| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K024287 |
03/21/2003 |
FIXOBRIDGE 3-CEMENT |
ADVANCED HEALTHCARE LTD. |
DAGMAR MAESER |
| K030674 |
03/28/2003 |
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD |
ADVANCED NEUROMODULATION SYSTEMS |
DREW JOHNSON |
| K030118 |
03/11/2003 |
RAPID PROGRAMMAR |
ADVANCED NEUROMODULATION SYSTEMS |
RASHMI MOZA |
| K030825 |
03/28/2003 |
MPM-NET |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
| K030698 |
03/20/2003 |
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV |
AESCULAP, INC. |
MATTHEW M HULL |
| K024349 |
03/24/2003 |
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER |
AESCULAP, INC. |
MATTHEW M HULL |
| K030647 |
03/20/2003 |
EVA DIGITAL DENTAL X-RAY SYSTEM |
AFP IMAGING CORP. |
MARY MCNAMARA-CCULLINANE |
| K023693 |
03/12/2003 |
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 |
AIREX INC. |
WILLIAM HASLEBACHER |
| K024074 |
03/07/2003 |
REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K024087 |
03/11/2003 |
REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K024015 |
03/04/2003 |
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K024183 |
03/17/2003 |
ALTON PT STEPPER |
ALTON DESIGN, LLC |
GREG WIITA |
| K023954 |
03/18/2003 |
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES |
ALTUS MEDICAL, INC. |
KATHY MAYNOR |
| K030161 |
03/17/2003 |
SUPERBOND |
AMERICAN DENT-ALL, INC. |
PHILIP HACOPIANS |
| K022446 |
03/28/2003 |
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C |
AOMORI OLYMPUS CO., LTD. |
LAURA STORMS-TYLER |
| K023753 |
03/25/2003 |
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E |
ARISTA LATINDO INDUSTRIAL LTD. P.T |
LINGA SUMARTA |
| K023754 |
03/25/2003 |
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K024291 |
03/20/2003 |
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 |
ARTHREX, INC. |
SALLY FOUST |
| K030096 |
03/18/2003 |
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW |
ARTHREX, INC. |
SALLY FOUST |
| K030551 |
03/07/2003 |
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K030163 |
03/03/2003 |
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 |
ASEPTICO, INC. |
GRANT RAMALEY |
| K030339 |
03/07/2003 |
CAUTERY TIP CLEANER, MODEL-TC-100 |
ASPEN SURGICAL PRODUCTS, INC. |
DEBBIE DALY |
| K030149 |
03/20/2003 |
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 |
AVAIL MEDICAL PRODUCTS, INC. |
CARROLL COUNCILMAN |
| K021033 |
03/21/2003 |
STIMUPLEX-DIG-RC NERVE STIMULATOR |
B. BRAUN MEDICAL, INC. |
SHERI L MUSGNUNG |
| K023189 |
03/20/2003 |
VISTA BASIC WITH FM SYSTEM |
B. BRAUN MEDICAL, INC. |
LINDA MORGAN |
| K030721 |
03/31/2003 |
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE |
BALLARD MEDICAL PRODUCTS |
CINDY ELLIS |
| K024062 |
03/03/2003 |
ASCENSIA BREEZE BLOOD GLUCOSE METER |
BAYER CORP. |
GEORGE M TANCOS |
| K030452 |
03/03/2003 |
BAYER LIGAND PLUS 1, 2, 3 CONTROLS |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K022096 |
03/18/2003 |
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K024240 |
03/26/2003 |
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS |
BD |
JING ZHANG |
| K030408 |
03/04/2003 |
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K030579 |
03/21/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K024132 |
03/21/2003 |
CHROMOPHARE X 65 |
BERCHTOLD HOLDING GMBH |
JORG SCHNEIDER |
| K030075 |
03/05/2003 |
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) |
BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER |
DAVID C YOUNG |
| K022855 |
03/06/2003 |
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 |
BIO-MEDICAL RESEARCH, LTD. |
ROBERT A DORMER |
| K030446 |
03/06/2003 |
REPICCI LOCKED KEEL TIBIAL BEARING |
BIOMET, INC. |
