
07/25/2014 |
VOLUSON P6, VOLUSON P8 |
GE HEALTHCARE |
BRYAN BEHN |
| K141639 |
07/18/2014 |
VOLUSON S6, VOLUSON S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K140518 |
07/18/2014 |
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER |
GEISTLICH PHARMA AG |
DANIEL A KRACOV |
| K133077 |
07/28/2014 |
GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET |
GENERICA MEDICAL INTERNATIONAL, INC. |
JIM BARLEY |
| K140295 |
07/24/2014 |
GIS ENDOSCOPIC OPTICAL LENS |
GI SCIENTIFIC LLC |
MICHELE LUCEY |
| K140411 |
07/01/2014 |
ALTERA SPACER |
GLOBUS MEDICAL INC. |
CHRISTINA KICHULA |
| K141063 |
07/15/2014 |
LINSCAN 808, LINSCAN 980 |
GME (GERMAN MEDICAL ENGINEERING) GMBH |
MIKE JOHNSON, M.D. |
| K140869 |
07/03/2014 |
DCAS I |
GP&P CO., LTD. |
CHARLIE MACK |
| K141532 |
07/14/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K133528 |
07/03/2014 |
H&H EMERGENCY CRICOTHYROTOMY KIT |
H&H MEDICAL CORPORATION |
J. Lawrence Stevens |
| K132214 |
07/07/2014 |
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE |
HAGER & MEISINGER GMBH |
WIEBKE STOLTEN |
| K140890 |
07/24/2014 |
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) |
HARTALEGA NGC SDN. BHD. |
NURUL AISYAH KONG |
| K141647 |
07/17/2014 |
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) |
HEALGEN SCIENTIFIC, LLC |
Joe Shia |
| K132856 |
07/15/2014 |
HEARTWAY POWER WHEELCHAIR |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K131720 |
07/25/2014 |
HIVOX SELF ADHESIVE ELECTRODE GEL PADS |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
| K140316 |
07/11/2014 |
EXAMINATION GLOVES |
HL RUBBER INDUSTRIES SDN BHD |
NOORZALIZA AHMAD |
| K140096 |
07/24/2014 |
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE |
HMICRO, INC. |
KIM TOMPKINS |
| K133676 |
07/11/2014 |
ABX PENTRA MICRO ALB CONTROL L/H |
HORIBA ABX SAS |
CAROLINE FERRER |
| K141102 |
07/08/2014 |
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE |
HOSPIRA, INC. |
TOM GUTIERREZ |
| K140351 |
07/02/2014 |
ARROW GPSCATH BALLOON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME |
ERIC ANKERUD, JD |
| K131926 |
07/24/2014 |
THERMOPULSE |
IBRAMED EQUIPAMENTOS MEDICOS |
TARA CONRAD |
| K140876 |
07/22/2014 |
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW |
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
JAN TRIANI |
| K140129 |
07/02/2014 |
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER |
ICU MEDICAL, INC. |
KRISTIN CASPER |
| K141406 |
07/01/2014 |
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS |
Immunalysis Corporation |
joseph Ginete |
| K141027 |
07/10/2014 |
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
| K132912 |
07/30/2014 |
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT |
IN2BONES SAS |
NORMAN F ESTRIN, PH.D. |
| K132353 |
07/30/2014 |
SUCTION LIPOPLASTY ACCESSORIES |
INEX |
RAYMOND PATEL |
| K141750 |
07/24/2014 |
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K132765 |
07/14/2014 |
PFX SPINOUS PROCESS FIXATION SYSTEM |
INNOVASIS, INC. |
MARSHALL MCCARTY |
| K140903 |
07/17/2014 |
NUVIS ARTHROSCOPE |
INTEGRATED ENDOSCOPY, INC. |
ANIL BHALANI |
| K133759 |
07/23/2014 |
INTELLIJOINT HIP |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K134005 |
07/09/2014 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
JINYOUNG LEE |
| K140553 |
07/25/2014 |
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS |
INTUITIVE SURGICAL, INC. |
DAWN CHANG |
| K132919 |
07/10/2014 |
GANTRY BEAM LINE |
ION BEAM APPLICATIONS S.A. |
BRUCE D ARMON |
| K141452 |
07/02/2014 |
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW |
JEIL MEDICAL CORPORATION |
Priscilla Chung |
| K141359 |
07/25/2014 |
HARD PACK SYRINGE |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
Diana Hong |
| K140512 |
07/02/2014 |
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE |
JUNO DENTISTRY LP |
ROGER MASTRONY |
| K133288 |
07/01/2014 |
