| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K101374 |
03/16/2011 |
AAXTER A3 POSTERIOR SPINAL SYSTEM |
AAXTER CO., LTD |
JACK CHEN |
| DEN070014 |
03/31/2011 |
MANDOMETER III |
AB MANDO |
KIM BLOOM |
| K101422 |
03/22/2011 |
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K110218 |
03/31/2011 |
INSPIRA AIR BALLOON DILATION SYSTEM |
ACCLARENT, INC. |
KERI YEN |
| K103471 |
03/14/2011 |
UBM PLUS |
ACCUTOME, INC. |
BRIAN T.S. BARRETT |
| K103499 |
03/31/2011 |
A SCOPE |
ACTIVE SIGNAL TECHNOLOGIES, INC. |
HARVEY KNAUSS |
| K110458 |
03/14/2011 |
SILVER ANTIMICROBIAL WOUND GEL |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K092622 |
03/04/2011 |
STERRAD 100NX STERILIZER EXPRESS CYCLE |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K101154 |
03/28/2011 |
CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L |
AIRSEP CORP. |
PETER WEISENBORN |
| K110503 |
03/10/2011 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) |
AIRSTRIP TECHNOLOGIES, LP |
ANDY MILLER |
| K102402 |
03/30/2011 |
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K110108 |
03/16/2011 |
MODALIXX |
AMPRONIX, INC. |
ASAL NAMINI |
| K110018 |
03/15/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
| K101913 |
03/11/2011 |
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM |
ANTHOGYR SAS |
ERIC GENEVE |
| K102241 |
03/23/2011 |
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT |
ANTHOGYR SAS |
BRAYETTE SABINE |
| K102825 |
03/02/2011 |
BLOOD PRESSURE CUFF |
APK TECHNOLOGY CO., LTD |
Diana Hong |
| K102636 |
03/03/2011 |
ZENITH PEDICLE SYSTEM |
APOLLO SPINE, INC. |
CHRISTINE SANTAGATE |
| K110660 |
03/31/2011 |
ARTHREX BIOCOMPOSITE SUTURETAK |
ARTHREX, INC. |
COURTNEY SMITH |
| K103705 |
03/18/2011 |
LOW PROFILE SCREWS |
ARTHREX, INC. |
COURTNEY SMITH |
| K101985 |
03/07/2011 |
ASAHI GUIDE WIRE EXTENSION 165CM |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K110553 |
03/18/2011 |
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE |
ASAHI INTECC USA, INC. |
YOSHI TERAI |
| K103828 |
03/29/2011 |
BILI-THERAPY SPOT TYPE |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K102554 |
03/03/2011 |
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES |
AVITA CORPORATION |
JENNIFER REICH |
| K103679 |
03/03/2011 |
AXIS PACS, HMS PACS |
AXIS HEALTH CARE, LLC |
RONALD W GRAHAM |
| K103546 |
03/17/2011 |
AYCAN WORKSTATION OSIRIX PRO |
AYCAN DIGITALSYSTEME GMBH |
MATTHIAS BROENNER |
| K103792 |
03/04/2011 |
BARCO MAMMO TOMOSYNTHESIS |
BARCO NV |
LIEVEN DE WANDEL |
| K103245 |
03/23/2011 |
CELSTAT |
BAXTER HEALTHCARE CORP. |
SAMUEL MATHEW |
| K102936 |
03/30/2011 |
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K103551 |
03/25/2011 |
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K102064 |
03/07/2011 |
BD FACS SAMPLE PREP ASSISTANT III (SPA III) |
BECTON DICKINSON & CO. |
Katy Campbell |
| K103798 |
03/18/2011 |
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS |
BECTON DICKINSON & CO. |
Thalia Charles |
| K101901 |
03/08/2011 |
IPL THERAPY SYSTEM |
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT |
Diana Hong |
| K110796 |
03/31/2011 |
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE |
BIOMERS PRODUCTS, LLC |
DARYL WISDAHL |
| K101607 |
03/11/2011 |
