| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K120438 |
02/13/2012 |
FLASH (DIFFERENT MATERIALS) |
3M DEUTSCHLAND GMBH |
DESI W SOEGIARTO |
| K120453 |
02/14/2012 |
FILTEK BULK FILL FLOWABLE RESTORATIVE |
3M ESPE DENTAL PRODUCTS |
SCOTT ERICKSON |
| K123875 |
12/17/2012 |
AAP RADIUS SET 2.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K123888 |
12/18/2012 |
Z CARTRIDGE IOL DELIVERY SYSTEM |
AAREN SCIENTIFIC, INC |
ROBERT K SHEEHAN |
| K120568 |
02/27/2012 |
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K123890 |
12/18/2012 |
ACUMED CANNULATED SCREW SYSTEM |
ACUMED LLC |
KARA BUDOR |
| K123936 |
12/20/2012 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K120450 |
02/14/2012 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K120447 |
02/14/2012 |
X4 |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K120350 |
02/06/2012 |
EXTENDED LIFE BATTERY |
AED BATTERY EXCHANGE, LLC |
KEITH HOCHHALTER |
| K123909 |
12/19/2012 |
AESCULAP CESPACE XP |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K123939 |
12/20/2012 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K120559 |
02/24/2012 |
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K123882 |
12/17/2012 |
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR |
AGELESS HEALTH INDUSTRIAL |
VICTOR WAN |
| K123861 |
12/14/2012 |
AIDI DENTAL IMPLANT SYSTEM |
AIDI BIOMEDICAL LLC |
CHEN TIAN |
| K120615 |
02/29/2012 |
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE |
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
EDWARD BREHM, PH.D. |
| K123986 |
12/26/2012 |
ACTIM PROM |
ALERE SCARBOROUGH, INC |
Angela Drysdale |
| K123953 |
12/21/2012 |
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ PH.D. |
| K120401 |
02/08/2012 |
ALAMO T |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K123796 |
12/10/2012 |
NEURO OMEGA SYSTEM |
ALPHA OMEGA ENGINEERING LTD. |
ILAN SHARON |
| K120527 |
02/22/2012 |
ALPHA ORTHOPAEDICS AT2 SYSTEM |
ALPHA ORTHOPAEDICS, INC |
GINA TO |
| K123993 |
12/26/2012 |
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
ALPHATEC SPINE, INC. |
TREVOR DENBO |
| K123834 |
12/13/2012 |
EASYSTAND BANTAM MEDIUM |
ALTIMATE MEDICAL, INC. |
STACEY FRANK |
| K120371 |
02/06/2012 |
DR GREENBURGS HYBRID ACRYLIC |
ALWAYS MORE MARKETING INC |
JONATHAN GREENBURG |
| K120372 |
02/06/2012 |
DR GREENBURGS HYBRID VACUUM |
ALWAYS MORE MARKETING INC |
JONATHAN GREENBURG |
| K123943 |
12/20/2012 |
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER |
AMECO MEDICAL INDUSTRIES |
Ray Kelly |
| K123746 |
12/06/2012 |
AMES THERAPY DEVICE |
AMES TECHNOLOGY, INC. |
SHEILA RAMERMAN, RAC |
| K123935 |
12/20/2012 |
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K123699 |
12/03/2012 |
FAHL TRACHEOSTOMY TUBES (MULTIPLE) |
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH |
CLAUDIA WINTERSCHLADEN |
| K123823 |
12/12/2012 |
INTERLIG |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
LILIAN LLULL |
| K120394 |
02/08/2012 |
LIFESTYLES ZERO LUBRICATED LATEX CONDOM |
ANSELL HEATHCARE PRODUCTS LLC |
CYNTHIA INGRAM |
| K120448 |
02/14/2012 |
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL |
APEX BIOTECHNOLOGY CORP. |
LISA LIU |
| K124027 |
12/28/2012 |
MONSTER SCREW SYSTEM |
APOGEE ORTHOSOLUTIONS |
KAREN E WARDEN, PHD |
| K120340 |
02/03/2012 |
VENUS FACET SCREW SYSTEM |
APOLLO SPINE, INC. |
CHRISTINE SANTAGATE |
| K123716 |
12/04/2012 |
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT |
APPLIED MEDICAL TECHNOLOGY, INC. |
GRANT W PHILLIPS |
| K120587 |
02/27/2012 |
AMT T-FASTENER ANCHOR KIT |
APPLIED MEDICAL TECHNOLOGY, INC. |
ELIZABETH MEYER |
| K120412 |
02/10/2012 |
3M SPOTON TEMPERATURE MONITORING SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K124021 |
12/27/2012 |
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY FACTORY INC. |
LONNA M DENDOOVEN |
| K123759 |
12/07/2012 |
CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, |
ELIZABETH DUNCAN |
| K120540 |
02/23/2012 |
BIOBOLT |
ARTHREX, INC. |
COURTNEY SMITH |
| K123760 |
12/07/2012 |
MULTIPLE NAME |
ASSURGUARD SDN. BHD. |
LIM HUI GUAN |
| K123757 |
12/07/2012 |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR |
ASSURGUARD SDN. BHD. |
LIM H GUAN |
| K120414 |
02/10/2012 |
OSSEOSPEED PLUS |
ASTRA TECH AB |
LINDA K SCHULZ |
| K120338 |
02/03/2012 |
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA |
ASTRA TECH INC. |
B A BROWN |
| K123937 |
12/20/2012 |
ATOM TRANSCAPSULE V-707 |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K120431 |
02/13/2012 |
HALO90 ULTRA ABLATION CATHETER |
BARRX MEDICAL, INC. |
DAWN CHANG |
| K123921 |
12/20/2012 |
BODYTRONIC 200 |
BAUERFEIND AG |
INES EXNER |
| K123736 |
12/05/2012 |
CRYSTALSERT DELIVERY SYSTEM |
BAUSCH & LOMB |
JASON SMITH |
| K123874 |
12/17/2012 |
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K123868 |
12/17/2012 |
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET |
BAXTER HEALTHCARE CORP. |
GARY CHUMBIMUNE |
| K120443 |
02/14/2012 |
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
NANETTE HEDDEN |
| K120384 |
02/07/2012 |
PROTECTOR, INJECTOR, CONNECTOR |
BD MEDICAL-MEDICAL SURGICAL SYSTEMS |
JOHN ROBERTS |
| K123903 |
12/19/2012 |
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) |
BECTON DICKINSON & CO. |
Paul Swift |
| K123734 |
12/05/2012 |
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
KIMBERLY GEISLER |
| K124038 |
12/28/2012 |
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) |
BEDSIDE CLINICAL SYSTEMS INC |
DIANE SUDDUTH |
| K123929 |
12/20/2012 |
BEGOPAL+ |
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
HEIKE GUSTKE |
| K123871 |
12/17/2012 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K120375 |
02/06/2012 |
MED-RX PATIENT DELIVERY SET |
BENLAN INC |
CHERYL BROWN |
| K123896 |
12/18/2012 |
CCS-200 SPIROMETER |
BENSON MEDICAL INSTRUMENTS CO. |
DAVID MAYOU |
| K120392 |
02/08/2012 |
CHROMOPHARE F 628 AND F 528 |
BERCHTOLD GMBH & CO. KG |
VOLKER HORNSCHEIDT |
| K123710 |
12/04/2012 |
UNITOX BOTOX SYRINGE |
BIO-MED USA INC |
YOUNG CHI |
| K123775 |
12/10/2012 |
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K123798 |
12/10/2012 |
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K120439 |
02/13/2012 |
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG |
BIO-RAD LABORATORIES, INC. |
Juang Wang |
| K120572 |
02/27/2012 |
BIOPLEX 2200 TORC IGG |
BIO-RAD LABORATORIES, INC. |
Juang Wang |
| K120504 |
02/21/2012 |
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK |
BIO-RAD LABORATORIES, INC. |
ELIZABETH PLATT |
| K120552 |
02/23/2012 |
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA |
BIOCOSMETICS LABORATORIES |
Ray Kelly |
| K123947 |
12/21/2012 |
ARCHITECT IVANCOMYCIN |
BIOKIT S.A. |
GUILLEM ANGLERILL |
| K120437 |
