FDA 510(k) Decisions During December, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062770 12/14/2006 COPILOT HEALTH MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. MARY ROSE
K062582 12/14/2006 SUPRACOR BALLOON CATHETER ABIOMED, INC. ROBERT T.V. KUNG
K062795 12/11/2006 MUGARD MUCOADHESIVE ORAL WOUND RINSE ACCESS PHARMACEUTICALS, INC DAVID NOWOTNIK, PH.D.
K063460 12/07/2006 ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K063080 12/12/2006 TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS ADVANCED NEUROMODULATION SYSTEMS AMY CLENDENING
K063127 12/22/2006 ENTEROCOCCUS FAECALIS PNA FISH ADVANDX, INC. AMY AULWES
K063013 12/01/2006 PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S AEARO COMPANY ANN L PHILLIPS
K063017 12/27/2006 AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM AESCULAP, INC. MATTHEW M HULL
K062217 12/13/2006 AESKULSKA BETA2-GLYCO-A AESKU, INC DAVID BELL
K062951 12/12/2006 TAP III ANTI-SNORING DEVICE AIRWAY MANAGEMENT INC. DARREN HENDERSON
K062971 12/18/2006 BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS AKERS BIOSCIENCES, INC. BARBARA A BAGBY
K062371 12/04/2006 PREVIEW ANTERIOR CERVICAL PLATE SYSTEM ALPHASPINE, INC. MIKE ENSIGN
K063379 12/11/2006 AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 AMEDICA BIOTECH, INC. JEFF CHEN
K063015 12/20/2006 AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 AMEDITECH, INC. JOHN WU
K062794 12/07/2006 PRN THERMALCARE, MODEL 3000 AMERICAN HEALTHCARE PRODUCTS, INC. KENT D ELLIS
K063519 12/01/2006 DYNAMIC GAS SCAVENGING SYSTEM (DGSS) ANESTHETIC GAS RECLAMATION LLC JAMES M BERRY
K062664 12/06/2006 HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 APEX MEDICAL CORP. ALAN CHANG
K063244 12/27/2006 ARC SURGICAL BONE REDUCTION SCREW ARC SURGICAL LLC. ED BOEHMER
K052719 12/05/2006 URITEST 10 URINALYSIS REAGENT STRIPS ARJ MEDICAL, INC. AARON BEHAR
K062100 12/05/2006 ARJOWRAP 47/100 AND 47/88 ARJO WIGGINS MEDICAL, INC. ARTHUR WARD
K063068 12/20/2006 FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 ARKRAY USA, INC. TOM SPEIKERS
K063424 12/21/2006 FILM DIGITZER, MODEL 2908 MAMMO PRO ARRAY CORP. TAKASHI INAMI
K063479 12/13/2006 ARTHREX PUSHLOCK ARTHREX, INC. ANN WATERHOUSE
K063538 12/01/2006 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K062692 12/13/2006 BIS BILATERAL SENSOR ASPECT MEDICAL SYSTEMS, INC. RENEE GOULD
K062277 12/20/2006 ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE ATLANTIS COMPONENTS, INC. FRANKLIN UYLEMAN
K061680 12/15/2006 ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER ATRIUM MEDICAL CORP. JOSEPH P DEPAOLO
K062198 12/19/2006 SUNSPOTS PRE-GELLED SURFACE ELECTRODES AXON SYSTEMS, INC. HOWARD BAILIN
K063194 12/04/2006 TUFFLEX POLYESTER SUTURE AXYA MEDICAL, INC. HOWARD L SCHRAYER
K062714 12/15/2006 SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW BAODING GUANZHONG GLOVE CO., LTD. MARY A DOUCETTE
K062905 12/29/2006 NIO FUSION 4MP; MDNC 4130 BARCOVIEW LIEVEN DE WANDEL
K063331 12/19/2006 BAUSCH & LOMB NGX MICROSURGICAL SYSTEM BAUSCH & LOMB, INC. LISA C GRANEY
K063276 12/28/2006 CLINITEK ADVANTUS, MODEL 1420 BAYER HEALTHCARE, LLC NOOR MALKI
K063301 12/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063643 12/27/2006 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI JACKIE BUCKLEY
K062211 12/08/2006 BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. DAVID BHEND
K062213 12/08/2006 BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. DAVID BHEND
K063400 12/01/2006 VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K063492 12/21/2006 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOHN TENLLADO
K062997 12/08/2006 ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS BIOMET MANUFACTURING CORP. BECKY EARL
K060694 12/11/2006 MODULAR HYBRID GLENOID BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K063398 12/05/2006 ESA LEADCARE II LEAD CONTROL BIONOSTICS, INC. RANDY BYRD
K062819 12/04/2006 BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. JESUS T FARINAS
K063343 12/13/2006 BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM BIOPTIGEN, INC. RUSSELL PAGANO
K063505 12/12/2006 VISUALASE ENVISION SOFTWARE SYSTEM BIOTEX, INC. MATHEW FOX
