| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K023033 |
11/26/2002 |
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) |
INTL., INC. |
MICHAEL D CECCHI |
| K013535 |
01/18/2002 |
EVTOOL MODEL # V. 1.0 |
3D LINE USA, INC. |
KAREN RIGAMONTI |
| K013841 |
01/17/2002 |
3DFIS, MODEL IES-FL-101 |
3DSHARP, INC. |
DONALD KRIEGER |
| K022973 |
11/22/2002 |
ADHESIVE 14 |
AB ARDENT |
CLYDE E INGERSOLL |
| K022975 |
11/22/2002 |
ETCHING 15 |
AB ARDENT |
CLYDE E INGERSOLL |
| K022972 |
11/22/2002 |
MICROFILL 13 |
AB ARDENT |
CLYDE E INGERSOLL |
| K022971 |
11/25/2002 |
MICROHYBRID 11 |
AB ARDENT |
CLYDE E INGERSOLL |
| K022974 |
11/22/2002 |
MICROHYBRID 12 |
AB ARDENT |
CLYDE E INGERSOLL |
| K014118 |
01/11/2002 |
MODIFICATION TO SUPERCROSS CATHETER |
ABBOTT VASCULAR INC. |
SEVRINA CIUCCI |
| K023772 |
11/22/2002 |
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
ACUSON CORP. |
BOB LEIKER |
| K023711 |
11/21/2002 |
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE |
ACUTE IDEAS CO. LTD. |
ALBERT CHEN |
| K011618 |
11/15/2002 |
CALGITROL AG SILVER ALGINATE WOUND DRESSING |
ADRI |
GEORGE H SCHERR |
| K012534 |
01/24/2002 |
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
JOANNA MROZ |
| K023418 |
11/06/2002 |
HEARTONE EVENT RECORDER AND TRANSMITTER |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
| K022672 |
11/08/2002 |
COLUMBUS TOTAL KNEE SYSTEM (CR) |
AESCULAP, INC. |
JOYCE KILROY |
| K012037 |
01/17/2002 |
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 |
AIRSEP CORP. |
CHARLOTTE H HAMILTON |
| K022829 |
11/05/2002 |
INSTANT-VIEW LH OVULATION PREDICTING TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K022501 |
11/13/2002 |
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K022915 |
11/29/2002 |
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K023425 |
11/06/2002 |
DRAPES WITH ABSORBENT REINFORCEMENT |
ALLEGIANCE HEALTHCARE CORP. |
SHARON NICHOLS |
| K010933 |
01/08/2002 |
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY |
ALLTRACEL PHARMA LTD. |
CHARLES H KYPER |
| K022954 |
11/06/2002 |
AMEDICA DRUG SCREEN COCAINE TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K023047 |
11/06/2002 |
AMEDICA DRUG SCREEN OPIATES TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K022955 |
11/06/2002 |
AMEDICA DRUG SCREEN THC TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K022729 |
11/14/2002 |
VENTED CEMENT RESTRICTOR |
AMEDICA CORP. |
ASHOK C KHANDKAR |
| K023126 |
11/18/2002 |
AMEDITECH IMMUTEST HCG PREGANCY TEST |
AMEDITECH, INC. |
JOHN WU |
| K012576 |
01/29/2002 |
CIC-C1Q EIA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD E CONLEY |
| K023516 |
11/19/2002 |
MONARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
David Worrell |
| K022970 |
11/22/2002 |
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 |
AMICAS, INC. |
PATRICE NEDELEC |
| K023153 |
11/13/2002 |
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| K020032 |
01/31/2002 |
APEX MEDICAL MINI TENS |
APEX MEDICAL CORP. |
ALAN CHANG |
| K012884 |
01/17/2002 |
DILATING TIP OBTURATOR |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
| K022572 |
11/08/2002 |
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES |
AR ALLIANCE HEALTHCARE SDN. BHD. |
CHUA C CHUAN |
| K021434 |
11/07/2002 |
ARTHREX FIBERWIRE IN USP SIZES |
ARTHREX, INC. |
ANN WATERHOUSE |
| K014222 |
01/18/2002 |
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K022892 |
11/25/2002 |
ASCENSION SILLICONE MCP |
ASCENSION ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K021767 |
11/19/2002 |
ASSUFIL |
ASSUT EUROPE S.P.A. |
LUCIO IMPROTA |