02/13/2012 |
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC SIA (LATVIA) |
HARRY HAYES |
| K123745 |
12/06/2012 |
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL |
BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO |
TARA CONRAD |
| K124022 |
12/28/2012 |
SPEED SHIFT |
BIOMEDICAL ENTERPRISES, INC |
JOE SOWARD |
| K123907 |
12/19/2012 |
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
| K120557 |
02/24/2012 |
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 |
BIOMET SPINE & BONE HEALING TECHNOLOGIES |
MARGARET F CROWE |
| K120423 |
02/13/2012 |
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
BIONIME CORPORATION |
Feng-Yu Lee |
| K120335 |
02/03/2012 |
EMBRACE THERMOPLASTIC |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER M.D., PH.D. |
| K123966 |
12/26/2012 |
GLUCOSE METER-CHECK SOLUTION FOR BAYER |
BIONOSTICS, INC. |
RANDY BYRD |
| K123851 |
12/14/2012 |
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK |
BIONOSTICS, INC. |
RANDY BYRD |
| K123961 |
12/26/2012 |
SENTREX BIOSPONGE MPD |
BIONOVA MEDICAL, INC |
ALEX GREENE |
| K120550 |
02/23/2012 |
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K123837 |
12/13/2012 |
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K120425 |
02/13/2012 |
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K120464 |
02/15/2012 |
INNESIS PEEK CAGE |
BK MEDITECH CO., LTD. |
SHIN KUK YOO |
| K123821 |
12/12/2012 |
AIO HD OTOSCOPE |
BLUE FOCUS |
KI CHEOL HAN |
| K120353 |
02/06/2012 |
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM |
BM KOREA CO., LTD. |
Priscilla Chung |
| K123820 |
12/12/2012 |
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS |
BOSSONG HOSIERY MILLS, INC |
ROGER RAND |
| K123765 |
12/07/2012 |
GUIDEZILLA GUIDE EXTENSION CATHETER |
BOSTON SCIENTIFIC |
HOLLY RAMIREZ |
| K120495 |
02/17/2012 |
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC CORP. |
YUMI WACKERFUSS |
| K120520 |
02/21/2012 |
EXACTRAC ROBOTICS NOVALIS ROBOTICS |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K120533 |
02/22/2012 |
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K123718 |
12/04/2012 |
PERMASORB DISPOSABLE FIXATION DEVICE |
C.R. BARD INC |
RADHIKA PONDICHERRY |
| K123911 |
12/19/2012 |
SENOMARK ULTRA BREAST TISSUE MARKER |
C.R. BARD, INC. |
SARAH MCCARTNEY |
| K120327 |
02/02/2012 |
VERTESSA |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K123810 |
12/11/2012 |
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K120409 |
02/09/2012 |
PICCOLO COMPOSITE PLATE SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K120543 |
02/23/2012 |
TANDEMHEART FEMORAL ARTERIAL CANNULA SET |
CARDIACASSIST INC. |
KATIE DILLON |
| K123857 |
12/14/2012 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K120542 |
02/23/2012 |
CARDINAL HEALTH DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
LAVENIA FORD |
| K120518 |
02/21/2012 |
END TIDAL CO2 NASAL CANNULA |
CAREFUSION |
ERIKA FERNANDEZ |
| K120560 |
02/24/2012 |
TRINITY WRINKLE REMOVER |
Carol Cole Company |
BOB DUFFY |
| K124053 |
12/31/2012 |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
CARTICEPT MEDICAL, INC. |
Tanya Eberle |
| K123700 |
12/03/2012 |
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K123967 |
12/26/2012 |
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K123905 |
12/19/2012 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM, PHARM. D |
| K123844 |
12/13/2012 |
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
| K120570 |
02/27/2012 |
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM |
CHOICE SPINE, LP |
MARK BEKKALA |
| K123994 |
12/26/2012 |
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL |
CIBA VISION CORPORATION |
MARTINA HEIM, PH.D., RAC |
| K123946 |
12/21/2012 |
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS |
CINCINNATI SUB-ZERO PRODUCTS, INC |
STEVEN J BERKE |
| K120469 |
02/16/2012 |
ERISMA-LP |
CLARIANCE |
WILLIAM JACKSON |
| K123752 |
12/06/2012 |
ACCULIF TL AND PL CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
| K123914 |
12/19/2012 |
RESTORELLE Y CONTOUR |
COLOPLAST A/S |
TIM CRABTREE |
| K120316 |
02/01/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K120322 |
02/02/2012 |
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K120476 |
02/16/2012 |
MACROLYTE DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K120595 |
02/28/2012 |
UNISYN PLUS HIP STEM |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K120501 |
02/21/2012 |
CHAMP CHAMP TRANSIT |
CONVAID PRODUCTS, INC. |
MERVYN WATKINS |
| K124030 |
12/28/2012 |
COOK HOLMIUM LASER FIBER |
COOK INCORPORATED |
CONNIE RICE |
| K120468 |
02/16/2012 |
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR |
COOK INCORPORATED |
SUSANNE GALIN |
| K123712 |
12/04/2012 |
RETRACTA DETACHABLE EMBOLIZATION COIL |
COOK INCORPORATED |
JENNIFER RICHARDSON |
| K123707 |
12/03/2012 |
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE |
COOK, INC. |
DAVID LEHR |
| K120362 |
02/06/2012 |
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY |
CORIN U.S.A. |
LUCINDA GERBER, BA (HONS) |
| K123705 |
12/03/2012 |
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS |
CORIN USA |
DIANA L MARTONE |
| K123756 |
12/07/2012 |
COVAGEN |
COVALON TECHNOLOGIES LTD. |
CHRISTOPHER FREDRIC |
| K120605 |
02/28/2012 |
PERMACOL SURGICAL IMPLANT |
Covidien LLC |
JAMES MCMAHON |
| K120402 |
02/08/2012 |
CRUX VENA CAVA FILTER SYSTEM |
CRUX BIOMEDICAL |
ELISA HEBB |
| K123893 |
12/18/2012 |
CURA COLLIMATOR |
CURA MEDICAL TECHNOLOGIES, LLC |
THOMAS H FARIS |
| K123897 |
12/18/2012 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K123818 |
12/12/2012 |
URSA ANGIOGRAPHIC CATHETER |
CURATIVE MEDICAL TECHNOLOGY, INC. |
AMY MCKINNEY |
| K120597 |
02/28/2012 |
KOMPREDA |
CUSTOM SPINE, INC. |
DAVID BRUMFIELD |
| K120303 |
02/01/2012 |
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM |
CYBERSONICS, INC. |
LORI COLVIN |
| K123971 |
12/26/2012 |
CYNOSURE 1064NM DIODE LASER |
CYNOSURE, INC. |
IRINA KULINETS |
| K123830 |
12/12/2012 |
INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. |
DORIS DONG |
| K120592 |
02/28/2012 |
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS |
DANA PRODUCTS, INC. |
HARRY BALA |
| K123869 |
12/17/2012 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD |
RAY ZHOU |
| K124018 |
12/27/2012 |
AMIA AUTOMATED PD SYSTEM |
DEKA RESEARCH & DEVELOPMENT CORP. |
ROGER A LEROUX |
| K123940 |
12/20/2012 |
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE |
DEMETECH CORP. |
JOHN O'BRIEN |
| K124025 |
12/28/2012 |
ALPHA-PRO WHITE VARNISH |
DENTAL TECHNOLOGIES, INC. |
PAULA ERICKSON |
| K123849 |
12/14/2012 |
NEW COMFORT-FIT DENTAL GUARD |
DENTEK ORAL CARE, INC. |
LINDA GILES |
| K120530 |
02/22/2012 |
DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S |
DENTIN IMPLANTS TECHNOLOGIES LTD. |
DANIELA LEVY |
| K123925 |
12/20/2012 |
MTM CLEAR ALIGNER IN-OFFICE |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K123991 |
12/26/2012 |
DEPUY CORAIL AMT HIP PROSTHESIS |
DEPUY FRANCE S.A.S. |
ALMA RELJA, RAC |
| K120449 |
02/14/2012 |
HEALIX ADVANCE PEEK ANCHOR |
Depuy Mitek |
YAYOI FUJIMAKI |
| K120589 |
02/28/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K123924 |
12/20/2012 |
DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS |
DEPUY ORTHOPAEDICS |
CORRENE RAMY |
| K120599 |
02/28/2012 |
DEPUY M-SPEC 36MM FEMORAL HEADS |
DEPUY ORTHOPAEDICS |
CORRENE RAMY |
| K123959 |
12/21/2012 |
CIRCUFLOW 5150 |
DEVON MEDICAL INC. |
RUTH WU |
| K123824 |
12/12/2012 |
VITRO FIL LC |
DFL INDUSTRIA E COMERCIO S.A. |
TARA CONRAD |
| K123826 |
12/12/2012 |
VITRO MOLAR |
DFL INDUSTRIA E COMERCIO S.A. |
TARA CONRAD |
| K120591 |
02/28/2012 |
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K124009 |
12/27/2012 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K123785 |
12/10/2012 |
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K123969 |
12/26/2012 |
XIPHOS |
DIFUSION TECHNOLOGIES |
KAREN E WARDEN, PHD |
| K124016 |
12/27/2012 |
EMPI PHOENIX |
DJO, LLC |
KEN FISHER |
| K123776 |
12/10/2012 |
POLARIS 100/200 |
DRAGER MEDICAL GMBH |
BETH ZIS |
| K120465 |
02/15/2012 |
EARLYSENSE (EVERON) SYSTEM |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K123806 |
12/10/2012 |
FIBROSCAN |
ECHOSENS |
ZVI LADIN, PH.D. |
| K123714 |
12/04/2012 |
EDWARDS EMBOL-X INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
LUKE MEIDELL |
| K120407 |
02/09/2012 |
2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K120451 |
02/14/2012 |
8MP COLOR LCD MONITOR, REDIFORCE RX840 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K123808 |
12/11/2012 |
AGILITY |
ELEKTA LTD. |
Patrick Hull |
| K120604 |
02/28/2012 |
K-LASER |
ELTECH S.R.L |
RICHARD ALBRIGHT |
| K123729 |
12/05/2012 |
VERSARATE FLOW RATE CONTROLER |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K123982 |
12/26/2012 |
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ |
ENCORE MEDICAL, L.P. |
MICHAELA NORRIS |
| K123696 |
12/03/2012 |
MEDUSA VASCULAR PLUG |
ENDOSHAPE, INC. |
MICHAEL PARMENTER |
| K124055 |
12/31/2012 |
T1040 AKA AURAWAVE |
ENDURANCE THERAPEUTICS |
BRAD BREZDEN |
| K120513 |
02/21/2012 |
GLOW BY ENDYMED |
ENDYMED MEDICAL LTD |
YORAM LEVY |
| K123740 |
12/05/2012 |
EOS |
EOS IMAGING |
JOHN J SMITH |
| K124064 |
12/31/2012 |
YOUNG AGAIN |
ESPANSIONE MARKETING SPA |
GUIDO BONAPACE |
| K120334 |
02/03/2012 |
VIVA EB |
ETVIEW LTD. |
YORAM LEVY |
| K123853 |
12/14/2012 |
VIVASIGHT-DL SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
| K123687 |
12/03/2012 |
OPTETRAK LOGIC POROUS FEMORAL COMPONENT |
EXACTECH, INC. |
PATRICK HUGHES |
| K123728 |
12/04/2012 |
RETRIEVAL BAG |
FLEXBAR MACHINE CORP. |
STEPHEN T MLCOCH |
| K120452 |
02/14/2012 |
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN III |
| K120413 |
02/10/2012 |
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K120304 |
02/01/2012 |
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER |
FOOTPRINT MEDICAL INC. |
CLYDE BAKER |
| K123831 |
12/12/2012 |
OPHTACATH KIT |
FRANCE CHIRURGAE INSTRUMENTATION |
BARBARA S FANT |
| K124035 |
12/28/2012 |
2008K@HOME HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K120505 |
02/21/2012 |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
DENISE OPPERMANN |
| K124024 |
12/28/2012 |
APD LUER-LOCK ADAPTER |
FRESENSIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K123701 |
12/03/2012 |
HEARLAB ACA |
FRYE ELECTRONICS, INC. |
KRISTINA FRYE |
| K120361 |
02/06/2012 |
SYNAPSE 3D BASE TOOLS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DEBBIE PEACOCK |
| K120446 |
02/14/2012 |
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 |
FUJINON, INC. |
MARK JOB |
| K123814 |
12/12/2012 |
HUMELOCK II CEMENTED SHOULDER SYSTEM |
FX SOLUTIONS |
JEAN-JACQUES MARTIN |
| K123865 |
12/17/2012 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K120333 |
02/03/2012 |
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K120473 |
02/16/2012 |
PIXEL APP |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K120521 |
02/21/2012 |
GC BLUE SILICONE |
GC AMERICA, INC. |
MARK HEISS |
| K120613 |
02/29/2012 |
OEC 9900 ELITE |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K120598 |
02/28/2012 |
PROCARE MONITOR B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
ROBERT CASARSA |
| K123996 |
12/26/2012 |
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MARY CARTER |
| K123894 |
12/18/2012 |
GE ECHOPAC |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
| K120601 |
02/28/2012 |
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O |
GEISTLICH PHARMA AG |
DANIEL A KRACOV |
| K120569 |
02/27/2012 |
GEMORE TENS SYSTEM |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K123838 |
12/13/2012 |
PRO HMPV+ ASSAY |
GEN-PROBE PRODESSE, INC. |
KAREN HARRINGTON |
| K120532 |
02/22/2012 |
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM |
GETINGE SOURCING LLC |
BARB SMITH |
| K120441 |
02/13/2012 |
GETINGE 700HC-E SERIES STEAM STERILIZER |
GETINGE SOURCING LLC |
BARB SMITH |
| K123864 |
12/17/2012 |
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
Tim Thomas |
| K123731 |
12/05/2012 |
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
PAUL KRUMM |
| K123782 |
12/10/2012 |
PARAGON HIP SYSTEM |
GLOBAL MANUFACTURING TECHNOLOGY |
HOLLACE S RHODES |
| K124058 |
12/31/2012 |
CREO STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
| K123913 |
12/19/2012 |
LATIS SPACER |
GLOBUS MEDICAL INC. |
CHRISTINA KICHULA |
| K123783 |
12/10/2012 |
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS |
GLOBUS MEDICAL, INC. |
SARAH M FITZGERALD |
| K123915 |
12/19/2012 |
DE48-PLUS |
GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO |
PHILLIP SOARES |
| K120474 |
02/16/2012 |
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY |
GYRUS ACMI, INC. |
GRAHAM BAILLE |
| K120567 |
02/27/2012 |
GYRUS AMCI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
NEIL KELLY |
| K120586 |
02/27/2012 |
CELL SAVER ELITE |
HAEMONETICS CORP. |
GREG CALDER |
| K120574 |
02/27/2012 |
HAMILTON-C1 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K120336 |
02/03/2012 |
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K123703 |
12/03/2012 |
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) |
HEALGEN SCIENTIFIC, LLC |
BRYAN FANG |
| K120548 |
02/23/2012 |
HLIC NEEDLE-LESS VALVE |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K120536 |
02/22/2012 |
HEART SYNC PEDIATRIC PHYSIO AED PAD |
HEART SYNC INC. |
DANIEL KAMM |
| K123881 |
12/17/2012 |
HEARTSINE SAMARITAN PAD 350P |