TRACY J BICKEL |
| K030501 |
03/20/2003 |
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K023082 |
03/03/2003 |
BABYCARE |
BIONET COMPANY LTD |
JAY MANSOUR |
| K023694 |
03/17/2003 |
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K022004 |
03/12/2003 |
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 |
BIOSENSORS INTERNATIONAL-USA |
JORGE HAIDER |
| K024089 |
03/11/2003 |
VACUFLASH BIOPSY SYSTEM |
BIP USA, INC. |
SIEGFRIED GRUCHOT |
| K022965 |
03/28/2003 |
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K030107 |
03/21/2003 |
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM |
BOSTON SCIENTIFIC CORP. |
JENNIFER JOHNSON |
| K030645 |
03/25/2003 |
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT |
BOSTON SCIENTIFIC CORP. |
TODD KORNMANN |
| K030503 |
03/17/2003 |
MODIFICATION TO CONTOUR POLARIS URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
DONNA M GARDNER |
| K030475 |
03/14/2003 |
GDC STRETCH RESISTANT DETACHABLE COIL |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K030856 |
03/28/2003 |
ER800 SERIES ECG EVENT RECORDER |
BRAEMAR CORP. |
DAVID NORBERG |
| K030460 |
03/07/2003 |
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
BRENNEN MEDICAL, INC. |
KENNETH B HERLAND |
| K030438 |
03/17/2003 |
BARD AQUAGUIDE URETERAL CONDUIT |
C.R. BARD, INC. |
FRAN HARRISON |
| K030387 |
03/11/2003 |
C.T.M. MOBILITY SCOOTER, MODEL HS-890 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K024371 |
03/31/2003 |
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM |
CANDELA CORP. |
WILLIAM H MCGRAIL |
| K022923 |
03/13/2003 |
CANDELA GENTLE YAG LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
| K024260 |
03/21/2003 |
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS |
CANDELA CORP. |
WILLIAM H MCGRAIL |
| K024335 |
03/12/2003 |
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS |
CANDELA CORP. |
WILLIAM H MCGRAIL |
| K023565 |
03/28/2003 |
OXICHECK |
CARADYNE, LTD. |
PAUL DRYDEN |
| K023658 |
03/25/2003 |
STERILIZATION CASES AND TRAYS |
CARR METAL PRODUCTS, INC. |
PAUL DRYDEN |
| K030853 |
03/21/2003 |
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI |
CASE MEDICAL, INC. |
MARCIA FRIEZE |
| K023513 |
03/26/2003 |
LOGOS JUNIOR DENTAL CHAIR AND UNIT |
CASTELLINI S.P.A. |
GIULIANO LANZARINI |
| K030538 |
03/10/2003 |
AMERICAN CATHETER, MODEL W3 |
CATHETER LLC. |
JOHN C DEVANNEY |
| K030524 |
03/03/2003 |
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN |
CD LEYCOM BV |
T. LOPES |
| K030373 |
03/06/2003 |
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM |
CENTERPULSE ORTHOPEDICS, INC. |
AUDREY SWEARINGEN |
| K024290 |
03/03/2003 |
PROMOTOR FINAL RINSE SPERM WASH MEDIUM |
CERES FERTILITY, INC. |
GRACE HOLLAND |
| K024124 |
03/14/2003 |
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT |
CHF SOLUTIONS, INC. |
AMY PETERSON |
| K023472 |
03/18/2003 |
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 |
CLASS A ENTERPRISES, INC. |
SAMANTHA L DRAPER |
| K030768 |
03/21/2003 |
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K030705 |
03/26/2003 |
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K030566 |
03/13/2003 |
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K030462 |
03/06/2003 |
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 |
COBE CARDIOVASCULAR, INC. |
CHARLES COPPERBERG |
| K030464 |
03/14/2003 |
GEM, MODEL 004110 |
COLLINS MEDICAL, INC. |
DONALD HENTON |
| K030476 |
03/11/2003 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 |
CONCENTRIC MEDICAL, INC. |
KEVIN F MACDONALD |
| K030117 |
03/20/2003 |
ENHANCE SPERM FREEZE |
CONCEPTION TECHNOLOGY, INC. |
GRACE HOLLAND |
| K030409 |
03/10/2003 |
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K030351 |
