| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K082734 |
11/13/2008 |
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K082714 |
11/19/2008 |
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K082762 |
11/12/2008 |
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE |
AARDVARK MEDICAL |
|
| K081975 |
11/26/2008 |
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K080503 |
11/12/2008 |
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K082392 |
11/13/2008 |
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH ASCENZI, PH.D. |
| K082991 |
11/20/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K081062 |
11/07/2008 |
AIRSONNETT AIRSHOWER AIR 3 |
AIRSONETT, INC. |
CONSTANCE G BUNDY |
| K082284 |
11/20/2008 |
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM |
ALVEOLUS, INC |
TONY ALEXANDER |
| K082861 |
11/25/2008 |
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEXANDER B HENDERSON SR. |
| K082730 |
11/26/2008 |
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K082266 |
11/07/2008 |
DIGITAL CLINICAL THERMOMETER MODEL V9XX |
AMPEROR-ELECTRONIC(SZ) CO., LTD |
LARRY YANG |
| K082457 |
11/10/2008 |
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) |
ANSELL HEALTHCARE PRODUCTS, INC. |
CYNTHIA A INGRAM |
| K082575 |
11/25/2008 |
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES |
APATECH LTD. |
CANDACE F CEDERMAN |
| K081979 |
11/06/2008 |
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K080467 |
11/25/2008 |
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, |
APPLIED DNA TECHNOLOGIES, INC. |
FENG YU-LEE |
| K081011 |
11/07/2008 |
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 |
AREX USA |
ELLEN HOKANSON |
| K082980 |
11/05/2008 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K083146 |
11/21/2008 |
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K080294 |
11/04/2008 |
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT |
ASTORIA-PACIFIC,INC. |
JASON REYNOLDS |
| K083189 |
11/21/2008 |
STERI-LUB LUBRICATION GEL |
AVAIL MEDICAL PRODUCTS, INC. |
PATRICIA A GOEREE |
| K081940 |
11/18/2008 |
AVALON ELITE VASCULAR ACCESS KIT |
AVALON LABORATORIES, LLC |
LEE WIRTH |
| K082538 |
11/20/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K082125 |
11/21/2008 |
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT |
BEST GLOVE, INC |
NEIL DOW |
| K083148 |
11/07/2008 |
TELECTRODE WET GEL ECG ELECTRODE |
BIO PROTECH, INC. |
KEVIN HAN |
| K082011 |
11/28/2008 |
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K082381 |
11/14/2008 |
GENEX |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K081818 |
11/13/2008 |
BIOLOK MICRO-LOK IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K083069 |
11/13/2008 |
EZLASE 10W |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K082432 |
11/21/2008 |
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
BIOPTICS, INC. |
PATRICIA WADE |
| K082933 |
11/03/2008 |
PASSEO-35 PTA CATHETER |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K082253 |
11/25/2008 |
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J. MEEUWSEN |
| K082971 |
11/13/2008 |
BONART ART-L5 LED CORDLESS CURING LIGHT |
BONART CO. LTD. |
ERIC L ONG |
| K082568 |
11/17/2008 |
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K082508 |
11/21/2008 |
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K083139 |
11/25/2008 |
VIPERSPHERE PTA BALLOON CATHETER |
CARDIOVASCULAR SYSTEMS, INC. |
David Brooke |
| K081088 |
11/06/2008 |
MYRAY SKYVIEW |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K082628 |
11/20/2008 |
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 |
CIRCLE CARDIOVASCULAR IMAGING INC. |
SHIRANTHA SAMARAPPULI |
| K081858 |
11/05/2008 |
RETCAM 3 OPHTHALMIC IMAGING SYSTEM |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
| K082641 |
11/10/2008 |
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K082066 |
11/07/2008 |
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K082322 |
11/14/2008 |
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS |
COVIDIEN |
VIRGINIA VETTER |
| K082454 |
11/07/2008 |
MICROMYST APPLICATOR, MODEL 20-5000 |
COVIDIEN |
VIRGINIA VETTER |