HEARTSINE TECHNOLOGIES, INC. |
JAMES MCGUINNESS |
| K124039 |
12/28/2012 |
HERO GRAFT |
HEMOSHPERE, INC., A CRYOLIFE COMPANY |
LAURIE LYNCH |
| K124032 |
12/28/2012 |
METANEB |
HILL-ROM SERVICES PTE LTD |
PAUL DRYDEN |
| K123828 |
12/12/2012 |
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VAN ARSDALE |
| K120369 |
02/06/2012 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
BUNICHIRO NAKAJIMA |
| K123822 |
12/12/2012 |
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET |
HK SURGICAL, INC. |
CLARE BENNETT |
| K120564 |
02/24/2012 |
CALYPSO SYSTEM |
HOGAN LOVELLS US LLP |
JANICE M HOGAN |
| K123804 |
12/10/2012 |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
HOLLISTER, INC. |
CHRIS STUKEL |
| K120500 |
02/21/2012 |
THE PAIN PILOT (A.K.A PAIN PILOT) |
HOLLYWOG, LLC |
MICHAEL W TREAS |
| K120398 |
02/08/2012 |
WITOUCH PRO |
HOLLYWOG, LLC |
MICHAEL W TREAS |
| K123873 |
12/17/2012 |
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY |
HOLOGIC, INC. |
DEBORAH THOMAS |
| K120388 |
02/07/2012 |
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K120593 |
02/28/2012 |
MYOSURE CONTROL UNIT |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K120472 |
02/16/2012 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE A WILLIAMS |
| K120582 |
02/27/2012 |
HEATLUX |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN, PH.D |
| K120358 |
02/06/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HONGXIN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K120578 |
02/27/2012 |
ACCOLADE II HIP STEM |
HOWMEDICA OSTEONICS |
VALERIE GIAMBANCO |
| K120602 |
02/28/2012 |
APACERAM BONE GRAFT SUBSTITUTE |
HOYA CORPORATION |
PATSY J TRISLER |
| K120351 |
02/06/2012 |
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA |
i-SENS, Inc. |
HYUN JOON OH |
| K123724 |
12/04/2012 |
DERMISEB CREAM |
IGI LABORATORIES, INC. |
FREDERICK WEISS |
| K124006 |
12/26/2012 |
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY |
ILLUMINA, INC. |
LEANNE M KIVIHARJU |
| K123713 |
12/04/2012 |
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
| K123763 |
12/07/2012 |
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K120373 |
02/06/2012 |
INSORB ABSORBALBE STAPLE |
INCISIVE SURGICAL, INC. |
DAVID HERRIDGE |
| K120374 |
02/06/2012 |
SEVIIN REVERSE SHOULDER |
INGEN ORTHOPEDICS LLC |
PERRY GEREMAKIS |
| K123860 |
12/14/2012 |
INMODE SR IPL DEVICE |
INMODE MD LTD. |
AHAVA STEIN |
| K120339 |
02/03/2012 |
PROCOLL |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K123761 |
12/07/2012 |
VITA ENAMIC STAINS |
INNOVATION MEDITECH GMBH |
ELIZABETH WOLFSEN |
| K123987 |
12/26/2012 |
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET |
INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
BRAD BROWN |
| K123972 |
12/26/2012 |
WALKAIDE SYSTEM |
INNOVATIVE NEUROTRONICS INC. |
GLEN NEALLY |
| K123880 |
12/17/2012 |
QUANTA FLASH CENTROMERE |
INOVA DIAGNOSTICS, INC. |
ANDREA SEAMAN |
| K120462 |
02/15/2012 |
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K120493 |
02/17/2012 |
MINI CANNULATED HEADED AND HEADLESS SCREW SET |
INSTRATEK, INC. |
Jeff Seavey |
| K120600 |
02/28/2012 |
DURAGEN SECURE DURAL REGNERATION MATRIX |
INTEGRA LIFESCIENCES |
AAKASH JAIN |
| K123753 |
12/06/2012 |
IMDX VANR FOR ABBOTT M2000 |
INTELLIGENT MEDICAL DEVICES, INC |
FRAN WHITE |
| K124048 |
12/31/2012 |
IMAGEQUBE |
INTUITIVE IMAGING INFORMATICS, LLC |
CINDY SIMONI |
| K123840 |
12/13/2012 |
CONNECT FOR DA VINCI SURGICAL SYSTEM(S) |
INTUITIVE SURGICAL, INC. |
CHERECE L JONES |
| K124031 |
12/28/2012 |
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM |
INTUITIVE SURGICAL, INC. |
CINDY DOMECUS |
| K124061 |
12/31/2012 |
MRI PATIENT MONITORING SYSTEM (MODEL 865214) |
INVIVO CORPORATION |
RUSTY KELLY |
| K120432 |
02/13/2012 |
TELIO CS CEM IMPLANT |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
| K124008 |
12/27/2012 |
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE |
IVOCLAR VIVADENT, AGIN |
DONNA MARIE HARTNETT |
| K120377 |
02/06/2012 |
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K124014 |
12/27/2012 |
SUREFIX INTERSPINOUS FUSION SYSTEM |
JG SPINE, LLC |
JOHN KAPITAN |
| K120526 |
02/22/2012 |
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
NED DEVINE |
| K123787 |
12/10/2012 |
GREENCROSS SURGICAL MASK |
JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L |
XIANGYANG SONG |
| K124037 |
12/28/2012 |
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE |
JUNG RIM MEDICAL INDUSTRIAL CO., LTD |
KYU LEE |
| K120492 |
02/17/2012 |
K2 MEDICAL VASCULAR CLAMPS |
K2 MEDICAL GMBH & CO. KG |
PETER FETZER |
| K123956 |
12/21/2012 |
POWER LED 175 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SHIVEN GANDHI |
| K120499 |
02/21/2012 |
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K123878 |
12/17/2012 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
Shannon Scott |
| K120477 |
02/16/2012 |
AEROSYNC FOR AERODR SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RESSELL MUNVES |
| K120538 |
02/22/2012 |
PALLS M SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
APRIL LEE |
| K120590 |
02/28/2012 |
DILATOR TUBE SET |
KOROS USA, INC. |
GABRIEL KOROS |
| K123749 |
12/06/2012 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
CHO SOW FONG |
| K123944 |
12/20/2012 |
KOSTEC MEDICAL GRADE LDC MONITORS |
KOSTEC CO., LTD |
RHONDA ALEXANDER, MS, MPA |
| K120379 |
02/07/2012 |
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S |
KURARAY MEDICAL INC. |
MICHIO TAKIGAWA |
| K120378 |
02/07/2012 |
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S |
KURARAY MEDICAL INC. |
MICHIO TAKIGAWA |
| K123999 |
12/26/2012 |
ILLUMASK ACNE LIGHT THERAPY MASK |
LA LUMIERE, LLC |
ROBERT SEIPLE, RAC |
| K124052 |
12/31/2012 |
OSTAVI HYDROPHILIC GUIDEWIRE |
LAKE REGION MEDICAL |
TRACY MEYER |
| K123767 |
12/07/2012 |
LANX FUSION SYSTEM- SA |
LANX, INC. |
Alan Burkholder |
| K120399 |
02/08/2012 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
MICHAEL FUNK |
| K124059 |
12/31/2012 |
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) |
LAUER MEMBRAN WASSERTECHNIK GMBH |
STEPHAN KRIETEMEYER |
| K123859 |
12/14/2012 |
TBD |
LENSAR, INC. |
SHIRLEY K MCGARVEY |
| K120511 |
02/21/2012 |
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM |
LETO ENTERPRISE LTD. |
SABRINA WEI |
| K123955 |
12/21/2012 |
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT |
LIFE TECHNOLOGIES CORPORATION |
DEANNA VELLA |
| K120558 |
02/24/2012 |
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION |
LIFESCAN, INC. |
ANDREA TASKER |
| K123842 |
12/13/2012 |
LAWMAX DILATOR |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
LILY SHI |
| K124043 |
12/28/2012 |
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