| K023631 |
11/07/2002 |
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K013577 |
01/25/2002 |
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT |
ATRIUM MEDICAL CORP. |
JOSEPH P PAOLO |
| K020077 |
01/31/2002 |
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
| K013629 |
01/25/2002 |
FINGER JOINT PROSTHESIS |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K023604 |
11/27/2002 |
MODIFICATION TO RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE FOCHT |
| K022681 |
11/01/2002 |
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) |
AZOG, INC. |
AZUBUIKE OGALA |
| K022680 |
11/01/2002 |
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) |
AZOG, INC. |
AZUBUIKE OGALA |
| K023457 |
11/01/2002 |
ULTRASOUND SCANNER, TYPE 1101 |
B-K MEDICAL A/S |
VILLY BRAENDER |
| K013610 |
01/25/2002 |
PERIFIX SAFETY EPIDURAL NEEDLES |
B. BRAUN MEDICAL, INC. |
SHERI L MUSGNUNG |
| K013922 |
01/28/2002 |
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSON |
| K022760 |
11/18/2002 |
MILLENNIUM MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
DENNIS POZZO |
| K021615 |
11/18/2002 |
BAXTER ACCURA SYSTEM, MODEL 5M5660 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K023584 |
11/20/2002 |
ASCENSIA DEX 2 DIABETES CARE SYSTEM |
BAYER CORP. |
GEORGE M TANCROS |
| K013750 |
01/18/2002 |
ADVIA 1650 CHOLINESTERASE ASSAY |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K013959 |
01/29/2002 |
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K022329 |
11/27/2002 |
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K022178 |
11/12/2002 |
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K023184 |
11/18/2002 |
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K013171 |
01/03/2002 |
3420 DIGIT PULSE OXIMETER, MODEL 3420 |
BCI, INC. |
DONALD ALEXANDER |
| K011967 |
01/23/2002 |
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE |
BD |
GREGORY W MORGAN |
| K023075 |
11/25/2002 |
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE |
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
JING ZHANG |
| K023093 |
11/25/2002 |
ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
DENISE THOMPSON |
| K023048 |
11/07/2002 |
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K013978 |
01/15/2002 |
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K014103 |
01/28/2002 |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K023301 |
11/12/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON DICKINSON & CO. |
MONICA E GIGUERE |
| K023331 |
11/25/2002 |
BD VACUTAINER SST II PLUS TUBES |
BECTON DICKINSON & CO. |
JING ZHANG |
| K013304 |
01/02/2002 |
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K023444 |
11/12/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
BRADFORD SPRING |
| K022645 |
11/05/2002 |
CURAD |
BEIERSDORF AG |
DANIEL J DILLON |
| K023521 |
11/19/2002 |
EASY LIFE |
BERKLINE CORP. |
DAVID POPKIN |
| K011518 |
11/15/2002 |
VITALSAT SERIES |
BETA BIOMED SERVICES, INC. |
E J SMITH |
| K023473 |
11/20/2002 |
SONOREAL 3D |
BIO MEDI COM |
COLLEEN DENSMORE |
| K020003 |
11/07/2002 |
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE |
BIO PROTECH, INC. |
JANNA P TUCKER |
| K012749 |
01/24/2002 |
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 |
BIOCARDIA, INC. |
DANIEL C ROSENMAN |
| K013062 |
01/08/2002 |
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K021551 |
11/01/2002 |
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT |
BIOCOMPOSITES LTD. |
J. STEPHEN BRATT |
| K013243 |
01/09/2002 |
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 |
BIOFORM, INC. |
VICTOR M BOWERS |
