FDA 510(k) Decisions During January, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K040890 11/02/2004 3M TEGADERM SILVER 3M COMPANY AMY E SHORT
K043097 11/19/2004 3VISEON 3MENSIO MEDICAL IMAGING BV CARL ALLETTO
K042390 11/19/2004 ETEST FOR GEMIFLOXACIN AB BIODISK ANNE BOLMSTROM
K040115 01/30/2004 PICCOLO MAGNESIUM TEST SYSTEM ABAXIS, INC. Dennis M Bleile
K040114 01/29/2004 ABBOTT DATA PORT PC, MODEL 12181 ABBOTT LABORATORIES PATRICIA MELERSKI
K033845 01/08/2004 PRECISION XCEED DIABETES MONITORING SYSTEM ABBOTT LABORATORIES TRACEY H WIELINSKI
K032051 01/09/2004 BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P ACCESS BATTERY, INC. ALEXANDER B HENDERSON
K042752 11/10/2004 ACCUPACH V ACCUTOME ULTRASOUND, INC. JEFFREY L WRIGHT
K042069 11/01/2004 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM ACMI CORPORATION TERRENCE E SULLIVAN
K033639 01/15/2004 ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM ACUMED LLC ED BOEHMER
K042880 11/03/2004 JETSTREAM WORKSPACE ADAC LABORATORIES COLEEN A COLEMAN
K042496 11/02/2004 ADEPT ULTRALITE 532 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K031588 01/21/2004 CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM ADVANCED DIAGNOSTIC SYSTEMS DEBRA J RASMUSSEN
DEN040001 01/21/2004 CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM ADVANCED DIAGNOSTIC SYSTEMS DEBRA J RASMUSSEN
K033757 01/30/2004 MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K041855 11/10/2004 PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S AEARO CO. ANN PHILLIPS
K032108 01/15/2004 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) AESCULAP, INC. JOYCE KILROY
K042227 11/19/2004 INSTANT-VIEW TROPONIN I TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K041978 11/23/2004 REPROCESSED DIAMOND BURS ALLIANCE MEDICAL CORP. ERIC VARTY
K033423 01/15/2004 REVOLIX LASER SYSTEMS ALLMED SYSTEMS INC. PETER ALLEN
K033437 01/20/2004 SPHINX LASER SYSTEMS ALLMED SYSTEMS INC. PETER ALLEN
K040015 01/21/2004 MODIFICATION TO PRISMALIX SURGICAL LIGHT ALM S.A. FREDERICK R CATT
K043196 11/30/2004 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K042250 11/12/2004 SENSATOUCH ALUNA MANAGEMENT CO., LTD. CHARITY MARTIN
K042843 11/12/2004 AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS AMBU, INC. SANJAY PARIKH
K042682 11/15/2004 AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR AMBU, INC. SANJAY PARIKH
K041712 11/03/2004 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K032003 01/07/2004 PREMIER PLUS AMERICAN IMEX ALEX FONG
K030275 11/29/2004 MB SYSTEM, BIOENERGY LIGHT THERAPY AMEST CORP. JOHN IEST
K042889 11/16/2004 DYNAMOMETER - MODEL FCE AND MODEL MSC AMETEK PHILIP LACHANCE
K042906 11/19/2004 AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K043025 11/19/2004 SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 ANALOGIC CORP. DONALD J SHERRATT
K042685 11/18/2004 METRICATH SYSTEM ANGIOMETRX INC. TIM VERSPAGEN
K032710 01/09/2004 CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT APOGEE MEDICAL, INC. DIANE N PEPER
K041766 11/26/2004 EZY-TRAVEL WRISTBAND APOTHECARY PRODUCTS, INC. DAVID KRAMER
K031715 01/08/2004 ARIOL HER-2/NEU IHC APPLIED IMAGING CORP. DIANE C OATES
K042443 11/24/2004 SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL ARKRAY, INC. HELEN LANDICHO
K041427 11/24/2004 THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS ARKRAY, INC. HELEN LANDICHO
K032245 01/14/2004 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 ARTHREX, INC. ANN WATERHOUSE
K041356 11/04/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC. ANN WATERHOUSE
K041189 11/04/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC. ANN WATERHOUSE
K032822 01/08/2004 ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUENDEROTH
K042690 11/13/2004 ASCENSION PYROSPHERE (PCS) ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K042968 11/24/2004 MCL 30 DERMABLATE ER:YAG LASER SYSTEM ASCLEPION LASER TECHNOLOGIES GMBH GEORGE CHO
K033532 01/28/2004 ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K033530 01/28/2004 ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K030267 01/15/2004 EEG MONITOR WITH BIS, MODEL A-2000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K043138 11/22/2004 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 ATOS MEDICAL AB EDDY ABERG
K030655 01/29/2004 HOLOTC RIA AXIS-SHIELD BIOCHEMICALS, ASA RONALD G LEONARDI
K033606 01/30/2004 ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST AXIS-SHIELD DIAGNOSTICS, LTD. JUDITH FINLAYSON, PH.D.