LIGHTMED CORP. |
JOCELYN LIU |
| K123800 |
12/10/2012 |
WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
SELINA QIAN |
| K120454 |
02/14/2012 |
SAFEAIR SMOKE PENCIL, |
LNA MEDICAL APS |
RICK GILLIS, PH.D |
| K120514 |
02/21/2012 |
CARDIOPACS |
LUMEDX |
CHRIS PEARCE |
| K120617 |
02/29/2012 |
PTFE SUPER SHEATH INTRODUCER |
MARTECH MEDICAL PRODUCTS |
ALEXIS ERAZO |
| K123697 |
12/03/2012 |
MATRICEL DENTAL BARRIER MEMBRANE |
MATRICEL GMBH |
DR. INGO HESCHEL |
| K123908 |
12/19/2012 |
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES |
MATRIX SURGICAL USA |
JULIE STEPHENS |
| K124003 |
12/26/2012 |
MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE |
MED-FIBERS, INC. |
ARMIN KAUS PHD |
| K123721 |
12/04/2012 |
GMK REVISION EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K124034 |
12/28/2012 |
MECTALIF ANTERIOR |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K120531 |
02/22/2012 |
VERSAFITCUP CC TRIO-ADDITIONAL LINERS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K124000 |
12/26/2012 |
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM |
MEDAPPS INC., DBA ALERE CONNECT |
KENT DICKS |
| K120573 |
02/27/2012 |
MEDART 620 |
MEDART A/S |
DARREN THOMAS |
| K123866 |
12/17/2012 |
TANYX |
MEDECELL US, INC |
RHONDA ALEXANDER, M.S., M.P.A. |
| K120497 |
02/21/2012 |
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL |
MEDICA CORP. |
Photios Makris |
| K123802 |
12/10/2012 |
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT |
MEDICA CORP. |
Photios Makris |
| K124046 |
12/31/2012 |
VALVED TEARAWAY INTRODUCER GENERATION II |
MEDICAL COMPONENTS INC |
TIMOTHY HOLWICK |
| K123807 |
12/11/2012 |
SHARPSCAN |
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. |
TIM CORESSEL |
| K120555 |
02/23/2012 |
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) |
MEDICAL-LATEX (DUA) SDN. BHD |
UMA DEVI |
| K124060 |
12/31/2012 |
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
MEDICALGORITHMICS S.A. |
MARTIN JASINSKI |
| K120577 |
02/27/2012 |
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX |
MEDIKRO OY |
MIKKO ELORANTA |
| K120460 |
02/15/2012 |
SMARTLUX |
MEDMIX CO., LTD |
PETER CHUNG |
| K120517 |
02/21/2012 |
DEPUY PULSE CERVICAL CAGE SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K120424 |
02/13/2012 |
MEDSOURCE IV ADMINSTRATION SET |
MEDSOURCE INTERNATIONAL, LLC. |
JENNIFER NESS |
| K123771 |
12/07/2012 |
KYPHON EXPRESS II INFLATABLE BONE TAMPS |
Medtronic |
HETAL JAWAHAR THAKKER |
| K120537 |
02/22/2012 |
AQUAMANTYS3 9.5 XL BIPOLAR SEALER |
MEDTRONIC INC. |
TARA N TURNEY, RAC |
| K123733 |
12/05/2012 |
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM |
MEDTRONIC INC. |
KARI CHRISTIANSON |
| K123762 |
12/07/2012 |
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF |
MEDTRONIC INC. |
CHELSEA PIOSKE |
| K120612 |
02/29/2012 |
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT |
MEDTRONIC INC. |
KELLEY BREHEIM |
| K124004 |
12/26/2012 |
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS |
MEDTRONIC NAVIGATION, INC. |
MICHAEL BLASCO |
| DEN120017 |
12/21/2012 |
Medtronic DUET External Drainage and Monitoring System |
MEDTRONIC NEUROSURGERY |
DONOVAN MAY |
| K123978 |
12/26/2012 |
CAPSTONE L SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
| K120368 |
02/06/2012 |
CAPSTONE CONTROL SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K123809 |
12/11/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
SOWMYA SHETTY |
| K123906 |
12/19/2012 |
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CLAIRE EVANS |
| K123691 |
12/03/2012 |
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) |
MEDTRONIC SOFAMOR DANEK, INC. |
MURIEL ASHIE |
| K123990 |
12/26/2012 |
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING |
MEDTRONIC VASCULAR |
KELLEY LAMKE |
| K123988 |
12/26/2012 |
ANYONETM INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
APRIL LEE |
| K123870 |
12/17/2012 |
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD. |
APRIL LEE |
| K123792 |
12/10/2012 |
HORIZON XVU (FFR) |
MENNEN MEDICAL LTD. |
IFAT SHWARTS |
| K120404 |
02/09/2012 |
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K123926 |
12/20/2012 |
METASURG NITINOL STAPLE IMPLANT |
METASURG |
JOSHUA SCOTT |
| K124010 |
12/27/2012 |
ACCUSONIC ADVANTAGE |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVID MITCHELL |
| K120484 |
02/17/2012 |
VISIA ONCOLOGY |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
| K124007 |
12/26/2012 |
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY |
MICRO THERAPEUTICS, INC D/B/A: EV3 INC |
ANALIA STAUBLY |
| K120430 |
02/13/2012 |
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN GOLDSTEIN-FALK |
| K124029 |
12/28/2012 |
MICROLINE FLEXIBLE LIGATING SHEARS |
MICROLINE SURGICAL, INC |
DEAN CIPORKIN |
| K120608 |
02/29/2012 |
ENDOSCOPIC APPLICATOR |
MICROMEDICS, INC. |
LISE W DURAN |
| K123847 |
12/14/2012 |
MALLEABLE TIP ENDOSCOPIC APPLICATOR |
MICROMEDICS, INC. |
JODI L RAUS |
| K120563 |
02/24/2012 |
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT |
MICROPHAGE, INC. |
DREW SMITH |
| K120306 |
02/01/2012 |
RAPICIDE OPA-28 |
MINNTECH CORP. |
BRENT GREIGER, MS, RAC |
| K123980 |
12/26/2012 |
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES |
MISONIX, INC. |
RONALD MANNA |
| K123892 |
12/18/2012 |
MEPILEX TRANSFER AG |
MOLNLYCKE HEALTH CARE |
ANGELA L BUNN, RAC |
| K123945 |
12/21/2012 |
STRIVE DUAL ZONE PEAK FLOW METER |
MONAGHAN MEDICAL CORP. |
CARI J REIL |
| K120561 |
02/24/2012 |
NEUROBLATE SYSTEM |
MONTERIS MEDICAL, INC. |
JEFF WILSON |
| K123904 |
12/19/2012 |
PROTHELIAL |
MUELLER MEDICAL INTERNATIONAL LLC |
RICKY W MCCULLOUGH MD |
| K120524 |
02/22/2012 |
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM |
MUI SCIENTIFIC |
TAMMY MUI |
| K120479 |
02/16/2012 |
MTF FASCIA |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
RANDY PREBULA |
| K120415 |
02/10/2012 |
CRYO-TOUCH III |
MYOSCIENCE INC |
TRACEY HENRY |
| K124056 |
12/31/2012 |
FREND PSA PLUS (REAGENT CARTRIDGE) |
NANOEN TEK, INC. |
JUDITH E LOEBEL |
| K120466 |
02/15/2012 |
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K120356 |
02/06/2012 |
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD |
NCS LAB SRL |
MATTEO MANTOVANI |
| K123910 |
12/19/2012 |
WOUNDWASH SALINE SPRAY |
NEILMED PHARMACEUTICALS, INC. |
KETAN MEHTA |
| K120503 |
02/21/2012 |
CMI IMPLANT IS II ACTIVE |
NEOBIOTECH CO., LTD. |
APRIL LEE |
| K120515 |
02/21/2012 |
TEMPUS CERVICAL PLATE SYSTEM |
NEUROSTRUCTURES, LLC |
MEREDITH MAY |
| K120380 |
02/07/2012 |
SATURN 8000 |
NEW MEDICAL CO., LTD. |
JUN-HSIUNG LIN |
| K123797 |
12/10/2012 |
NT1D VITAL SIGNS MONITOR |
NEW TECH, INC. |
Diana Hong |
| K120345 |
02/03/2012 |
HONOUR SPACER SYSTEM |
NEXXT SPINE LLC |
KAREN E WARDEN |
