| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K110629 |
04/27/2012 |
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER |
3B PRODUCTS, INC. |
NORMA F ESTRIN, PH.D. |
| K112440 |
04/18/2012 |
AB DENTAL DEVICES IMPLANTS AND ACCESSORIES |
A.B. DENTAL DEVICES, LTD. |
CHARLES HURWITZ |
| K120662 |
04/24/2012 |
PICCOLO HDL-CAPILLARY TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K120664 |
04/24/2012 |
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K113719 |
04/20/2012 |
SAFETY SCREW CONNECTOR |
ABBOTT LABORATORIES |
ELIZABETH M ZOLA |
| K113332 |
04/18/2012 |
ON CALL CHOSEN LANCING DEVICE |
ACON LABORATORIES, INC. |
AARON FRIDAY |
| K112653 |
04/09/2012 |
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS |
ACON LABORATORIES, INC. |
QIYI XIE |
| K120300 |
04/13/2012 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
John j Smith, M.D., J.D. |
| K112094 |
04/24/2012 |
BRAIN BIOPSY NEEDLE |
AD-TECH MEDICAL INSTRUMENT CORP. |
Gary J Syring |
| K113371 |
04/03/2012 |
STAPHYLOCOCCUS QUICKFISH BC |
ADVANDX, INC. |
BENJAMIN S CRYSTAL |
| K120939 |
04/26/2012 |
AERONEB PRO |
AEROGEN LTD |
MARTHA FOLAN |
| K120032 |
04/13/2012 |
MECHANICAL WHEELCHAIR |
AIKIN HEALTHCARE CO., LTD |
Kevin Walls |
| K120209 |
04/12/2012 |
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE |
AMERICAN I.V. PRODUCTS, INC. |
MAJDI SHOMALI |
| K120805 |
04/13/2012 |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
ANGIOSLIDE, LTD |
CLAY ANSELMO |
| K120448 |
04/06/2012 |
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL |
APEX BIOTECHNOLOGY CORP. |
LISA LIU |
| K121004 |
04/24/2012 |
APEX KIRSCHNER WIRES AND STEINMANN PINS |
APEX TOOLS & ORTHOPEDICS CO. |
HOLLACE SAAS RHODES |
| K112734 |
04/24/2012 |
APLAN A.V. FISTULA NEEDLE SET |
APLAN WELL ENTERPRISE CO., LTD |
JEN KE-MIN |
| DEN100016 |
04/27/2012 |
PROSTATE MECHANICAL IMAGER |
ARTANN LABORATORIES, INC |
GERARD J PRUD'HOMME |
| K112899 |
04/06/2012 |
ARTHREX BIO-SUTURE |
ARTHREX, INC. |
SALLY FOUST |
| K112481 |
04/09/2012 |
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT |
ASCENSION ORTHOPEDIC |
BRADLEY W STRASSER |
| K112438 |
04/11/2012 |
TITAN MODULAR TOTAL SHOULDER SYSTEM |
ASCENSION ORTHOPEDIC |
SUSAN WALTON |
| K110481 |
04/05/2012 |
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE |
ASI MEDICAL, INC. |
JOHN MCPEEK |
| K113424 |
04/17/2012 |
LOFRIC SINGLE USE URINARY CATHETER |
ASTRA TECH AB |
FLOYD G LARSON |
| K111547 |
04/12/2012 |
BILI-THERAPY PAD TYPE |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K121070 |
04/26/2012 |
C-QUR RPM MESH |
ATRIUM MEDICAL CORP. |
JOSEPH DEPAOLO |
| K113831 |
04/19/2012 |
PRIMUS HEARING INSTRUMENT TEST UNIT |
AUDITDATA A/S |
DAN HAUGBOL |
| K120971 |
04/19/2012 |
ATLAS PTA BALLOON DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
MEGAN BROWN |
| K120722 |
04/19/2012 |
RIVAL PTA DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
MARK JOB |
| K112909 |
04/30/2012 |
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION |
BAUSCH & LOMB, INC. |
TRICIA GARRETT |
| K113533 |
04/11/2012 |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
BAXANO, INC. |
EDWARD SINCLAIR |
| K120037 |
04/20/2012 |
BLUWHITE DIAMOND DENTAL BURS MODIFIED |
BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. |
Wendy Garman |
| K103230 |
04/24/2012 |
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K120231 |
04/24/2012 |
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES, PH.D |
| K120437 |
04/26/2012 |
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC SIA (LATVIA) |
HARRY HAYES |
| K113593 |
04/17/2012 |