03/28/2003 |
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE |
CP MEDICAL |
MARY ANN GREENAWALT |
| K030532 |
03/14/2003 |
CPCA2000 COUNTERPULSATION SYSTEM |
CPCA2000 INC |
ROD SHIPMAN |
| K021539 |
03/05/2003 |
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS |
CREATIVE CONTRACT (M) SDN BHD |
MARK REIBER |
| K021546 |
03/05/2003 |
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR |
CREATIVE CONTRACT (M) SDN BHD |
MARK REIBER |
| K021533 |
03/05/2003 |
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) |
CREATIVE CONTRACT (M) SDN BHD |
MARK REIBER |
| K024261 |
03/26/2003 |
DENTAL PROTECTOR |
DENTAL CONCEPTS LLC. |
HOWARD HOLSTEIN |
| K023969 |
03/25/2003 |
REACTIVE SKIN DECONTAMINATION LOTION |
DEPT. OF THE ARMY |
RONALD E CLAWSON |
| K030763 |
03/26/2003 |
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM |
DIAGNOSTIC ULTRASOUND CORP. |
NANCY GERTLAR |
| K030154 |
03/31/2003 |
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K024235 |
03/17/2003 |
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER |
DOLPHIN MEDICAL INC. |
JON WERNER |
| K030140 |
03/18/2003 |
DUOMED, SERIES 500, (MODELS ID 500, FL 500) |
DUOMED INC. |
CHARLES KOKINOS |
| K030706 |
03/20/2003 |
EBI DYNAFIX COMPRESSION BONE SCREW |
EBI, L.P. |
FREDERIC TESTA |
| K030372 |
03/06/2003 |
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K030363 |
03/27/2003 |
ORG@NIZER, MODEL VERSION 3.0 |
EBIT SANITA, S.P.A. |
COLLEEN DENSMORE |
| K024358 |
03/25/2003 |
20.1 MONOCHROME LCD MONITOR, RADIFORCE G21 |
EIZO NANAO CORPORATION |
AKIRA WAKAYAMA |
| K023105 |
03/13/2003 |
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K030621 |
03/19/2003 |
ATAC CALIBRATOR |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K030006 |
03/07/2003 |
ATAC PAK ALBUMIN REAGENT |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K030010 |
03/10/2003 |
ATAC PAK MAGNESIUM REAGENT |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K030015 |
03/07/2003 |
ATAC PAK PHOSPHORUS REAGENT |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K030483 |
03/06/2003 |
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES |
EMERALD MEDICAL, INC. |
SUSAN D GOLDSTEIN-FALK |
| K030484 |
03/06/2003 |
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES |
EMERALD MEDICAL, INC. |
SUSAN D GOLDSTEIN-FALK |
| K030859 |
03/27/2003 |
NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN |
ENAMELITE LLC |
PHILLIP PITTS |
| K023796 |
03/03/2003 |
MS PAED-BABY BODY |
ERICH JAEGER GMBH |
EARL DRAPER |
| K021878 |
03/04/2003 |
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS |
ESKA AMERICA CORP. |
THOMAS P MONKUS |
| K030571 |
03/28/2003 |
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER |
ETHICON ENDO-SURGERY, INC. |
KATIE FORDYCE |
| K030411 |
03/20/2003 |
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 |
ETHICON ENDO-SURGERY, INC. |
CAROL SPRINKLE |
| K024205 |
03/07/2003 |
AUDIOSCREENER OAE+ABR |
EVEREST BIOMEDICAL INSTRUMENTS CO. |
RANDALL KROHN |
| K020189 |
03/27/2003 |
EXEL BUTTERFLY SCALP VEIN SET |
EXELINT INTERNATIONAL CO. |
TAMMIE EWING |
| K022609 |
03/06/2003 |
SURGICAL PATIENT WARMER, MODEL PW820 JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
ROBERT PETRY |
| K023162 |
03/20/2003 |
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS |
FRESENIUS MEDICAL CARE |
NICHOLE RIEK |
| K022412 |
03/05/2003 |
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR E EILINSFELD |
| K024004 |
03/03/2003 |
XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
| K030420 |
03/10/2003 |
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM |
GE MEDICAL SYSTEMS |
JOHN W JAECKLE |
| K030575 |
03/21/2003 |
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ANDREW KLUESSENDORF |