| K123738 |
12/05/2012 |
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD |
NIDEK MEDICAL PRODUCTS, INC. |
VAN MUTH |
| K120485 |
02/17/2012 |
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P |
NIHON KOHDEN AMERICA, INC. |
STEVE GEERDES |
| K120397 |
02/08/2012 |
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K123839 |
12/13/2012 |
WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 |
NINGBO DIAIER ELECTRONIC CO., LTD. |
LAO XIKUN |
| K120490 |
02/17/2012 |
QUICK SAMPLER HOLDER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K120553 |
02/23/2012 |
ESPIN |
NLT SPINE LTD |
JOHN J SMITH |
| K123976 |
12/26/2012 |
NOBELCLINICIAN |
NOBEL BIOCARE AB |
PHUONG NGUYEN |
| K120302 |
02/01/2012 |
MECHANICAL WHEELCHAIR |
NOVAF ANDALUCIA 2007, SL |
FERNANDO SAENZ DE SANTAMARIA |
| K123766 |
12/07/2012 |
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN |
NOVO NORDISK INC. |
LOIS KOTKOSKIE, PH. D |
| K120619 |
02/29/2012 |
ORTHODONTIC FLOWABLE BRACKET ADHESIVE |
NOVOCOL, INC. |
STEVE RUDOLPH |
| K124062 |
12/31/2012 |
QDC-PRO, AND NOX-RIP |
NOX MEDICAL |
KOLBRUN E OTTOSDOTTIR |
| K120581 |
02/27/2012 |
SC TIP CLEANER |
NSI |
GORDON WEHNER |
| K123764 |
12/07/2012 |
DURETTE OCULAR IMPLANT |
OCULO-PLASTIK, INC. |
SYLVAIN DESROSIERS |
| K123876 |
12/17/2012 |
SYNERGY |
ODONTIT SA |
BLIX WINSTON |
| K123902 |
12/18/2012 |
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) |
OKTX LLC |
MARY ROSE C REASTON |
| K123704 |
12/03/2012 |
AUTOMATED ENDOSCOPE LEAK TESTER |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K120357 |
02/06/2012 |
ENDOSCOPE REPROCESSOR OER-MINI |
OLYMPUS MEDICAL SYSTEMS CORP. |
LAURA STORMS-TYLER |
| K120418 |
02/10/2012 |
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
OLYMPUS WINTER & IBE GMBH |
SHERI MUSGNUNG |
| K120516 |
02/21/2012 |
LONG LIFE PADTM |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K123690 |
12/03/2012 |
CAPNOSTREAM20P WITH HIFI C02 MONITORING |
ORIDION MEDICAL 1987 LTD. |
DALIA GIVONY |
| K123811 |
12/11/2012 |
STITCHKIT |
ORIGAMI SURGICAL LLC |
JOHN GILLESPIE |
| K124041 |
12/28/2012 |
NBM-200MP |
ORSENSE LTD |
MARK A HELLER |
| K120360 |
02/06/2012 |
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K120609 |
02/29/2012 |
VITROS CHEMISTRY PRODUCTS DHDL SLIDES |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K123930 |
12/20/2012 |
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
| K124023 |
12/28/2012 |
STARBAND |
ORTHOMERICA PRODUCTS, INC. |
DAVID L HOOPER |
| K120459 |
02/15/2012 |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
Oscor Inc. |
MILA DOSKOCIL |
| K123755 |
12/07/2012 |
MULTI ANGLED ABUTMENT |
OSSTEM IMPLANT CO., LTD |
PATRICK LIM |
| K123885 |
12/18/2012 |
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR |
OSTEOMED LP |
PIEDAD PENA |
| K123916 |
12/19/2012 |
PSA SERIES |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
| K123795 |
12/10/2012 |
AXON-BUS PROSTHETIC SYSTEM |
OTTO BOCK AUSTRIA |
REINHARD WOLKERSTORFER |
| K120566 |
02/27/2012 |
O2PAK OXYGEN GENERATOR |
PACIFIC PRECISION PRODUCTS |
GERALD WHITE |
| K120491 |
02/17/2012 |
DSS STABILIZATION SYSTEM-RIGID |
PARADIGM SPINE, LLC |
MICHELLE MCDONOUGH |
| K120489 |
02/17/2012 |
TISSUE OF ORIGIN TEST KIT FFPE |
PATHWORK DIAGNOSTICS, INC. |
ANNA LONGWELL |
| K123973 |
12/26/2012 |
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES |
Pegavision Corporation |
TONY HSU |
| K120585 |
02/27/2012 |
CONVEY GUIDING CATHETER |
PENDRACARE INTERNATIONAL, B.V. |
TOM NOLAN |
| K120330 |
02/02/2012 |
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 |
PENUMBRA, INC. |
EMILLY T NURTHEN |
| K123995 |
12/26/2012 |
MICRODOSE SI |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
GUSTAV LINS |
| K120321 |
02/02/2012 |
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS HEALTHCARE |
ROB BUTLER |
| K120525 |
02/22/2012 |
QLAB QUANTIFICATION SOFTWARE |
PHILIPS HEALTHCARE GROUP |
PENNY GRECO |
| K123900 |
12/18/2012 |
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K120366 |
02/06/2012 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K123754 |
12/06/2012 |
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
|
| K120355 |
02/06/2012 |
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K120367 |
02/06/2012 |
3MENSIO WORKSTATION |
PIE MEDICAL IMAGING B.V. |
Florie Daniels |
| K123970 |
12/26/2012 |
CAAS INTRAVASCULAR |
PIE MEDICAL IMAGING B.V. |
Florie Daniels |
| K124012 |
12/27/2012 |
INFILL OBLIQUE TLIF DEVICE |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K120313 |
02/01/2012 |
NEO CR KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K123692 |
12/03/2012 |
PIPELINE KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K123829 |
12/12/2012 |
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK |
PORTABLE THERAPEUTIX, LLC |
Sharyn Orton |
| K123799 |
12/10/2012 |
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K123725 |
12/04/2012 |
FASTPACK CONTROL KIT |
Qualigen, Inc. |
Michael Poirier |
| K123983 |
12/26/2012 |
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS |
Qualigen, Inc. |
MICHAEL S POIRIER |
| K123998 |
12/26/2012 |
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY |
QUIDEL CORP. |
Ronald H Lollar |
| K123793 |
12/10/2012 |
SOFIA STREP A FIA |
QUIDEL CORPORATION |
JOHN D TAMERIUS, PH.D. |
| K120381 |
02/07/2012 |
Q50 PLUS STENT GRAFT BALLOON CATHETER |
QXMEDICAL, LLC |
|
| K123984 |
12/26/2012 |
QUANTIEN MEASUREMENT SYSTEM |
RADI MEDICAL SYSTEMS AB |
ANNA-LISA TIENSUU |
| K120344 |
02/03/2012 |
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE |
RADIADYNE, LLC (SPECIFICATION DEVELOPER) |
STUART R GOLDMAN |
| K123748 |
12/06/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
SOREN BOGESTRAND |
| K120326 |
02/02/2012 |
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE |
RADIOMETER MEDICAL APS |
OLE SCHOU |
| K123977 |
12/26/2012 |
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K120387 |
02/07/2012 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
| K120396 |
02/08/2012 |
RELIANCE CERVICAL IBF SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K123835 |
12/13/2012 |
2008 HEMODIALYSIS SORBENT SYSTEM |
RENAL SOLUTIONS, INC. |
DAVID VANELLA |
| K123805 |
12/11/2012 |
E-Z CHEK BLOOD LEAK TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
TED WILLIAMS |
| K123979 |
12/26/2012 |
QUATTRO AIR |
RESMED LTD. |
JIM CASSI |
| K123789 |
12/10/2012 |
SWIFT FX NANO |
RESMED LTD. |
JIM CASSI |
| K120562 |
02/24/2012 |
PERFORMAX PEDIATRIC EE TOTAL FACE MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K123803 |
12/10/2012 |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K120346 |
02/03/2012 |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K120342 |
02/03/2012 |