NEXTGEN ALTIUS OCT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY |
| K120853 |
04/20/2012 |
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
BIONESS, INC. |
KIM TOMPKINS |
| K120694 |
04/03/2012 |
ENCORE 26 ADVANTAGE KIT |
BOSTON SCIENTIFIC CORP. |
ADRIENNE HOTCHKISS |
| K103227 |
04/11/2012 |
ORATECT ORAL FLUID DRUG SCREEN DEVICES |
BRANAN MEDICAL CORPORATION |
HUIYING WANG |
| K120881 |
04/18/2012 |
MANTARAY GUIDEWIRES |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K113119 |
04/27/2012 |
ENDOGATOR ADVANTAGE IRRIGATION PUMP |
BYRNE MEDICAL, INC. |
Brent Geiger |
| K120076 |
04/19/2012 |
RESOLUTIONMD WEB |
CALGARY SCIENTIFIC, INC. |
KYLE PETERSON |
| K111924 |
04/10/2012 |
FINESSE PERSONAL INSULIN DELIVERY PATCH |
CALIBRA MEDICAL, INC. |
RICHARD J MEADER |
| K111824 |
04/23/2012 |
FLAT PANEL DETECTOR |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
DIANE RUTHERFORD |
| K120746 |
04/27/2012 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
CANOPUS MEDICAL SUPPLY CO., LTD. |
GLORIA CHANG |
| K120292 |
04/13/2012 |
CAPLOX II PEDICLE SCREW SYSTEM |
CAPTIVA SPINE, INC |
RICH JANSEN |
| K113707 |
04/27/2012 |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
TATYANA BOGDAN |
| K120086 |
04/24/2012 |
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM |
CARDIOSOLUTIONS |
MICHELE LUCEY |
| K120979 |
04/25/2012 |
CAREFUSION NICOLET EDX |
CAREFUSION 209, INC. |
CURTIS TRUESDALE |
| K112535 |
04/27/2012 |
GENESIS REUSABLE RIGID CONTAINER SYSTEM |
CAREFUSION 2200, INC. |
KATE FULLER |
| K113096 |
04/13/2012 |
MICRO I |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K120062 |
04/13/2012 |
DRX-REVOLUTION MOBILE X-RAY SYSTEM |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K110590 |
04/13/2012 |
INTRABEAM NEEDLE APPLICATOR |
CARL ZEISS SURGICAL GMBH |
JUDITH A BRIMACOMBE, MA |
| K120830 |
04/16/2012 |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
CARTICEPT MEDICAL INC |
Tanya Eberle |
| K112141 |
04/13/2012 |
SMARTEPIL,DEPILASE YAG LASE PLUS |
CASTLE LASER SYSTEMS, LIMITED |
RAYMOND R BLANCHE |
| K120570 |
04/05/2012 |
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM |
CHOICE SPINE, LP |
MARK BEKKALA |
| K120757 |
04/24/2012 |
SLEEPWEAVER ELAN NASAL CPAP MASK |
CIRCADIANCE LLC |
DAVID GROLL |
| K120117 |
04/16/2012 |
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM |
Codman & Shurtleff, Inc. |
MEGAN HERMAN |
| K120686 |
04/04/2012 |
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
Codman & Shurtleff, Inc. |
KIM FONDA |
| K113585 |
04/25/2012 |
NASAL/EPISTAXIS PACK |
COGENT THERAPEUTICS, LLC |
ANNE WORDEN |
| K120828 |
04/05/2012 |
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES |
COLOPLAST A/S |
REBEKA STOLTMAN |
| K120316 |
04/19/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K112342 |
04/26/2012 |
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM |
CONVATEC INC |
KATRINA FIEDLER |
| K111695 |
04/02/2012 |
HYBRID GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN, PHD, RAC |
| K113759 |
04/03/2012 |
AVAIRA (ENFILCON A) CONTACT LENS |
COOPERVISION, INC. |
KARIN GASTINEAU |
| K120696 |
04/02/2012 |
TIGER SPINE SYSTEM |
CORELINK LLC |
J.D. WEBB |
| K120674 |
04/04/2012 |
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER |
COVIDIEN |
WING NG |
| K112536 |
04/19/2012 |
SONICISION STERILIZATION TRAY |
COVIDIEN |
DAVID M HORTON |
| K120863 |
04/19/2012 |
WHOLEY GUIDE WIRE SYSTEM |
Covidien LLC |
DAVID RBERTSON |
| K120043 |
04/27/2012 |
CSM INTERNAL-R IMPLANT SYSTEM |
CSM IMPLANT |
APRIL LEE |
| K113361 |
04/03/2012 |
SECURIS SPINAL FIXATION |
CUMTOM SPINE |
DAVID BRUMFIELD |