| K030495 |
03/05/2003 |
3.0T TORSO PHASED ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K024012 |
03/20/2003 |
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM |
GE OEC MEDICAL SYSTEMS |
JEFF WAGNER |
| K030874 |
03/28/2003 |
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
| K024338 |
03/03/2003 |
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE |
GENERAL GLOVES CORP. |
JOHN CHEN |
| K030269 |
03/20/2003 |
GENICON CLIP APPLIER |
GENICON, LC |
FRANK GOLDFARB |
| K030212 |
03/27/2003 |
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
GENZYME BIOSURGERY |
STEVE PAGE |
| K023833 |
03/31/2003 |
GISH ARTERIAL FILTER WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K030077 |
03/14/2003 |
GISH TUBING AND CONNECTORS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K024065 |
03/05/2003 |
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J HARVEY KNAUSS |
| K023381 |
03/31/2003 |
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K023888 |
03/05/2003 |
CIMOFLUOR |
GLOBAL DENTAL PRODUCTS, INC. |
JERRY L BARTICK |
| K024324 |
03/25/2003 |
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 |
GLOBAL PROTECTION CORP. |
DAVIN T WEDEL |
| K030658 |
03/25/2003 |
STANDARD THERMOMETER |
GLOBAL TREASURE INDUSTRIES LTD. |
FRAN WHITE |
| K023025 |
03/04/2003 |
SELF SEAL STERILIZATION POUCH |
GRANTON MEDICAL LTD. |
E. J. SMITH |
| K023111 |
03/13/2003 |
GYRUS PLASMA SKIN RESURFACING SYSTEM |
GYRUS MEDICAL, INC. |
MARK JENSEN |
| K024009 |
03/20/2003 |
CRYOPROBE |
H&O EQUIPMENTS NV/SA |
LEWIS WARD |
| K030590 |
03/21/2003 |
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
MARY ANN DU BROCK |
| K022917 |
03/04/2003 |
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES |
HOME CARE TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| K023692 |
03/20/2003 |
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K030397 |
03/21/2003 |
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA |
HYCOR BIOMEDICAL LTD. |
DANIELLE M KNIGHT |
| K024347 |
03/28/2003 |
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K024201 |
03/12/2003 |
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K012706 |
03/07/2003 |
IM2001 PULSE OXIMETER |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
SANDRA COHEN KALTER |
| K030250 |
03/04/2003 |
IGLIDE MANUAL ASSIST WHEELCHAIR |
INDEPENDENCE TECHNOLOGY, L.L.C. |
JAMES P O'DONNELL |
| K022465 |
03/21/2003 |
MODIFICATION TO NASAL-AIRE |
INNOMED TECHNOLOGIES |
MARGE WALLS-WALKER |
| K024334 |
03/27/2003 |
QUANTA LITE H.PYLORI IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K024282 |
03/21/2003 |
ACRYLIC |
INOVATIV, LLC |
ROBERT BOWERS |
| K030287 |
03/19/2003 |
HEMOSIL FACTOR XI DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K030016 |
03/28/2003 |
TEOAE25 |
INTERACOUSTICS A/S, ASSENS |
DANIEL EGGAN |
| K022873 |
03/21/2003 |
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) |
INTERNATIONAL BIOMEDICAL, INC. |
AMY R PIEPER |
| K023808 |
03/10/2003 |
IRRIGATION SETS |
INTERNATIONAL MEDSURG CONNECTION |
MICHELE H VOVOLKA |
| K030814 |
03/20/2003 |
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 |
INVACARE CORP. |
RAE ANN FARROW |
| K030492 |
03/03/2003 |
TITANIUM OSSICULAR REPLACMENT SYSTEM |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K020102 |
03/21/2003 |
IQTEQ SPIROMETER |
IQTEQ DEVELOPMENT |
RAY WRIGHT |
| K030162 |
03/28/2003 |
LAWRENCE CSERION, MODEL CS-1 |
ISORAY, INC |
DAVID SWANBERG |
| K030467 |
03/14/2003 |
GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET |
IV MEDICAL, INC. |
MICHAEL G SIMON |
| K024113 |
03/05/2003 |
IVD CRYPTO/GIARDIA DFA |
IVD RESEARCH, INC. |
DAVE LAMBILLOTTE |
| K024329 |
03/21/2003 |