K063237 12/08/2006 THERACAL LC BISCO, INC. BENJAMIN LICHTENWALNER
K063313 12/05/2006 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) BOSTON SCIENTIFIC CORP. DONNA PAGE
K063493 12/21/2006 I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 BOSTON SCIENTIFIC CORP. CHRISTINE DUNBAR
K062750 12/04/2006 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K063028 12/12/2006 VECTORVISION HIP SR BRAINLAB, AG RAINER BIRKENBACH
K063446 12/15/2006 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. PEGGY KEIFFER
K063074 12/27/2006 CANDELA 3630 LASER SYSTEM CANDELA CORP. JEFFREY ROBERTS
K063073 12/20/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS CANDELA CORP. JEFFERY ROBERTS
K063072 12/20/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES CANDELA CORP. JEFFERY ROBERTS
K063308 12/04/2006 ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 CARBYLAN BIOSURGERY ROXANNE DUBOIS
K051817 12/06/2006 BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM CARDIVA MEDICAL, INC. KARIN GASTINEAU
K062314 12/22/2006 HORUS LASER KERATOME CARL ZEISS MEDITEC AG KENT W JONES
K063087 12/11/2006 MODIFICATION TO MODEL 750 SERIES MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K063070 12/14/2006 APERFIX TIBIAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. FLOYD LARSON
K062897 12/14/2006 C-U2 CEFLA S.C.R.L. CLAUDE BERTHOIN
K062948 12/08/2006 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B CEPHEID RUSSEL K ENNS
K062280 12/11/2006 OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE CEREMED, INC. TADEUSZ WELLISZ
K062922 12/13/2006 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K063579 12/14/2006 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K062635 12/19/2006 MODEL 2200 CLARIMEDEX, INC. JOHN DUNNING
K063030 12/04/2006 COMFORT SCOOTER MODEL LY-EW406 COMFORT ORTHOPEDIC CO. LTD. KE-MIN JEN
K063457 12/05/2006 TRUEHD (1080P) DIGITAL CAMERA SYSTEM CONMED LINVATEC ELIZABETH PAUL
K061937 12/01/2006 COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON COOK ENDOSCOPY MABEL L HUNTER
K063619 12/20/2006 FLIPPER DETACHABLE EMBOLIZATION COILS COOK, INC. LISA WEBB
K063254 12/07/2006 THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K063206 12/28/2006 DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH DADE BEHRING, INC. KATHLEEN DRAY- LYONS
K063366 12/08/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE DADE BEHRING, INC. ROBERT EUSEBIO
K062924 12/26/2006 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK DADE BEHRING, INC. PAMELA A JURGA
K063365 12/08/2006 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE DADE BEHRING, INC. ROBERT EUSEBIO
K062710 12/08/2006 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K063478 12/15/2006 VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FOSTADT
K062426 12/15/2006 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K062814 12/15/2006 PIPELINE II ACCESS SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K063045 12/05/2006 IMMULITE 2000, IMMULITE 2500 VANCOMYCIN DIAGNOSTIC PRODUCTS CORP. DEBORAH L MORRIS
K063057 12/22/2006 IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP DIAGNOSTIC PRODUCTS CORPORATION DEBORAH L MORRIS
K061805 12/06/2006 STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM DIAGNOSTICA STAGO, INC. LAURA WORFOLK
K062674 12/01/2006 MISSION TRINITY B DIAMOND DIAGNOSTICS, INC. RANDOLPH QUINN
K063482 12/14/2006 CROSSPLAN / ACCUSOFT-XL V.4.04 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K061466 12/04/2006 INTIMOL DLC LABORATORIES, INC. JUAN MANZUR
K062364 12/06/2006 I-SCOPE 200 DONGJIN MEDICAL CO., LTD MIN-KANG KIM
K060988 12/06/2006 TOTAL AND HEMI SHOULDER SYSTEM DVO EXTREMITY SOLUTIONS, LLC DINA WEISSMAN
K063469 12/01/2006 MEDICAN ALPHA EASTERN MEDIKIT LTD. RAJEEV ASRI
K062508 12/05/2006 NEUROWAVE MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K063414 12/12/2006 MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K063182 12/21/2006 ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX ENPATH MEDICAL, INC. JAMES JENKINS
K061533 12/11/2006 PROCEED VENTRAL PATCH ETHICON, INC. BRYAN A LISA