| K072687 |
11/25/2008 |
VALLEYLAB MICROWAVE ABLATION GENERATOR |
COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON |
PHILIP E AKE |
| K082619 |
11/07/2008 |
SILS PORT, MODELS SILSPT5, SILSPT12 |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K083321 |
11/26/2008 |
CARDIO-VIEW |
CURLVIEW IGT, LLC |
|
| K082606 |
11/10/2008 |
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) |
D3 RADIATION PLANNING |
NABIL ADNANI |
| K081287 |
11/21/2008 |
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT |
DEN-MAT HOLDINGS, LLC |
ALAN MATTHEWS |
| K082974 |
11/07/2008 |
MYSTIQUE MB CERAMIC BRACKETS |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K082282 |
11/07/2008 |
HEALIX TI ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON CO. |
KRISTINE CHRISTO |
| K082500 |
11/18/2008 |
DEPUY SIGMA CR-F FEMORAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K082128 |
11/14/2008 |
DEPUY SPINE LATERAL CAGE SYSTEM |
DEPUY SPINE |
DENISE DUCHENE |
| K073390 |
11/21/2008 |
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS |
DIASORIN, INC. |
Mari Meyer |
| K082050 |
11/03/2008 |
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081685 |
11/18/2008 |
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K081687 |
11/10/2008 |
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG |
DIASORIN, INC. |
CAROL A DEPOUW |
| K082763 |
11/12/2008 |
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B |
DIAZYME LABORATORIES |
Abhijit Datta |
| K082512 |
11/07/2008 |
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER |
DIMENSIONAL DOSING SYSTEMS, INC. |
EJ Smith |
| K082600 |
11/26/2008 |
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) |
DRAEGER MEDICAL B.V. |
JOYCE KILROY |
| K082888 |
11/26/2008 |
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 |
Draeger Medical Systems, Inc. |
PRADEEP GUPTA |
| K082261 |
11/06/2008 |
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
DXRAD SOLUTIONS LTD. |
DANIEL KAMM |
| K082187 |
11/13/2008 |
BIOMET ANTERIOR LUMBAR PLATE |
EBI, L.P. |
VIVIAN KELLY MS, RAC |
| K082369 |
11/07/2008 |
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K082602 |
11/26/2008 |
FETAL & MATERNAL MONITOR, MODEL F6, F9 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K072634 |
11/19/2008 |
EMG TRITON -COMP,MODEL NCA01-XXX SERIES |
EMG TECHNOLOGY CO., LTD. |
SALLY CHUANG |
| K082844 |
11/25/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K082339 |
11/20/2008 |
ENABLER-P SUPPORT CATHETER |
ENDOCROSS, LTD. |
JOHN J SMITH |
| K082655 |
11/25/2008 |
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K082579 |
11/20/2008 |
EVERCROSS .035 OTW PTA DILATATION CATHETER |
EV3 INC. |
David Worrell |
| K080278 |
11/28/2008 |
TABATABA COTESTER |
FIM MEDICAL |
DANIEL KAMM |
| K080649 |
11/25/2008 |
POGO SCREW |
FXDEVICES |
RICH LIPSCHUTZ |
| K082740 |
11/26/2008 |
GC AADVA ZR DISK |
GC AMERICA, INC. |
MARK HEISS |
| K082434 |
11/14/2008 |
GDLS-200 |
GC AMERICA, INC. |
MARK HEISS |
| K082540 |
11/28/2008 |
GE ENTROPY SENSOR |
GE HEALTHCARE |
JOEL C KENT |
| K083018 |
11/14/2008 |
CENTRICITY PACS WEB DIAGNOSTIC |
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS |
JILLIAN M REED |
| K082851 |
11/19/2008 |
MULTLINK CABLE AND LEADWIRE SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MATTHIAS BUERGER |
| K072664 |
11/21/2008 |
GE LUNAR FEMUR STRENGTH SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES RASKOB |
| K083147 |
11/04/2008 |
DISCOVERY MR450 |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K082243 |
11/07/2008 |
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS |
GENERAL MEDICAL MERATE S.P.A. |
Kevin Walls |
| K082205 |
11/20/2008 |
FACTOR VIII ANTIBODY SCREEN |
GENETIC TESTING INSTITUTE |
MICHELLE A STAPLETON |
| K082252 |
11/05/2008 |
INDEPENDENCE SPACER |
GLOBUS MEDICAL, INC. |
KELLY BAKER |
| K081906 |
11/14/2008 |
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K081889 |
11/12/2008 |
RHAPSODY CT |
GRANTADLER CORPORATION |
ARTHUR WARD |
| K082126 |
11/13/2008 |
RHAPSODY MRI |
GRANTADLER CORPORATION |
ARTHUR WARD |
| K081806 |
11/07/2008 |
IDI IMPLANT SYSTEM |
IDI BIOMEDICAL LLC |