| K113548 |
04/10/2012 |
PEDCAT |
CURVEBEAM, LLC |
DAVID W COWAN |
| K120868 |
04/20/2012 |
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
HELDER A SOUSA |
| K120589 |
04/24/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K120095 |
04/06/2012 |
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
| K120591 |
04/17/2012 |
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K111464 |
04/19/2012 |
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES |
DIPPED PRODUCTS (THAILAND) LTD |
L.G.S. GUNAWARDANA |
| K111250 |
04/27/2012 |
DRY MOUTH MOUTHWASH |
DR. FRESH, INC. |
CAMILLE THORNTON |
| K112992 |
04/20/2012 |
EARLOGIC OAE TESTER |
EARLOGIC CORPORATION |
SHIN KUK YOO |
| K113796 |
04/26/2012 |
SOLITAIRE-C CERVICAL SPACER SYSTEM |
EBI, LLC |
MARGARET CROWE |
| K113170 |
04/06/2012 |
CERVICAL PLATE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K120407 |
04/19/2012 |
2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K113240 |
04/20/2012 |
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K120962 |
04/27/2012 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
| K120735 |
04/02/2012 |
PATHASSIT LIGHT SEEKER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
| K120721 |
04/06/2012 |
EOS |
EOS IMAGING |
JOHN J SMITH |
| DEN110016 |
04/30/2012 |
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS |
ETHICON ENDO-SURGERY |
THOMAS BOSTICCO |
| K103767 |
04/16/2012 |
DUAL HEATED INFANT VREATHING CIROUITS |
FISHER & PAYKEL HEALTHCARE LTD. |
ROBERT PETRY |
| K120452 |
04/24/2012 |
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN III |
| K113433 |
04/04/2012 |
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
FOCUS DIAGNOSTICS, INC. |
SHARON YOUNG |
| K110333 |
04/12/2012 |
NATURALASE CO2 LASER SYSTEM |
FOCUS MEDICAL, LLC. |
JOHN LEE |
| K120361 |
04/06/2012 |
SYNAPSE 3D BASE TOOLS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DEBBIE PEACOCK |
| K112398 |
04/12/2012 |
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT |
GALT MEDICAL |
BETSY CORTELLONI |
| K120473 |
04/09/2012 |
PIXEL APP |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K121019 |
04/19/2012 |
OPTIMA NM/CT 640 |
GE HEALTHCARE |
ELI WERNER |
| K120741 |
04/27/2012 |
VOLUSON S6, VOLUSON S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K120613 |
04/06/2012 |
OEC 9900 ELITE |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K113286 |
04/27/2012 |
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS |
GE MEDICAL SYSTEMS LUNAR |
TRISHIA DWYER |
| K120201 |
04/19/2012 |
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
| K110835 |
04/26/2012 |
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
GEO MEDICAL CO., LTD. |
ALBERT REGO |
| K120092 |
04/13/2012 |
PLYMOUTH THORACOLUMBAR PLATE SYSTEM |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
| K113847 |
04/11/2012 |
BORRELIA BURGDORFERI IGG BLOT TEST |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
| DEN120013 |
04/30/2012 |
PORTRAIT ANALYZER |
GREAT BASIN SCIENTIFIC |
LARRY REA |
| K111636 |
04/03/2012 |
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM |
GUNNELL, INC. |
ANDREW EVANCHO |
| K120670 |
04/03/2012 |
HAMILTON-T1 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K120055 |
04/24/2012 |
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS |
HAMILTON THORNE, INC. |
DIARMAID H DOUGLAS-HAMILTON |
| K113674 |
04/05/2012 |
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT |
HANDPIECE HEADQUARTERS INC. - HPR INC. |
TINA STEFFANIE-OAK |
| K111999 |
04/17/2012 |
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL |
HEALGEN SCIENTIFIC, LLC |
YONGQUAN WANG |
