FDA 510(k) Applications Received During December, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K034051 12/30/2003 DYNATRAC, COD. 50-1A 3D LINE USA, INC. NADER SALEHI
K033996 12/24/2003 HERMES 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K033974 12/22/2003 HERMES BOND 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K033845 12/11/2003 PRECISION XCEED DIABETES MONITORING SYSTEM ABBOTT LABORATORIES TRACEY H WIELINSKI
K033909 12/17/2003 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES JOANNA KUSKOWSKI
K034057 12/30/2003 LACRYTEST ADIATEC SA JOEL LESSER
K033749 12/01/2003 TITANIUM CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS PATRICK JANIN
K033757 12/01/2003 MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K033897 12/16/2003 MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM AGA-LINDE HEALTH CARE JAMES JOCHEN ROGERS
K033768 12/03/2003 ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE ALTUS MEDICAL, INC. KATHY MAYNOR
K033990 12/23/2003 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K033978 12/23/2003 ADAM ASTRO-MED, INC. MICHAEL J SULLIVAN
K034066 12/31/2003 B.BRAUN PREMIXED DIALYSATE B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K033952 12/22/2003 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY SMITH
K033997 12/24/2003 SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 BACCHUS VASCULAR, INC. LISA CAPARRA
K033859 12/11/2003 BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033941 12/19/2003 MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K033791 12/04/2003 BAYER SPECIFIC PROTEIN REFERENCE SERUM BAYER HEALTHCARE, LLC ANDRES HOLLE
K033781 12/04/2003 BEBIG ISOSEED I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K033784 12/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K033907 12/17/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K033889 12/16/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE BECTON, DICKINSON & CO. DAVID STREETT
K033861 12/12/2003 BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. COLLEEN A KISTLER
K033771 12/03/2003 BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR BIO-DETEK, INC. ROBERT MORSE
K033924 12/18/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K033761 12/02/2003 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K033792 12/05/2003 BILOK ST SCREW BIOCOMPOSITES LTD. J. STEPHEN BRATT
K033838 12/10/2003 TITANIUM TOGGLE BUTTON(S) BIOMET MANUFACTURING, INC. TRACY J BICKEL
K033871 12/12/2003 IM TOTAL FEMUR BIOMET, INC. PATRICIA SANDBORN BERES
K033862 12/12/2003 BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK BIOTEQUE CORP. WILLIAM LEE
K034024 12/29/2003 TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS BISCO, INC. BENJAMIN LICHTENWALNER
K033980 12/23/2003 BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K034068 12/31/2003 CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K034061 12/31/2003 MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC CORP. CHRISTINA L ROWE
K033829 12/09/2003 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K033752 12/01/2003 BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD A KELLER
K033979 12/23/2003 CORLINK AUTOMATED ANASTOMOTIC SYSTEM BY-PASS MAKAFIM LTD. JONATHAN S KAHAN
K033936 12/19/2003 BARD ELIMINATOR PET BALLOON DILATORS C.R. BARD, INC. MICHAEL A PATZ
K033814 12/09/2003 BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 C.R. BARD, INC. SUZANNE LASCALZA
K034020 12/24/2003 GROSHONG NXT PICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K033778 12/04/2003 MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. BARD, INC. FRAN HARRISON
K034065 12/29/2003 MODIFICATION TO X-PORT DUO PORT C.R. BARD, INC. ANGELA BRADY
K034019 12/24/2003 POLY PER-Q-CATH PICC CATHETERS C.R. BARD, INC. MICHAELA RIVKOWICH
K033789 12/04/2003 LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING Cardinal Health ERICA SETHI
K033905 12/17/2003 PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING Cardinal Health ERICA SETHI
K033799 12/05/2003 CLINICAL LASETTE P-200 CELL ROBOTICS, INC. LINDA A BLAIR
K033840 12/10/2003 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB CONSTANCE G BUNDY