ANGELA BLACKWELL |
| K082706 |
11/06/2008 |
INFINITT CARDIOLOGY PACS |
INFINITT CO., LTD. |
CARL ALLETTO |
| K082990 |
11/20/2008 |
INFINITT XELIS |
INFINITT CO., LTD. |
TRISTAN CHOI |
| K081773 |
11/06/2008 |
OSV II |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JON CAPAROTTA |
| K083115 |
11/26/2008 |
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 |
INTEL CORP. |
TAE-WOONG KOO |
| K073689 |
11/13/2008 |
LEP2000 THERAPY SYSTEM |
INTERNATIONAL MEDICAL INSTRUMENTS, INC. |
M. JOYCE HEINRICH |
| K082987 |
11/06/2008 |
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL |
INVIVO |
ANDREW ADAMS |
| K081673 |
11/14/2008 |
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE |
IONICS MEDICAL CORP. |
M. LAINE MASHBUM |
| K081943 |
11/24/2008 |
MODEL ES-130 |
ITO CO., LTD. |
KENNETH L BLOCK |
| K082349 |
11/21/2008 |
JARIT HULKA UTERINE TENACULUM FORCEPS |
J. JAMNER SURGICAL INSTRUMENTS, INC. |
JENNIFER BOSLEY |
| K080623 |
11/17/2008 |
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA |
JAS Diagnostics, Inc. |
SAMUEL BURGOS |
| K081380 |
11/19/2008 |
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K082347 |
11/18/2008 |
DIGITAL RADIOGRAPHY, FLEXDR C30 |
KONICA MINOLTA TECHNOPRODUCT CO., LTD. |
RUSSEL MUNVES |
| K081981 |
11/17/2008 |
LANG DENTAL ACRYLIC PRIMER |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K081570 |
11/07/2008 |
DPL THERAPY SYSTEM |
LED TECHNOLOGIES, LLC |
LEWIS WARD |
| K083340 |
11/26/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K082056 |
11/07/2008 |
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 |
LIFE-TECH, INC. |
JEFF KASOFF |
| K082176 |
11/14/2008 |
LTM-BPS SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K082348 |
11/18/2008 |
FIBERNET EMBOLIC PROTECTION SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| K082153 |
11/25/2008 |
MAJOR.REPAIR |
MAJOR PRODOTTI DENTARI S.P.A. |
MONICA FUNAI |
| K081867 |
11/25/2008 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K082172 |
11/28/2008 |
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM |
MAKO SURGICAL CORPORATION |
WILLIAM F TAPIA |
| K082412 |
11/10/2008 |
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 |
MAPQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K082541 |
11/26/2008 |
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM |
MEDI NUCLEAR CORP., INC. |
JERRY SCHOEN |
| K080823 |
11/17/2008 |
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT |
MEDICA CORP. |
Photios Makris |
| K081505 |
11/19/2008 |
THERAGEM PROFESSIONAL T1002 |
MEDICA HEALTH, LTD |
TERRI CMOREY |
| K082475 |
11/07/2008 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
DEBBIE KIDDER |
| K083076 |
11/20/2008 |
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K082463 |
11/10/2008 |
PROGENIX |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K082002 |
11/24/2008 |
PROGENIX PLUS |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K081080 |
11/21/2008 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
| K083071 |
11/14/2008 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
| K082581 |
11/14/2008 |
C-QUEST |
MEDX, INC. |
WILLIAM GREENROSE |
| K082881 |
11/24/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K080613 |
11/06/2008 |
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 |
MINIMALLY INVASIVE DEVICES LLC |
MICHAEL H SOUTHWORTH |
| K082627 |
11/07/2008 |
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL |
MINXRAY, INC. |
DANIEL KAMM |
| K080217 |
11/05/2008 |
COMPONENT NEUROMONITORING SYSTEM |
MOBERG RESEARCH, INC. |
Damon Lees |
| K082354 |
11/18/2008 |
STEREO NAVIGATOR ACCESSORY, STN-1000 |
NAVISCAN PET SYSTEMS |
HEATHER JALISI |
| K080976 |
11/10/2008 |
NEXUS I.V. FLUID TRANSFER DEVICE |
NEXUS MEDICAL, LLC |
LARRY SMITH |
| K081123 |
11/14/2008 |
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS |
NEXUS MEDICAL, LLC |
LARRY SMITH |
| K082785 |
11/26/2008 |
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K081128 |
11/07/2008 |
MOLAR IMPLANT |
NOBEL BIOCARE AB |
THUONG NGUYEN SON |
| K083100 |
11/19/2008 |
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP |
NOBEL BIOCARE USA, LLC |
HERBERT CRANE |
| K082441 |