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3 |
JI-EE INDUSTRY CO., LTD. |
Ke-Min Jen |
| K030053 |
03/31/2003 |
JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 |
JOMED AG |
TERRY SCHULTZ |
| K030200 |
03/20/2003 |
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE |
KAOHSIUNG BROTHERS PRODUCTS CORP. |
CHIEN LIN |
| K030368 |
03/20/2003 |
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIO T MARCELO |
| K024214 |
03/12/2003 |
KAVO EVEREST TITANBLANK |
KAVO AMERICA |
JOHN R FRANZ |
| K023465 |
03/10/2003 |
KENDRO HERACELL 240 INCUBATOR |
KENDRO LABORATORY PRODUCTS, L.P. |
JOSEPH M AZARY |
| K024356 |
03/26/2003 |
CLEARFIL SILANE KIT |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
| K030509 |
03/04/2003 |
SKINTACT ECG TAB ELECTRODE |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K020271 |
03/25/2003 |
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 |
LEVITRONIX LLC. |
FARZAD PARSAIE |
| K024374 |
03/10/2003 |
RMO PLASMA CURING LIGHT |
LOKKI LASERS MEDICAUX |
HILLARD W WELCH |
| K030666 |
03/25/2003 |
MULTICARE PLATINUM SYSTEM AND ACCESSORIES |
LORAD, A HOLOGIC CO. |
GAIL YAEKER-DAUNIS |
| K024301 |
03/24/2003 |
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT |
LSI SOLUTIONS |
CHRISTOPHER A KLACZYK |
| K030679 |
03/14/2003 |
MAS LIPID LEVEL 1 AND 2 |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K024266 |
03/12/2003 |
MSI TA ELECTRODES |
MEDSPHERE INTERNATIONAL, INC |
ERIC KAO |
| K030601 |
03/25/2003 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K030552 |
03/19/2003 |
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K030201 |
03/26/2003 |
MODIFICATION TO EXPORT ASPIRATION CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K024310 |
03/24/2003 |
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K022212 |
03/21/2003 |
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS |
MENTOR MEDICAL LIMITED |
STEVE OGILVIE |
| K030648 |
03/28/2003 |
VECTORSURGE 5 MODEL 470 |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVE TOMAN |
| K030878 |
03/28/2003 |
ACCOUSONIC, MODEL AS-270 |
METRON MEDICAL AUSTRALIA, PTY, LTD. |
DAVE TOMAN |
| K030018 |
03/26/2003 |
MHS 7000 |
MICRO HEALTH SYSTEMS INC. |
ROBERT BARNES |
| K030688 |
03/28/2003 |
ECHELON MICRO CATHETER, MODEL 105-5092-150 |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
| K024122 |
03/07/2003 |
NAUTICA MICRO CATHETER, MODEL 105-5094-153 |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
| K030616 |
03/31/2003 |
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 |
MICROGENICS CORP. |
RUEYMING LOOR |
| K023348 |
03/03/2003 |
MIDMARK M9 ULTRACLAVE STEAM STERILIZER |
MIDMARK CORP. |
GENE JARSHNARGER |
| K030317 |
03/25/2003 |
MODEL 1300GE-64: PEDIATRIC POSITIONER |
MIDWEST R.F. LLC. |
HELMUT KEIDL |
| K024115 |
03/13/2003 |
MICROFIX QUICKANCHOR PLUS |
MITEK WORLDWIDE |
RUTH C FORSTADT |
| K023097 |
03/07/2003 |
TRUEZONE PEAK FLOW METER |
MONAGHAN MEDICAL CORP. |
JAMES A COCHIE |
| K030242 |
03/10/2003 |
FYRELINK |
MPACS, LLC. |
GREG SOPOTNICK |
| K024180 |
03/14/2003 |
ORAMAGICRX ORAL WOUND RINSE |
MPM MEDICAL, INC. |
RICHARD A HAMER |
| K030609 |
03/17/2003 |
MODULEAF |
MRC SYSTEMS GMBH |
JOERG STEIN |
| K030611 |
03/24/2003 |
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM |
NELLCOR PURITAN BENNETT (MELVILLE) LTD. |
Rob Matheson |
| K030105 |
03/04/2003 |
ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K023319 |
03/04/2003 |
NUVASIVE MASH |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K030635 |
03/28/2003 |
THE OBSIDIAN PACS SYSTEM |
OBSIDIAN MEDICAL TECHNOLOGY, INC. |
BIANCA GREEN |
| K024138 |
03/12/2003 |
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE |
OLYMPUS OPTICAL CO., LTD. |
TINA STEFFANIC-OAK |
| K030032 |