K042580 11/17/2004 TIDI BRAND STERILIZATION WRAP BANTA HEALTHCARE GROUP, LTD. INA GORDON
K042942 11/22/2004 MGP 15 DICOM THEATER BARCO NV BARCOVIEW FRANK FURGUSON
K042660 11/19/2004 NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K042661 11/19/2004 NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FURGUSON
K042662 11/22/2004 NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K041172 11/18/2004 BASBA E-MACHINE BASBA INC. M. JOYCE HEINRICH
K040985 11/30/2004 PUMP CONNECTIVITY INTERFACE BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K042936 11/26/2004 SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K033643 01/08/2004 CO2 CALIBRATOR/DILUENT BAYER HEALTHCARE, DIAGNOSTICS DIVISION KENNETH T EDDS, PH.D.
K042459 11/17/2004 SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT BECKMAN COULTER, INC. KIM WALKER
K042291 11/12/2004 UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS BECKMAN COULTER, INC. MARY BETH TANG
K042812 11/22/2004 BBLCHROMAGAR MRSA BECTON DICKINSON & CO. DENNIS R MERTZ
K033500 01/29/2004 BD CAREFLOW CENTRAL VENOUS CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K042491 11/22/2004 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K033560 01/14/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K033557 01/14/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K033279 01/15/2004 GOLD DENTAL CASTING ALLOYS BEGO U.S.A. WILLIAM OREMUS
K042400 11/24/2004 MUCOTROL CONCENTRATED ORAL GEL WAFER BELCHER PHARMACEUTICALS, INC. KOTHA SEKHARAM
K042586 11/03/2004 BEST BREAST BRACHYTHERAPY APPLICATOR BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K042786 11/18/2004 BEST MODEL # 81-01 SERIES IR-192 SOURCES BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K031568 11/23/2004 BICONITE SURFACE TREATMENT BICON, INC. VINCENT J MORGAN
K042637 11/15/2004 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K042837 11/02/2004 LIQUICHEK ELEVATED CRP CONTROL BIO-RAD ELIZABETH PLATT
K042836 11/05/2004 LIQUICHEK RETICULOCYTE CONTROL (A) BIO-RAD ELIZABETH PLATT
K042865 11/24/2004 LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) BIO-RAD SUZANNE S PARSONS
K042815 11/05/2004 QUEST TUMOR MARKER CONTROL, MODEL 955 BIO-RAD ELIZABETH PLATT
K042446 11/02/2004 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K033155 01/12/2004 BIOCENTREX CARDIAC PANEL BIOCENTREX THOMAS H GROVE
K042231 11/12/2004 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K041432 11/30/2004 ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT BIOFILM, INC. ROBERT L DE ARMOND
K042314 11/22/2004 SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE BIOGEN VICTOR J GANGI
K030523 01/30/2004 WATERLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K041388 11/23/2004 COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K033455 01/15/2004 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 BIOMEDICAL LIFE SYSTEMS, INC. DONNA HERATY
K042093 11/01/2004 VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS BIOMET, INC. TAACY BICKEL JOHNSON
K042029 11/09/2004 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K041595 11/12/2004 TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 BIOPRO, INC. DAVID MARK
K032235 01/28/2004 MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFFREY R DAHLEN
K042890 11/29/2004 TRIAGE D-DIMER TEST, MODEL 98100 BIOSITE INCORPORATED JEFFERY R DAHLEN
K042083 11/16/2004 MODIFICATION TO VISITOME 20-10 MICROKERATOME BIOVISION AG DALE SADLIK
K033521 01/16/2004 BISBLOCK BISCO, INC. BENJAMIN LICHTENWALNER
K033585 01/16/2004 DIAPEX BISCO, INC. BENJAMIN LICHTENWALNER
K033472 01/15/2004 TESCERA U-BAR AND BARRELS BISCO, INC. BENJAMIN LICHTENWALNER
K042134 11/01/2004 VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED RICHARD WESTON
K033742 01/12/2004 BOSTON SCIENTIFIC V-18 CONTROL WIRE BOSTON SCIENTIFIC CORP. DEBORAH THOMAS
K042882 11/09/2004 ENTERYX INJECTION CATHETER BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K040018 01/20/2004 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K034061 01/30/2004 MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC CORP. CHRISTINA L ROWE