CASPIAN OCT SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K141284 |
07/23/2014 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K133402 |
07/30/2014 |
K2M MODULAR HOOKS |
K2M, INC. |
KAREN E WARDEN |
| K140765 |
07/10/2014 |
RANGE/MESA/DENALI SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K140451 |
07/11/2014 |
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) |
KEELER LIMITED |
EUGENE VAN ARSDALE |
| K141071 |
07/28/2014 |
KIMGUARD ONE-STEP STERILIZATION WRAP |
KIMBERLY-CLARK HEALTH CARE |
THOMAS KOZMA, PH.D. |
| K141489 |
07/24/2014 |
LINOS MOH HAND PLATING SYSTEM |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K140976 |
07/10/2014 |
ENADEN FLOW |
KM CORPORATION |
Priscilla Chung |
| K141334 |
07/11/2014 |
REUSABLE GUIDE |
KOELIS |
LAETITIA GERVAIS |
| K141109 |
07/29/2014 |
APERIO EPATHOLOGY EIHC IVD SYSTEM |
LEICA BIOSYSTEMS IMAGING, INC. |
CHRISTINE KISHI |
| K140500 |
07/29/2014 |
SKINTACT |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K133811 |
07/08/2014 |
RESTORIS POROUS PARTIAL KNEE SYSTEM |
MAKO SURGICAL CORP. |
TERRY POWELL |
| K141432 |
07/07/2014 |
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K132293 |
07/31/2014 |
SYVEK RADIAL BAND |
MARINE POLYMER TECHNOLOGIES |
SERGIO FINKIELSZTEIN |
| K131692 |
07/10/2014 |
BLOSSOM SALINE DELIVERY ASSIST DEVICE |
MARZ MEDICAL, INC |
MARY PASCUAL GALLUP |
| K133466 |
07/25/2014 |
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) |
MAUNA KEA TECHNOLOGIES |
MICHAEL A DANIEL |
| K140909 |
07/02/2014 |
MCKESSON RADIOLOGY |
MCKESSON MEDICAL IMAGING COMPANY |
PAUL SUMNER |
| K140826 |
07/15/2014 |
GMK SPHERE EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K141151 |
07/08/2014 |
CT MIDLINE |
MEDCOMP (MEDICAL COMPONENTS, INC.) |
TIMOTHY HOLWICK |
| K133906 |
07/24/2014 |
C-JAWS CERVICAL COMPRESSIVE STAPLE |
MEDICREA INTERNATIONAL |
JOHN J SMITH |
| K140753 |
07/15/2014 |
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM |
MEDIVATORS |
KINNARI SHAH |
| K133444 |
07/25/2014 |
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
KAYE WAITE |
| K141605 |
07/14/2014 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHAEL SCOTT |
| K140750 |
07/17/2014 |
SHILLA GROWTH GUIDANCE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K140417 |
07/09/2014 |
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
SHWETA SHARMA |
| K132732 |
07/18/2014 |
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE |
MEDYSSEY USA, INC. |
JOHN KUCZYNSKI |
| K140626 |
07/10/2014 |
MELUNA CLASSIC/SPORT MENSTRUAL CUP |
MELUNA |
YOLANDA SMITH |
| K140513 |
07/09/2014 |
MERIT SAFETY INTRODUCER NEEDLE |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN CHRISTENSEN |
| K133683 |
07/24/2014 |
MICR02 OSA DEVICE |
MICRODENTAL, INC. |
LAURA SHEPPARD |
| K140572 |
07/02/2014 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
SUSAN D GOLDSTEIN-FALK |
| K133725 |
07/31/2014 |
TRAXCESS 14 GUIDEWIRE |
MICROVENTION, INC. |
Naomi Gong |
| K140456 |
07/22/2014 |
BIO-CONNEKT WOUND MATRIX |
MLM BIOLOGICS, INC. |
GREGG RITTER |
| K141832 |
07/31/2014 |
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE |
NEOCOIL, LLC |
MICHAEL LEIGH |
| K133670 |
07/24/2014 |
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE |
NEOCOIL, LLC |
MICHEAL LEIGH |
| K140200 |
07/18/2014 |
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES |
NEUROINVENT INC. |
CHAO-SHENT CHAO |
| K140333 |
07/03/2014 |
ASCEND |
NEUROMETRIX, INC. |
RAINER MAAS |
| K141368 |
07/11/2014 |
NEUROPACE BURR HOLE COVER |
NEUROPACE INC |
ISABELLA R ABATI |
| K132749 |
07/24/2014 |
NOBELPROCERA OVERDENTURE BAR |
NOBEL BIOCARE USA, LLC |
PHUONG NGUYEN SON |
| K140785 |
07/07/2014 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
BRODIE PEDERSEN |
| K140962 |
07/03/2014 |
NORMED VARIO SUBTALAR SCREW |
NORMED NEDIZIN TECHNIK GMBH |
DAVID FURR |
| K131226 |
07/24/2014 |
NOVAPROBE LED LIGHT SOURCE |