03/21/2003 |
CROSSEAL APPLICATION DEVICE |
OMRIX BIOPHARMACEUTICALS, INC. |
SUE BHADARE |
| K030770 |
03/27/2003 |
OTI SCAN WITH TRANSDUCERS |
OPHTHALMIC TECHNOLOGIES, INC. |
GEORGE MYERS |
| K023090 |
03/19/2003 |
OPTION-VF URINARY CATHETER, FV14218 |
OPTICON MEDICAL, INC. |
GLENN D BRUNNER |
| K030350 |
03/13/2003 |
EXPRESS MINI GLAUCOMA SHUNT |
OPTONOL, LTD |
PENNY NORTHCUTT |
| K023487 |
03/20/2003 |
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K023121 |
03/10/2003 |
LIFESTENT BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
| K030626 |
03/18/2003 |
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K023377 |
03/04/2003 |
ORIA CERVICAL PLATES |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K030500 |
03/20/2003 |
ORIA ZENITH |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K023074 |
03/11/2003 |
IMBIBE BONE MARROW ASPIRATION SYRINGE |
ORTHOVITA, INC. |
ANDREINA IDE |
| K023564 |
03/11/2003 |
OSSE-LIGN |
OSSEUS, LLC |
SHAWN T HUXEL |
| K024199 |
03/14/2003 |
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER |
| K023218 |
03/24/2003 |
MODIFICATION TO PLEXOLONG SETS |
PAJUNK GMBH |
BURK BRANDT |
| K022167 |
03/07/2003 |
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM |
PALL CORP. |
LEONARD S BERMAN |
| K023445 |
03/11/2003 |
TRACERS BONE CEMENT OPACIFIER |
PARALLAX MEDICAL, INC. |
LINDA BRADLEY |
| K023819 |
03/26/2003 |
FIBERFILL SGP |
PENTRON CLINICAL TECHNOLOGIES |
ANNMARIE TENERO |
| K024061 |
03/07/2003 |
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K024085 |
03/11/2003 |
CCD CAMERA, MODEL PKP-06000-000 |
PERKINS ELECTRONICS CO. |
JIM FURSE |
| K030333 |
03/21/2003 |
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K030331 |
03/21/2003 |
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K030335 |
03/03/2003 |
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K030520 |
03/06/2003 |
INTERA FAMILY |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K030731 |
03/21/2003 |
M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
HERBERT VAN DYK |
| K030038 |
03/12/2003 |
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVID OSBORN |
| K030455 |
03/13/2003 |
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
LYNN HARMER |
| K024006 |
03/31/2003 |
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K030610 |
03/21/2003 |
POD PAC-20M |
PORTABLE OPHTHALMIC DEVICES, INC. |
TIM EHRECKE |
| K030653 |
03/31/2003 |
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BABARA J WHITMAN |
| K023990 |
03/19/2003 |
CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 |
PRECISION BIOLOGIC |
STEPHEN L DUFF |
| K024182 |
03/03/2003 |
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS |
PRECISION SYSTEMS, INC. |
BILL HADEN |
| K024190 |
03/17/2003 |
FENESTRATED INFUSION CATHETER |
PROMEDIC, INC. |
PAUL DRYDEN |
| K023257 |
03/28/2003 |
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX |
PROSURG, INC. |
ASHVIN DESAI |
| K030228 |
03/14/2003 |
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K030134 |
03/25/2003 |
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K030325 |
03/28/2003 |
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K030560 |
03/21/2003 |
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K030284 |
03/25/2003 |
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) |
PT. SMARTGLOVE INDONESIA |
FOO KHON PU |
| K030273 |
03/26/2003 |
GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K010705 |
03/11/2003 |
OPTIDOS |
PTW-NEW YORK CORP. |
STEPHEN R SZEGLIN |
| K030036 |
03/12/2003 |
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT |
PULPDENT CORPORATION |
KENNETH J BERK |
| K024327 |
03/25/2003 |
SETPOINT ENDOVASCULAR TEMPERATURE PROBE |
RADIANT MEDICAL |