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K101608 |
03/11/2011 |
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K110555 |
03/24/2011 |
ARCOMXL ACTIVE ARTICULATION |
BIOMET MANUFACTURING CORP. |
BEKCY EARL |
| K102580 |
03/03/2011 |
VANGUARD REMOVABLE MOLDED POLY TIBIA |
BIOMET MANUFACTURING CORP. |
TAMARA J WEST |
| K110145 |
03/04/2011 |
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR |
BIOMET, INC. |
ELIZABETH WRAY |
| K103751 |
03/22/2011 |
MUSTANG BALLOON DILATATION CATHETERS |
BOSTON SCIENTIFIC |
ANNE V ROSSI |
| K110686 |
03/28/2011 |
ACCUTRAC |
BOSTON SCIENTIFIC CORP. |
LAUREN ANDERSON |
| K110685 |
03/29/2011 |
FLEXIVA TRACTIP |
BOSTON SCIENTIFIC CORP. |
LAUREN ANDERSON |
| K110295 |
03/03/2011 |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
BOSTON SCIENTIFIC CORP. |
SHANNON PETTIT |
| K102912 |
03/03/2011 |
INTERLOCK FIBERED IDC OCCLUSION SYSTEM |
BOSTONSCIENTIFIC |
DEBBIE MCINTIRE |
| K103246 |
03/16/2011 |
IPLAN RT |
BRAINLAB, AG |
ALEXANDER SCHWIERSCH |
| K103640 |
03/22/2011 |
MIDMARK IQECG |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
GREG HOLLAND |
| K101928 |
03/23/2011 |
VENTRALEX ST HERNIA PATCH |
C.R. BARD, INC. |
MICHELLE GODIN |
| K101920 |
03/23/2011 |
VENTRIO ST HERNIA PATCH |
C.R. BARD, INC. |
MICHELLE GODIN |
| K103591 |
03/29/2011 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K110585 |
03/25/2011 |
CAPTIVA SPINE FUSELOX CERVICAL CAGE |
CAPTIVA SPINE, INC |
JOHN SANDERS |
| K100698 |
03/14/2011 |
STCC |
CARDINAL SPINE, LLC |
DAVID J COLLETTE |
| K110389 |
03/11/2011 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
MEGAN M BRANDT |
| K103106 |
03/30/2011 |
CHLORASHIELD TM ANTIMICROBIAL DRESSING |
CARE FUSION 213 LLC |
ARLEN JOHNSON |
| K103410 |
03/30/2011 |
NEOPAP SYSTEM |
CHILDRENS MEDICAL VENTURES LLC |
SCOTT WRIGHT |
| K103172 |
03/11/2011 |
CIV-OB (PLUS) |
CIVNET COMMUNICATION LTD |
NATHAN BEN-NATHAN |
| K110332 |
03/24/2011 |
CLEARCANVAS RIS / PACS |
CLEARCANVAS INC. |
CLINTON CHAU |
| K103038 |
03/29/2011 |
DUET DRF |
CMT MEDICAL TECHNOLOGIES, LTD. |
SHLOMI DINES |
| K101830 |
03/31/2011 |
ZMACHINE, MODEL DT-100 |
CONSOLIDATED RESEARCH OF RICHMOND, INC |
RICHARD KAPLAN |
| K101530 |
03/29/2011 |
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K110347 |
03/16/2011 |
DOPPLER MONITOR |
COOK VASCULAR, INC. |
JIM FERGUSON |
| K103518 |
03/09/2011 |
TRINITY ACETABULAR SYSTEM |
CORIN U.S.A. |
LUCINDA GERBER, BA (HONS) |
| K102635 |
03/22/2011 |
APOLONIA LASER IMPLANT SYSTEM |
CSM IMPLANT CO., LTD |
JOYCE BANG |
| K103709 |
03/10/2011 |
CERACELL DENTAL |
CURASAN AG |
ROGER GRAY |
| K110511 |
03/11/2011 |
E4D COMPASS |
D4D TECHNOLOGIES |
Allison Scott |
| K102320 |
03/04/2011 |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) |
DAESUNG MAREF CO., LTD. |
BRANDON CHOI |
| K100424 |
03/21/2011 |
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS |
DANMEDICAL LIMITED |
IAN DRYSDALE |
| K103371 |
03/11/2011 |
COUDE/ OR TIEMANN |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K103712 |
03/11/2011 |
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K103756 |
03/15/2011 |
DEPUY ATTUNE TOTAL KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K093736 |
03/10/2011 |
