FDA 510(k) Decisions During September, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062505 09/26/2006 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES ABBOTT SPINE, INC. NOAH BARTSCH
K062458 09/15/2006 ETHMOID SINUS SPACER ACCLARENT, INC. DEBBIE COGAN
K062514 09/28/2006 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K062059 09/06/2006 AIE REGION OF INTEREST IMAGE ENHANCEMENT ADVANCED IMAGE ENHANCEMENT JILLIAN M REED
K062406 09/15/2006 AESCULAP NEURO PATTIES AESCULAP, INC. LISA M BOYLE
K060762 09/14/2006 AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM AESCULAP, INC. MATTHEW M HULL
K062048 09/07/2006 AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM AESTHERA CORPORATION ANNE WORDEN
K062223 09/01/2006 AGFA MODEL CR30-X AGFA CORPORATION PATRICK J LYNCH
K062390 09/18/2006 CRYSTALVIEW R200 ALARA, INC. DIANE M KING
K062504 09/05/2006 CERAMAX ALPHADENT CO., LTD. NOH HAK
K052544 09/29/2006 PULSE OXIMETER ADAPTER CABLES AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K061850 09/29/2006 MINI-YAG LASER AMERICAN LASERS, INC. DAVID K QUON
K062307 09/01/2006 XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS ANULEX TECHNOLOGIES, INC TIMOTHY MILLER
K061763 09/19/2006 ARC SURGICAL BIOTRAK SCREW ARC SURGICAL LLC. ED BOEHMER
K062365 09/29/2006 ARTHREX ASPIRATE KIT ARTHREX, INC. SALLY FOUST
K062679 09/27/2006 ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES ARTHREX, INC. NANCY HOFT
K062747 09/29/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC. ANN WATERHOUSE
K061776 09/25/2006 ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE ARTHROTEK, INC. PATRICIA SANDBORN BERES
K061759 09/05/2006 REPROCESSED EXTERNAL FIXATION DEVICE ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K060787 09/27/2006 TATTOOSTAR FAMILY ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K061856 09/28/2006 V-2200 INFANT INCUBATOR ATOM MEDICAL INC MARY STANIEWICZ
K062159 09/05/2006 RB12 SUCTION RECTAL BIOPSY SYSTEM AUS SYSTEMS PTY LTD. IAN P GORDON
K061422 09/25/2006 SURGICAL DRAPES AUSTIN MEDICAL, INC. PAUL DRYDEN
K060182 09/07/2006 TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE AUSTRALIAN SURGICAL DEVICES MARIO KUNA
K060165 09/01/2006 AXYAFLEX POLYESTER SUTURE AXYA MEDICAL, INC. HOWARD SCHRAYER
K061924 09/05/2006 CORONIS 3MP AND MDCG 3120-CB BARCOVIEW LIEVEN DE WANDEL
K061928 09/05/2006 CORONIS COLOR 2MP AND MDCC 2121 BARCOVIEW LIEVEN DE WANDEL
K061927 09/05/2006 CORONIS COLOR 3MP AND MDCC 3120-DL BARCOVIEW LIEVEN DE WANDEL
K062465 09/06/2006 ZYOPTIX XP EPI SEPARATOR SYSTEM BAUSCH & LOMB, INC. NED LUCE
K061515 09/11/2006 RENALSOFT BAXTER HEALTHCARE CORP. DAVID E CURTIN
K062457 09/21/2006 INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K062058 09/11/2006 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 BAYER HEALTHCARE ROGER SONNENBERG
K062087 09/14/2006 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 BD BIOSCIENCES CARTER NAVARRO
K061190 09/15/2006 ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 BECKMAN COULTER, INC. VALYNDA L MACHEN
K062207 09/13/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062206 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K061744 09/15/2006 COCHLEA-SCAN / COCHLEA-SCAN PLUS BIO-LOGIC SYSTEMS CORP. NORMAN BRUNNER
K061311 09/22/2006 ALLOGRAN-R BIOCOMPOSITES LTD. SIMON FITZER
K061949 09/25/2006 DOUBLEPLAY SUTURE ANCHOR BIOCOMPOSITES LTD. SIMON FITZER
K062141 09/13/2006 MAMMOPAD RADIOLUCENT CUSHION BIOLUCENT, INC. SHERYL HIGGINS
K061945 09/19/2006 VITEK 2 AST-YS FLUCONAZOLE BIOMERIEUX, INC. NANCY WEAVER