ANDREW CLEELAND |
| K022198 |
03/21/2003 |
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K023918 |
03/28/2003 |
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS |
RUSCH INTL. |
RICK LYKINS |
| K030628 |
03/17/2003 |
SAS RSV CONTROL KIT |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K024140 |
03/06/2003 |
AIGIS-A |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024143 |
03/10/2003 |
AIGIS-FINE |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024139 |
03/07/2003 |
AIGIS-INLAY |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024135 |
03/10/2003 |
AIGIS-PLUS |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024144 |
03/07/2003 |
AIGIS-PT |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024136 |
03/10/2003 |
AIGIS-SOFT |
SB LUCIUS, INC. |
DAEKYU CHANG |
| K024142 |
03/10/2003 |
AIGIS-SUPER |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024145 |
03/07/2003 |
AIGIS-XO |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K024141 |
03/06/2003 |
NEO 76 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K022627 |
03/18/2003 |
DSG RELAXER SPLINT |
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP |
G. BRENT CONNOR |
| K023852 |
03/04/2003 |
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT |
SERVICES INDUSTRIELS SAVARIA, INC. |
ANSIS M HELMANIS |
| K024346 |
03/04/2003 |
THE MULTILIFT |
SERVICES INDUSTRIELS SAVARIA, INC. |
STEPHEN W BROPHY |
| K030386 |
03/28/2003 |
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE |
SHAMROCK MANUFACTURING COMPANY |
EMMY TJOENG |
| K030657 |
03/21/2003 |
SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 |
SIEMENS MEDICAL SOLUTIONS |
PENELOPE H GRECO |
| K030615 |
03/21/2003 |
INFINITY EXPLORER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K013936 |
03/18/2003 |
SILVERLEAF CONTACT WOUND DRESSING |
SILVERLEAF TECHNOLOGIES INC |
ALAN THOMPSON |
| K030344 |
03/04/2003 |
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K023210 |
03/28/2003 |
SEEDLINKS, MODELS 70301, 70302, 70303 |
SOURCETECH MEDICAL, L.L.C. |
DAVID T SIERACKI |
| K030057 |
03/19/2003 |
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
| K030625 |
03/28/2003 |
SPINAL CONCEPTS INC. PATHFINDER |
SPINAL CONCEPTS, INC. |
LISA PERTERSON |
| K030577 |
03/25/2003 |
PROVEN MODULAR TIBIAL TRAY |
STELKAST COMPANY |
DONALD A STEVENS |
| K012677 |
03/28/2003 |
REPROCESSED PULSE OXIMETER SENSORS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K030789 |
03/26/2003 |
AMSCO CENTURY STEAM STERILIZER |
STERIS Corporation |
LORI HALLER |
| K030665 |
03/25/2003 |
BONE WIRE |
STORK INSTRUMENTE GMBH |
LORI ADVIDS |
| K030007 |
03/31/2003 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
| K023192 |
03/20/2003 |
STRYKER BIOZIP SUTURE ANCHOR |
Stryker Endoscopy |
ALISA MILLER |
| K024159 |
03/10/2003 |
STRYKERWARE SYSTEM |
Stryker Endoscopy |
EVAN NORTON |
| K030378 |
03/20/2003 |
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
| K030227 |
03/17/2003 |
SUTURTEK FASTCLOSE SUTURING DEVICE |
SUTURTEK INCORPORATED |
DEBBIE IAMPIETRO |
| K024198 |
03/05/2003 |
SMEARCLEAR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K024284 |
03/11/2003 |
VICTOREEN THEBES II, MODEL 7020 |
SYNCOR RADIATION MANAGEMENT |
CHRISTINE G CASTLEBERRY |
| K030377 |
03/06/2003 |
MODIFICATION TO SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K030597 |
03/20/2003 |
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K022949 |
03/24/2003 |
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K024364 |
03/17/2003 |
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) |
SYNTHES (USA) |
JONATHAN GILBERT |
| K023297 |
03/06/2003 |
URS-1B (BLOOD TEST) |
TECO DIAGNOSTICS |
LISA TO |
| K030336 |
03/06/2003 |
