FDA 510(k) Decisions During September, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K031287 09/10/2003 STERI-DRAPE SURGICAL DRAPES 3M COMPANY SCOTT S SARDESON
K032122 09/09/2003 AUDIT MICROCONTROLS MICROFD BNP CONTROL AALTO SCIENTIFIC LTD. ALAN J VEKICH
K032159 09/05/2003 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY ACCESS BIO INCORPORATE YOUNG HO CHOI
K032345 09/03/2003 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. ANNE SCHLAGENHAFT
K031758 09/02/2003 ACMI M4 TELESCOPES ACMI CORPORATION GABRIEL J MURACA
K032510 09/22/2003 ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K032430 09/05/2003 ACUEITY MEDICAL LIGHT SOURCE ACUEITY, INC. NANCY LINCE
K032847 09/26/2003 EXCISOR BIOPTOME, MODEL 01-0004 ACUEITY, INC. NANCY LINCE
K032030 09/25/2003 BLINK CL LUBRICANT EYE DROPS ADVANCED MEDICAL OPTICS, INC. PAUL J NOWACKI
K031356 09/24/2003 HEMAPROMPT GASTRIC AERSCHER DIAGNOSTICS ROBERT SCHREIBER
K031810 09/09/2003 AMPLATZER VASCULAR PLUG AGA MEDICAL CORP. PATRICE M STROMBERG
K032635 09/24/2003 DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 AGFA CORP. JEFF JEDLICKA
K030815 09/17/2003 AKERS LABORATORIES INC. BLOOD CELL SEPARATOR AKERS LABORATORIES, INC. BARBARA A BAGBY
K032248 09/25/2003 PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 AKTINA MEDICAL PHYSICS CORP. TONY SPACCAROTELLA
K032233 09/09/2003 MEDLEY PCA MODULE, MODEL 8120 ALARIS MEDICAL SYSTEMS, INC. STACEY L LEWIS
K030187 09/24/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL, INC. MOIRA BARTON
K032875 09/30/2003 ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM ALOKA CO. LTD USA RICHARD J CEHOVSKY
K031889 09/22/2003 ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES CORP. MARY JO STEGWELL
K031944 09/23/2003 VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K030553 09/02/2003 ARKIT HBA1C ARKRAY, INC. GARY M HAIGHT
K032187 09/22/2003 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM ARTHREX, INC. SALLY FOUST
K031945 09/22/2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC. ANN WATERHOUSE
K031937 09/04/2003 ALANTECH GRAFT FIXATION SCREW ARTHROCARE CORP. VALERIE DEFIESTA-NG
K032615 09/16/2003 ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 ASAHI INTECC CO., LTD. YOSHI TERAI
K031972 09/15/2003 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K031974 09/29/2003 ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K032678 09/24/2003 MODIFICATION TO: AURORA AURORA IMAGING TECHNOLOGY, INC. JAMES R VEALE
K030622 09/09/2003 AXIOM BIOLASER LLLT SERIES-1 AXIOM USA. INC JAMES J GIBSON
K022258 09/11/2003 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDOCO GOMEZ
K031882 09/05/2003 ENDOSCOPIC APPLICATOR BAXTER HEALTHCARE CORP. LORI DONDIEGO
K031857 09/04/2003 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K032524 09/08/2003 ADVIA 60 HEMATOLOGY ANALYZER BAYER HEALTHCARE, LLC KENNETH T EDDS
K032525 09/09/2003 BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC ANDRES HOLLE
K031951 09/11/2003 TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 BAYLIS MEDICAL CO., INC. KRIS SHAH
K032153 09/11/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML BD DIAGNOSTIC SYSTEMS KATHRYN BABKA POWERS
K032518 09/15/2003 PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) BD DIAGNOSTIC SYSTEMS LINDA K DILLON
K032342 09/26/2003 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K032528 09/09/2003 BD ECLIPSE BIFURCATED NEEDLE BECTON DICKINSON & CO. PETER ZURLO
K032299 09/22/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML BECTON, DICKINSON & CO. BRADFORD SPRING
K032567 09/17/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K032275 09/29/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MICHELLE B BANDY