K061340 09/25/2006 23 MM SINGLE-PEG PATELLA COMPONENT BIOMET MANUFACTURING, INC. LESTER F PADILLA
K061787 09/21/2006 MAXFORCE TTS SINGLE-USE BALLOON DILATOR BOSTON SCIENTIFIC CORP. WING NG
K061877 09/15/2006 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. ELENA BICKOFF
K061231 09/01/2006 WELLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K062594 09/20/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORPORATION SARAH PETERSON
K061884 09/06/2006 BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 BOVIE MEDICAL RICHARD KOZLOFF
K061764 09/06/2006 MEDIBYTE, MODEL MP8 BRAEBON MEDICAL CORP. RICHARD A BONATO
K062086 09/20/2006 NAVIVISION BRAINLAB AG RAINER BIRKENBACH
K061394 09/06/2006 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K062164 09/22/2006 RESOLUTIONMD, VERSION 1.3 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K061528 09/22/2006 SELFCHECK GLUCO CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K061932 09/14/2006 BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE CARDIOPULMONARY CORP. JORDAN SCHRECK
K061075 09/01/2006 BOOMERANG WIRE CARDIVA MEDICAL, INC. GLENN FOY
K061960 09/05/2006 FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K062031 09/27/2006 CHASE CARDIAC ANALYSIS SYSTEM CHASE MEDICAL, LP DAVID M HERNON
K061568 09/29/2006 CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 CODMAN & SHURTLEFF, INC. JOCELYN RAPOSO
K061967 09/25/2006 SCD GARMENT, MODEL VP530 COMPRESSION THERAPY CONCEPTS, INC. LEN NASS
K052206 09/12/2006 ZEUS MALE CONDOM APPLICATOR CONDAX LLC. ELI J CARTER
K061972 09/18/2006 CONNECT IMAGING PACS CONNECT IMAGING, INC. PHILIP J MANLY
K060623 09/06/2006 SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE COOK IRELAND LTD EMMETT DEVEREUX
K062531 09/22/2006 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP., A JOHNSON & JOHNSON CO. JOAN MARTIN
K060482 09/28/2006 CYTORI CELUTION CELL CONCENTRATION DEVICE CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K061825 09/06/2006 DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062316 09/06/2006 DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061852 09/22/2006 DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K061802 09/11/2006 DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062334 09/22/2006 DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 DADE BEHRING, INC. VICTOR M CARRIO
K061990 09/19/2006 DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K061795 09/11/2006 DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR DADE BEHRING, INC. PAMELA A JUNGA
K062034 09/06/2006 DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) DADE BEHRING, INC. VICTOR M CARRIO
K062199 09/06/2006 DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) DADE BEHRING, INC. VICTOR M CARRIO
K062162 09/14/2006 DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) DADE BEHRING, INC. VICTOR M CARRIO
K062182 09/14/2006 DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 DADE BEHRING, INC. VICTOR M CARRIO
K062585 09/19/2006 MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN DADE BEHRING, INC. SHANNON POPSON
K062290 09/01/2006 MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K062596 09/19/2006 MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID DADE BEHRING, INC. SHANNON POPSON
K052532 09/05/2006 IMAX 9.5 STERILIZERS DENTAL X SRL CYNTHIA J.M. NOLTE
K061658 09/18/2006 SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L DENTALL CORP. EDWIN FIRST