NOVAPROBE INCORPORATED |
MANISH INGLE |
| K140162 |
07/02/2014 |
AP EXPANDABLE XLIF SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K140921 |
07/28/2014 |
COROENT SMALL INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
Cynthia Adams |
| K140479 |
07/28/2014 |
COROENT XL-F SYSTEM |
NUVASIVE, INCORPORATED |
Cynthia Adams |
| K140770 |
07/25/2014 |
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K140379 |
07/01/2014 |
MEGA BIG BOY CONDOM |
OKAMOTO U.S.A., INC. |
JEFFREY N GIBBS |
| K141256 |
07/23/2014 |
OKAMOTO STUDDED CONDOM |
OKAMOTO U.S.A., INC. |
JOSEPH W CORMIER, JD, PHD |
| K133311 |
07/30/2014 |
ENDOLED |
OLYMPUS WINTER & IBE GMBH |
SHERI L MUSGNUNG |
| K141001 |
07/30/2014 |
ALPINE HIP STEM; ALPINE HA HIP STEM |
ORTHO DEVELOPMENT |
MIKE ENSIGN |
| K141784 |
07/23/2014 |
ORTHO SOLUTIONS ULTOS PLATING SYSTEM |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K140260 |
07/02/2014 |
SKYHAWK LATERAL PLATE SYSTEM |
ORTHOFIX INC. |
TROY BROOKS |
| K141301 |
07/11/2014 |
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
| K140431 |
07/29/2014 |
PEDILOC FRAGMENT SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K140917 |
07/09/2014 |
INTRODUCER, MODEL ADELANTE MAGNUM |
Oscor Inc. |
LAURA SOBRIN |
| K133861 |
07/02/2014 |
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
OSTIAL CORPORATION |
JAKE WOLENBERG |
| K141550 |
07/11/2014 |
INSTAFIX SHAPE MEMORY FIXATION SYSTEM |
OT MEDICAL |
WILLIAM RHODA |
| K140845 |
07/18/2014 |
LEVO TINNITUS MASKING SOFTWARE DEVICE |
OTOHARMONICS CORP |
YARMELA PAVLOVIC |
| K133809 |
07/28/2014 |
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE |
OXFORD PERFORMANCE MATERIALS |
LEIGH AYRES |
| K141130 |
07/30/2014 |
ENCOMPASS |
PANORAMIC CORP. |
DANIEL KAMM, P.E. |
| K141028 |
07/24/2014 |
COLONGLIDE LUBRICANT |
PEDIATRIC PHARMACEUTICALS INC. |
ROBERT M HARRIS |
| K141134 |
07/03/2014 |
POD SYSTEM |
PENUMBRA, INC. |
CHARLES DENAULT |
| K141736 |
07/25/2014 |
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST |
PHILIPS MEDICAL SYSTEMS DMC GMBH |
GEROLD SCHWARZ |
| K133819 |
07/10/2014 |
VERADIUS |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
RUOJUAN ZHANG |
| K141369 |
07/02/2014 |
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
SARASWATHI DEORA |
| K133233 |
07/18/2014 |
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE |
PJUR GROUP LUXEMBOURG SA |
CANDACE CEDERMAN |
| K133336 |
07/24/2014 |
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE |
PJUR GROUP,LUXEMBOURG S.A. |
CANDACE CEDERMAN |
| K141711 |
07/24/2014 |
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE |
PONTIS ORTHOPAEEICS, LLC |
LEONARD GORDON |
| K132778 |
07/07/2014 |
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL |
PRAXAIR HEALTHCARE SERVICES |
TINA WU, PH.D. |
| K141208 |
07/23/2014 |
DYNAMIC NEUROSCREENING DEVICE |
PROSENEX |
WILLIAM G MCLAIN |
| K133689 |
07/03/2014 |
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K133699 |
07/18/2014 |
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES |
PT. SMART GLOVE INDONESIA |
KHON PU FOO |
| K140998 |
07/11/2014 |
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL |
QUALITY ELECTRODYNAMICS, LLC. |
Kathleen Aras |
| K131601 |
07/07/2014 |
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE |
QUBYX LIMITED |
ALICE KOTYLARENKO |
| K141173 |
07/24/2014 |
AMPLIVUE GAS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K141154 |
07/22/2014 |
OARTRAC SYSTEM |
RADIADYNE |
STUART R GOLDMAN |
| K132761 |
07/08/2014 |
WIRELESS THERMOMETER |
RAIING MEDICAL COMPANY |
WU WEI |
| K141566 |
07/16/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC |
RAYENCE CO., LTD |
DAVE KIM |
| K141563 |
07/16/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC |
RAYENCE CO., LTD |
DAVE KIM |
| K141838 |
07/25/2014 |
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) |
REGULATORY TECHNOLOGY SERVICES, LLC |
MARK JOB |