| K020133 |
01/25/2002 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
DONALD E DALTON |
| K012511 |
01/18/2002 |
WATERLASE MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| K011355 |
01/17/2002 |
BIOLIGHT PCD |
BIOLIGHT INTERNATIONAL AB |
CONSTANCE G BUNDY |
| K013383 |
01/10/2002 |
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM |
BIOMEDICAL IMPLANT TECHNOLOGY, INC. |
RODNEY J SHAUGHNESSY |
| K022925 |
11/19/2002 |
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K022841 |
11/19/2002 |
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K020045 |
01/30/2002 |
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K023357 |
11/06/2002 |
ARCPM 1050 RESIN-HIPS |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
| K020076 |
01/30/2002 |
PATRIOT PROTRUSIO CAGE |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
| K023409 |
11/08/2002 |
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K012551 |
01/30/2002 |
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K023034 |
11/14/2002 |
CARDIOTOUCH-3000 |
BIONET COMPANY LTD |
JAY MANSOUR |
| K022769 |
11/13/2002 |
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K023665 |
11/22/2002 |
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
| K022986 |
11/19/2002 |
THE BIOPLATE BATTERY POWERED DRILL |
BIOPLATE, INC. |
BRUCE F MACKLER |
| K012745 |
01/10/2002 |
TRIAGE TOX DRUG SCREEN, CATALOG #94000 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K021397 |
11/22/2002 |
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION |
BIOSPHERE MEDICAL, INC. |
SHIELA HEMEON-HEYER |
| K022674 |
11/06/2002 |
BIRD AVEA VENTILATOR |
BIRD PRODUCTS CORP. |
JEFFREY K SHAPIRO |
| K013519 |
01/17/2002 |
SIMPLE |
BISCO, INC. |
STEPHEN D SMITH |
| K012184 |
01/30/2002 |
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K013558 |
01/23/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K023498 |
11/13/2002 |
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K021846 |
11/22/2002 |
804SIII; 804W; LIBRA TENS; 410; S-TENS II |
BODY CLOCK HEALTH CARE LTD |
JONATHAN BASH |
| K022731 |
11/14/2002 |
V TENS PLUS |
BODY CLOCK HEALTH CARE LTD |
JONATHAN BASH |
| K013976 |
01/08/2002 |
BOEHRINGER MRI SUCTION REGULATORY |
BOEHRINGER LABORATORIES |
JOHN KARPOWICZ |
| K020028 |
01/22/2002 |
6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX |
BOSTON SCIENTIFIC |
TODD KORNMANN |
| K023337 |
11/18/2002 |
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K022059 |
11/13/2002 |
MICROVASIVE PULMONARY GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
JAMES D MCMAHON |
| K023681 |
11/26/2002 |
RENEGADE STC 18 MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M CAMERON |
| K022860 |
11/21/2002 |
ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
BOSTON SCIENTIFIC, TARGET |
IRENE JAWORSKI |
| K012985 |
01/31/2002 |
MATRIX DETACHABLE COILS |
BOSTON SCIENTIFIC, TARGET |
SETH A SCHULMAN |
| K020012 |
01/29/2002 |
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER |
BOSTON SCIENTIFIC/MEDI-TECH |
JODI L GREENIZEN |
| K023344 |
11/06/2002 |
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE |
BOWEL MANAGEMENT SYSTEMS, LLC |
CHAD A COBERLY |
| K013852 |
01/28/2002 |
JOBST READY-TO-WEAR GAUNTLET |
BSN-JOBST, INC. |
ANGELO R PEREIRA |
| K014212 |
01/17/2002 |
BARD CONQUEST PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
CAROL VIERLING |
| K022236 |
11/27/2002 |
RECOVERY FILTER SYSTEM, MODEL RF-048F |
C.R. BARD, INC. |
KAY FULLER |
| K013598 |
01/11/2002 |
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES |
C.R. BARD, INC. |
EBORAH L HERRINGTON |
| K023750 |
11/22/2002 |