K033943 12/19/2003 ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033810 12/08/2003 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033919 12/18/2003 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K033983 12/23/2003 VITALAB IRON REAGENT CLINICAL DATA, INC. WYNN STOCKING
K034000 12/24/2003 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR CLINICAL DATA, INC. WYNN STOCKING
K033910 12/17/2003 OLYMPUS URINE CALIBRATOR CLINIQA CORPORATION CAROL RUGGIERO
K033869 12/12/2003 CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) COLOPLAST CORP. ELIZABETH BOOTS
K033760 12/02/2003 ONE COAT SE BOND COLTENE/WHALEDENT INC. HENRY J VOGELSTEIN
K034039 12/29/2003 SIS PLASTIC SURGERY MATRIX COOK BIOTECH, INC. MARK BLEYER
K033903 12/17/2003 MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, COOK UROLOGICAL, INC. BRENDA DAVIS
K033904 12/17/2003 PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC. BRENDA DAVIS
K033875 12/15/2003 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K033843 12/10/2003 SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING COOK, INC. JENNIFER BOSLEY, MBA
K034050 12/30/2003 CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F CORDIS CORPORATION DONNA MARSHALL
K034013 12/24/2003 REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 CORGENIX, INC. NANCI DEXTER
K034062 12/31/2003 CP SLEEVE AND RIVER SLEEVE CP MEDICAL MARY ANN GREENAWALT
K033912 12/17/2003 CRADLE PACS CRADLE TECHNOLOGY CORP. JEN KE-MIN
K034030 12/29/2003 APOGEE ELITE CYNOSURE, INC. GEORGE CHO
K033809 12/08/2003 DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D DADE BEHRING, INC. RICHARD M VAUGHT
K033948 12/19/2003 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K033940 12/19/2003 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K033908 12/17/2003 N HIGH SENSITIVITY CRP DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K033865 12/12/2003 IDEIA PCE CHLAMYDIA DAKOCYTOMATION LTD JENNIE OATES
K033896 12/16/2003 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P DEFIBTECH, LLC JOHN L ROGERS
K033925 12/18/2003 BIOFREE DENTAL COMPONENTS, INC. RICHARD W HANSON
K033878 12/15/2003 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K033806 12/08/2003 ACE PROXIMAL HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K033893 12/16/2003 SPECTRUM MODULAR SYSTEM DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
K033901 12/17/2003 MERLIN SPINE SYSTEM DEPUY SPINE,INC JENNIFER MOONEY
K033959 12/22/2003 LPS DEPUY, INC. DINA L WEISSMAN
K033921 12/18/2003 AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K034055 12/30/2003 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D.
K034022 12/29/2003 UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES DIAMODENT JEFF RASSOLI
K033987 12/23/2003 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS DIDECO S.P.A. BARRY SALL
K034037 12/29/2003 SKY BONE EXPANDER SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHN
K033785 12/04/2003 PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE DISCUS DENTAL, INC. VIVIAN LAI
K033892 12/16/2003 ULTRAFLEX INFUSION SET DISETRONIC MEDICAL SYSTEMS AG BERND HENNINGSEN
K033876 12/15/2003 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 DOLPHIN MEDICAL INC. BILL CURNAN
K033957 12/22/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL Draeger Medical Systems, Inc. PENELOPE H GRECO
K033807 12/08/2003 INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER Draeger Medical Systems, Inc. PENELOPE H GRECO
K034067 12/31/2003 ZTI IMPLANTS SYSTEM, DRM IMPLANTS DRM RESEARCH LABORATORIES, INC. SAMUEL WAKNINE
K033950 12/22/2003 DORC VITRECTOMY LENSES, MODEL 1284 SERIES DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) FRAN CARLETON
K033821 12/09/2003 KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY EASTMAN KODAK COMPANY STEPHEN SLAVENS
K033918 12/18/2003 EBI LACTOSORB GRAFT CONTAINMENT SYSTEM EBI, L.P. JON CAPAROTTA
K033795 12/05/2003 PLASMACURE BXE EELE LABORATORIES, LLC ROBERT GRASMAN
K034043 12/29/2003 H-FLOW VALVE ELCAM MEDICAL A.C.A.L. TALI HAZAN
K033963 12/22/2003 EP DEFLECTABLE CATHETERS EP MEDSYSTEMS, INC. JAMES E KUHN, JR.