K032136 09/04/2003 WIROBOND C BEGO U.S.A. WILLIAM OREMUS
K032674 09/16/2003 BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K032778 09/22/2003 LARGE VOLUME FLUID RESERVOIR BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K032611 09/17/2003 LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 BIO-RAD MARIA ZEBALLOS
K030328 09/02/2003 VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 BIOMERIEUX, INC. SANDRA PERREAND
K032399 09/10/2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K031337 09/15/2003 ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. KRISTINE C ARNOLD
K032507 09/05/2003 INTERLOK BIO-MODULAR HUMERAL STEMS BIOMET, INC. PATRICIA S BERES
K031280 09/22/2003 ULTRA-DRIVE 3 BIOMET, INC. PATRICIA SANDBORN BERES
K031801 09/11/2003 PANTOS, MODELS: PANTOS 16, AND PANTOS DG BLUE X IMAGING SRL AL SOSA
K030966 09/23/2003 CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032707 09/23/2003 CONTOUR SE MICROSPHERES (SYRINGE) BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032542 09/16/2003 MODIFICATION TO CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032025 09/25/2003 SENTINOL NITINOL BILLARY STENT SYSTEM BOSTON SCIENTIFIC CORP. TODD KOMMANN
K032600 09/09/2003 VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K030846 09/16/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K032116 09/30/2003 TULIP COLORSWITCH CAVEX HOLLAND B.V. RICHARD WOORTMAN
K032838 09/26/2003 CELON ENT SYSTEM CELON AG MEDICAL INSTRUMENTS ANDRE ROGGAN
K032380 09/22/2003 WAGNER CONE PROSTHESIS CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K032076 09/30/2003 SENOVA(R) BLOOD GLUCOSE MONITOR CHDIAGNOSTICS LLC RICHARD N PHILLIPS
K032027 09/05/2003 CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) CHOLESTECH CORP. THOMAS E WORTHY
K030522 09/12/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K030691 09/17/2003 FETAL SPIRAL ELECTRODE, MODEL FSE07000 CLINICAL INNOVATIONS, INC. WILLIAM DEAN WALLACE
K032402 09/24/2003 RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, CONVAID PRODUCTS, INC. DONALD GRIGGS
K031850 09/08/2003 DURASIS DURAL SUBSTITUTE COOK BIOTECH, INC. MARK BLEYER
K032457 09/04/2003 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K032137 09/17/2003 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K032553 09/23/2003 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. Amarilys Machado
K030832 09/17/2003 PRIMOSPLINT SYSTEM COSMEDENT, INC. MICHAEL O'MALLEY
K032169 09/22/2003 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) CYBERORTHOLOGY, INC. ARTHUR WARD
K032237 09/05/2003 N/T PROTEIN CONTROL DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K031377 09/08/2003 SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 DADE BEHRING, INC. RADAMES RIESGO
K031849 09/09/2003 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX DATASCOPE CORP. SUSAN E MANDY
K032355 09/25/2003 ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW DENTSPLY GENDEX JOHN R MILLER
K032321 09/30/2003 CERA F ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032319 09/30/2003 CERA R PLUS ALLOY DENTSPLY INTERNATIONAL P. JFFERY LEHN
K032318 09/30/2003 MINERVA 58 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032851 09/26/2003 ULTRACROWN 75 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K031932 09/15/2003 FLUORIDE VARNISH DENTSPLY INTL. P. JEFFERY LEHN
K032892 09/26/2003 MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K032316 09/30/2003 ORION E ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K032317 09/30/2003 ORION GX ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K023103 09/29/2003 DEPUY 1 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K031971 09/24/2003 GLOBAL CAP RESURFACING REPLACEMENT SHOULDER DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K032151 09/26/2003 DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS DEPUY, INC. CHERYL HASTINGS