DEPUY CORAIL HIP SYSTEM, REVISION STEM |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K103146 |
03/11/2011 |
ISOGRAY TREATMENT PLANNING SYSTEM |
DOSISOFT SA |
ROBERT J MORTON |
| K102474 |
03/04/2011 |
FLAATZ 750E |
DRTECH CORP. |
BEOM-JIN MOON |
| K110393 |
03/04/2011 |
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W |
EKF-DIAGNOSTIC GMBH |
STEPHEN GORSKI |
| K101482 |
03/31/2011 |
EM-9000 |
ELITE MEDICAL INC |
STEVEN J DE BROCK |
| K102647 |
03/24/2011 |
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... |
ELITECHGROUP VITAL SCIENTIFIC BV |
DEBRA K HUTSON |
| K103696 |
03/22/2011 |
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES |
ERBE USA, INC. |
JOHN TARTAL |
| K110699 |
03/25/2011 |
LIGAMAX 5 |
ETHICON ENDO-SUGERY, LLC |
EMILY KRUETZKAMP |
| K110385 |
03/25/2011 |
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER |
ETHICON ENDO-SURGERY, INC. |
ASIFA VONHOF |
| K103786 |
03/24/2011 |
ZEST PETITE NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K092433 |
03/10/2011 |
DYSIS |
FORTH PHOTONICS HELLAS SA |
JUAN CARLOS SERNA |
| K101552 |
03/14/2011 |
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
S.DAVID PIPER, PE |
| K110721 |
03/30/2011 |
GAUNYING INFRARED LAMP |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
LADI LEE |
| K103687 |
03/04/2011 |
SYNAPSE 3D CEREBRAL ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K103720 |
03/16/2011 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KIMERLY A SHARP |
| K103596 |
03/29/2011 |
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KATHERINE Y CHOI |
| K103134 |
03/11/2011 |
FUKUDA DENSHI |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K103335 |
03/07/2011 |
GEM OPTION FOR 1.5 MRI SYSTEMS |
GE HEALTHCARE |
MICHAEL S PRETO |
| K103458 |
03/04/2011 |
VIEWPOINT 6 |
GE HEALTHCARE |
NICOLE LANDREVILLE |
| K103649 |
03/09/2011 |
VOLUSON S6, VOLUSON S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K103411 |
03/22/2011 |
IDEAL IQ SOFTWARE OPTION |
GE MEDICAL SYSTEMS |
TRACEY FOX |
| K103480 |
03/07/2011 |
THORACIC VCAR |
GE MEDICAL SYSTEMS, LLC |
STEPHEN SLAVENS |
| K110601 |
03/18/2011 |
SENTINELLA 102 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A |
SEVERINE MOINE |
| K103425 |
03/29/2011 |
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM |
GENORAY AMERICA INC. |
JAE KIM |
| K102299 |
03/18/2011 |
CPR FACE MASK |
GENUINE FIRST AID LLC |
Gary Lehnus |
| K103504 |
03/16/2011 |
GETINGE 400HC/500HC SERIES STEAM STERILIZER |
GETINGE SOURCING, LLC |
BARB SMITH |
| K101250 |
03/07/2011 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES |
GIVEN IMAGING LTD. |
Tim Thomas |
| K102172 |
03/01/2011 |
MSA HIP SYSTEM |
GLOBAL MANUFACTURING TECHNOLOGY |
HOLLACE S RHODES |
| K103072 |
03/17/2011 |
REVERE SACRAL PLATES |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K110299 |
03/21/2011 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K102964 |
03/07/2011 |
EU-TTG IGA AND EU-TTG IGG |
GRIFOLS USA, INC. |
CATHERINE L WONG |
| K102692 |
03/11/2011 |
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO |
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. |
CHENGYU SHEN |
| K103585 |
03/04/2011 |
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP |
HARRY J. BOSWORTH CO. |
GARY CHUVEN |
| K103537 |