K033949 12/19/2003 VARILUX VISIONPRINT SYSTEM (VPS) ESSILOR INTL. MARC J SCHEINESON
K033746 12/01/2003 MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, INC. REY LIBROJO
K033825 12/10/2003 ORTHOPACS ETRAUMA.COM CORP. DEBBIE IAMPIETRO
K033858 12/11/2003 TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE EUROPEAN CUSTOM MANUFACTURING BV MAARTEN KANTERS
K033883 12/15/2003 OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI EXACTECH, INC. GARY MILLER
K034026 12/29/2003 RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS FISHER & PAYKEL HEALTHCARE, LTD. ADELE BINDON
K033967 12/22/2003 TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P FLIR SYSTEMS PAUL DRYDEN
K034064 12/31/2003 FRESENIUS ULTRAFLO HPX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K033808 12/08/2003 GRADIA GUM GC AMERICA, INC. TERRY L JORITZ
K033874 12/15/2003 MYOLIGHT GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K033964 12/22/2003 SOLAR 9500 INFORMATION MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ANDREW KLUESSENDORF
K033815 12/09/2003 BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN GEISTLICH-PHARMA PETER S REICHERTZ
K033867 12/12/2003 GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS GENERAL ELECTRIC CO. LARRY A KROGER
K033864 12/12/2003 GENZYME OSOM TRICHOMONAS RAPID TEST GENZYME CORP. E.V. GOORCHENKO
K033988 12/23/2003 GOLDWAY UT4000A VITAL SIGNS MONITOR GOLDWAY (US), INC. YINGCHAO XIAO
K033834 12/10/2003 OMNILINK .018 BILIARY STENT SYSTEM GUIDANT CORP. MICHELLE GROSSMAN
K034004 12/24/2003 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE GYRUS ENT L.L.C. ALICIA FARAGE
K034029 12/29/2003 TI CLIP APPLIER GYRX, LLC BRIAN S ZIMOVAN
K033751 12/01/2003 AEGIS PIT & FISSURE SEALANT WITH ACP HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K033853 12/11/2003 MODIFICATION TO V-CATH POLY PICC HDC CORP. EARL SMART
K033796 12/05/2003 KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS HEINZ KURZ GMBH MEDIZINTECHNIK ANGELIKA SCHERP
K034049 12/30/2003 HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K034060 12/31/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) HONG HUANG TANG INDUSTRIAL CO., LTD. HUAN-CHUNG LI
K033769 12/03/2003 EIUS UNICOMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K033972 12/22/2003 SCORPIO TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K033971 12/22/2003 SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K034002 12/24/2003 GAMMA3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K033968 12/22/2003 HANSSON PIN SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K033837 12/10/2003 STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K033744 12/01/2003 AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA HYCOR BIOMEDICAL LTD. DANIELLE M KNIGHT
K033851 12/11/2003 DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) HYPOGUARD USA, INC. BRUCE MACFARLANE
K033756 12/01/2003 VOLAR RADIUS PLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K033786 12/04/2003 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA IBL GMBH Gary Lehnus
K033783 12/04/2003 IMALUX OCT IMAGING SYSTEM IMALUX COPORATION STEPHANIE A.S. HARRINGTON
K034035 12/29/2003 3I PATIENT-SPECIFIC OVERDENTURE BAR IMPLANT INNOVATIONS, INC. JIM BANIC
K033776 12/03/2003 INSTEAD INTIMATE LUBRICANT INSTEAD, INC. JOE PIKE
K033922 12/18/2003 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG CAROLYN BITETTI
K033984 12/23/2003 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K034007 12/24/2003 HEMOSIL FACTOR VIII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K033775 12/03/2003 HEMOSIL LIQUID ANTITHROMBIN XL INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K033961 12/22/2003 ALTIUS OCT SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K033929 12/18/2003 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K033819 12/09/2003 INVACARE 3G TARSYS INVACARE CORP. CARROLL MARTIN
K034063 12/31/2003 MULTIBLAST MEDIUM IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K033956 12/22/2003 MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) IS2 RESEARCH, INC. VICTOR WOODBURN
K033770 12/03/2003 ISOAID ADVANTAGE PD-103, MODEL IAPD-103A ISOAID, L.L.C. MAX TAGHIZADEH
K033773 12/03/2003 CONCEPT HP ADD-ON; CONCEPT HP ENAMEL IVOCLAR VIVADENT AG DONNA MARIE HARTNETT
K033767 12/03/2003 DUAL TOP ANCHOR SYSTEM SCREWS JEIL MEDICAL CORPORATION DANIEL KAMM
K033846 12/11/2003 KAEN YIH UMBILICAL CORD CLAMP KAEN YIH ENTERPRISE CO., LTD. ANTONIO L GIACCIO
K033930 12/18/2003 KAPP CUSTOM ULNAR HEAD WRIST IMPLANT KAPP SURGICAL INSTRUMENT, INC. ALBERT SANTILLI
K034027 12/29/2003 KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM KLS-MARTIN L.P. JENNIFER DAMATO
K033970 12/22/2003 CLEARFIL PHOTO CORE PLT KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K033938 12/19/2003 CLEARFIL PROTECT BOND KURARAY MEDICAL INC. KEITH A BARRITT
K033801 12/08/2003 KYPHX HV-R, MODEL C01A KYPHON, INC. CINDY DOMECUS
K033916 12/18/2003 GRI-BAG, GRI-BAG AP LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K033758 12/02/2003 HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K034011 12/24/2003 GEMINI SURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K034052 12/30/2003 BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES LATEXX MANUFACTURING SDN.BHD. LAW SIAU WOEI (TERRY LAW)
K033899 12/17/2003 LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR LIFESTREAM TECHNOLOGIES, INC. JACKSON CONNOLLY
K033885 12/15/2003 BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc. CHENG-I LIN, PH.D.