K032012 09/03/2003 HOMOCYSTEINE MICROTITER PLATE ASSAY DIAZYME LABORATORIES GREG HOLLAND
K032588 09/12/2003 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K030629 09/04/2003 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER DOLPHIN MEDICAL INC. BILL CURNAN
K031805 09/09/2003 BLU-U, MODEL 4170 DUSA PHARMACEUTICALS, INC. SCOTT LUNDAHL
K031919 09/04/2003 EBI XFIX DFS SYSTEM EBI, L.P. PETER ALLAN
K030630 09/03/2003 EDWARDS DIRECTIONAL CATHETER EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K031898 09/24/2003 EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM EKF DIAGNOSTIC GMBH STEPHEN GORSKI
K030003 09/29/2003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR ELAN DIAGNOSTICS WYNN STOCKING
K030014 09/26/2003 ATAC TOTAL BILIRUBIN REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K032393 09/12/2003 INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) ELCAM MEDICAL ACAL BRUCE WARD
K030466 09/12/2003 HANDYDOP ELCAT, GMBH JAY MANSOUR
K031214 09/23/2003 CYCLONE ANTERIOR CERVICAL PLATE SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K030867 09/22/2003 ESKA MODULAR HIP SYSTEM CEMENTED ESKA IMPLANTS GMBH THOMAS P MONKUS
K031925 09/17/2003 PROCEED TRILAMINATE SURGICAL MESH ETHICON, INC. REY LIBROJO
K032606 09/23/2003 OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS EXACTECH, INC. MARTIN SPRUNCK
K032769 09/23/2003 EYESOPEN TONOMETER EYE-DEAS, LLC STEVEN E FELDON
K023758 09/17/2003 BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) FCI OPHTHALMICS, INC. HILLARD W WELCH
K032161 09/30/2003 PHEM-ALERT FEMTEK,LLC. JOEL S FADEN
K032173 09/03/2003 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K030145 09/17/2003 GALIX WINTER GALIX BIOMEDICAL INSTRUMENTATION, INC. EDUARDO REY
K032431 09/15/2003 PRISMA M60/M100 SETS GAMBRO, INC. ROD J RYLANDS
K032582 09/17/2003 UNITY NETWORK PATIENT DATA SERVER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN LUNDE
K031225 09/29/2003 TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 GFE MEDIZINTECHNIK GMBH JOHN E SAWYER
K031360 09/24/2003 GI SUPPLY BILIARY STENT GI SUPPLY ROB WHALEN
K030393 09/25/2003 OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER HAAG-STREIT HOLDING AG EDUARDO MARCH
K030563 09/09/2003 ARABELLA NCPAP MASKS HAMILTON MEDICAL AG J. DAVID THOMPSON
K031811 09/04/2003 PIT & FISSURE SEALANT WITH FLUORIDE HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K022752 09/09/2003 PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 HDC CORP. EARL SMART
K032404 09/10/2003 SELDINGER SAFETY NEEDLE INTRODUCER HDC CORP. EARL SMART
K024076 09/26/2003 MAKY 21.1 DIALYZER REPROCESSING SYSTEM HDC MAQUINOLAS, LLC LORI K HOLDER
K030903 09/23/2003 OSTEOPAL HERAEUS KULZER GMBH & CO. KG K.D. KUHN
K030902 09/23/2003 PALACOS R HERAEUS KULZER GMBH & CO. KG K.D. KUHN
K030904 09/23/2003 PALAMED Heraeus Medical Gmbh Technology Karen Liu
K023983 09/22/2003 MODIFICATION TO HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS KAREN E WARDEN
K032232 09/29/2003 AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K032557 09/09/2003 TRIUMPH VTX WITH LIFEVALVE CATHETER HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K032754 09/12/2003 VORTEX MP HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K032163 09/12/2003 DURACON TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. DENISE DUCHENE
K032418 09/11/2003 DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP. DENISE DUCHENE