03/10/2011 |
ET III SA ULTRA WIDE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K103265 |
03/16/2011 |
NHANES WHOLE BODY DXA REFERENCE DATABASE |
HOLOGIC, INC. |
CHRISTINA HURTON |
| K102019 |
03/03/2011 |
RESTORATION ACETABULAR WEDGE AUGMENTS |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K103613 |
03/02/2011 |
INPECTRA STO2 SPOT CHECK |
HUTCHINSON TECHNOLOGY, INC. |
COLIN M MCGRAW |
| K110412 |
03/16/2011 |
IDS-ISYS IFG-I CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K103493 |
03/11/2011 |
HEAD FIATION DEVICE (HFD 100) |
IMRIS, INC. |
THOMAS M TSKERIS |
| K103416 |
03/17/2011 |
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM |
INFIMED, INC. |
JIGAR SHAH |
| K103670 |
03/31/2011 |
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) |
INNOVATIVE GLOVES CO; LTD |
RAJEEV SOOD |
| K101644 |
03/23/2011 |
QUANTA FLASH H-TTG IGG |
INOVA DIAGNOSTICS, INC. |
RUFUS BURLINGAME |
| K102164 |
03/17/2011 |
HEMOSIL PROTEIN S ACTIVITY ASSAY |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
| K103742 |
03/17/2011 |
ACCELL EVO3 (FORMERLY ACCELL A2I) |
INTEGRA LIFESCIENCES |
JENNY FAM |
| K103741 |
03/02/2011 |
SURGISURE TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL, INC. |
JOHN J VOZELLA |
| K103700 |
03/15/2011 |
ESSENTIAL MRI PATIENT MONITOR |
INVIVO CORPORATION |
RUSTY KELLY |
| K103586 |
03/30/2011 |
IOS FASTSCAN SPRAY |
IOS TECHNNOLOGIES, INC. |
DUANE DURBIN |
| K101852 |
03/23/2011 |
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT |
IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I |
DAVID W GATES |
| K102704 |
03/10/2011 |
EASY CUFF |
JOAN SPIEGEL, MD |
PAUL DRYDEN |
| K102190 |
03/17/2011 |
WINSTIM |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
| K103743 |
03/17/2011 |
CONCORDE CURVE SYSTEM |
JOHNSON & JOHNSON |
EUGENE BANG |
| K103488 |
03/02/2011 |
CONCORDE BULLET CAGE SYSTEM |
JOHNSON AND JOHNSON |
KEVIN G STEVENS |
| K103169 |
03/07/2011 |
ALEUTTIAN |
K2M, INC. |
NANCY GIEZEN |
| K103440 |
03/17/2011 |
EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K102229 |
03/04/2011 |
PULMOTRACK 2020 SYSTEM |
KARMELSONIX |
YORAM LEVY |
| K103156 |
03/14/2011 |
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K102574 |
03/07/2011 |
PALLA M SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
JOYCE BANG |
| K103026 |
03/29/2011 |
ELECTRO SENSOR -BODY COMPOSITION |
L.D. TECHNOLOGY, LLC |
RICHARD CLEMENT |
| K103498 |
03/31/2011 |
LAKONG ULTRASONIC SCALER |
LAKONG MEDICAL DEVICE COMPANY, LTD |
DANNY WANG |
| K103666 |
03/23/2011 |
LANX LATERAL |
LANX, INC. |
ALAN BRUKHOLDER |
| K103237 |
03/25/2011 |
LANX SPINAL SYSTEM |
LANX, INC. |
DAMON BELLONI |
| K110036 |
03/28/2011 |
FX 222-02 POWERED WHEELCHAIR |
LANZHOU WANLI AVIATION ELECTROMECHANICAL INC. |
JUNNATA CHANG |
| K103686 |
03/15/2011 |
STAR 50 N |
LARSEN & TOUBRO LIMITED |
E. J SMITH |
| K103763 |
03/11/2011 |
STELLAR 300 |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K102727 |
03/16/2011 |
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY |
LENSAR, INC. |
SHIRLEY MCGARVEY |
| K101458 |
03/11/2011 |
LINA XCISE MODEL MOR-1515 |
LINA MEDICAL APS |
WALT BRITTLE |
| K101792 |
03/18/2011 |
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 |
LINDE GAS NORTH AMERICA LLC |