K041818 11/10/2004 SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K032214 01/29/2004 MEDONIC CA620/530 HEMATOLOGY ANALYZER BOULE MEDICAL AB ANDREW SWANSON
K032511 01/21/2004 INTUITION IMAGE BRAINLAB, AG RAINER BIRKENBACH
K041464 11/05/2004 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K033936 01/14/2004 BARD ELIMINATOR PET BALLOON DILATORS C.R. BARD, INC. MICHAEL A PATZ
K034020 01/21/2004 GROSHONG NXT PICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K034065 01/15/2004 MODIFICATION TO X-PORT DUO PORT C.R. BARD, INC. ANGELA BRADY
K042949 11/09/2004 PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) C.R. BARD, INC. JOHN C KNORPP
K034019 01/21/2004 POLY PER-Q-CATH PICC CATHETERS C.R. BARD, INC. MICHAELA RIVKOWICH
K041088 11/01/2004 TRIFUSION, MODEL 0609190/0659350 C.R. BARD, INC. LYNN M KIRCHOFF
K042350 11/03/2004 TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR CADWELL LABORATORIES, INC. CHRIS BOLKAN
K033331 01/16/2004 CANDELA CBEAM PULSE DYE LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K041242 11/22/2004 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K033461 01/16/2004 CANDELA VBEAM PULSE DYE LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K041392 11/08/2004 SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US CAO GROUP, INC. ROBERT K LARSEN
K042615 11/05/2004 CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K043096 11/24/2004 COMMANDER II CARDIOCOM CONSTANCE G BUNDY
K042806 11/24/2004 QUADRANT UNIT-1-BOND CAVEX HOLLAND B.V. RICHARD WOORTMAN
K033514 01/06/2004 CODA CX1 MOTION ANALYSIS SYSTEM CHARNWOOD DYNAMICS LTD. DAVID L MITCHELSON
K042144 11/12/2004 NICOM CHEETAH MEDICAL INC. BENNY ARAZY
K042176 11/03/2004 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION STEVEN DOWDLEY
K042039 11/17/2004 FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K033910 01/30/2004 OLYMPUS URINE CALIBRATOR CLINIQA CORPORATION CAROL RUGGIERO
K032604 01/20/2004 GII SPINAL FIXATION SYSTEM CO-LIGNE AG ARIEL DUJOVNE, ING. M.SC.
K042796 11/05/2004 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE COAPT SYSTEMS, INC. BANKIM MEHTA
K042473 11/19/2004 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM COBE CARDIOVASCULAR, INC. JACK ELLISON
K033760 01/23/2004 ONE COAT SE BOND COLTENE/WHALEDENT INC. HENRY J VOGELSTEIN
K042746 11/22/2004 PET-DOSE COMECER S.R.L. E.J. Smith
K031621 01/22/2004 HERO 1, MODEL LY-ESB220 COMFORT ORTHOPEDIC CO. LTD. ERIC H.C. LEE
K033515 01/22/2004 HUBERPRO SAFETY HUBER INFUSION SET COMMAND MEDICAL PRODUCTS JOYCE VYTLACIL
K033344 01/16/2004 LIGAND PLUS CONTROL LEVEL 1-3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K033903 01/16/2004 MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, COOK UROLOGICAL, INC. BRENDA DAVIS
K033904 01/16/2004 PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC. BRENDA DAVIS
K042611 11/12/2004 LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE COOK, INC. EARL KNIGHT
K042824 11/16/2004 FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. BONNIE J TSYMBAL
K042969 11/08/2004 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. DONNA MARSHALL
K034013 01/08/2004 REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 CORGENIX, INC. NANCI DEXTER
K042680 11/19/2004 RHIGENE HEP-ANA TEST SYSTEM CORGENIX, INC. YUSUKE KOBE
K034062 01/30/2004 CP SLEEVE AND RIVER SLEEVE CP MEDICAL MARY ANN GREENAWALT
K042230 11/05/2004 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K030876 01/22/2004 CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM CYNOSURE, INC. GEORGE CHO
K033176 01/21/2004 TRISTAR AESTHETIC WORKSTATION LASER CYNOSURE, INC. GEORGE CHO
K041080 11/30/2004 SURGICAL DRAPE KIT - D.I.R.R.A. SRL D.I.R.R.A. S.R.L. ELISABETTA BACCHI
K033525 01/12/2004 DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 DADE BEHRING, INC. RICHARD M VAUGHT
K042347 11/19/2004 MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD DADE BEHRING, INC. GEORGE M PLUMMER