K033866 12/12/2003 CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) Lin-Zhi International, Inc. CHENG-I LIN
K033804 12/08/2003 BIOANCHOR WITH DISPOSABLE DRIVER LINVATEC CORP. LAURA D KREJCI
K033748 12/01/2003 TRIDENT RESECTION ABLATOR LINVATEC CORP. LAURA D KREJCI
K034031 12/29/2003 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K033879 12/15/2003 VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 MAINE STANDARDS CO. CHRISTINE BEACH
K033998 12/24/2003 MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V MASIMO CORP. JAMES J CRONIN
K033849 12/11/2003 SIMPLANT SYSTEM MATERIALISE N.V. CARL VAN LIERDE
K033894 12/16/2003 PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 MATSUSHITA ELECTRIC WORKS, LTD. CAROLANN KOTULA
K033835 12/10/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR MDM ENTERPRISE CORP. ELIZABETH DENG
K033880 12/15/2003 ELECTRO-LUBE MECTRA LABS, INC. CHARLES E ALLGOOD JR.
K034054 12/30/2003 PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 MED-TEC,INC. DONALD F RIIBE
K033986 12/23/2003 MLT-1000 IR LASER SYSTEM MEDICAL LASER THERAPEUTICS LP M. JOYCE HEINRICH
K034015 12/24/2003 EARLOOP PROCEDURE MASK MEDIPACK MEDICAL PACKAGING MFG. CO. ANTONIO L GIACCIO
K033774 12/03/2003 CT-MASS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K033906 12/17/2003 PORTASCAN BLADDER SCANNER, MODEL PA00146 MEDIWATCH PLC ANDREW HOPKINS
K033881 12/15/2003 MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE MEDRAD, INC. TROY A JACK
K033888 12/16/2003 MSI MODEL S-500 RF GENERATOR MEDSPHERE INTERNATIONAL, INC ERIC KAO
K033989 12/23/2003 MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT KRISTY K MOLLNER
K033850 12/11/2003 MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K033926 12/18/2003 HOURGLASS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K034056 12/30/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K034058 12/30/2003 SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 MEDTRONIC VASCULAR PREETI JAIN
K034009 12/24/2003 LAPEX 2000 MERIDIAN CO., LTD. DANIEL KAMM
K033847 12/11/2003 A1CNOW FOR HOME AND PROFESSIONAL USE METRIKA, INC. ERIKA AMMIRATI
K033828 12/10/2003 CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K034036 12/29/2003 MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 MICRO THERAPEUTICS, INC. Bill Hyatt
K034023 12/29/2003 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K033817 12/09/2003 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K033818 12/09/2003 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K033820 12/09/2003 MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
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K033833 12/10/2003 EFLOW ELECTRONIC INHALER/NEBULIZER PARI INNOVATIVE MANUFACTURERS, INC. LAWRENCE WEINSTEIN
K033856 12/11/2003 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN PETER STEVENS, MD PETER STEVENS, MD
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K033933 12/19/2003 POWERLITE 600 EX SYSTEM PRESWEDE AB SUSAN D GOLDSTEIN-FALK
K033779 12/04/2003 VIANOX DELIVERY SYSTEM, MODEL II PULMONOX MEDICAL, INC. PAULA TOMAT
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K034033 12/29/2003 RESCAN RESMED LTD. DAVID D'CRUZ
K033841 12/10/2003 RESMED S8 PRIME CPAP SYSTEM RESMED LTD. DAVID D'CRUZ
K034032 12/29/2003 PLV CONTINUUM VENTILATOR, MODEL P2000 RESPIRONICS CALIFORNIA, INC. MARY FUNK
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K034040 12/29/2003 ESPRIT VENTILATOR, MODEL V1000 RESPIRONICS, INC. ANIL BHALANI
K033822 12/10/2003 RESPIRONICS CUSTOM I ORAL APPLIANCE RESPIRONICS, INC. ZITA A YURKO
K033823 12/10/2003 RESPIRONICS CUSTOM II ORAL APPLIANCE RESPIRONICS, INC. ZITA A YURKO
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K033793 12/05/2003 CLEANER II ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL SUSAN D GOLDSTEIN-FALK
K033827 12/10/2003 UB 140 RIVERTRAIL MOBILITY CLARK STANCIL
K034046 12/29/2003 RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 RNK PRODUCTS CHARLES R ABBRUSCATO
K033873 12/15/2003 ELECSYS C-PEPTIDE CALSET ROCHE DIAGNOSTICS CORP. THERESA M AMBROSE
K033937 12/19/2003 ELECSYS PRECICONTROL MULTIANALYTE ROCHE DIAGNOSTICS CORP. THERESA M AMBROSE