| K140279 |
07/31/2014 |
S9 GREENHILLS |
RESMED LTD. |
JIM CASSI |
| K140186 |
07/11/2014 |
THE STORK OTC |
RINOVUM WOMEN'S HEALTH, INC |
ANDREW ZELTWANGER |
| K131513 |
07/11/2014 |
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY |
RITM OKB ZAO |
LARISA SHPUNGINA |
| K141143 |
07/17/2014 |
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET |
Roche Diagnostics |
KHOA TRAN |
| K141620 |
07/02/2014 |
RS80A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| K140603 |
07/31/2014 |
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM |
SAPHENA MEDICAL, INC. |
CHERYL BLAKE |
| K141280 |
07/18/2014 |
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS |
SEINOH OPTICAL CO. LTD. |
JENNIFER TING |
| K141728 |
07/28/2014 |
ACE CALIBRATOR |
SENTINEL CH. SpA |
Patricia Dupe |
| K141583 |
07/22/2014 |
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY |
SHASER, INC. |
ANTHONY BURNS |
| K134029 |
07/25/2014 |
BELTER BLOOD PRESSURE METER |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
PANG MING |
| K132036 |
07/01/2014 |
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) |
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
RUSSELL OLSEN |
| K141049 |
07/23/2014 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K133156 |
07/24/2014 |
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA |
Siemens Healthcare Diagnostics Inc. |
PHILIP LIU |
| K141444 |
07/09/2014 |
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL |
Siemens Healthcare Diagnostics Inc. |
DONNA VELASQUEZ |
| K141554 |
07/11/2014 |
ESIE APPS SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K133648 |
07/07/2014 |
SYNGO, CT DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K140897 |
07/18/2014 |
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L FIELDS, ESQ. |
| K133370 |
07/22/2014 |
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE |
SIGNATURE ORTHOPAEDICS PTY LIMITED |
DECLAN BRAZIL |
| K132907 |
07/24/2014 |
PLIF LITE AND TLIF LITE |
SINTEA PLUSTEK |
RICH JANSEN |
| K140777 |
07/25/2014 |
ZQUIET-SA |
SLEEPING WELL, LLC |
WILLIAM MCLAIN |
| K140879 |
07/21/2014 |
BIOSURE HEALICOIL PK INTERFERENCE SCREW |
Smith & Nephew, Inc |
VIVEK MUKHATYAR |
| K141193 |
07/25/2014 |
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 |
SMITHS MEDICAL ASD, INC. |
TOM BLISS |
| K140775 |
07/23/2014 |
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM |
SPECTRANETICS CORPORATION |
AMANDA JOHNSON |
| K140498 |
07/24/2014 |
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
BILL BRODBECK |
| K140494 |
07/25/2014 |
V-PRO STERILIZATION TRAY/ STERILIZATION MAT |
STERIS Corporation |
TONY PIOTRKOWSKI |
| K140515 |
07/17/2014 |
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL |
STERIS Corporation |
BILL BRODBECK |
| K140499 |
07/17/2014 |
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES |
STERIS Corporation |
BILL BRODBECK |
| K140487 |
07/22/2014 |
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING |
STERIS Corporation |
TONY PIOTRKOWSKI |
| K141217 |
07/16/2014 |
ACCULIF TL AND PL CAGE |
STRYKER CORPORATION |
KRISTEN MEANY |
| K140400 |
07/01/2014 |
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS |
STRYKER CORPORATION |
SORAYA KING |
| K141430 |
07/18/2014 |
VARIAX DISTAL RADIUS PLATING SYSTEM |
Stryker Leibinger GmbH & Co. KG |
ELIJA WREH |
| K141677 |
07/22/2014 |
VARIAX ELBOW PLATING SYSTEM |
Stryker Trauma AG |
ELIJAH N WREH |
| K141625 |
07/18/2014 |
POLYSYN SURGICAL SUTURE |
SURGICAL SPECIALTIES CORP. |
PAUL AMUDALA |
| K141558 |
07/11/2014 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE |
SURGICAL SPECIALTIES CORP. |
KIRSTEN STOWELL FRANCO |
| K141778 |
07/30/2014 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORPORATION |
KIRSTEN STOWELL FRANCO |
| K141392 |
07/02/2014 |
SPHYGMOMANOMETER |
SUZHOU JJ METER CO., LTD. |
LONG YANG |
| K133840 |
07/29/2014 |