K033908 01/22/2004 N HIGH SENSITIVITY CRP DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K032692 01/22/2004 DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 DAKO A/S GITTE BRINKMANN
K033865 01/21/2004 IDEIA PCE CHLAMYDIA DAKOCYTOMATION LTD JENNIE OATES
K033215 01/09/2004 PREPAIR DANVILLE MATERIALS, INC. CRAIG R BRUNS
K024252 01/22/2004 MATCH MASTER LOW FUSION PORCELAIN DAVIS SCHOTTLANDER & DAVIS, LTD. CLYDE E INGERSOLL
K041680 11/10/2004 ORAJEL ADVANCED TOOTH DESENSITIZER DEL PHARMACEUTICALS, INC. MARLENE TIETJEN
K042196 11/01/2004 SAVEDENT BLUE DENFOTEX LIGHT SYSTEMS LTD JOHN COLLES
K042153 11/08/2004 SOUTH BEACH SMILE LIGHT WHITENING SYSTEM DENTOVATIONS, INC. M. JOYCE HEINRICH
K033667 01/23/2004 CARRARA PRESS SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K032361 01/12/2004 ENDOPURE ROOT CANAL CLEANSER DENTSPLY INTL. P. JEFFERY LEHN
K042905 11/04/2004 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY DENTSPLY INTL. HELEN LEWIS
K041075 11/09/2004 FASTIN RC ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K041069 11/09/2004 SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K033338 01/08/2004 PINNACLE REVISION SYSTEM DEPUY ORTHOPAEDICS, INC. BOB FRIDDLE
K042544 11/23/2004 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K041928 11/23/2004 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041926 11/23/2004 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041927 11/23/2004 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K034055 01/21/2004 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D.
K034022 01/30/2004 UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES DIAMODENT JEFF RASSOLI
K033056 01/30/2004 BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033058 01/30/2004 CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033055 01/30/2004 GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS DIAMOND DIAGNOSTICS, INC. LINDA STUNDTNER
K033323 01/13/2004 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING DIDECO S.P.A. BARRY SALL
K033987 01/08/2004 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS DIDECO S.P.A. BARRY SALL
K034037 01/28/2004 SKY BONE EXPANDER SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHN
K033381 01/27/2004 DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL DISCUS DENTAL INC. STEVEN L ZIEMBA
K033227 01/16/2004 LUXAFORM PLUS DMG USA, INC. PAMELA PAPINEAU
K042607 11/26/2004 PRIMUS US DRAEGER MEDICAL, INC. JAMES J BRENNAN
K033312 01/13/2004 EBI TOP LOADING MAS SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K042197 11/15/2004 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K042704 11/26/2004 REUSABLE FINGER CLIP SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K031367 01/23/2004 DUOPATH VEROTOXINS GLISA TEST EMD CHEMICALS INC. ANNA G BENTLEY
K040354 11/04/2004 METAL/METAL HIP SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K042918 11/22/2004 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 ENDO OPTIKS, INC. KEITH HERTZ
K041708 11/30/2004 ENPATH SAFETY INTRODUCER ENPATH MEDICAL INCORPORATED KARYL HASKELL
K042700 11/08/2004 IMAGE MEDICAL ACQUISITION STATION (IMAS) ERAD IMAGEMEDICAL CORP. GARY J ALLSEBROOK
K033590 01/30/2004 ERBE HELIX HYDRO-JET ERBE USA, INC. JOHN TARTAL
K032199 01/30/2004 ESA PLASMA FREE METANEPHRINE ANALYSIS KIT ESA, INC. HAROLD ASP
K042897 11/19/2004 AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K042753 11/08/2004 MAMMOTOME MR BIOPSY SYSTEM ETHICON ENDO-SURGERY, INC. CAROL J SPRINKLE
K031147 01/12/2004 OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR ETHICON ENDO-SURGERY, INC. KIMBERLY SHOEMAKER
K030341 01/16/2004 MODIFICATION TO INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD ROBBIE WALSH
K042842 11/09/2004 NOVATION 12/14 PRESS-FIT FEMORAL STEM EXACTECH, INC. Lisa Simpson
K031841 01/22/2004 SPACER G TEMPORARY HIP PROSTHESIS EXACTECH, INC. GARY J MILLER
K041869 11/18/2004 SELF RETAINING BICANALICULUS INTUBATION SET FCI OPHTHALMICS, INC. LOUIS ARMAND
K041470 11/22/2004 MORTON IUI CATHETERS FERTILITY TECHNOLOGY RESOURCES, INC. CONSTANCE W STURGEON