K061648 09/11/2006 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062654 09/29/2006 DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062196 09/11/2006 SFX SNAP-FIT CROSS CONNECTOR DEPUY SPINE, INC. MARY GRAY
K052536 09/13/2006 ALGICELL AG DERMA SCIENCES CANADA, INC. DELA SHARMINI ATHERAY
K062234 09/11/2006 MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K060333 09/08/2006 DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. MIKE STERLING
K061797 09/01/2006 SM IMPLANT SYSTEMS DIO DEPARTMENT DSI, INC. DAE KYU CHANG
K062758 09/27/2006 OWL URF-3AP DIROS TECHNOLOGY, INC. GEORGE DARMOS
K062424 09/14/2006 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K061864 09/15/2006 DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 DUKAL CORP. PATRICK J LAMB
K062404 09/08/2006 TRANSEAR BONE CONDUCTION HEARING AID EAR TECHNOLOGY CORP. RICK GILBERT
K062429 09/27/2006 MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH EDWARDS LIFESCIENCES RESEARCH MEDICAL KAREN JONES
K061134 09/01/2006 EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES EFS EBERLE FEINWERKTECHNISCHE SYSTEME GERALD GOIGITZER
K060329 09/11/2006 ENDOFAST RELIANT SYSTEM ENDOGUN MEDICAL SYSTEMS YORAM LEVY
K061597 09/27/2006 EPOC BLOOD ANALYSIS SYSTEM EPOCAL, INC. ROY LAYER
K061992 09/19/2006 EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 EPS BIO TECHNOLOGY CORP. Y C LEI
K061770 09/25/2006 ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM ETHICON ENDO-SURGERY, INC. TOM BOSTICCO
K062000 09/25/2006 HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH ETHICON ENDO-SURGERY, INC. CAROL WALSH
K060700 09/08/2006 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. EUROIMMUN US LLC KATHRYN KOHL
K061668 09/12/2006 OPTECURE +CCC EXACTECH, INC. MARITZA ELIAS
K060734 09/05/2006 FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K062576 09/29/2006 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE HEALTHCARE JOEL KENT
K062393 09/01/2006 GE VANTAGE PET NEURO SOFTWARE GE HEALTHCARE D. DUERSTELER
K061741 09/15/2006 MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM GE HEALTHCARE ALLEN TABOR
K061942 09/29/2006 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE HEALTHCARE JOEL C KENT
K062039 09/11/2006 BIOPSY DIGIT-AM GIOTTO USA, LLC ALLISON SCOTT
K061735 09/08/2006 INFIBRA, MODEL 1200 GLOBAL DENTAL PRODUCTS, INC. JERRY BARTICK
K062407 09/06/2006 GATEWAY THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K062385 09/27/2006 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES GRACE MEDICAL, INC. JEFF COBB
K061690 09/15/2006 SURGICAL HEADLIGHT GULF MEDICAL FIBEROPTICS MARCELINO AFANADOR
K061611 09/11/2006 BOSWORTH DENTIN RESIN HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K062448 09/20/2006 LYRA ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K060765 09/06/2006 HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 HEMOCUE AB ALLEN WHITE
K061138 09/29/2006 ABX PENTRA 400 : CRP HORIBA ABX TIM LAWTON
K061432 09/11/2006 HOSPIRA ENTERAL FEEDING SET, MODEL 20640 HOSPIRA, INC. DIANE RENNPFERD
K061573 09/19/2006 TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT HOSPIRA, INC. THOMAS KOZMA
K062488 09/19/2006 IQ-SYSTEM PACS SYSTEM IMAGE INFORMATION SYSTEMS, LTD. CARL ALLETTO
K062417 09/15/2006 XPLORER 1100 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062405 09/13/2006 XPLORER 1590 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062586 09/29/2006 XPLORER 1600 PLUS IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K061979 09/22/2006 MODIFICATION TO MYALLERGY TEST IMMUNETECH CORPORATION NANCY BENSON
K061319 09/29/2006 SPECTRA SYSTEM IMPLANT DIRECT LLC LESLIE TERRY