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G |
CANON U.S.A., INC. |
SHEILA DRISCOLL |
| K003689 |
01/02/2002 |
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 |
CANON U.S.A., INC. |
SHEILA DRISCOLL |
| K023586 |
11/05/2002 |
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS |
CANON U.S.A., INC. |
SHIELA DRISCOLL |
| K023816 |
11/26/2002 |
CANON FULL AUTO TONOMETER TX-F |
CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION |
SHEILA DRISCOLL |
| K013354 |
01/31/2002 |
GLOBALCARDIO |
CARDIOCOMM SOLUTIONS, INC. |
ANGELA HALWAS |
| K023431 |
11/13/2002 |
QUANTIX/ND DEVICE |
CARDIOSONIX, LTD. |
AHAVA STEIN |
| K012727 |
01/31/2002 |
HUMPHREY OCT3 |
CARL ZEISS OPHTHALMIC SYSTEMS, INC. |
MELISSSA R HORNE |
| K023747 |
11/15/2002 |
PHASEAL |
CARMEL PHARMA AB. |
KJELL ANDREASSON |
| K011855 |
01/08/2002 |
WAMPOLE HS-CRP ELISA |
CARTER-WALLACE, INC. |
Maureen Garner |
| K012089 |
01/28/2002 |
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM |
CATHEFFECTS, LLC. |
SHAWN FOJTIK |
| K023106 |
11/05/2002 |
PROMOTOR |
CERES FERTILITY, INC. |
GRACE HOLLAND |
| K013950 |
01/10/2002 |
VENTED VIAL ACCESS DEVICE |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PALUCH |
| K023671 |
11/25/2002 |
AQUEOUS ACRYLIC DISPERSION 28% W/W |
CHX TECHNOLOGIES, INC. |
ROSS PERRY |
| K022687 |
11/19/2002 |
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K013165 |
01/18/2002 |
USA SERIES LAPAROSCOPES |
CIRCON ACMI |
WAYNE B STERNER |
| K011876 |
01/08/2002 |
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 |
CIRCON VIDEO |
John DeLucia |
| K022610 |
11/05/2002 |
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 |
CLARUS MEDICAL, LLC. |
TOM BARTHEL |
| K013664 |
01/24/2002 |
COALESCENT SURGICAL U-CLIP |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K023095 |
11/15/2002 |
HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
CATHY STUPAK |
| K013690 |
01/30/2002 |
IDENT-A100 INTRAORAL VIDEO CAMERA |
CONFIDENT TECHNOLOGY, INC. |
LEWIS LIN |
| K013574 |
01/15/2002 |
ACCENT |
CONFIRMA, INC. |
CHERYL SHEA |
| K014234 |
01/17/2002 |
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER |
CONTINUUM ELECTRO-OPTICS, INC. |
RONALD KOHLHARDT |
| K023504 |
11/13/2002 |
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K022798 |
11/19/2002 |
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS |
CORIN U.S.A. |
JOEL K BATTS |
| K013507 |
01/25/2002 |
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH |
COSMO HEALTH INC. |
ROBERT SCHIFF |
| K020920 |
11/05/2002 |
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE |
COZART BIOSCIENCE LTD. |
ROBERTO LIDDI |
| K013964 |
01/24/2002 |
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS |
CP MEDICAL |
MARY ANN GREENWALT |
| K014012 |
01/28/2002 |
DOC BAND |
CRANIAL TECHNOLOGIES, INC. |
TIMOTHY R LITTLEFIELD |
| K012602 |
01/22/2002 |
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX |
CROSSTEX INTL. |
SUSAN D GOLDSTEIN-FALK |
| K023518 |
11/08/2002 |
ECAT LSO PET/CT 16 |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K023768 |
11/25/2002 |
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K021444 |
11/20/2002 |
CYNOSURE PHOTOGENICA SV |
CYNOSURE, INC. |
GEORGE CHO |
| K023309 |
11/01/2002 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
DONNA A WOLF |
| K023312 |
11/01/2002 |
CONTROL PLASMA P |
DADE BEHRING, INC. |
DONNA A WOLF |
| K013155 |
01/18/2002 |
DADE THROMBOPLASTIN C PLUS |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K013128 |
01/18/2002 |
N LATEX LP(A) |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K022977 |
11/27/2002 |