K033087 01/14/2004 ORACLE ORAL MASK, MODEL HC451A FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K033569 01/13/2004 FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH FLOWMEDICA, INC. JEFF ELKINS
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K032126 01/08/2004 PROMOS SHOULDER PLUS ORTHOPEDICS J.D. WEBB
K041882 11/23/2004 FLOWCARE SYSTEM POINTCARE TECHNOLOGIES INC. CYNTHIA A SINCLAIR
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K041144 11/03/2004 RANDOX OPIATES ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
K032882 01/28/2004 RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 RECOM MANAGED SYSTEMS, INC. WILLAM R MATTHEWS
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K033937 01/07/2004 ELECSYS PRECICONTROL MULTIANALYTE ROCHE DIAGNOSTICS CORP. THERESA M AMBROSE
K043095 11/23/2004 ROCHE DIAGNOSTICS ELECSYS AFP CALSET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K032334 01/12/2004 ROCHE ONLINE TDM LIDOCAINE ROCHE DIAGNOSTICS CORP. MIKE FLIS
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K042264 11/24/2004 GUIDEWIRES ROCKET MEDICAL PLC T. CHARLTON
K032585 01/09/2004 TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM RON-TECH MEDICAL LTD. DORON KILCHEVSKY
K033391 01/12/2004 MEDICAL MAGGOTS RONALD A. SHERMAN RONALD A SHERMAN
K042773 11/23/2004 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS ROSTAM LTD. ROBERT J STAAB
K033660 01/07/2004 STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 RUDOLF STORZ GMBH ANGELIKA SCHERP
K042614 11/22/2004 S&C-SELF ETCH PR-BOND S & C POLYMER GMBH CHRISTIAN BOETTCHER
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K042119 11/03/2004 POWDER-FREE VINYL PATIENT EXAMINTION GLOVES SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., CHEN YUHONG
K042120 11/04/2004 POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., CHEN YUHONG
K042617 11/05/2004 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA SIEMENS MEDICAL SOLUTIONS USA INC. NEALIE HARTMAN
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K032966 01/13/2004 THE ANSWER SCREW SUPPLEMENTATION SYSTEM SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC BARRY T BICKLEY
K033675 01/15/2004 PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
K031860 01/21/2004 SK MED ME202 MONITORING MIXER SK MED DIPAK GHOSH
K034005 11/18/2004 SDS-4I SKYLARK DEVICE & SYSTEMS CO., LTD GEORGE CHIANG
K033683 01/08/2004 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR SMART GLOVE CORP. SDN BHD FOO KHON PU
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K033686 01/23/2004 PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM SMITHS MEDICAL MD, INC. PATRICIA A LAFORTE
K033376 01/15/2004 UGYTEX MESH SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
K042619 11/05/2004 ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT SONOTECH, INC. MARGARET J LARSON
K023713 01/28/2004 SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 SONTRA MEDICAL INC. ALBERT FARINHA
K033310 01/15/2004 REMEEX SYSTEM FOR URINARY INCONTINENCE SPECIALITIES REMEEX INTERNATIONAL, S.L. JEFFREY R SHIDEMAN
K040684 11/05/2004 T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 SPECTROS CORPORATION DAVID A BENARON
K033772 01/27/2004 SHIRAZ-JAVA SPINAL FIXATION SYSTEM SPINE NEXT AMERICA DIANE JOHNSON
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K032124 01/16/2004 DUREX PLAY LUBRICANT SSL AMERICAS, INC. KATHLEEN HARRIS
K042733 11/15/2004 STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM STANDARD IMAGING, INC. RAYMOND RIDDLE
K042909 11/12/2004 STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A STELLARTECH RESEARCH CORP. JAMES R SANTOS
K032303 01/16/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER INSTRUMENTS JEAN W SHEPPARD
K033019 01/22/2004 SUNPEX TECHNOLOGIES MODEL SE03 SUNPEX TECHNOLOGY CO., LTD. LEONARD FRIER
K042438 11/08/2004 SUPERDIMENSION/BRONCHUS SUPERDIMENSION, LTD. GEORGE MYERS
K042211 11/08/2004 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS SURGICAL LASER TECHNOLOGIES, INC. BOB ROSE