K061974 09/15/2006 GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K061598 09/22/2006 HEMOSIL HOMOCYSTEINE AND CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062431 09/01/2006 HEMOSIL LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062430 09/01/2006 HEMOSIL PROTEIN C INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062599 09/27/2006 MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS INTEGRA LIFESCIENCES CORPORATION DARLENE M WELSH
K053540 09/06/2006 INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE INTERMEDIC ARFRAN, S.A. KLAUS SIVEC
K062402 09/21/2006 EASYSTAND EVOLV INVACARE CORP. RONALD CLINES
K061874 09/05/2006 INVACARE'S TWILIGHT II NASAL MASKS INVACARE CORP. JANICE BROWNLEE
K062252 09/27/2006 MOLTENO3 IOP, INC. JASON MALECKA
K061781 09/05/2006 MULTILINK SPRINT IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K060882 09/01/2006 EXCEL BOND DC, MODEL 28-200100 J. MORITA USA, INC. HOWARD ROWE
K061664 09/08/2006 FORMCORE DC, MODEL 28-700100 J. MORITA USA, INC. TAKESHI INOUE
K062462 09/29/2006 NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L JAWON MEDICAL CO., LTD. W. H PARK
K062522 09/08/2006 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K062401 09/28/2006 MODIFICATION TO LUCAS JOLIFE AB HOWARD M HOLSTEIN
K060917 09/22/2006 KENSEY NASH BONE VOID FILLER KENSEY NASH CORPORATION JENNIFER J BOSLEY
K062275 09/20/2006 RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K052870 09/29/2006 INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 KIMBERLY-CLARK CORP. TIERNEY NORSTED
K051165 09/07/2006 KLS MARTIN STERNAL TALON KLS-MARTIN L.P. JENNIJER DAMATO
K061507 09/21/2006 SONICWELD RX ENDOBROW FIXATION KLS-MARTIN L.P. JENNIFER DAMATO
K062356 09/27/2006 KOWA NONMYD ALPHA-D KOWA CO. LTD. SATOHIKO TAKANASHI
K061906 09/28/2006 CLEARFIL CERAMIC PRIMER KURARAY MEDICAL INC. KOJI NISHIDA
K062382 09/27/2006 CLEARFIL DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K062410 09/26/2006 CLEARFIL ESTHETIC CEMENT & DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K061860 09/18/2006 CLEARFIL MAJESTY ESTHETIC KURARAY MEDICAL INC. KOJI NISHIDA
K060153 09/29/2006 ACUMED LASER, MODEL 1000 LASER THERA, LLC SHELLY HENRY
K061871 09/20/2006 LEICA MODEL FL800 LEICA MICROSYSTEMS, INC. MAX STURGIS
K061023 09/20/2006 THERMOSUIT SYSTEM LIFE RECOVERY SYSTEMS HD, LLC PAUL A TENTHOREY
K061364 09/05/2006 PILOT POSTERIOR LUMBAR PLATING SYSTEM LIFE SPINE ERIN MALLOY
K061966 09/27/2006 LITETOUCH DENTAL LASER SYSTEM LIGHT INSTRUMENT LTD YORAM LEVY
K062242 09/29/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. MARIE LIN
K062483 09/08/2006 MINI POWER CHAIR, MODEL MN 5000 LINE IND.(SHANGHAI) CO., LTD. SID MATHUR
K061742 09/06/2006 URYXXON RELAX URINE ANALYZER MACHEREY-NAGEL GMBH & CO., KG. ARMOND WELCH
K060847 09/26/2006 MAGSTIM 200-2 MAGSTIM COMPANY US, LLC. REZA JALINOUS
K062501 09/29/2006 VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 MAINE STANDARDS CO. HOLLY CRESSMAN
K061473 09/21/2006 SURGI-WRAP MAST BIORESORBABLE SHEET MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K061502 09/15/2006 MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062229 09/11/2006 CTC WORKSTATION, MODEL 2200 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. JAMES M BENSON
K061731 09/06/2006 MEDGRAPHICS ULTIMA SYSTEM MEDICAL GRAPHICS CORP. LYNN BROSIOUS
K062611 09/20/2006 IGUIDE SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K062639 09/21/2006 MODIFICATION TO HEXAPOD RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K061339 09/19/2006 HIERSPEC SPECULUM MEDICAL PRODUCTS DIV. THOMAS W COPELAND