MICHAEL PIACENZA |
| K110042 |
03/24/2011 |
MANUKATEX |
MANUKA MEDICAL LIMITED |
James Smith |
| K102919 |
03/11/2011 |
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K102464 |
03/04/2011 |
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K103191 |
03/08/2011 |
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K102533 |
03/22/2011 |
ROTATING GAMMA SYSTEM INFINI (INFINI) |
MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN |
SUSAN D GOLDSTEIN-FALK |
| K110028 |
03/17/2011 |
MASIMO RADICAL Y PULSE CO-OXIMETER |
MASIMO CORPORATION |
SHELLY HARRIS |
| K103136 |
03/18/2011 |
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K110343 |
03/11/2011 |
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP |
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD |
NEIL HEWITT |
| K103721 |
03/21/2011 |
MPACT ACETABULAR SYSTEM |
MEDACTA INTERNATIONAL |
NATALIE J KENNEL |
| K103170 |
03/24/2011 |
GMK REVISION KNEE SC LINERS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K093830 |
03/03/2011 |
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE |
MEDLINE INDUSTRIES, INC. |
MATT CLASEN |
| K101560 |
03/25/2011 |
MEDLINE RETRACTABLE SAFETY SYRINGE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K103375 |
03/16/2011 |
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL |
MEDTEK DEVICES, INC. |
GREG PEPE |
| K102588 |
03/18/2011 |
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE |
MEDTRONIC ABLATION FRONTIERS, LLC |
BRENDA CLAY |
| K101930 |
03/15/2011 |
MEMOMETAL NAVIS BONE PLATING SYSTEM |
MEMOMETAL TECHNOLOGIES |
GILES AUDIC |
| K103427 |
03/24/2011 |
MOBILEECG SYSTEM |
MEMTEC CORP. |
DENNIS GARBOSKI |
| K100569 |
03/11/2011 |
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 |
MERIT MEDICAL SYSTEMS, INC. |
LINDSAY MARTIN |
| K103123 |
03/10/2011 |
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) |
MICRO-MEGA SOCIETE ANONYME |
CONCHE PHILIPPE |
| K103656 |
03/24/2011 |
THERMO SCIENTIFIC MAS R DOA TOTAL |
Microgenics Corporation |
LISA CHARTER |
| K102563 |
03/15/2011 |
SINGLE CANNULA EXTENDED APPLICATOR |
MICROMEDICS, INC. |
TOM LOPAC |
| K110591 |
03/29/2011 |
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL |
MR INSTRUMENTS, INC. |
JOSHUA J HOLWELL |
| K110322 |
03/04/2011 |
OLECRA INTRAMEDULLARY FIXATION SYSTEM |
MYLAD ORTHOPEDIC SOLUTIONS |
SCOTT G EDWARDS |
| K093584 |
03/04/2011 |
EZ-MISTER |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K103126 |
03/03/2011 |
TROPHON CHEMICAL INDICATOR |
NANOSONICS LIMITED |
RON WEINBERGER |
| K102677 |
03/24/2011 |
BODYTOM NL 4000 |
NEUROLOGICA CORPORATION |
DONALD D FICKETT |
| K102874 |
03/28/2011 |
NEW STETIC ACRYLICS |
NEW STETIC |
ARTHUR WARD |
| K110445 |
03/17/2011 |
FLEXFUSION (TM) FIXATION IMPLANT |
NEXTREMITY SOLUTIONS, LLC |
ARTHUR A ALFARO |
| K110058 |
03/31/2011 |
BPA-FREE PIT AND FISSURE SEALANT |
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC |
CORA BRACHO-TROCONIS |
| K103750 |
03/03/2011 |
NUVASIVE TRAVERSE PLATE SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K102115 |
03/30/2011 |
ODFS PACE |
ODSTOCK MEDICAL LTD |
STEVEN CROOK |
| DEN100025 |
03/31/2011 |
WIDEXLINK IN CLEAR SERIES HEARING AIDS |
OFFICE RESEARCH IN CLINICAL AMPLIFICTION |
FRANCIS KUK |
| K102578 |