| K113837 |
04/27/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. |
RICHARD LU |
| K112215 |
04/12/2012 |
HEMCON HEMOSTATIC GEL |
HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. |
KENDRA RATHKEY |
| K102428 |
04/18/2012 |
WUNDER TEST |
HIEN HELEN NGUYEN |
HIEN NGUYEN |
| K120388 |
04/06/2012 |
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K110530 |
04/30/2012 |
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL |
HORIBA ABX S.A.S. |
CAROLINE FERRER |
| K113760 |
04/25/2012 |
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
VALERIE GIAMBANCO |
| K120187 |
04/06/2012 |
MULTI-MODALITY IMAGE FUSION |
IGT LLC DBA EIGEN |
WILLIAM MANDEL |
| K113662 |
04/20/2012 |
FENESTRATED NERVE BLOCK NEEDLE |
IMD INC |
WALTER ZOHMANN |
| K103037 |
04/17/2012 |
IND URINARY TRACT INFECTION (UTI) TEST STRIPS |
IND DIAGNOSTIC, INC. |
KAI LOU |
| K120935 |
04/27/2012 |
SECURACATH |
INTERRAD MEDICAL INC |
Sew-Wah Tay |
| K120215 |
04/30/2012 |
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE |
INTUITIVE SURGICAL, INC. |
KIM T SERVANCE |
| K111274 |
04/04/2012 |
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 |
JETPREP, LTD. |
JOHN SMITH |
| K112110 |
04/10/2012 |
STERILE LUBRICATING JELLY |
JIANERKANG MEDICAL DRESSING COMPANY |
JORDON CHU |
| K102327 |
04/13/2012 |
CLEARVISION DR 7000F |
JPI HEALTHCARE CO., LTD |
WILLIAM LITTLE |
| K120492 |
04/30/2012 |
K2 MEDICAL VASCULAR CLAMPS |
K2 MEDICAL GMBH & CO. KG |
PETER FETZER |
| K120656 |
04/04/2012 |
EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K111997 |
04/06/2012 |
IMAGE1 GI CCU MODEL 22203020-114 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
WINKIE WONG |
| K120264 |
04/11/2012 |
KONAN SPECULAR MICROSCOPE XIV |
KONAN MEDICAL, INC. |
DAVID S FERNQUIST |
| K120477 |
04/09/2012 |
AEROSYNC FOR AERODR SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RESSELL MUNVES |
| K120063 |
04/19/2012 |
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L&K BIOMED CO., LTD |
HEE KYEONG JOO |
| K120234 |
04/19/2012 |
EZONO 3000 |
LIFE-TECH, INC. |
SKIP RIMER |
| K113115 |
04/03/2012 |
EPICARE YAG |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
| K113616 |
04/27/2012 |
ACCUDXA2 |
LONE OAK MEDICAL TECHNOLOGIES, LLC |
DAVID COMLEY |
| K113502 |
04/05/2012 |
ADVANTAGE LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K112470 |
04/05/2012 |
2GC HIP/KNEE MODULAR SPACER |
MANDELL HORWITZ CONSULTANTS LLC |
DIANE M HORWITZ |
| K113599 |
04/27/2012 |
SURGICASE CONNECT |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K113829 |
04/02/2012 |
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K120208 |
04/20/2012 |
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES |
MICHAEL A DANIEL |
| K113633 |
04/20/2012 |
MCKESSON ANESTHESIA CARE |
MCKESSON TECHNOLOGIES INC. |
JANICE M HOGAN |
| K120531 |
04/18/2012 |
VERSAFITCUP CC TRIO-ADDITIONAL LINERS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K120108 |
04/27/2012 |
APTUS PROXIMAL HUMERUS SYSTEM |
MEDARTIS AG |
KEVIN A THOMAS |
| K120718 |
04/19/2012 |
INSTAPACS/INSTARISPACS |
MEDDIFF TECHNOLOGIES PVT. LTD |
CARL ALLETTO |
| K113583 |
04/12/2012 |
CURAD ANTIBACTERIAL BANDAGE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K120069 |
04/03/2012 |
MEDLINE STOPCOCK AND MANIFOLD |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K120517 |
04/26/2012 |
DEPUY PULSE CERVICAL CAGE SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K113677 |
04/05/2012 |
GRINDCARE MEASURE |
MEDOTECH A/S |
Calley Herzog |
| K120368 |
04/09/2012 |
CAPSTONE CONTROL SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K120207 |
04/23/2012 |
VISIA |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
| K120908 |
04/25/2012 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K112666 |
04/20/2012 |
SALINE WOUND WASH |
NANOPLAS, INC. |
RYAN LYTLE |
| K120279 |
04/06/2012 |
NANOFUSE DBM |
NANOTHERAPEUTICS |
GREGG RITTER |
| K120880 |
04/19/2012 |
ORBIT |
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC |
MARY KAY JENSEN |
| K112247 |
04/02/2012 |
A BAER WITH ABAER I/O FUNCTION |
NATUS MEDICAL INCORPORATED |
CHARLES L MORIN |
| K120709 |
04/06/2012 |
THE DOME GX4MP COLOR NONITOR |
NDS SURGICAL IMAGING |
JIM LENG |
| K113554 |
04/05/2012 |
CMI IMPLANT IS SYSTEM |
NEOBIOTECH CO., LTD. |
APRIL LEE |
| K120764 |
04/27/2012 |
EPIFLO(R) |
NEOGENIX, LLC |
SRINIVASAN SARANGAPANI |
| K120182 |
04/19/2012 |
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES |
NEOMED, INC. |
PENNY NORTHCUTT |
| K120051 |
04/20/2012 |
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML |
NEPHRON PHARMACEUTICALS CORP. |
MARCUS JULIANO |
| K112314 |
04/27/2012 |
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER |
NEPHROS, INC. |
GREG COLLINS |
| K112286 |
04/19/2012 |
NOVAC 11 |
NEW RADIANT TECHNOLOGY S.P.A. |
MAUREEN O'CONNEL |
| K112315 |
04/23/2012 |
HOME PREGNANCY TEST |
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD |
CHANDRAVADAN PATEL |
| K113398 |
04/18/2012 |
NEXUS TKO-6, LUER-ACTIVATED DEVICE |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K113494 |
04/19/2012 |
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
MARIA HATEGAN |
| K112843 |
04/19/2012 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
BRODIE PEDERSON |
| K113221 |
04/27/2012 |
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS |
NORTH AMERICAN SCIENCE ASSOC., INC. |
JULIE WHEELER |
| K121001 |
04/17/2012 |
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) |
NOVITAS MEDICAL, LLC |
MARSHAL FRYMAN |
| K112717 |
04/13/2012 |
NUVASIVE NVJJB SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K113608 |
04/10/2012 |
DEFLEX |
NUXEN S.R.L. |
HERNAN ILARI |
| K113687 |
04/30/2012 |
EQUINOX RELIEVE |
O-TWO MEDICAL TECHNOLOGIES, INC. |
David Zhang |
| K120196 |
04/19/2012 |
OLEA SPHERE |
OLEA MEDICAL |
KRISTI GUSMAN |
| K111425 |
04/20/2012 |
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI MUSGNUNG |
| K120238 |
04/03/2012 |
RTVUE XR OCT |
OPTOVUE, INC. |
JOHN J TALARICO |
| K120034 |
04/17/2012 |
RADIOGRAPHIC X-RAY SYSTEM |
ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. |
JUN PENG |
| K120165 |
04/17/2012 |
INTRAOSSEOUS FIXATION SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K120157 |
04/10/2012 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K120291 |
04/16/2012 |
OP SPINE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K120015 |
04/24/2012 |
OSTEOMED WRIST PLATING SYSTEM |
OSTEOMED LP |
SUZANNE CHEANG |
| K112795 |
04/20/2012 |
PALTOP DENTAL IMPLANT SYSTEM |
PALTOP ADVANCED DENTAL SOLUTIONS LTD |
TAL HAMMER-TOPAZ |
| K120942 |
04/20/2012 |
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
| K113839 |
04/12/2012 |
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K120028 |
04/17/2012 |
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES |
Pegavision Corporation |
TONY HSU |
| K120330 |
04/02/2012 |
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 |
PENUMBRA, INC. |
EMILLY T NURTHEN |
| K120255 |
04/19/2012 |
PHILIPS MICRODOSE |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
GUSTAV LINS |
| K113144 |
04/03/2012 |
PAGEWRITER TC 20, 30, 50, 70 |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K120367 |
04/17/2012 |