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K033939 12/15/2003 FLOSENSE II, MODEL 29-8040 SDI DIAGNOSTICS, INC. MICHAEL J BOYLE
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K033762 12/02/2003 SERRALAPG SERRAL, S.A. DE C.V. SCOTT HENDERSON
K033831 12/10/2003 SIENET COSMOS SIEMENS AG, MEDICAL SOLUTIONS EVA-MARIA REITER
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K033812 12/09/2003 SIROAIR L AIR SCALER SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
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K033981 12/23/2003 SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 SMITH & NEPHEW, INC. JANICE HASELTON
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K033953 12/22/2003 OPTIMESH 500E CEMENT RESTRICTOR SPINEOLOGY, INC. PAMELA SNYDER
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K034021 12/24/2003 VACUUM ASSISTED CORE BIOPSY DEVICE SUROS SURGICAL SYSTEMS, INC. JOSEPH L MARK
K033777 12/04/2003 ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES SYNTEX HEALTHCARE PRODUCTS CO. LTD. TITO ALDAPE
K033995 12/24/2003 3.5 MM LCP DISTAL HUMERUS SYSTEM SYNTHES (USA) LISA M BOYLE
K033805 12/08/2003 SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES (USA) LISA M BOYLE
K033816 12/09/2003 SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA) LISA M BOYLE
K033868 12/12/2003 SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS SYNTHES (USA) LISA M BOYLE
K033975 12/23/2003 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA) LISA M BOYLE
K033844 12/11/2003 SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM SYNTHES (USA) SUSAN LEWANDOWSKI
K033790 12/04/2003 THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES TECNIMED S.R.L. CAROLANN KOTULA
K033800 12/05/2003 CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems Corporation GARRY A COURTNEY
K033913 12/17/2003 PROGREAT TERUMO MEDICAL CORP. MARK UNTERREINER
K033811 12/09/2003 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER THE BINDING SITE, LTD. JAY H GELLER
K033942 12/19/2003 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K034014 12/24/2003 SPI CONTACT DENTAL IMPLANT THOMMEN MEDICAL, AG FLOYD G LARSON
K033923 12/18/2003 TH0R DDII IR LAMP SYSTEM THOR INTL. M. JOYCE HEINRICH
K034053 12/30/2003 TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K033794 12/05/2003 ULTICARE DISPOSABLE SYRINGE 3 ML/CC ULTIMED, INC. ELLEN G REDDING
K033753 12/01/2003 PELVIC ARRAY COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K033954 12/22/2003 SHAPE LOCKING ENDOSCOPIC OVERTUBE USGI MEDICAL, INC. JEFFREY A ANDERSON
K033960 12/22/2003 OLINDA/EXM VANDERBILT UNIVERSITY MICHAEL STABIN
K033902 12/17/2003 ONTRAK TESTCUP II AND ONSITE CUPKIT VARIAN INC LORNA GAMBOA
K034010 12/24/2003 GELSOFT PLUS ERS VASCUTEK LTD. STEVEN ARICK
K033842 12/10/2003 NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE VERNON-CARUS LIMITED C. ROBERT PAYNE, JR., P.E.
K034017 12/24/2003 JEJE TEETHER VIBE 2000 CAROL PATTERSON
K033969 12/22/2003 ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER VISTAKON ANNETTE M HILLRING
K033982 12/23/2003 MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST VYSIS KERRY J FLOM
K033927 12/18/2003 ARTHOSCOPY PUMP A115 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K033860 12/12/2003 AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K033870 12/12/2003 IMAGE MANAGEMENT SYSTEM WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K033857 12/11/2003 T-TECH DIGITAL, MODEL WL-22XXA SERIES WELL-LIFE HEALTHCARE, INC. JENNY HSIAH
K033754 12/01/2003 TRACER METRO SMART WIRE GUIDE WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K033890 12/16/2003 ADVANCE DOUBLE HIGH INSERT WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K034028 12/29/2003 ATH FEMORAL STEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
K033887 12/15/2003 NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES YTY INDUSTRY (MANJUNG) SDN. BHD. JANNA P TUCKER
K033802 12/08/2003 ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K033977 12/23/2003 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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