K062119 09/22/2006 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 MEDICAL PRODUCTS MFG., LLC ROSINA ROBINSON
K060681 09/15/2006 MEDTRONIC PS MEDICAL STRATA TYPE VALUE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K062348 09/08/2006 TIMESH SELF DRILLING SCREW MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K062606 09/25/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD S CHIN
K061635 09/05/2006 MSD BIPOLAR FORCEPS MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K062427 09/12/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD CHIN
K061591 09/08/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K062133 09/26/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SPINAL AND BIOLOGICS DIV LEE GRANT
K062420 09/08/2006 5F SHERPA ACTIVE NX GUIDE CATHETER MEDTRONIC VASCULAR MARK PUOPOLO
K061958 09/05/2006 MEDTRONIC EXPORT XT CATHETER MEDTRONIC VASCULAR KAREN A BROZOWSKI
K061557 09/15/2006 FUSION MEDWAVE, INC. DONNA R LUNAK
K061809 09/13/2006 ARTEGRAL IMCROWN MERZ DENTAL GMBH RICHARD G HUNTER
K061471 09/11/2006 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K061092 09/13/2006 BAXTER DUPLOSPRAY MIS APPLICATOR MICROMEDICS, INC. THOMAS LOPAC
K062163 09/22/2006 MIMVIEWER MIMVISTA CORP. PETER SIMMELINK
K052492 09/05/2006 AIRNERGY+STREAM NATURAL ENERGY SOLUTIONS AG MARTINA GUNDEROTH
K062451 09/28/2006 NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K062210 09/25/2006 COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 NEW STAR LASERS, INC. DONALD V JOHNSON
K061618 09/25/2006 COOLTOUCH, MODEL CTEV NEW STAR LASERS, INC. DONALD V JOHNSON
K060644 09/18/2006 AHMED GLAUCOMA VALVE, MODEL M4 NEW WORLD MEDICAL, INC. A. MATEEN AHMED
K061768 09/28/2006 MP-1 MICROPERIMETER NIDEK TECHNOLOGIES SRL ALDO COCCHIGLIA
K062020 09/05/2006 LIFESOUND ESOPHAGEAL STETHOSCOPE NOVAMED, LLC PAUL DRYDEN
K062317 09/01/2006 MODIFICATION TO NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K062610 09/28/2006 CARE-E-VAC 3 OHIO MEDICAL CORPORATION HOBY CHAE
K062049 09/22/2006 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K062423 09/21/2006 OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K061524 09/26/2006 ISS INTEGRATED SPINE SYSTEM ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K060770 09/15/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. SARAH PARSONS
K060678 09/14/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. SARAH PARSONS
K052968 09/08/2006 MODIFICATION TO: ORLUS MINI SCREW ORTHOLUTION CO., LTD. CATHRYN CAMBRIA
K062072 09/22/2006 PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K061494 09/21/2006 DERMADAPT WOUND DRESSING PEGASUS BIOLOGICS, INC. PAMELA MISAJON
K061695 09/14/2006 LED PROLUX 770 PENG LIM ENTERPRISE CO., LTD. C.S. WANG
K062650 09/21/2006 EP NAVIGATOR SOFTWARE PHILIPS MEDICAL SYSTEMS LYNN HARMER
K061685 09/15/2006 PULSERA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. JOSEPH S ARNAUDO
K061995 09/06/2006 XCELERA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN T HARMER
K062283 09/20/2006 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. ANDREAS SUCHI
K062392 09/06/2006 PHILIPS MP5 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MARKUS STACHA
K061961 09/06/2006 ART LAB SOFTWARE PIE MEDICAL CARRI GRAHAM
K062042 09/06/2006 PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) PLETHORA SOLUTIONS KIMBERLEY DONEY
K061564 09/01/2006 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD PORTLAND ORTHOPAEDICS PTY. LTD. ELAINE DUNCAN
K062172 09/20/2006 FETCH ASPIRATION CATHETER POSSIS MEDICAL, INC. FRANK B FREEDMAN