EMG RECORDING ELECTRODE ASSEMBLY |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES MEWBORNE |
| K120556 |
02/24/2012 |
VILET VILET QUICK |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K123726 |
12/04/2012 |
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 |
Roche Diagnostics |
DAVID TRIBBETT |
| K123965 |
12/26/2012 |
COBAS INTEGRA BILIRUBIN DIRECT GEN.2 |
Roche Diagnostics |
Susan Hollandbeck |
| K123695 |
12/03/2012 |
TRAUS SIP10 |
SAESHIN PRECISION CO., LTD. |
Y.S. LEE |
| K123743 |
12/06/2012 |
ULTRASAFE PLUS PASSIVE NEEDLE GUARD |
SAFETY SYRINGES, INC. |
SUZANNE RICHARDSON |
| K123694 |
12/03/2012 |
SAM JUNCTIONAL TOURNIQUET |
SAM MEDICAL PRODUCTS |
JACK N MCCUTCHEON |
| K124026 |
12/28/2012 |
LOBSTER AUTO-INJECTOR |
SCANDINAVIAN HEALTH LIMITED |
James Haynes |
| K120545 |
02/23/2012 |
HX-461 |
SEERS TECHNOLOGY CO, LTD |
PETER CHUNG |
| K120554 |
02/23/2012 |
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K123985 |
12/26/2012 |
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 |
SENSUS HEALTHCARE |
KAL FISHMAN |
| K124044 |
12/31/2012 |
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS |
SEVEN OAKS RANCH, INC. |
Calley Herzog |
| K120420 |
02/10/2012 |
STERILE BLUNT FOR SINGLE USE |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
Diana Hong |
| K120475 |
02/16/2012 |
ANESTHESIA CONDUCTION NEEDLES |
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD |
MIKE GU |
| K123816 |
12/12/2012 |
DIGITAL ELECTROCARDIOGRAPHS |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
| K123711 |
12/04/2012 |
PATIENT MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
CHARLIE MACK |
| K120502 |
02/21/2012 |
PC-60NW FINGERTIP OXIMETER |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
CHARLES MACK |
| K123801 |
12/10/2012 |
FINGER PULSE OXIMETER |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD |
Diana Hong |
| K123850 |
12/14/2012 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
CINDY DOMECUS |
| K120331 |
02/02/2012 |
SYNGO CT DYNAMIC ANGIO |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K123920 |
12/20/2012 |
SYNGO.VIA |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K123933 |
12/20/2012 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Elisabeth Warriner |
| K123737 |
12/05/2012 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEIDO, RAC |
| K123812 |
12/11/2012 |
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K123922 |
12/20/2012 |
SYNGO DYNAMICS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
YURI IKEDA |
| K123938 |
12/20/2012 |
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K120363 |
02/06/2012 |
SYNGO RT INTERFACE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K120315 |
02/01/2012 |
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K120579 |
02/27/2012 |
SOMATOM DEFINITION EDGE |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K123758 |
12/07/2012 |
TASMIN R |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN, PHD |
| K120551 |
02/23/2012 |
SIMUPLAN TREATMENT PLANNING SYSTEM |
SIMUPLAN S.L. |
LU ANNE JOHNSON |
| K123952 |
12/21/2012 |
CEREC BLOCS C IN |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K120354 |
02/06/2012 |
BETA-TCP GRANULES |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K120463 |
02/15/2012 |
MOJO, VERASEAL |
SLEEPNET CORPORATION |
PAUL DRYDEN |
| K123948 |
12/21/2012 |
CHINA NAILS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K123957 |
12/21/2012 |
PNEUPAC PARAPAC PLUS |
SMITHS MEDICAL INTERNATIONAL LTD. |
LORI BERENDS |
| K120506 |
02/21/2012 |
PARIETEX COMPOSITE VENTRAL PATCH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K120390 |
02/07/2012 |
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
LOUISE ROCHT |
| K124045 |
12/31/2012 |
FUSEFORCE IMPLANT SYSTEM |
SOLANA SURGICAL, LLC |
JOE CLIFT |
| K123855 |
12/14/2012 |
WATER-FILLED TEETHER |
SOLID TOYS IND. LTD. |
PAUL DRYDEN |
| K120433 |
02/13/2012 |
CLEAR + BRILLIANT LASER SYSTEM |
SOLTA MEDICAL, INC. |
KRISTINE FOSS |
| K124051 |
12/31/2012 |
THE VAULT SYSTEM |
SOMERSAULT ORTHOPEDICS, INC. |
PAMELA M BUCKMAN |
| K120440 |
02/13/2012 |
PRESTO BREAST BIOPSY DEVICE |
SONTINA MEDICAL, LLC |
ROBERT PELIKS |
| K120611 |
02/29/2012 |
SONY PVM-2551MD OLED MONITOR |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K123962 |
12/26/2012 |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
SOPHONO, INC |
KRISTA B TRAYNOR |
| K120328 |
02/02/2012 |
ORIGINS LIPOHARVESTING SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
STEPHEN C SMITH |
| K120616 |
02/29/2012 |
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 |
SPACELABS MEDICAL, INC. |
THOMAS KROENKE |
| K123891 |
12/18/2012 |
SPARTAN RX CYP2C19 TEST SYSTEM |
SPARTAN BIOSCIENCE INC |
LORRY HUFFMAN |
| K124049 |
12/31/2012 |
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM |
Spectral MD, Inc |
DIANE RUTHERFORD |
| K120416 |
02/10/2012 |
INSULATION TESTER |
SPECTRUM SURGICAL SUPPLY CORP. |
DENNIS A KOVIT |
| K123912 |
12/19/2012 |
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
| K123941 |
12/20/2012 |
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
| K120494 |
02/17/2012 |
DISPOSABLE ADHESIVE SURFACE ELECTRODE |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECHIA |
| K120467 |
02/15/2012 |
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K123769 |
12/07/2012 |
ZX-I POWER ADD ON |
SPINERGY, INC. |
EDWARD A KROLL |
| K120544 |
02/23/2012 |
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN |
ST. JUDE MEDICAL |
MARLENE PETERSON |
| K120435 |
02/13/2012 |
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR |
STERIS Corporation |
BILL BRODBECK |
| K123768 |
12/07/2012 |
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
MARCIA L BENEDICT |
| K123784 |
12/10/2012 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA, LLC |
JENNIFER M JACKSON, MS |
| K123843 |
12/13/2012 |
NEUROEPG SYSTEM |
STROHL MEDICAL TECHNOLOGIES |
JIM GRECO |
| K120509 |
02/21/2012 |
STRYKER ALL SUTURE ANCHORS |
Stryker |
KELLY KUCHARCZYK |
| K120352 |
02/06/2012 |
STRYKER QUIKFLAP STERILE PROCEDURE PACK |
Stryker |
JAMSHED BADARPURA |
| K123786 |
12/10/2012 |
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM |
Stryker |
JAMSHED BADARPURA |
| K120434 |
02/13/2012 |
POWER ADAPTOR INSTRUMENT ACCESSORY |
STRYKER CORP. |
TIFFANI ROGERS |
| K123942 |
12/20/2012 |
STRYKER IVAS BALLOON CATHETER |
STRYKER CORPORATION |
CHRISTINA MCKEE |
| K120486 |
02/17/2012 |
AVS AS PEEK SPACER |
STRYKER SPINE |
SORAYA KING |
| K123964 |
12/26/2012 |
AXSOS 3 TI LOCKING PLATE SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| DEN120019 |
12/13/2012 |
CEFALY |
STX-MED SPRL |
JEAN-YVES MIGNOLET |
| K123975 |
12/26/2012 |
QUICKIE & ZIPPIE SERIES |
SUNRISE MEDICAL |
LAURIE ROBERTS |
| K124033 |