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K023641 |
11/27/2002 |
DATEX-OHMEDA HMEF MINI |
DATEX-OHMEDA |
JOEL C KENT |
| K013389 |
01/10/2002 |
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
| K022740 |
11/14/2002 |
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE |
DATEX-OHMEDA |
JOEL C KENT |
| K013387 |
01/08/2002 |
DATEX-OHMEDA S/5 WEB VIEWER |
DATEX-OHMEDA |
JOEL KENT |
| K023497 |
11/04/2002 |
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE |
DATEX-OHMEDA |
JOEL C KENT |
| K012924 |
01/30/2002 |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER |
DATEX-OHMEDA, INC. |
BILL EXNER |
| K014238 |
01/24/2002 |
DELSONIC 2000 |
DELDENT LTD. |
ALAN EDEL |
| K014245 |
01/29/2002 |
JETSONIC 2000 |
DELDENT LTD. |
ALAN EDEL |
| K013969 |
01/10/2002 |
MINIBLASTER |
DELDENT LTD. |
ALAN EDEL |
| K023029 |
11/25/2002 |
DEMETECH SILK NONABSORBABLE SUTURE |
DEMETECH CORP. |
LUIS ARGUELLO |
| K013808 |
01/30/2002 |
SLEEPBITE |
DENTAL IMAGINEERS, LLC. |
WILLIAM A BELFER |
| K013824 |
01/30/2002 |
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH |
DENTAL MANUFACTURING S.P.A |
Kevin Walls |
| K020171 |
01/29/2002 |
COOLBLU2 DENTAL RESIN CURING DEVICE |
DENTAL SYSTEMS.COM, INC. |
SHINOBU DOI |
| K023697 |
11/06/2002 |
STERI-MATE STERILIZABLE HANDPIECE |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K023438 |
11/13/2002 |
MODIFICATION TO MONARCH SPINE SYSTEM |
DEPUY ACROMED |
LISA GILMAN |
| K011533 |
01/28/2002 |
DEPUY FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K023453 |
11/13/2002 |
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K012328 |
01/18/2002 |
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER |
DI-CHEM, INC. |
KEITH A BUCHHOLZ |
| K012547 |
01/18/2002 |
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION |
DI-CHEM, INC. |
KEITH A BUCHHOLZ |
| K013465 |
01/22/2002 |
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT |
DIABETES TECHNOLOGIES, INC. |
ARTHUR G WILLIAMS |
| K012077 |
01/10/2002 |
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K012075 |
01/10/2002 |
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K013956 |
01/08/2002 |
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K013938 |
01/28/2002 |
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
| K014080 |
01/08/2002 |
APEX ADULT HOLLOWE FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY S SALL |
| K021732 |
11/04/2002 |
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT |
DIDECO S.P.A. |
BARRY SALL |
| K023110 |
11/22/2002 |
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 |
DIGIRAD CORP. |
COREY STEWART |
| K012398 |
01/22/2002 |
DIOMED 15 DIODE LASER |
DIOMED, LTD. |
MAUREEN O'CONNELL |
| K023437 |
11/14/2002 |
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
| K013674 |
01/24/2002 |
LUXATEMP/LUXATEMP SOLAR/INSTATEMP |
DMG USA, INC. |
PAMELA PAPINEAU |
| K013571 |
01/17/2002 |
MAGICFIL |
DMG USA, INC. |
PAMELA PAPINEAU |
| K011736 |
01/30/2002 |
DRG QUICKMIX |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIES |
| K014218 |
11/07/2002 |
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' |
DOLPHIN MEDICAL INC. |
JON WERNER |
| K023434 |
11/14/2002 |
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM |
DOREX, INC. |
MEL KUTAS |
| K011839 |
01/17/2002 |
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C |
DOXA CERTEX AB |
JONATHAN S KAHAN |
| K012139 |
01/17/2002 |
VAMOS ANESTHETIC GAS MONITOR |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K011537 |
01/07/2002 |
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS |
DYNAMIC TECHNOLOGY CORP. |
YAW C YANG |
| K013835 |