K032479 09/04/2003 HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K031729 09/02/2003 TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K032529 09/16/2003 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 HYDROCISION, INC. DEBBIE IAMPIETRO
K031739 09/02/2003 I-STAT CARDIAC TROPONIN (CTNI) TEST I-STAT CORPORATION GREGORY W SHIPP
K023582 09/08/2003 I-STAT KAOLIN ACT TEST I-STAT CORPORATION PAUL VANDERWERF
K032075 09/17/2003 CONDUCTIVITY STANDARD SOLUTION-METERCARE IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K030504 09/16/2003 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 IDEV TECHNOLOGIES, INC. LYNNE A DAVIES
K032020 09/02/2003 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW IIYAMA CORPORATION KAZUYOSHI TATEIWA
K032491 09/04/2003 ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR IMAGYN MEDICAL TECHNOLOGIES, INC. JULIE POWELL
K031897 09/23/2003 PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER IMC-HEARTWAY, LLC JUAN CARLOS RIVERA
K030701 09/09/2003 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K030702 09/09/2003 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K030614 09/15/2003 3I DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K031632 09/16/2003 OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES, RAC
K031449 09/23/2003 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION IMPLEX CORP. ROBERT A POGGIE
K031983 09/15/2003 INOVO, INC, ECONOMIZER CONSERVING REGULATOR INOVO, INC. SUSAN D GOLDSTEIN-FALK
K032693 09/30/2003 DURAGEN PLUS DURAL GRAFT MATRIX INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K031772 09/05/2003 TI FENESTRATED PLATE INTERPORE CROSS INTL. WENDY SPIELBERGER
K031960 09/29/2003 INTRALASE FS LASER INTRALASE CORP. CHARLINE GAUTHIER
K032780 09/24/2003 INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC INVIRO MEDICAL JIM BARLEY
K032493 09/04/2003 ALEXANDER IVOCLAR VIVADENT, INC. ANDERJEET S GULATI
K032715 09/26/2003 DW 296 #15 SOLDER IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K032267 09/17/2003 R&D DESIGNATION AP-052-5 JENSEN INDUSTRIES, INC. JOHN SLANSKI
K032277 09/24/2003 JUSTWIN SCOOTER, MODEL JS-401 JOY RIDE TECH CO., LTD. SHU CHEN CHANG
K032492 09/09/2003 BLOOD PRESSURE MONITOR, MODEL KP-7000 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K022490 09/29/2003 KSEA MEDI PACK KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K031895 09/23/2003 KSEA OPSERVER LAP KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K031485 09/25/2003 RINSPIRATION SYSTEM KERBEROS PROXIMAL SOLUTIONS TOM MASON
K032681 09/24/2003 KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 KONICA MEDICAL AND GRAPHIC CORPORATION SHINICHI YAMANAKA
K032134 09/10/2003 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K032212 09/15/2003 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A KYPHON, INC. TIM REEVES
K032495 09/17/2003 THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM LIFECORE BIOMEDICAL, INC. Diane Brinza
K032365 09/05/2003 BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. CHENG-I LIN
K031785 09/04/2003 MACROPORE CARDIO-WRAP (TS) MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K031955 09/22/2003 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K021471 09/08/2003 MARQUETTE HUBER TRAP SAFETY INFUSION SET MARQUETTE MEDICAL, INC. E.J. Smith
K032549 09/08/2003 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES MATANG MFG. SDN. BHD. KOK-KEE HON
K032642 09/23/2003 BEELINE SYSTEM MCKINLEY, INC. ANDY LAMBORNE
K032684 09/26/2003 RAYCELL MDS NORDION A. WARBICK-CERONE
K032550 09/25/2003 EXOMIO, MODEL 2.0 SP1 MEDCOM GMBH STEFAN WALTER
K031351 09/17/2003 FLEX-NECK PD CATHETER, INFANT MEDIGROUP, INC. JOHN A NAVIS
K032065 09/22/2003 MEDLINE BAND BAGS AND EQUIPMENT COVERS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K031933 09/16/2003 MEDLINE REUSABLE SURGICAL GOWNS (100X) MEDLINE INDUSTRIES, INC. STACEY BOLEN-WOLVERTON
