| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| 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 |
| 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 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 |
| K140683 |
06/03/2014 |
0180 INTUITION, 0072 PRECISION |
ARCOMA AB |
DANIEL KAMM |
| DEN130034 |
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 |
| 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 CO. LTD |
HARVEY KNAUSS |
| K140996 |
06/11/2014 |
MAMMI |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
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 |
| K122807 |
06/13/2014 |
DENTAL IMPLANT SYSTEM |
HAGER & MEISINGER GMBH |
ALEX MILLER |
| 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 |
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 |
| K140695 |
06/12/2014 |
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE |
MEDTRONIC INC. |
NISARG SHAH |
| 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 |
QUALIS |
MENICON CO., LTD. NEW BUSINESS DIVISION |
MARCIA PALMA |
| 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 |
| K133965 |
06/16/2014 |
OTC EMS STIMULATOR |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
QILIAN LIU |
| K133478 |
06/02/2014 |
POWDER FREE POLYETHYLENE EXAMINATION GLOVES |
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD |
KATHY LIU |
| K140243 |
06/30/2014 |
SHUNTONG |
SHUNTONG GLOVE CO., LTD. |
CHU XIAOAN |
| 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 |
| K141346 |
06/26/2014 |
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD |
SONY ELECTRONICS, INC. |
JOANNE BRONIKOWSKI |
| K134022 |
06/11/2014 |
BASE IT |
SPIDENT CO., LTD. |
LENA PAK |
| K134021 |
06/10/2014 |
ESTEMP IMPLANT, ESTEMP CLEAR |
SPIDENT CO., LTD. |
LENA PAK |
| K133575 |
06/30/2014 |
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM |
SPINEVISION, S.A. |
J.D. WEBB |
| K132920 |
06/10/2014 |
SPIROX INEX DEVICE |
SPIROX, INC. |
MIKE ROSENTHAL |
| K141050 |
06/06/2014 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K140134 |
06/16/2014 |
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE |
STARBOARD MEDICAL, LLC |
ANTHONY BERAN |
| K132566 |
06/14/2014 |
REPROCESSED HARMONIC SHEAR |
STERILMED, INC. |
SKRAMSTED |
| K140708 |
06/16/2014 |
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR |
STERIS Corporation |
BILL BRODECK |
| K140588 |
06/26/2014 |
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS |
STRYKER CORPORATION |
JULIA HELGESON |
| K141121 |
06/20/2014 |
AXSOS 3 TI LOCKING PLATE SYSTEM |
Stryker Trauma AG |
Elijah Wreh |
| K141204 |
06/20/2014 |
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K140289 |
06/27/2014 |
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM |
SUMMIT MEDICAL, INC. |
NICOLE DOVE |
| K140819 |
06/27/2014 |
SURGICAL NAVIGATION ADVANCED PLATFORM |
SURGICAL THEATER, LLC |
MORDECHAI AVISAR |
| K140053 |
06/26/2014 |
KANGLI PEDICLE SCREW SPINAL SYSTEM |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
ALICE GONG |
| 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 |
| K132956 |
06/05/2014 |
U FIT DENTAL IMPLANT SYSTEM |
T STRONG, INC |
SUSAN PARK |
| K133439 |
06/16/2014 |
PILLING ESOPHAGEAL BOUGIES |
Teleflex Medical, Inc. |
HOLLY KORNEGAY |
| K132415 |
06/06/2014 |
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE |
Teleflex Medical, Inc. |
LORI PFOHL |
| K132946 |
06/04/2014 |
SOFTECH PLUS ETC02 CANNULA |
Teleflex Medical, Inc. |
Angela Bouse |
| K141329 |
06/20/2014 |
RADSPA |
TELERAD TECH PRIVATE LIMITED |
MANOJ ZACHARIAS |
| 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 |
| K141306 |
06/12/2014 |
TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE |
TEVA MEDICAL LTD., MIGADA PLANT |
ROGER GRAY |
| K132016 |
06/02/2014 |
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM |
TEXAS APPLIED BIOMEDICAL SERVICES, INC. |
M. JOYCE HEINRICH |
| K132891 |
06/19/2014 |
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
THE HYMED GROUP CORP. |
ANITA PETITO |
| K133799 |
06/20/2014 |
THERMEDX FLUID MANAGMENT SYSTEM |
THERMEDX LLC |
JEFF WILLIAMS |
| K140985 |
06/10/2014 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K133260 |
06/27/2014 |
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
Priscilla Chung |
| K141029 |
06/18/2014 |
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
KRISTINE TUCKER |
| K133553 |
06/13/2014 |
KALARE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K140651 |
06/11/2014 |
CELESTEION, PCA-9000A/2 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K133633 |
06/02/2014 |
CHOCOLATE PTCA BOLLOON CATHETER |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K130581 |
06/18/2014 |
KONIX STERILE GEL |
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
MICHAEL SCOTT, REGULATORY AGENT |
| K140234 |
06/02/2014 |
ASPIRON ACP SYSTEM |
U&I CORP. |
YOUNG-GEUN KIM |
| K134032 |
06/20/2014 |
ULTHERA SYSTEM |
ULTHERA, INC. |
ASHLEY FICKETT |
| K132551 |
06/30/2014 |
ZF 720 |
UMBEL CORPORATION |
HAYDEN WOOD |
| K132954 |
06/11/2014 |
JO PREMIUM PERSONAL LUBRICANT |
UNITED CONSORTIUM |
CRAIG MAY |
| K140073 |
06/16/2014 |
U2 FEMORAL COMPONENT, CR, CEMENTED |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K140075 |
06/13/2014 |
U2 FEMORAL COMPONENT, CR, POROUS COATED |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K140823 |
06/27/2014 |
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER |
VARIAN MEDICAL SYSTEMS, INC. |
LISA LEVINE |
| K140629 |
06/25/2014 |
VENUS SWAN(MP)2 |
VENUS CONCEPT LTD. |
YORAM LEVY |
| K131567 |
06/05/2014 |
ALADDIN |
VISIA imaging S.r.l. |
Claude Berthoin |
| K141002 |
06/26/2014 |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
Visionsense Ltd. |
RAYMOND KELLY |
| K141360 |
06/12/2014 |
TRIPLEPLAY PRO |
WILDCAT MEDICAL, INC. |
MIKE BARTLETT |
| K141356 |
06/20/2014 |
ECHO TIP ULTRA FIDUCIAL NEEDLE |
WILSON-COOK MEDICAL INC. |
MARGE WALLS-WALKER |
| K140314 |
06/12/2014 |
WARTIE WART REMOVER |
YONMEDICAL BV |
KATHLEEN JOHNSON |
| K140570 |
06/16/2014 |
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL |
ZEST ANCHORS, LLC |
Allison C Komiyama |
| K133327 |
06/25/2014 |
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM |
ZEST ANCHORS, LLC |
LINDA SCHULZ |
| K140240 |
06/12/2014 |
ZHAOFENG |
ZHAOFENG GLOVE CO.,LTD. |
CHU XIAOAN |
| K133556 |
06/02/2014 |
VIRAGE OCT SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
HOLLY SEPPANEN |