K061649 09/01/2006 POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K062092 09/15/2006 PREVU POINT OF CARE SKIN STEROL TEST PREMD, INC. THOMAS M TSAKERIS
K062160 09/12/2006 GO GO MINI, MODEL SC30 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K061790 09/19/2006 PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES PROTEIN POLYMER TECHNOLOGIES, INC. RADINE POBUDA
K061008 09/08/2006 QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 QUIDEL CORP. JOHN D TAMERIUS
K060180 09/06/2006 BIOSET XC REGENERATION TECHNOLOGIES, INC. LISA SIMPSON
K061532 09/18/2006 GENTLE COLON (REVISION 2.0) RENDOSCOPY, INC. MIRA PATTANAYAK
K062291 09/08/2006 VPAP MALIBU WITH H2I RESMED LTD. DAVID D'CRUZ
K060919 09/22/2006 ACTICAL RESPIRONICS, INC. ZITA A YURKO
K061785 09/07/2006 CYL-FIL OXYGEN SYSTEM RESPONSIVE RESPIRATORY INC. THOMAS BANNON
K060948 09/05/2006 PORTRAIT PSR3 RHYTEC INCORPORATED MAUREEN O'CONNELL
K062578 09/18/2006 DIGI-LITE TCD DEVICE RIMED LTD. AHAVA STEIN
K061224 09/05/2006 LAPDOC I ROBODENT GMBH JUERGEN BIER
K062319 09/13/2006 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 ROCHE DIAGNOSTICS CORP. CORINA HARPER
K062239 09/11/2006 GLUCOSE HK NEW FORMULATION TEST SYSTEM ROCHE DIAGNOSTICS CORP. THERESA AMBROSE BUSH
K061780 09/15/2006 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + ROZINN ELECTRONICS, INC. MARK ROSOFF
K061663 09/06/2006 ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES RTC INC.-MEMCATH TECHNOLOGIES LLC MARC JAKER
K062304 09/29/2006 DLM112 DAYLINK MONITOR RTX HEALTHCARE A/S BJARNE FLOU
K062335 09/14/2006 SEDECAL X PLUS LP PLUS SEDECAL S.A. DANIEL KAMM
K062342 09/25/2006 TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT SENTRA MEDICAL DEVICES, LLC KARTHIK MARAYAN
K062204 09/22/2006 ARCHITECT CORTISOL ASSAY SERADYN INC. EARL E KNIGHT
K053254 09/19/2006 INFANT HEEL WARMER BY INTCO SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. JOHN ZHAO
K062067 09/06/2006 TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR SHEN WEI (USA), INC. CYNTHIA LIU
K061442 09/05/2006 PULSE OXIMETER, MODEL PM-50 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K062655 09/18/2006 POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. KATHY LIU
K062673 09/22/2006 MODIFICATION TO SYNGO INSPACE 4D SIEMENS AG, MEDICAL SOLUTIONS RUDIGER KOMER
K061577 09/14/2006 OVALTWIST PEDICLE SCREW SYSTEM SIGNUS MEDIZINTECHNIK GMBH MIKE ENSIGN
K062506 09/08/2006 INCORIS AL SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K062509 09/12/2006 INCORIS ZI SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K062216 09/15/2006 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K062408 09/12/2006 SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD SMITH & NEPHEW, INC. GINO ROUSS
K062396 09/28/2006 MODIFICATION TO STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON
K062095 09/29/2006 MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 SPACELABS MEDICAL INC. DAVID J GERAGHTY
K062278 09/19/2006 SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 SPACELABS MEDICAL INC. DAVID J GERAGHTY
K060012 09/29/2006 CLIRPATH TURBO PERIPHERAL CATHETERS SPECTRANETICS CORP. MICHAEL J RYAN
K062071 09/28/2006 PROMETEY, MODEL G1-03 SPECTRUM INTERNATIONAL GEORGE I BEKOV
K062468 09/13/2006 SPECTRUM M2 MONITOR SPECTRUM MEDICAL, LLP STEVE TURNER
K060288 09/01/2006 RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS SPIRE BIOMEDICAL, INC. RAY KELLY
K060651 09/13/2006 PROXIS SYSTEM, MODEL EPS101 ST. JUDE MEDICAL KIMBERLY BRIGGS