03/25/2011 |
APEX PS KNEE SYSTEM |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K110501 |
03/21/2011 |
HEM-4030 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K103650 |
03/23/2011 |
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM |
OON CORP. RESOURCES |
JANNA P TUCKER |
| K103837 |
03/24/2011 |
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K103384 |
03/16/2011 |
ESCALADE ACETABULAR CUP SYSTEM |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K103111 |
03/23/2011 |
FORZA SPACER SYSTEM |
ORTHOFIX INC. |
DARLA CHEW |
| K103114 |
03/14/2011 |
OSSPRAY SYLC CR |
OSSPRAY LTD |
IAN THOMPSON |
| K103105 |
03/25/2011 |
ORTHODONTIC SCREW |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K103664 |
03/17/2011 |
PRIMUS AESTHETIC PLATFORM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K103148 |
03/11/2011 |
AIDA DIAGNOSTIC ULTRASOUND SYSTEM |
PANASONIC HEALTHCARE CO., LTD. |
RAM BEDI |
| K110371 |
03/17/2011 |
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY |
PANORAMIC CORP. |
DANIEL KAMM |
| K103477 |
03/03/2011 |
PERMOBIL M300 / M400 |
PERMOBIL AB |
JAN ASTROM |
| K110456 |
03/02/2011 |
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM |
PHARMAJET, INC. |
MICHAEL J RYAN |
| K110151 |
03/22/2011 |
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T |
PHILIPS HEALTHCARE |
LYNN HARMER |
| K102958 |
03/18/2011 |
PHILIPS AVALON FETAL MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MICHAEL ASMALSKY |
| K110622 |
03/31/2011 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HERBERT VAN DYK |
| K102821 |
03/11/2011 |
DISCOVRED |
PHOENIX DENTAL, INC. |
JEFFREY S COX |
| K103748 |
03/02/2011 |
LAGUNA PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K103567 |
03/22/2011 |
LIFEPAK 15 MONITOR/DEFIBRILLATOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K101790 |
03/07/2011 |
QUANTUM SPINAL SYSTEM, QUANTUM MIS |
PIONEER SURGICAL TECHNOLOGY |
BARRY E SANDS |
| K110367 |
03/23/2011 |
PIONEER SPINAL PROCESS FUSION PLATE |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY M DOWNS |
| K103689 |
03/17/2011 |
PLANMECA PROMAX 3D MID |
PLANMECA OY |
LARS MORING |
| K110491 |
03/16/2011 |
BACKSTOP CATHETER |
PLUROMED, INC. |
JAMES WILKIE |
| K103339 |
03/31/2011 |
TDS ABUTMENT FOR FRIADENT XIVE |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K110416 |
03/24/2011 |
ABL835 FLEX ANALYZER WITH PLEURAL PH |
RADIOMETER MEDICAL APS |
SOREN BOGESTRAND |
| K092275 |
03/01/2011 |
RANDOX ECSTASY (MDMA) ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K103206 |
03/04/2011 |
RAUMEDIC- ICP-MONITORING SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K101721 |
03/24/2011 |
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
REGULATORY AND MARKETING SERVICES, INC. |
ARTHUR WARD |
| K103167 |
03/01/2011 |
STELLAR 150 |
RESMED GERMANY INC. |
SANDRA GRUNWALD |
| K110444 |
03/16/2011 |
MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K102586 |
03/18/2011 |
S9 VPAP ADAPT WITH H5I |
RESMED LTD. |
DAVID D'CRUZ |
| K102465 |
03/24/2011 |
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ELAINE LARKIN |
| K103395 |
03/24/2011 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K103661 |
03/23/2011 |
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE |
RUBBERCARE PROTECTION PRODUCTS SDN BHD |
LIM KWEE SHYAN |
| K102403 |
03/03/2011 |
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL |
SAM MEDICAL PRODUCTS |
JACK N MCCUTCHEON |
| K103841 |
03/15/2011 |
BELIMED STEAM STERILIZER MST-V |
SAUTER AG |
HANS STADLER |
| K101916 |
03/18/2011 |
JOULE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K101876 |
03/01/2011 |
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
| K101854 |
03/07/2011 |
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K102779 |
03/18/2011 |
EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C |
Siemens Healthcare Diagnostics Inc. |
JANET M FOSE |
| K093987 |
03/28/2011 |
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 |
Siemens Healthcare Diagnostics Inc. |
DONNA VELASQUEZ |
| K103127 |
03/04/2011 |
SOMATOM DEFINITION AS |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ALICIA BUSTOS-JUERGENSEN |
| K100370 |
03/07/2011 |
SYMMETRIC TOTAL KNEE AGUMENTS |
SIGNAL MEDICAL CORP. |
BRIAN KATERBERG |
| K103711 |
03/22/2011 |
ORTHOPHOS XG 3D / CEPH |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K103579 |
03/18/2011 |
INTRA SKAN DC |
SKANRAY TECHNOLOGIES |
PARASURAMAPPA BELUR |
| K103409 |
03/15/2011 |
ALLERGEAZE R CLEAR |
SMARTPRACTICE |
KIM SULLIVAN |
| K103389 |
03/25/2011 |
TRUCLEAR INCISOR PLUS BLADE 2.9 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K110038 |
03/30/2011 |
TRUCLEAR MORCELLATOR SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K110064 |
03/18/2011 |
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM |
SNAP DIAGNOSTICS, L.L.C. |
GIL RAVIV |
| K103682 |
03/04/2011 |
PARIETEX PROGRIP |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K102521 |
03/28/2011 |
PANTINO PRO POSITINER |
SOMNOMED INC. |
BRADLEY SOUTHWORTH |
| K102642 |
03/04/2011 |
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO |
SONOSCAPE COMPANY LIMITED |
MIN YAO |
| K103813 |
03/22/2011 |
SOPRO 281 |
SOPRO |
RICK ROSATI |
| K101850 |
03/02/2011 |
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION |
SPACELABS HEALTHCARE LTD. |
THOMAS KROENKE |
| K103142 |
03/03/2011 |
SPACELABS MULTI-PARAMETER MODULE |
SPACELABS HEALTHCARE, INC. |
THOMAS KROENKE |
| K110065 |
03/02/2011 |
SPAULDING IQ ELECTROCARDIOGRAPH |
SPAULDING CLINICAL RESEARCH, LLC |
PAUL SCHULTZ |
| K101947 |
03/16/2011 |
IVD-GE02 |
SPHERE MEDICAL LTD. |
MARY HUTCHENS |
| K103505 |
03/15/2011 |
ALTUM ANTERIOR CERVICAL PLATE |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K092138 |
03/22/2011 |
JTS EXTENDEABLE IMPLANT |
STANMORE IMPLANTS WORLDWIDE LTD. |
GERARD J PRUD'HOMME |
| K094035 |
03/24/2011 |
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM |
STELKAST COMPANY |
DONALD A STEVENS |
| K110453 |
03/16/2011 |
RELIANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K103053 |
03/10/2011 |
VERIFY 270FP CHALLENGE PACK |
STERIS Corporation |
ROBERT SULLIVAN |
| K103479 |
03/10/2011 |
NOVEL TAPERED HIP STEM |
STRYKER CORP |
ESTELA CELI |
| K110476 |
03/18/2011 |
AXSOS (TM) LOCKING PLATE SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K103400 |
03/07/2011 |
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP |
STRYKER CORPORATION |
LILIAN ECKERT |
| K103292 |
03/04/2011 |
TRIO TRAUMA SPINAL SYSTEM |