K042555 11/09/2004 SURGICHIP TAG SURGICAL MARKER SURGICHIP, INC. BRUCE WAXMAN
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K042422 11/15/2004 D3 CHROMA SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K032514 01/27/2004 AC APPLICATOR, AURORA AC SYNERON MEDICAL LTD. AMIR WALDMAN
K041959 11/08/2004 POLARIS DS/COMET SYNERON MEDICAL LTD. AMIR WALDMAN
K040141 01/30/2004 EMORY CARDIAC TOOLBOX VERSION 2.6 SYNTERMED, INC. KENNETH F VAN TRAIN
K042986 11/17/2004 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM SYNTHES (USA) LISA M BOYLE
K042987 11/23/2004 MODIFICATION TO SYNTHES CRANIAL PLATES SYNTHES (USA) LISA M BOYLE
K033556 01/13/2004 SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM SYNTHES (USA) BONNIE SMITH
K042365 11/18/2004 SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K042895 11/16/2004 SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES SYNTHES (USA) SHERI L MUSGNUNG
K033403 01/22/2004 T.S. MEDICAL CIRCUMCISION CLAMP T.S. MEDICAL CAROLANN KOTULA
K042652 11/04/2004 TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR TAIWAN KING STRONG CO., LTD. KE-MEN JEN
K033654 01/15/2004 FORCE FIBER TELEFLEX MEDICAL LYNN MATOS
K042152 11/22/2004 BINDING SITE IGG SUBLCASS OLYMPUS KITS THE BINDING SITE JAY H GELLER
K041891 11/05/2004 MININEPH HUMAN RHEUMATOID FACTOR KIT THE BINDING SITE JAY H GELLER
K033811 01/30/2004 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER THE BINDING SITE, LTD. JAY H GELLER
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K043111 11/18/2004 PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K033659 01/06/2004 VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK VARIAN INC LORNA GAMBOA
K042566 11/08/2004 VASC-ALERT VASC-ALERT, INC. JOHN B KENNEDY
K030864 01/30/2004 VADI MANUAL RESUSCITATOR VEDI CORP. ERIC LUO
K042910 11/22/2004 VENTURE WIRE CONTROL CATHETER, MODEL WCC VELOCIMED INC. JOHN CARLINE
K042468 11/17/2004 IVENT 201 PORTABLE VENTILATOR VERSAMED MEDICAL SYSTEMS, INC. JERRY KORTEN
K033547 01/07/2004 VNUS VESSEL AND TISSUE COAGULATION SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. SAM NANAVATI
K042670 11/01/2004 FUTURABOND NR VOCO GMBH GERALD W SHIPPS
K042996 11/24/2004 COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE VOLCANO THERAPEUTICS, INC. LORRY HUFFMAN
K042188 11/10/2004 VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM VOLCANO THERAPEUTICS, INC. JAMES FARNWORTH
K033982 01/22/2004 MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST VYSIS KERRY J FLOM
K033927 01/15/2004 ARTHOSCOPY PUMP A115 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K042549 11/08/2004 MULTI CHEM CAL B WAKO CHEMICALS, USA, INC. LORI CREASY
K042551 11/16/2004 MULTI-CHEM CALIBRATOR A WAKO CHEMICALS, USA, INC. LORI CREASY
K042550 11/08/2004 MULTI-LIPID CALIBRATOR WAKO CHEMICALS, USA, INC. LORI CREASY
K042516 11/08/2004 OTOMIMIX WALTER LORENZ SURGICAL, INC. KIM REED
K042948 11/03/2004 I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM WANDONG MEDICAL WANG WEIMIN
K033890 01/15/2004 ADVANCE DOUBLE HIGH INSERT WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K033456 01/28/2004 EVOLVE RADIAL PLATE WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K031402 11/22/2004 PERFECTA FEMORAL STEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K042466 11/24/2004 X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE ZEST ANCHORS, INC. PAUL ZUEST
K042702 11/23/2004 SILHOUETTE SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. TIM CRABTREE
K043061 11/23/2004 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX ZIMMER TRABECULAR MARCI HALEVI
K042776 11/04/2004 VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX ZIMMER, INC. KAREN CAIN
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K042337 11/04/2004 ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING ZIMMER, INC. DALENE BINKLEY
K033363 01/16/2004 ZIMMER UNICOMPARTMENTAL KNEE SYSTEM ZIMMER, INC. STEPHEN MCKELVEY


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