12/28/2012 |
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
BRANDI J PANTELEON |
| K123836 |
12/13/2012 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K123877 |
12/17/2012 |
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K123917 |
12/19/2012 |
DECLIPSESPECT VIEWER |
SURGICEYE GMBH |
MORITZ HOYER |
| K124042 |
12/28/2012 |
TANDA MINI SKINCARE SYSTEM |
SYNERON BEAUTY |
JANICE M HOGAN |
| K123845 |
12/13/2012 |
ME |
SYNERON BEAUTY LTD. |
JANICE M HOGAN |
| K120510 |
02/21/2012 |
TRANSCEND |
SYNERON MEDICAL LTD. |
SAM WADE |
| K123723 |
12/04/2012 |
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM |
SYNTHES |
ALAN T HALEY |
| K120571 |
02/27/2012 |
SYNTHES USS CONNECTOR |
SYNTHES SPINE |
HEMAL MEHTA |
| K124040 |
12/28/2012 |
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
PINJUNG CHEN |
| K120426 |
02/13/2012 |
VICTUS LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
KEN NEHMER |
| K123974 |
12/26/2012 |
PERCUTANEOUS INTRODUCER KIT |
TELEFLEX, INC. |
DAWN L MOORE |
| K123832 |
12/13/2012 |
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME |
THE ORTHOPAEDIC IMPLANT COMPANY (OIC) |
ITAI NEMOVICHER |
| K123889 |
12/18/2012 |
ACLEARA, THERACLEAR |
THERAVANT CORPORATION |
Marcy Moore |
| K120305 |
02/01/2012 |
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV |
THINKING SYSTEMS CORP. |
JB WANG |
| K123819 |
12/12/2012 |
MULTIPLE NAME |
TOP CALIBRE SDN BHD |
ROSNITA MAODIN |
| K120481 |
02/16/2012 |
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, |
TOSAMA D.O.O. |
MARJETKA KRALJ KUNCIC |
| K123992 |
12/26/2012 |
APLIO 500/400/300 V3.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K120487 |
02/17/2012 |
VANTAGE TITAN 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K120546 |
02/23/2012 |
AQUILION PREMIUM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K123901 |
12/18/2012 |
TRACTUS TISSUEMAPPER REVIEWER APPLICATION |
TRACTUS CORPORATION |
ERIC EGGERS |
| K123997 |
12/26/2012 |
TRANS1LATERAL INTERBODY FUSION SYSTEM |
TRANS1, INC. |
CHERYL L WAGONER |
| K120403 |
02/09/2012 |
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER |
TRANSENTERIX, INC. |
TAMMY B CARREA |
| K120419 |
02/10/2012 |
DYNA LOCKING ANKLE NAIL |
U&I CORP. |
GYEONG-JE KWON |
| K123863 |
12/14/2012 |
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K123717 |
12/04/2012 |
UCENTUM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K123777 |
12/10/2012 |
MULTILASER SYSTEM |
ULTRALIGHT LASER TECHNOLOGIES, LLC |
MARK ROHRER |
| K120349 |
02/06/2012 |
SONIXGPS VASCULAR ACCESS NEEDLE KIT |
ULTRASONIX MEDICAL CORPATION |
CHAS YU |
| K120364 |
02/06/2012 |
UNIMED DISPOSABLE BLOOD PRESSURE CUFF |
UNIMED MEDICAL SUPPLIES INC. |
XINMEI TAN |
| K120507 |
02/21/2012 |
UNITED U2 FEMORAL COMPONENT, PS, #7 |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K120337 |
02/03/2012 |
I-PORT ADVANCE INJECTION PORT |
UNOMEDICAL A/S |
SOREN MELSTED |
| K120395 |
02/08/2012 |
NERIA MULTI SUBCUTANEOUS INFUSION SET |
UNOMEDICAL DEVICES S.A DE C.V |
JOHN M LINDSKOG |
| K123708 |
12/03/2012 |
SPINE COIL |
USA PARAMED MEDICAL SYSTEMS, INC. |
RICHARD OLSON |
| K124002 |
12/26/2012 |
VERIFICATION CONSOLE |
VARIAN MEDICAL SYSTEMS |
PETER J CORONADO |
| K123788 |
12/10/2012 |
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K120341 |
02/03/2012 |
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K123815 |
12/12/2012 |
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K123813 |
12/11/2012 |
VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE |
VASONOVA INC. |
CHRISTINE FORD |
| K120318 |
02/02/2012 |
VIVI ERGON-X HF |
VIVI S.R.L. |
GUIDO BONAPACE |
| K123773 |
12/07/2012 |
X-TRA BASE |
VOCO GMBH |
T. GERKENSMEIER |
| K123898 |
12/18/2012 |
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
JWALA JAWHARKAR |
| K120428 |
02/13/2012 |
GORE DRYSEAL SHEATH |
W. L. GORE & ASSOCIATES, INC. |
NANCY B LOWE |
| K120480 |
02/16/2012 |
GORE(R) EMBOLIC FILTER |
W.L. GORE & ASSOCIATES |
MICHELLE ANN WELLS |
| K123732 |
12/05/2012 |
HYSTEROSCOPY PUMP HM6 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K120405 |
02/09/2012 |
WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR |
WALK ON WHEELS AUSTRALIA PTY LTD |
SHEILA RAMERMAN |
| K120508 |
02/21/2012 |
CLEARLUMEN THROMBECTOMY SYSTEM |
WALK VASCULAR LLC |
DAVID LOOK |
| K120391 |
02/07/2012 |
MR4500 WHEELCHAIR |
WARDRAY PREMISE LTD |
JAMES WASON PH.D. |
| K120325 |
02/02/2012 |
CONNECTED CARE MOBILE APPLICATION |
WATERMARK MEDICAL |
MICHAEL J LEIGH |
| K120470 |
02/16/2012 |
MIPAL |
WATERMARK MEDICAL |
MICHAEL J LEIGH |
| K120320 |
02/02/2012 |
CONNECTED CARE CLINICAL APPLICATION |
WATERMARK MEDICAL INC |
MICHAEL J LEIGH |
| K120584 |
02/27/2012 |
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES |
WEALTH ON (JIANGSU) CO., LTD |
CHARLES SHEN |
| K120343 |
02/03/2012 |
CONNEX WORKSTATION |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K120314 |
02/01/2012 |
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM |
WELLDOC, INC |
LAUREN BRONICH-HALL |
| K123751 |
12/06/2012 |
LOFRIC SENSE |
WELLSPECT HEALTHCARE |
Allison C Komiyama |
| K120603 |
02/28/2012 |
VARILIFT -C |
WENZEL SPINE |
SOURABH MISHRA |
| K123770 |
12/07/2012 |
WARMING JELLY PERSONAL LUBRICANT |
WISCONSIN PHARMACAL CO., LLC |
JOHN NYGAARD |
| K120471 |
02/16/2012 |
MACH BRACKETS BRIGHT BRACKETS |
WORLD BIO TECH CO., LTD |
PETER CHUNG |
| K123954 |
12/21/2012 |
INFINITY TOTAL ANKLE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
| K120359 |
02/06/2012 |
ORTHOLOC 3DI HALLUX SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K123688 |
12/03/2012 |
PROFEMUR TL CLASSIC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
YUAN LI |
| K123958 |
12/21/2012 |
JIAJIAN POINTOSELECT DIGITAL |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K123932 |
12/20/2012 |
ZYGAFIX SPINAL FACET SCREW SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K123702 |
12/03/2012 |
SILEX SACROILIAC JOINT FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN, M.D. |
| K120576 |
02/27/2012 |
ZAVATION IBF SYSTEM |
ZAVATION LLC |
JOHN WALKER |
| K123780 |
12/10/2012 |
TRANSTEK BLOOD PRESSURE MONITOR |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K123781 |
12/10/2012 |
TRANSTEK GLASS BODY FAT ANALYZER |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K123918 |
12/19/2012 |
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM |
ZIMMER, INC. |
STEPHEN H MCKELVEY, MA, RAC |
| K120370 |
02/06/2012 |
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS |
ZIMMER, INC. |
REBECCA BROOK |
| K123862 |
12/14/2012 |
ZIMMER NEXEL TOTAL ELBOW |
ZIMMER, INC. |
JOANNA L SURMA |
| K120406 |
02/09/2012 |
ZOLL FULLY AUTOMATIC AED PLUS |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
TANMAY B SHUKLA |