STRYKER CORPORATION |
CURTIS TRUESDALE |
| K101887 |
03/22/2011 |
CONFIDENT SURGERY SUITE 300, MODEL CSS300 |
SURGICEYE GMBH |
MORITZ HOYER |
| K101971 |
03/25/2011 |
SYNTEC OS SPINAL FIXATION SYSTEM |
SYNTEC SCIENTIFIC CORP. |
CAROL CHANG |
| K103002 |
03/02/2011 |
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K110354 |
03/04/2011 |
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM |
SYNTHES USA |
THOMAS N SHEA |
| K093046 |
03/22/2011 |
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES |
SYNVASIVE TECHNOLOGY, INC. |
DANIEL KAMM |
| K101569 |
03/01/2011 |
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER |
TaiDoc Technology Corporation |
TELING HSU |
| K101338 |
03/14/2011 |
NEWFIX EXTERNAL FIXATION SYSTEM |
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
ROBERT BARD |
| K102610 |
03/04/2011 |
FOCUS EMG DEVICE |
TELEEMG, LLC USA |
JOE F JABRE, M.D. |
| K102253 |
03/14/2011 |
ECHO BLASTER |
TELEMED |
YURY SOKOLOV |
| K110482 |
03/18/2011 |
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS |
TERATECH CORP. |
CHARLES F HOTTINGER |
| K102846 |
03/17/2011 |
PATIENT EXAMINATION GLOVES |
THAI HUA HOLDING CO., LTD. |
KOK-KEE HON |
| K103647 |
03/01/2011 |
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES |
THD SPA |
GUIDO BONAPACE |
| K102275 |
03/25/2011 |
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 |
THERMEDX, LLC |
JOHN R SCOVILLE |
| K102334 |
03/14/2011 |
TRANS1 AXIALIF PLUS |
TRANS1 INCORPORATED |
CHERYL WAGONER |
| K102839 |
03/15/2011 |
SPIDER STANDARD AND ADVANCED |
TRANSENTERIX, INC. |
BOBBI L HADERSBECK |
| K091010 |
03/01/2011 |
TROKAMED MORCELLATOR |
TROKAMED GMBH |
ANGELIKA SCHERP |
| K103814 |
03/17/2011 |
PEZO INTERBODY CAGES SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K103497 |
03/04/2011 |
CERAMIC FEMORAL HEAD |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K102102 |
03/11/2011 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K102196 |
03/25/2011 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K102640 |
03/25/2011 |
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS |
VERTEX-DENTAL B.V. |
WILLIAM F GREENROSE |
| K100928 |
03/07/2011 |
MICRO DIARY SPIROMETER |
VIASYS RESPIRATORY CARE INC. |
MERRITT GIRGIS |
| K110050 |
03/28/2011 |
FIT TEST C&B |
VOCO GMBH |
MANFRED T PLAUMANN |
| K110224 |
03/18/2011 |
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE |
WEIFANG BEIHAI COLOR PRINTING PACKAGGING CO., LTD |
HAIQI ZHANG |
| K102515 |
03/11/2011 |
NP15 |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K103773 |
03/16/2011 |
ZENOFLEX DIMENSION |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K110552 |
03/23/2011 |
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
| K101820 |
03/03/2011 |
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K110054 |
03/24/2011 |
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE |
ZIMMER CAS |
CHRISTOPHER MCLEAN |
| K103404 |
03/15/2011 |
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM |
ZIMMER GMBH |
JASON HECKAMAN |
| K110526 |
03/25/2011 |
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
| K110361 |
03/08/2011 |
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
| K110512 |
03/23/2011 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