K062045 12/04/2006 EDIA ANTI-CCP EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K063213 12/05/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063214 12/08/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063215 12/08/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063036 12/22/2006 OPUS HC482 DIRECT NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. JAYANTI KARANDIKAR
K062324 12/06/2006 MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN GE HEALTHCARE JOEL KENT
K063628 12/26/2006 CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY GE HEALTHCARE INTEGRATED IT SOLUTIONS KAREN M LUNDE
K063224 12/22/2006 GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL GENTRIS CORPORATION DEBORAH N KLOOS
K062836 12/19/2006 CITADEL ANTERIOR LUMBAR PLATE SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K063374 12/06/2006 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE GRACE MEDICAL, INC. JEFF COBB
K062950 12/21/2006 POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) HARTALEGA SDN BHD KUAN K HON
K062383 12/21/2006 UNISYN HA PLASMA MODULAR HIP HAYES MEDICAL, INC. LUKE ROSE
K063612 12/29/2006 MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. ROBIN BUSH
K052465 12/12/2006 REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 HEARTSINE TECHNOLOGIES, INC. GEORGE BRDLIK
K061879 12/15/2006 SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM HEMODIAGNOSTICA, LLC BRUNO BORGANTI
K063062 12/01/2006 HKBOND 2006 HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K063034 12/14/2006 AIR-FLEX WITH AUTO-DISTRACTION HILL LABORATORIES CO. BRADY ALLER
K063513 12/12/2006 ECHELON MR-RCC-150 CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS J THISTLEWAITE
K063518 12/21/2006 HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K063180 12/11/2006 ISECURE SYRINGE CARTRIDGE HOLDER HOSPIRA, INC. DIANE RENNPFERD
K063239 12/11/2006 LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 HOSPIRA, INC. DIANE RENNPFERD
K063616 12/20/2006 TRIDENT II ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP MANAL MORCOS
K063225 12/27/2006 METAIZEAU NAILING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K062845 12/13/2006 MODULAR REPLACEMENT ELBOW SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K063112 12/01/2006 REVLITE Q-SWITCHED ND:YAG LASER HOYA CONBIO, INC DONNA K TEMPLEMAN
K063166 12/22/2006 I.T.S. PELVIC RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K062626 12/20/2006 CORTISOL ELISA IBL-HAMBURG GMBH VICTOR HERBST
K063474 12/22/2006 ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) IMC-HEARTWAY, LLC MICHAEL CHEN
K063392 12/12/2006 IMCO-STAT IMCO TECHNOLOGIES MARK L SCHWARTZ
K062891 12/14/2006 PROTON THERAPY SYSTEM INDIANA UNIVERSITY CYCLOTRON FACILITY JONATHAN S KAHAN
K061902 12/08/2006 COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 INDITHERM MEDICAL M.W. (ANDY) ANDERSON
K062151 12/22/2006 BOX PEEK VBR SYSTEM INNOVASIS, INC. WARREN M DANSIE
K062707 12/08/2006 RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, LLC. GERALD GOIGITZER
K061901 12/14/2006 INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS FREDERICK MONTGOMERY
K062708 12/13/2006 QUANTA LITE CELIAC DGP SCREEN INOVA DIAGNOSTICS, INC. DONNA L GUSTAFSON
K061841 12/22/2006 QUANTA LITE INTRINSIC FACTOR ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K063020 12/14/2006 INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM INTAI TECHNOLOGY INC. PIEWEN LIN
K062353 12/20/2006 MOZAIK BONE REGENERATION MATRIX - PUTTY INTEGRA LIFESCIENCES CORPORATION DIANA M BORDON
K063230 12/21/2006 INTEGRA RADIONICS IMAGEFUSION 3 INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K063402 12/11/2006 WICK ELECTRODE, MODEL M019260 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K063484 12/22/2006 PATIENT DATA HANDLER & DEVICES (PDH&D) INTERMED ADVISORS, INC. CHRISTINA VULLO
K063220 12/01/2006 DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K061889 12/12/2006 BIOSTAR OIA SHIGATOX INVERNESS MEDICAL-BIOSTAR INC. ROBIN C HART
K062880 12/22/2006 SUBDERMAL WIRE ELECTRODE, MODEL SWE IVES EEG SOLUTIONS, INC. JOHN R IVES
K062602 12/11/2006 BAND-AID(R) BRAND LIQUID BANDAGE JOHNSON & JOHNSON CONSUMER COMPANIES, INC. MICHELLE R TURK