Kangli Locking Plate System |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
ALICE GONG |
| K140685 |
07/02/2014 |
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM |
SYBRONENDO |
COURTNEY CLARK |
| K140844 |
07/16/2014 |
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC |
SYNERGY BIOMEDICAL, INC. |
RANDY PREBULA |
| K141499 |
07/02/2014 |
X-REPAIRSL |
SYNTHASOME, INC. |
ANTHONY RATCLIFFE |
| K131923 |
07/03/2014 |
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS |
TECHLINK INTERNATIONAL |
TARA CONRAD |
| K140615 |
07/15/2014 |
VICTUS FEMTOSECOND LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
BETTY M JOHNSON |
| K133658 |
07/25/2014 |
CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
Kevin Kong |
| K140894 |
07/31/2014 |
ARGEN PMMA |
THE ARGEN CORPORATION |
CRAIG JOLICOEUR |
| K141100 |
07/18/2014 |
OPTILITE C1 INACTIVATOR KIT |
THE BINDING SITE GROUP LTD |
MARIANNE SENDER |
| K141475 |
07/31/2014 |
ENDOSIZE |
THERENVA SAS |
CEMIL GOKSU |
| K141000 |
07/16/2014 |
SENSITITRE SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K140055 |
07/02/2014 |
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE |
TITAN SPINE, LLC |
CHRISTINE SCIFERT |
| K140082 |
07/18/2014 |
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM |
Tornier SAS |
AYMEN AZAIEZ |
| K133535 |
07/23/2014 |
INFX-8000V, V5.30 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K141367 |
07/25/2014 |
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS |
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. |
JO QIAO |
| K141119 |
07/29/2014 |
CAMERA ENABLED PROBE |
TRICE MEDICAL, INC. |
TIFFINI DIAGE |
| K133419 |
07/21/2014 |
BABYMEG BIOMAGNETOMETER SYSTEM |
TRISTAN TECHNOLOGIES INC |
EUGENE HIRSCHKOFF |
| K132797 |
07/30/2014 |
L'DISQ |
U & I CORPORATION |
GYEONG-JE KWON |
| K140864 |
07/22/2014 |
VELOXTM INTERBODY FUSION SYSTEM |
U&I CORP. |
JI YEA LEE |
| K140504 |
07/17/2014 |
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM |
VASCULAR PATHWAYS, INC. |
BILL BOLD |
| K141117 |
07/08/2014 |
EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
VIDACARE LLC |
DIANA F MONTEZ, BSN, RN |
| K132820 |
07/23/2014 |
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES |
VILEX, INC. |
ABRAHAM LAVI |
| K141234 |
07/01/2014 |
ODISSEY TISSUE OXIMETER |
VIOPTIX, INC. |
GREG HOLLAND |
| K141167 |
07/29/2014 |
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) |
VITAL CONNECT INC. |
SAM MOSTAFAVI |
| K133568 |
07/16/2014 |
G-TL |
VITROLIFE, INC. |
MARK LARMAN |
| K132709 |
07/30/2014 |
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER |
VR MEDICAL |
LEE PAN, PHD |
| K141026 |
07/30/2014 |
LEADERFLEX |
VYGON |
JILLIAN MIKOVICH |
| K133053 |
07/15/2014 |
MILESTONE SPINAL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
| K141582 |
07/11/2014 |
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION |
WELCH ALLYN |
KEVIN CROSSEN |
| K141273 |
07/08/2014 |
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE |
WELLDOC, INC |
DIVYA KALLAMADI |
| K140531 |
07/09/2014 |
BIOFOAM BONE WEDGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K141417 |
07/09/2014 |
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K141011 |
07/30/2014 |
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DMITRI FALKNER |
| K133947 |
07/29/2014 |
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K140757 |
07/17/2014 |
D2 HEMOSTANTIC DRESSING |
Z-MEDICA, LLC |
SHEILA WALLIN |
| K132881 |
07/03/2014 |
Z5C |
Z-Systems AG |
LINDA K SCHULZ |
| K141120 |
07/29/2014 |
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K133551 |
07/18/2014 |
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
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VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
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07/18/2014 |
ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM |
ZONARE MEDICAL SYSTEMS, INC. |
DAN BRADFORD |