K032771 09/23/2003 MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC. ANDREW P ZELTWANGER
K030633 09/02/2003 MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT MEDTRONIC AVE, INC. SARAH SHEPPARD
K032037 09/04/2003 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K032033 09/12/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031833 09/03/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031967 09/17/2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K032578 09/17/2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K032622 09/03/2003 ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS MEDTRONIC VASCULAR LYNN JENSEN
K032561 09/11/2003 RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR MEDTRONIC VASCULAR LUCY TAN
K031691 09/03/2003 MERIT MAK (MINI ACCESS KIT) MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K032545 09/02/2003 ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) JOHANNES TSCHEPE
K032544 09/02/2003 VP-1000; MED CAM 100; VP-3000A; MED CAM 300 MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) J TSCHEPE
K024125 09/22/2003 HALM ZIELKE INSTRUMENTATION SYSTEM MICOMED ORTHO GMBH CORRINE M BONFIGLIO
K032653 09/12/2003 E275 MICRO CURRENT TECHNOLOGY, INC. DAVID SUZUKI
K032497 09/25/2003 SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT MICRO THERAPEUTICS, INC. FLORIN TRUUVENT
K030961 09/12/2003 MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K032364 09/23/2003 MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K032658 09/11/2003 MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K032624 09/10/2003 MICRUS MICROCATHETER MICRUS CORP. MARGARET WEBBER
K031721 09/11/2003 COMPOSITE RESTORATION MATERIAL MILTON HODOSH, M.D. MILTON HODOSH
K032633 09/25/2003 HRK-63-8 KNEE ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K032773 09/23/2003 DIAMOND D HIGH IMPACT DENTURE ACRYLIC MYCONE DENTAL SUPPLY CO., INC. LARRY STEFFIER
K031652 09/30/2003 VASCUPUNCTURE PICC GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K032238 09/09/2003 TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER NEUROSEL (MEDICAL) LIMITED PETER GIBSON
K032749 09/16/2003 BEDSIDE MONITOR, MODEL OPV-1500 NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K032589 09/05/2003 ENCLOSE II ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC. DAVID W SCHLERF
K032591 09/25/2003 NUMED TYSHAK MINI PEDIATRIC PTV CATHETER NUMED, INC. NICHELLE R LAFLESH
K030719 09/16/2003 PENTACAM SCHEIMPFLUG CAMERA OCULUS OPTIKGERATE GMBH TOM WEATHERBY
K032541 09/12/2003 POLESTAR N-20 ODIN MEDICAL TECHNOLOGIES LTD. EINAV SHLOMOVITZ
K031305 09/23/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM OLYMPUS OPTICAL CO., LTD. TINA STEFFANIE-OAK
K032242 09/23/2003 PERSONNA PLUS SAFETY SCALPEL SYSTEM OMI MANUFACTURING PTY., LTD. DANIEL KAMM
K031031 09/29/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. ANN M QUINN
K030790 09/10/2003 OSTEOMED ALVEOLAR DISTRACTION SYSTEM OSTEOMED L.P. DAWN T HOLDEMAN
K032833 09/23/2003 MYOSYSTEM WITH CUSTOMIZING OTTO BOCK HEALTH CARE, LP BERT HARMAN
K031670 09/23/2003 STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING P.T. SAPTINDO SURGICA WIDAGDO GONDOWARDOYO
K031669 09/23/2003 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING P.T. SAPTINDO SURGICA WIDAGDO GONDOWARDOYO
K032179 09/09/2003 COMP. E PARKELL, INC. NELSON J GENDUSA
K031815 09/10/2003 INTERA-SENSATION FAMILY PHILIPS MEDICAL SYSTEMS LYNN HARMER
K032638 09/11/2003 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY PLANAR SYSTEMS, INC. SUSAN HAMANN
K022156 09/11/2003 LATEX ULTRASONIC PROBE COVER PLEASURE LATEX PRODUCTS SDN. BHD. KOI-YONG LIM
