FDA 510(k) Decisions During November, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K082475 11/07/2008 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 MEDTRONIC INC. DEBBIE KIDDER
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
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact