| 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 |
| 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 |
| K032299 |
09/22/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML |
BECTON, DICKINSON & CO. |
BRADFORD SPRING |
| 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 |
| K032578 |
09/17/2003 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K031967 |
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 |
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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 |