K060763 09/22/2006 STRYKER INJECTABLE CEMENT STRYKER WADE T RUTKOSKIE
K061225 09/14/2006 STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS STRYKER CORP. DESIREE MAE CRISOLO
K061548 09/28/2006 STRYKER URETERAL ILLUMINATION SYSTEM IV STRYKER CORP. ERICA A WALTERS
K061835 09/08/2006 STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE STRYKER INSTRUMENTS JEAN W SHEPPARD
K061813 09/19/2006 MANTIS SPINAL SYSTEM STRYKER SPINE SIMONA VOIC
K062701 09/25/2006 QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR SUNRISE MEDICAL, INC. JOSEPH E OLSAVSKY
K062315 09/08/2006 SUPERDIMENSION/BRONCHUS PREMIUM 2 SUPERDIMENSION, LTD. GEORGE MYERS
K061910 09/21/2006 SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) SYNTHES (USA) SHERI L MUSGNUNG
K061973 09/11/2006 SYNTHES 3.5MM SPRING PLATE SYNTHES (USA) DEBORAH L JACKSON
K061940 09/08/2006 SYNTHES LCP ANKLE ARTHRODESIS PLATES SYNTHES (USA) SHERI L MUSGNUNG
K053418 09/06/2006 SYNTHES OC FUSION SYSTEM SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K062235 09/19/2006 EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST TAIDOC TECHNOLOGY CORPORATION PI-SHIOU LI
K061662 09/15/2006 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K061659 09/15/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K062725 09/29/2006 MAXIFLEX-SEMI FLEX SCOPE TECHNOLOGY DELIVERY SYSTEMS, INC. CAROLANN KOTULA
K062452 09/21/2006 KIT MENDEC SPINE AND DELIVERY SYSTEM TECRES SPA CHRISTINE BRAUER
K062608 09/15/2006 29G AND 30G K-PACK II NEEDLE TERUMO EUROPE N.V. M.J. AERTS
K061688 09/08/2006 ANTI-SNORING / SLEEP APNEA DEVICE TOMED DR. TOUSSAINT GMBH WINFRIED TOUSSAINT
K061824 09/14/2006 TORNIER CEMENT RESTRICTOR TORNIER MIREILLE LEMERY
K061976 09/27/2006 CKIS-004A INJECTOR SYNCHRONIZATION OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K062022 09/11/2006 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K062391 09/14/2006 DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 TRIAGE MEDICAL, INC. GAYLE HIROTA
K062428 09/29/2006 VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS TRIPATH IMAGING, INC. BRYAN J TUCKER
K062238 09/21/2006 TYTAN BLOOD PRESSURE CUFF TYTAN MEDICAL CORP. KE-MIN JEN
K062326 09/01/2006 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC DANIEL CAMPION
K062618 09/22/2006 TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K052523 09/07/2006 PROXIS SYSTEM VELOCIMED INC. KIMBERLY BRIGGS
K062093 09/20/2006 AVEA VENTILATOR VIASYS RESPIRATORY CARE INC TOM GUTIERREZ
K062062 09/11/2006 VOYAGER PACS SYSTEM VOYAGER IMAGING CARL ALLETTO
K062425 09/15/2006 LIFECATH S PICC AND MIDLINE CATHETER VYGON CORP. COURTNEY SMITH
K061250 09/29/2006 MULTICATH EXPERT VYGON CORP. COURTNEY SMITH
K060944 09/15/2006 NUTRISAFE 2 VYGON CORP. COURTNEY SMITH
K052475 09/14/2006 VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS VYGON US LLC COURTNEY SMITH
K062693 09/29/2006 GLADIATOR BIPOLAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K060953 09/18/2006 OCCULTECH FECAL OCCULT BLOOD RAPID TEST YD DIAGNOSTICS CORP. DUSIC KWAK
K061410 09/08/2006 SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT ZIMMER DENTAL INC. FLOYD LARSON
K061717 09/08/2006 ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED ZIMMER DENTAL INC. ERIN MCVEY
K062281 09/05/2006 ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 ZIMMER DENTAL INC. ERIN L MCVEY
K061155 09/22/2006 VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM ZIMMER TRABECULAR ROBERT A POGGIE
K061851 09/29/2006 ZIRKONZAHN ICE ZIRKONZAHN GMBH DONNA M HARTNETT


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