01/17/2002 |
GLOBAL HEALTHCARE VAGINAL SPECULUM |
DYNASCEND CONSULTING INT'L LLC. |
ALAM AHMED |
| K014137 |
01/16/2002 |
MODIFICATION TO EBI OMEGA 21 SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K014194 |
01/17/2002 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
| K021240 |
11/08/2002 |
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 |
EIKON HEALTHCARE DEVICE CORP. |
JEN KE-MIN |
| K021239 |
11/08/2002 |
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M |
EIKON HEALTHCARE DEVICE CORP. |
JEN KE-MIN |
| K002142 |
01/28/2002 |
SALINE IV FLUSH SYRINGE |
EMT-RX |
ROBERT J BARD |
| K013490 |
01/17/2002 |
CEMENTED CALCAR HIP SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K013442 |
01/15/2002 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K011074 |
01/25/2002 |
CRYOCARE SURGICAL SYSTEM |
ENDOCARE, INC. |
VINCENT CUTARTELLI |
| K012702 |
01/30/2002 |
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 |
ENDOTEC, INC. |
ALEX CANONACO |
| K013820 |
01/30/2002 |
FINN CHAMBER (R) |
EPITEST LTD. OY |
CLAWSON BOWMAN |
| K022464 |
11/21/2002 |
EQUILASE SYSTEM |
EQUILASERS, INC |
RICHARD C SAM |
| K023812 |
11/29/2002 |
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 |
ERBE USA, INC. |
JOHN TARTAL |
| K013576 |
01/25/2002 |
PERICSCOPE, MODEL # PERISC1 |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
| K021112 |
11/22/2002 |
INSPIRATION VENTILATOR SYSTEM |
EVENT MEDICAL LTD |
MIKE GRIFFITHS |
| K023524 |
11/29/2002 |
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES |
EVER-MORE LATEX PRODUCTS SDN BHD |
CHIA MENG CHENG |
| K023522 |
11/29/2002 |
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR |
EVER-MORE LATEX PRODUCTS SDN BHD |
CHIA MENG CHANG |
| K023523 |
11/29/2002 |
EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES |
EVER-MORE LATEX PRODUCTS SDN BHD |
CHIA MENG CHENG |
| K013116 |
01/18/2002 |
DURQ/ QUALIDURA |
EVER-SAFETY TECHNICAL SERVICE |
DANIEL YANG |
| K023646 |
11/13/2002 |
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM |
EXACTECH, INC. |
Lisa Simpson |
| K011757 |
01/23/2002 |
EXEL COMFORTPOINT INSULIN PEN NEEDLE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K012879 |
01/17/2002 |
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K023479 |
11/26/2002 |
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES |
FIRST QUALITY HYGIENIC, INC. |
ROBERT J STAAB |
| K022838 |
11/25/2002 |
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K022839 |
11/25/2002 |
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K022837 |
11/25/2002 |
FOTONA TANDEM LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K021060 |
11/13/2002 |
FRESENIUS ICARE MONITORING SYSTEM |
FRESENIUS MEDICAL CARE NORTH AMERICA |
NICHOLE RIEK |
| K013685 |
01/18/2002 |
PLLA CANNULATED INTERFERENCE SCREW |
FUTURE MEDICAL SYSTEMS, INC. |
PATRICK JANIN |
| K011950 |
01/29/2002 |
SEEDNET, MODEL FP6T5, FP5T5, FP5T3 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K013724 |
01/08/2002 |
BICART |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K013448 |
01/15/2002 |
PRISMASATE |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K023557 |
11/07/2002 |
CENTRICITY PACS PLUS |
GE MEDICAL SYSTEMS |
SCOTT EVANS |
| K023442 |
11/05/2002 |
EXTRA LARGE BODY COIL |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K014097 |
01/10/2002 |
GE LOGIQ 5 |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
| K013636 |
01/24/2002 |
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K023178 |
11/26/2002 |
INNOVA 4100 |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER, PH.D |
| K013533 |
01/18/2002 |