K032548 09/10/2003 IP-XS COMPRESSION NAIL SYSTEM PLUS ORTHOPEDICS J.D. WEBB
K032709 09/23/2003 MODULAR PLUS HIP STEM PLUS ORTHOPEDICS J.D. WEBB
K031948 09/16/2003 PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 PM DEVICES, INC. BRITTA DOMBOVARI
K030803 09/29/2003 PARAPAC 200D TRANSPORT, MODEL V200D PNEU PAC, LTD. DONALD ALEXANDER
K030570 09/17/2003 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE PORTEX LTD. STEVE OGILVIE
K032701 09/30/2003 SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K032494 09/05/2003 PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER PRECISION VASCULAR SYSTEMS, INC. RICK GAYKOWSKI
K023837 09/15/2003 LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA PRINCETON BIOMEDITECH CORP. JEMO KANG
K032022 09/02/2003 DIGITAL IMAGER PYRAMID MEDICAL, INC. CLAUDE BENNETT
K031964 09/05/2003 BPCARD QRS DIAGNOSTIC, LLC. MARY KAY JENSEN
K032229 09/12/2003 QUANTUM WARP 10 LIGHT DELIVERY SYSTEM QUANTUM DEVICES, INC. MICHELE H VOVOLKA
K023626 09/29/2003 AML HAIRCHECK-DT (COCAINE) QUEST DIAGNOSTICS, INC. PATRICK CARPENTER
K031899 09/11/2003 QUICKVUE INFLUENZA A+B TEST QUIDEL CORP. Robin Weiner
K032038 09/05/2003 PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 QUINTON, INC. KAREN BROWNE
K032054 09/15/2003 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K032176 09/25/2003 RATTAN IMACS BY RATTAN INFORMATION CORPORATION RATTAN INFORMATION CORPORATION CARL ALLETTO
K030044 09/30/2003 EXTENDED RANGE HS CRP KIT, CAT NO:9200 REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K031099 09/17/2003 SORB+HISORB+CARTRIDGE RENAL SOLUTIONS, INC. RICHARD G CONFER
K032569 09/16/2003 SHORT INTRODUCER SHEATH REX MEDICAL SUSAN D GOLDSTEIN-FALK
K031308 09/26/2003 RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 RHIGENE, INC. NANCI DEXTER
K032149 09/09/2003 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR RITA MEDICAL SYSTEMS INC KAREN J FRISCHMEYER
K032552 09/12/2003 ACCU-CHEK ADVANTAGE SYSTEM ROCHE DIAGNOSTICS CORP. Scott Thiel
K032535 09/10/2003 MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K031902 09/17/2003 ONLINE TDM CARBAMAZEPINE ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K023429 09/23/2003 ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) ROWENTA, INC. JONES STEVE
K032652 09/12/2003 RS-4I MUSCLE STIMULATOR FAMILY RS MEDICAL MICHAEL B MCGRAW
K032584 09/17/2003 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 RUBICOR MEDICAL, INC. ROBERT J CHIN
K031531 09/23/2003 S&T MICROSURGICAL SUTURE S & T AG BERNHARD TEITZ
K031359 09/12/2003 S-MONOVETTE EDTA K2-GEL SARSTEDT, INC. PETER RUMSWINKEL
K032150 09/12/2003 SAFETY-MULTIFLY SARSTEDT, INC. PETER RUMSWINKEL
K031938 09/05/2003 GEL MARK III BIOPSY SITE MARKER SENORX, INC. AMY BOUCLY
K031108 09/08/2003 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K032165 09/16/2003 VINTAGE AL SHOFU DENTAL CORP. ROBERT NOBLE
K032280 09/10/2003 SIREMOBIL ISO-C 3D SIEMENS AG NEALIE HARTMAN
K023354 09/05/2003 COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E SIEMENS ELEMA AB STEVE SHEEHAN
K031970 09/09/2003 INFINITY MEGACARE SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE GRECO
K031764 09/05/2003 ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES SIEMENS MEDICAL SOLUTIONS USA, INC. KEN NEHMER
K030821 09/17/2003 SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 SIMUPLAN S.L. CONRADO PLA
K024148 09/15/2003 SALINUM, ORCLAIR SINCLAIR PHARMACEUTICALS, LTD. DENISE SWIFT
K032680 09/26/2003 SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 SMITH & NEPHEW, INC. DEBORAH CONNORS
K031499 09/16/2003 DIOBEAM 830 SOFT-CORE TEXAS, INC. ROY MARTIN
K031800 09/10/2003 SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: SOLARC SYSTEMS, INC. BRUCE ELLIOTT