KMEDIC EXTERNAL FIXATION DEVICES |
TELEFLEX MEDICAL GROUP |
RICK LYKINS |
| K023997 |
03/03/2003 |
TENSCARE ULTIMA NMS/EMS |
TENSCARE LTD. |
BERNARD J TREMAINE |
| K022947 |
03/20/2003 |
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
MARK A BUR |
| K030449 |
03/05/2003 |
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR |
TERUMO CORP. |
GARRY A COURTNEY |
| K030238 |
03/24/2003 |
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K030194 |
03/24/2003 |
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K023998 |
03/26/2003 |
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE |
THERICS, INC. |
UMBERTO V PARROTTA |
| K023556 |
03/27/2003 |
FLU OIA A/B TEST KIT |
THERMO BIOSTAR, INC. |
JOHN G ADAMS |
| K030689 |
03/26/2003 |
SPI ELEMENT DENTAL IMPLANT O 3.5 MM |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K030380 |
03/03/2003 |
TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K024357 |
03/17/2003 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K024353 |
03/06/2003 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K024096 |
03/12/2003 |
OPTIMA, SPINAL SYSTEM |
U&I CORP., AMERICA |
PATRICK MOORE |
| K024275 |
03/14/2003 |
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SARAH HUBENY |
| K023505 |
03/31/2003 |
VBL SERUM TROPONIN I TEST, MODEL 1001 |
VANCOUVER BIOTECH LTD. |
ROBIN J HELLEN, M.S. |
| K030005 |
03/18/2003 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K030114 |
03/21/2003 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SIMMONS |
| K030745 |
03/12/2003 |
GAMMAMED 212 AND 232 SOURCE ASSEMBLY |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K030567 |
03/24/2003 |
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM |
VASCULAR ARCHITECTS, INC. |
PHYLLIS ELSON |
| K021537 |
03/03/2003 |
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 |
VERMONT MEDICAL, INC. |
MARC FILLION |
| K030073 |
03/28/2003 |
VERMED A10021 RESTING EKG TAB ELECTRODE |
VERMONT MEDICAL, INC. |
MARC FILLION |
| K024171 |
03/04/2003 |
VIDAR BONE TRACK SYSTEM SOFTWARE |
VIDAR SYSTEMS CORP. |
F. DAVID ROTHKOPF |
| K030185 |
03/11/2003 |
ENDOS AC/ACP |
VILLA SISTEMI MEDICALI S.P.A. |
ANDREW HRYNDZA |
| K030557 |
03/11/2003 |
MODIFICATION TO VNUS CLOSURE SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
| K023078 |
03/21/2003 |
BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR |
VSM MEDTECH LTD. |
DARYL WISDAHL |
| K024178 |
03/07/2003 |
VIATORR ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
| K024160 |
03/17/2003 |
NEOSPORIN SCAR SOLUTION |
WARNER-LAMBERT CO. |
JOHN R JACOBS |
| K030537 |
03/20/2003 |
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B |
WELL-LIFE HEALTHCARE, INC. |
TONY C. S. CHANG |
| K030168 |
03/21/2003 |
AGC CEM |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K030312 |
03/26/2003 |
PORTA IMPLANT |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K030482 |
03/19/2003 |
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 |
WIENER LABORATORIES |
VIVIANA CETOLA |
| K024305 |
03/18/2003 |
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K024251 |
03/18/2003 |
SIGHTFIX |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K024336 |
03/04/2003 |
MIIG II BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K023237 |
03/18/2003 |
XYLOS SURGICAL MESH |
XYLOS CORPORATION |
Patsy Trisler |
| K024054 |
03/07/2003 |
XYLOS XCELL ANTIMICROBIAL DRESSING |
XYLOS CORPORATION |
Patsy Trisler |
| K030164 |
03/07/2003 |
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K024077 |
03/10/2003 |
DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR |
ZEWA, INC. |
THOMAS ZEINDLER |
| K030265 |
03/04/2003 |
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 |
ZIMMER, INC. |
DALENE T BINKLEY |