11/21/2008 |
NORDICICE SOFTWARE |
NORDICIMAGINGLAB AS |
STIAN SCISLY SAGEVIK |
| K082113 |
11/07/2008 |
NOX T3, NOXTURNAL (PC APPLICATION) |
NOX MEDICAL |
KOLBRUN E OTTOSDOTTIR |
| K082642 |
11/07/2008 |
ONCENTRA RT VIEWER 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K083028 |
11/13/2008 |
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K081456 |
11/06/2008 |
OLYMPUS CHF TYPE V |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K082720 |
11/05/2008 |
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K080460 |
11/14/2008 |
SPECTRAL OCT/SLO |
OPKO HEALTH, INC. |
JANE HSIAO |
| K082838 |
11/25/2008 |
ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN CAMBRIA |
| K082949 |
11/25/2008 |
ORTHOPEDIATRICS BONE SCREWS |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083033 |
11/06/2008 |
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
DEBORAH L JACKSON |
| K081986 |
11/14/2008 |
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE |
Oscor Inc. |
MILA DOSKOCIL |
| K082108 |
11/14/2008 |
OBC BONE ANCHORED HEARING AID SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG |
| K082907 |
11/18/2008 |
IC-PRO SYSTEM, VERSION 3.1.0.4 |
PAIEON, INC. |
SHAHAR MANDELBOIM |
| K080241 |
11/28/2008 |
DDS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K083125 |
11/21/2008 |
NEURON SELECT CATHETER SIZE 070 |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K082803 |
11/13/2008 |
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
| K080591 |
11/14/2008 |
TANDA SKINCARE SYSTEM, MODEL: PTSCS |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K083228 |
11/24/2008 |
PHILIPS INTELLIVUE MP5 PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
JENS-PETER SEHER |
| K083048 |
11/21/2008 |
NEORAY DR 2520 DIGITAL IMAGING SYSTEM |
PORTAVISION MEDICAL LLC |
TERRY ANCAR |
| K081460 |
11/21/2008 |
TDS ABUTMENT |
POU YU BIOTECHNOLOGY CO., LTD. |
LINDA K SCHULZ |
| K082415 |
11/25/2008 |
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V |
PREMCO MEDICAL SYSTEMS, INC. |
HAROLD JACOBS |
| K082688 |
11/07/2008 |
PRO HMPV+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K082240 |
11/20/2008 |
SNTRYPACS |
QSTAR TECHNOLOGIES, INC. |
HERMAN OOSTERWIJK |
| K083160 |
11/07/2008 |
1.5T ATLAS SPEEDER HEAD-NECK COIL |
QUALITY ELECTRODYNAMICS |
|
| K083078 |
11/26/2008 |
QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 |
QUANTA COMPUTER INC. |
JENNIFER REICH |
| K083207 |
11/14/2008 |
ULTRAWAVE III EX 1320 |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K083181 |
11/26/2008 |
QV-9000 UNIVERSAL SYSTEM |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
| K083255 |
11/21/2008 |
16CH AI BREAST COILS 1.5 T AND 3 T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
| K081025 |
11/21/2008 |
ISOELASTICU |
REMI SCIENCES, INC. |
SANJIV H NAIDU |
| K082654 |
11/25/2008 |
ENTERAL ONLY EXTENSION SET |
RESPIRONICS, INC. |
ANDREW P ZELTWANGER |
| K081420 |
11/07/2008 |
VANISHPOINT I.V. CATHETER |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K082553 |
11/21/2008 |
REXASTOM ORAL EASE |
REXADERM, INC. |
CLYDE R GOODHEART |
| K082101 |
11/05/2008 |
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K082310 |
11/10/2008 |
HOLLYWOOD, PACIFICA, REDONDO, VENTURA |
SEASPINE, INC. |
JEFF BRITTAN |
| K080442 |
11/13/2008 |
SERISCAFFOLD SURGICAL MESH |
SERICA TECHNOLOGIES, INC. |
CONNIE H GARRISON |
| K082876 |
11/10/2008 |
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY |
SHARPLIGHT TECHNOLOGIES LTD. |
ILAN SHARON |
| K080398 |
11/26/2008 |
SI JOINT FUSION SYSTEM |
SI-BONE, INC. |
JEFFERY DUNN |
| K083035 |
11/13/2008 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
SUZANNE SCHWALLER |
| K082430 |
11/14/2008 |
SYNGO IMAGING XS |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K082506 |
11/21/2008 |
SYMBIA, VERSION 4.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GUNHILD PAULSEN |
| K082427 |
11/07/2008 |
SYNGO MR B17 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELIZABETH LAZARO |
| K082142 |
11/13/2008 |
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
SHELLY PEARCE |
| K083141 |
11/07/2008 |