3MENSIO WORKSTATION |
PIE MEDICAL IMAGING B.V. |
Florie Daniels |
| K120313 |
04/20/2012 |
NEO CR KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K120065 |
04/03/2012 |
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES |
PLAXTRON INDUSTRIAL (M) SDN. BHD. |
MING-YIE JAN |
| K113488 |
04/18/2012 |
JAZZY ELITE 6 |
PRIDE MOBILITY PRODUCT CORPORRATION |
KIMBERLY BLAKE |
| K111453 |
04/05/2012 |
STEAM DOT BLU PROCESS INDICATOR |
PROPPER MFG. CO., INC. |
ANDREW SHARAVARA |
| K120003 |
04/05/2012 |
NUCAL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K112696 |
04/18/2012 |
TWIN PEAKS LUMBAR CAGE |
QUALGENIX LLC |
RICHARD DESLAURIERS |
| K120859 |
04/19/2012 |
PRE-LOADED GOLD VISICOIL CK MARKER |
RADIOMED CORPORATION |
GORDON ROBERTS |
| K120161 |
04/13/2012 |
ALPHAPOINT IMAGING SOFTWARE |
RADLOGICS, INC. |
MOSHE BECKER |
| K120252 |
04/11/2012 |
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K120387 |
04/06/2012 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
| K112505 |
04/06/2012 |
ETHEREA |
REGULATORY INSIGHT, INC. |
Kevin Walls |
| K111085 |
04/25/2012 |
SHARPS TANK REUSABLE SHARPS CONTAINER |
REHRIG PACIFIC COMPANY |
DAVID OLMSTEAD |
| K113640 |
04/05/2012 |
STELLAR 150 |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K113780 |
04/20/2012 |
EASYCARE TX SYSTEM (CONNEXUNS) |
RESMED LTD. |
DAVID D'CRUZ |
| K120190 |
04/02/2012 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
ELIZABETH DENG |
| K112928 |
04/17/2012 |
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K112073 |
04/11/2012 |
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... |
RX DEVICES LLC |
CHARLES HOKANSON |
| K112153 |
04/26/2012 |
IROOT 100 MINI |
S-DENTI CO., LTD. |
PETER CHUNG |
| K120818 |
04/19/2012 |
OTIS-C PLUS |
SCIENCE FOR BIOMATERIALS |
DENIS CLEMENT |
| K113485 |
04/25/2012 |
ELECTROCARDIOGRAPH |
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
Diana Hong |
| K120699 |
04/19/2012 |
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
WU ZICUI |
| K121010 |
04/19/2012 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K113186 |
04/12/2012 |
STERILE INSULIN PEN NEEDLE |
SHINA CORP. |
JISEOP JEONG |
| K112149 |
04/09/2012 |
WEIGHT AND BODY FAT SCALE SHINE BS0105 |
SHINE OVERSEAS MARKETING LIMITED |
CHARLIE MACK |
| K120331 |
04/13/2012 |
SYNGO CT DYNAMIC ANGIO |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K120315 |
04/13/2012 |
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K112611 |
04/25/2012 |
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS |
SINTEA PLASTEK, LLC |
DANIELLE WERNIKOWSKI |
| K112982 |
04/02/2012 |
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) |
SMALL BONE INNOVATIONS INC. |
JOHN MINIER |
| K113789 |
04/19/2012 |
MODULAR PROXIMALLY FLUTED HIP STEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K113848 |
04/27/2012 |
R3 XLPE LINERS |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K120667 |
04/04/2012 |
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K120390 |
04/10/2012 |
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
LOUISE ROCHT |
| K120433 |
04/02/2012 |
CLEAR + BRILLIANT LASER SYSTEM |
SOLTA MEDICAL, INC. |
KRISTINE FOSS |
| K110840 |
04/17/2012 |
LIAC |
SORDINA S.P.A. |
BERTHOIN CLAUDE |
| K113626 |
04/05/2012 |
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K113611 |
04/20/2012 |
RAPID PROGRAMMER |
ST. JUDE MEDICAL |
TERI GILIO |
| K111050 |
04/12/2012 |
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR |
STARBOARD MEDICAL, LLC |
ANTHONY BERAN |
| K120204 |
04/03/2012 |
REPROCESSED FEMORAL COMPRESSION DEVICE |
STERILMED, INC. |
JASON SKRAMSTED |