K063426 12/13/2006 V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 KCI USA, INC. VERONIQUE SMITH
K062965 12/22/2006 CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM KOSSAN LATEX INDUSTRIES (M) SDN. BHD. JAMES F LOGAN
K063640 12/18/2006 KOWA SL-15 KOWA CO. LTD. SATOHIKO TAKANASHI
K063228 12/08/2006 SURFACE COAT KURARAY AMERICA, INC. KOJI NISHIDA
K061656 12/15/2006 LASER-D68 LASER PAIN CLINICS LP HOLLY WRIGHT
K062719 12/01/2006 GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K061462 12/15/2006 BF+ (PH) LDR SPINE USA EDWARD E NEWTON
K062811 12/20/2006 DPILOG, MODEL DPC-512 LIFE OUTCOMES, INC. CHARLES M HART
K061726 12/04/2006 LSC, MODEL 3 LIFESTAND STEFANIE D BANKSTON
K063025 12/01/2006 LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, LINA MEDICAL APS WALT BRITTLE
K063140 12/29/2006 RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K061484 12/07/2006 MODIFICATION TO: SMITHWICK CAROTID SHUNT MCPHERSON ENTERPRISES, INC. WILLIAM MCPHERSON
K063580 12/14/2006 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K062969 12/14/2006 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K063119 12/22/2006 LIFEPAK 20 DEFIBRILLATOR/ MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. MICHELLE ACKERMANN
K062821 12/19/2006 U-CLIP DEVICE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K060794 12/18/2006 PROGENIX DBM PUTTY AND PASTE MEDTRONIC SOFAMOR DANEK EDWARD S CHIN
K062986 12/08/2006 MEDTRONIC GRAFT DELIVERY SYRINGE MEDTRONIC SOFAMOR DANEK USA, INC. EDWARD S CHIN
K062879 12/22/2006 TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. ED CHIN
K062752 12/07/2006 MERCATOR MICROSYRINGE II INFUSION CATHETER MERCATOR MEDSYSTEMS, INC. KIRK SEWARD
K062355 12/27/2006 ENA CEM MICERIUM S.P.A. EUGENIO MICELI
K062367 12/08/2006 MINISCREWS ANCHORING SYSTEM, M.A.S. MICERIUM S.P.A. EUGENIO MICELI
K063381 12/22/2006 CT COMPATIBLE F/S/D APPLICATORS MICK RADIO-NUCLEAR INSTRUMENTS, INC. FLEIX MICK
K063382 12/26/2006 HDR CT COMPATIBLE SPLIT RING APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K061283 12/14/2006 PULMOLIFE MICRO MEDICAL, LTD. GLEN HILLSLEY
K062867 12/06/2006 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K061615 12/22/2006 INTERDRY TEXTILE WITH SILVER MILLIKEN CHEMICAL MARY MCNAMARA-CULLINANE
K061033 12/12/2006 MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) MILTEX, INC. CHARLES WEAVER
K062524 12/15/2006 OCTAX LASER SHOT SYSTEM MINITUBE OF AMERICA, INC FREDERICK KIKKERS
K061875 12/11/2006 MINISPIR; SPIROLAB III MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K061712 12/01/2006 SPIROBANK II MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K062847 12/20/2006 BIOGEL ECLIPSE INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K060852 12/26/2006 MOONCUP MOONCUP LIMITED SU HARDY
K053218 12/28/2006 DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ
K061774 12/13/2006 NFIX II PEDICLE SCREW SYSTEM N SPINE, INC. R. STEPHEN REITZLER
K062539 12/01/2006 NCONTACT COAGULATION SYSTEM KIT NCONTACT SURGICAL, INC. JANE RICUPERO
K063012 12/01/2006 NCONTACT COAGULATION SYSTEM KIT, MODEL CSK NCONTACT SURGICAL, INC. JANE RICUPERO
K062533 12/22/2006 BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 NEUROVIRTUAL USA, INC. EDUARDO FARIA
K063095 12/22/2006 HUMERUS LOCKING PLATING SYSTEM NEWCLIP TECHNICS J.D. WEBB
K063221 12/12/2006 MEDWEB ADVANCED 3D WEB PACS NEXSYS ELECTRONICS, INC. GARY J ALLSEBROOK
K062551 12/15/2006 NEXUS IRRIGATION TUBING SET NEXUS MEDICAL, LLC ANITA SMITH
K062115 12/27/2006 CARBON DIOXIDE MONITOR, MODEL OLG-2800A NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K062936 12/19/2006 NOBELPERFECT CONICAL CONNECTION NOBEL BIOCARE AB PHUONG NGUYEN SON
K062566 12/06/2006 NOBELREPLACE TAPERED CONICAL CONNECTION NOBEL BIOCARE USA LLC HERBERT CRANE
K063274 12/12/2006 ACCULOC BREAST LOCALIZATION SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K063153 12/07/2006 NOVAPACS NOVARAD CORP. PAUL SHUMWAY
K062517 12/22/2006 ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K062760 12/11/2006 ORI F6T DRY ECG MONITORING ELECTRODE ORBITAL RESEARCH INC. AARON ROOD
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