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SIMPACT LLC |
MARK SCHENK |
| K082215 |
11/03/2008 |
OSTEORAPTOR SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
JULIE ACKER |
| K082211 |
11/14/2008 |
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS |
Smith & Nephew, Inc |
LAURA KREJCI |
| K082358 |
11/25/2008 |
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K082200 |
11/25/2008 |
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 |
SOADCO, S.L. |
MARIA MITJANETA |
| K081145 |
11/05/2008 |
MODIFICATION TO 4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K081313 |
11/19/2008 |
SH14 HEMOCONCENTRATOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K082674 |
11/28/2008 |
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE |
SPECTRA MEDICAL DEVICES, INC. |
SCOTT HENDERSON |
| K081026 |
11/05/2008 |
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 |
SPORT-ELEC S.A. |
SHARON SCANNELL |
| K080796 |
11/17/2008 |
SRI LP DRAPE |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080707 |
11/13/2008 |
SRI PLR GOWN |
SRI/SURGICAL EXPRESS |
JEFFREY O STULL |
| K080723 |
11/13/2008 |
SRI LP GOWN |
SRI/SURGICAL EXPRESS, INC. |
JEFFERY O STULL |
| K083083 |
11/06/2008 |
AGILIS NXT STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
| K082773 |
11/19/2008 |
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K080430 |
11/21/2008 |
STOMA BONE BLOCK SCREW |
STORZ AM MARK GMBH |
FRANZ MENEAN |
| K081805 |
11/14/2008 |
CUFFALERT |
SUNMED |
PAUL DRYDEN |
| K083039 |
11/26/2008 |
VERITAS COLLAGEN MATRIX (DRY) |
SYNOVIS SURGICAL INNOVATIONS |
JODI JORGENSON |
| K082276 |
11/18/2008 |
SYNTHEMED DEVICE |
SYNTHEMED, INC. |
ELI PINES |
| K082807 |
11/24/2008 |
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS |
SYNTHES (USA) |
JILL R SHERMAN |
| K082072 |
11/07/2008 |
SYNTHES (USA) 3.5MM LCP HOOK PLATE |
SYNTHES (USA) |
KARL J NITTINGER |
| K082624 |
11/10/2008 |
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K082650 |
11/18/2008 |
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
SYNTHES (USA) |
JILL R SHERMAN |
| K082335 |
11/10/2008 |
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K082572 |
11/24/2008 |
USS ILIOSACRAL, USS POLYAXIAL |
SYNTHES SPINE |
JASON LIPMAN |
| K073667 |
11/19/2008 |
NITI-S BILIARY STENT |
TAEWOONG MEDICAL CO., LTD |
CATHRYN N CAMBRIA |
| K082013 |
11/10/2008 |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
TELOVITAL GMBH TELEMEDIZIN |
Calley Herzog |
| K081335 |
11/14/2008 |
TENACORE OXYGEN BLENDER, MODEL TB-2000 |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K073087 |
11/18/2008 |
NON-CONTACT TONOMETER, MODEL FT-1000 |
TOMEY CORPORATION |
KOJI KUBO |
| K080771 |
11/10/2008 |
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC |
TOP CORP. |
CATHRYN N CAMBRIA |
| K080650 |
11/26/2008 |
OMNI-DL SYSTEM |
TRANSVIVO INC. |
J. MICHAEL DELMAGE |
| K080532 |
11/12/2008 |
BENACEL, MODELS C-001, C-002 AND C-005 |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K082646 |
11/03/2008 |
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER |
USCI IRELAND |
MAUREEN O'CONNELL |
| K083190 |
11/12/2008 |
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
| K081725 |
11/07/2008 |
ENTERAL PUMP SET, MODEL 20-1010 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K083227 |
11/18/2008 |
VIDA PULMONARY WORKSTATION 2 (PW2) |
VIDA DIAGNOSTICS, INC. |
JACK SLOVICK |
| K081713 |
11/21/2008 |
VERTEBRAL ACCESS SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K080446 |
11/26/2008 |
RAPIDVIT AND RAPIDWARM CLEAVE |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K082604 |
11/21/2008 |
VIZTEK DR, MODELS: DR1000, DR3000, DR4000 |
VIZTEK, INC. |
DANIEL KAMM |
| K082753 |
11/24/2008 |
FUTURABOND M/FUTURABOND M SINGLE DOSE |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K082299 |
11/20/2008 |
VERICORE IMPLANT ABUTMENTS |
WHIP-MIX CORP. |
DAVID J STEINBOCK |
| K082320 |
11/05/2008 |
DARCO SMALL SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K082963 |
11/24/2008 |
WU'S 4-WHEELED NEO SCOOTER, WT-M3A |
WU'S TECH CO., LTD. |
JEN KEN-MIN |
| K082078 |
11/03/2008 |
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