| K120816 |
04/17/2012 |
INZONE DETACHMENT SYSTEM |
Stryker |
MARA CHOU |
| K113778 |
04/20/2012 |
EXCELSIOR XT-27 MICROCATHETER |
STRYKER NEUROVASCULAR |
YOKO Y ENRILE |
| K120850 |
04/17/2012 |
TARGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
RHODA SANTOS |
| K113802 |
04/16/2012 |
ESCALATE LAMINOPLASTY SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K121106 |
04/27/2012 |
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET |
SURGICAL APPLIANCE INDUSTRIES, INC. |
GARY PARSONS |
| K113463 |
04/06/2012 |
POWER WHEELCHAIR |
SUZHOU KD MEDICAL APPLIANCE CO., LTD. |
JUNNATA CHANG |
| K113857 |
04/23/2012 |
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE |
SYNERGETICS, INC |
GARY OLIVEROS |
| K113586 |
04/18/2012 |
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
| K120972 |
04/13/2012 |
FLEXITOUCH SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
PHILLIP ROSE |
| K113768 |
04/12/2012 |
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
MEIRU LI |
| K111480 |
04/04/2012 |
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM |
TECHNOLOGY DELIVERY SYSTEMS, INC. |
JAMES HARVEY KNAUSS |
| K112305 |
04/17/2012 |
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES |
THUNDER TIGER CORP. |
JO LEE |
| K112290 |
04/16/2012 |
SUPERCATH Z3V |
TOGO MEDIKIT CO., LTD. |
FUMIAKI KANAI |
| K120135 |
04/13/2012 |
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K120794 |
04/13/2012 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K112989 |
04/10/2012 |
AQUILION CXL |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K113466 |
04/10/2012 |
AQUILION ONE |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
PAUL BIGGINS |
| K120710 |
04/06/2012 |
AQUILION PRIME |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K113352 |
04/16/2012 |
TRANSCORP SPINAL ACCESS SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
| K120403 |
04/16/2012 |
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER |
TRANSENTERIX, INC. |
TAMMY B CARREA |
| K120349 |
04/09/2012 |
SONIXGPS VASCULAR ACCESS NEEDLE KIT |
ULTRASONIX MEDICAL CORPATION |
CHAS YU |
| K120872 |
04/20/2012 |
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS |
UNOMEDICAL A/S INFUSION DEVICES |
JOHN M LINDSKOG |
| K112148 |
04/30/2012 |
POWERED MUSCLE STIMULATOR |
VALMED, SA |
CARL MAGNELL |
| K120341 |
04/27/2012 |
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K111872 |
04/19/2012 |
VIRTUOSO SYSTEM FOR IHC P53 (DO-7) |
VENTANA MEDICAL SYSTEMS, INC. |
TROY QUANDER |
| K120697 |
04/05/2012 |
EAGLE EYE PLATINUM ST CATHETER |
VOLCANO CORPORATION |
MARILYN POURAZAR |
| K120428 |
04/20/2012 |
GORE DRYSEAL SHEATH |
W. L. GORE & ASSOCIATES, INC. |
NANCY B LOWE |
| K120774 |
04/10/2012 |
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K111895 |
04/27/2012 |
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE |
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY |
MARGE WALLS-WALKER |
| K120802 |
04/02/2012 |
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K120645 |
04/24/2012 |
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
| K112426 |
04/02/2012 |
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES |
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
CHU XIAOAN |
| K112816 |
04/18/2012 |
ZHENJIANG ASURE MECHANICAL WHEELCHAIR |
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD |
JEN KE-MIN |
| K112761 |
04/25/2012 |
ZOLL PROPAQ MD |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHARLES W KOLIFRATH |
| K120703 |
04/13/2012 |
ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM |
ZONARE MEDICAL SYSTEMS, INC. |
MARK JOB |