K031593 09/16/2003 SOPRO 61D SOPRO PIERRE MONTILLOT
K031985 09/11/2003 SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. LISA PETERSON
K031855 09/17/2003 SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM SPINAL CONCEPTS, INC. LISA PETERSON
K023722 09/02/2003 SAFETYWAND DISPOSABLE HANDPIECE SPINTECH, INC. DANIEL J MANELLI
K030180 09/17/2003 CRESCENT TINNITUS RETAINING SOUND GENERATOR STARKEY LABORATORIES, INC. SCOTT LAPOINTE
K032110 09/22/2003 PROCLASS PRESS FIT HIP STEM STELKAST COMPANY DONALD A STEVENS
K031659 09/10/2003 UNIVERSAL NEURO SYSTEM STRYKER INSTRUMENTS WADE T RUTKOSKIE
K032468 09/23/2003 SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE SUTURTEK INCORPORATED DEBBIE IAMPIETRO
K032042 09/29/2003 ENVISION SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K032269 09/17/2003 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA) LISA M BOYLE
K032032 09/04/2003 SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES SYNTHES (USA) LISA M BOYLE
K031761 09/03/2003 SYNTHES (USA) NEW/STERIAL ORBITAL PLATES SYNTHES (USA) Lisa Boyle
K031973 09/05/2003 SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE SYNTHES (USA) BONNIE J SMITH
K032039 09/08/2003 IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. NINA M GAMPERLING
K023778 09/29/2003 DRESSSKIN TEI BIOSCIENCES INC. KENNETH JAMES
K032505 09/24/2003 AIR PRESS MASSAGER TELEBRANDS CORP DONALD E SEGAL
K032157 09/24/2003 TELEMIS-MEDICAL SOLUTION TELEMIS S.A. THOMAS J BOUCHARD
K031563 09/10/2003 BINDAZYME CLQ CIC EIA KIT THE BINDING SITE, LTD. JAY H GELLER
K032240 09/29/2003 BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT THE BINDING SITE, LTD. JAY H GELLER
K032566 09/15/2003 NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP THE FIRST YEARS, INC. ROBIN C CONNOR
K032760 09/17/2003 APAX PACS SYSTEM TIS, INC. RONALD D ARKIN
K031315 09/04/2003 TMC ELECTRICAL SCOOTER, EASY 321 TMC TECHNOLOGY CORP. JEN KE-MIN
K031313 09/04/2003 TMC ELECTRICAL SCOOTER, EASY 405 TMC TECHNOLOGY CORP. JEN KE-MIN
K031314 09/04/2003 TMC ELECTRICAL SCOOTER, EASY 411 TMC TECHNOLOGY CORP. JEN KE-MIN
K031604 09/22/2003 GLYCOMARK TOMEN AMERICA INC. Erika B Ammirati
K030050 09/29/2003 TORAYSULFONE DIALYZER, BS-L SERIES TORAY INDUSTRIES (AMERICA), INC. LISA S JONES
K032640 09/11/2003 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM U-SYSTEMS, INC. SHEILA W PICKERING
K030652 09/03/2003 MEDRO SPD U.S. FILTER/IONPURE, INC. ROBERT DUDEK
K032247 09/30/2003 U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE U.S. TECHNOLOGIES, INC. ROSINA ROBINSION
K030564 09/12/2003 THERMOSKIN CONDUCTIVE PADS UNITED PACIFIC, INC. KEVIN OUTRED
K032618 09/12/2003 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K032538 09/12/2003 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K030836 09/17/2003 D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE VASCULAR SOLUTIONS, INC. DEBORAH JENSEN
K030662 09/03/2003 PATHWAY ACCESS SHEATH CATHETER VERTELINK CORPORATION ALBERT REGO
K030734 09/10/2003 PATHWAY ACCESS SHEATH CATHETER VERTELINK CORPORATION ALBERT REGO
K032832 09/26/2003 IRRIGATION SETS VITAL CONCEPTS, INC. E.J. Smith
K032271 09/10/2003 WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) WARTNER USA B.V. NANCY LUM-WILSON
K032594 09/05/2003 ONE DIMENSIONAL WATER PHANTOM, WP 1D WELLHOFER DOSIMETRIE MARK MARSICO
K032156 09/02/2003 ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT WFR/AQUAPLAST CORP. J. DAMON KIRK
K032440 09/23/2003 F-11 FOLDING POWER CHAIR WHEELCHAIR & SCOOTER EXPRESS CHRIS TINSLEY
K032489 09/24/2003 WU'S 4-WHEELED NEO SCOOTER, WT-M4JR WU'S TECH CO., LTD. JEN KE-MIN


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