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) |
GENERAL DEVICES |
MICHAEL SMITH |
| K014206 |
01/16/2002 |
LOGIQBOOK |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K014108 |
01/10/2002 |
MAC 5000 ECG ANALYSIS SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LISA LEE MICHELS |
| K021470 |
11/14/2002 |
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LISA LEE MICHELS |
| K022989 |
11/25/2002 |
RADLITE TISSUE RETRACTOR SYSTEM |
GENZYME BIOSURGERY |
KAREN K SYLVIA |
| K013857 |
01/22/2002 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOER |
| K022934 |
11/14/2002 |
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 |
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS |
ECKHARDT ALBERS |
| K013738 |
01/22/2002 |
WEINMANN SOMNOMASK |
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS |
ECKHARDT ALBERS |
| K013262 |
01/22/2002 |
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES |
GREAT GLOVE (THAILAND) CO. LTD. |
KM LEE |
| K003889 |
01/24/2002 |
ANCURE SHEATH MODEL # 40315, 40320, 40325 |
GUIDANT CARDIAC AND VASCULAR SURGERY |
JACQUELINE J JACKSON |
| K014250 |
01/10/2002 |
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 |
GUIDANT CORP. |
ANNE SCHLAGENHAFT |
| K014007 |
01/07/2002 |
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
| K023627 |
11/12/2002 |
ESSEX ENDOSCOPE, MODEL SXD-1000 |
GUIDANT CORP. |
ANNE SCHLAGENHAFT |
| K013833 |
01/16/2002 |
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 |
GUIDANT CORP. |
JENNIFER PAE RIGGS |
| K014184 |
01/18/2002 |
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
| K023629 |
11/12/2002 |
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 |
GUIDANT CORPORATION, CARDIAC SURGERY |
ANNE SCHALEGENHAFT |
| K013718 |
01/08/2002 |
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR |
GYNECARE, A DIV. OF ETHICON, INC. |
GREGORY R JONES |
| K023492 |
11/13/2002 |
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS |
GYRUS MEDICAL, INC. |
FREDERICK G MADES |
| K023493 |
11/13/2002 |
PK ZIP WING CUTTING DISSECTOR |
GYRUS MEDICAL, INC. |
FREDERICK G MADES |
| K012012 |
01/17/2002 |
ECG HOME |
H&C MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
| K014083 |
01/08/2002 |
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM |
HAEMONETICS CORP. |
JOHN SOKOLOWSKI |
| K022671 |
11/18/2002 |
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES |
HARTALEGA SDN BHD |
TITO ALDAPE |
| K014122 |
01/16/2002 |
HL168E |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K010577 |
01/10/2002 |
BODYGEM, MODEL HB211 |
HEALTHETECH, INC. |
NOEL L JOHNSON |
| K013078 |
01/10/2002 |
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K023298 |
11/04/2002 |
HEMCON BANDAGE |
HEMCON, INC. |
JAMES F HENSEL |
| K014094 |
01/11/2002 |
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM |
HILL-ROM MANUFACTURING, INC. |
CINDY L CROSBY |
| K013483 |
01/14/2002 |
INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT |
HOLLISTER, INC. |
JOSEPH TOKARZ |
| K013345 |
01/07/2002 |
INCARE INTERMITTENT CATHETER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K023398 |
11/08/2002 |
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY |
HOLOGIC, INC. |
RICHARD L FOLLETT |
| K014229 |
01/25/2002 |
MODIFICATION TO OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K020703 |
11/13/2002 |
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWN |
| K014220 |
01/25/2002 |
T2 FEMORAL NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K022799 |
11/21/2002 |
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K014226 |
01/25/2002 |
UNITRAX MODULAR UNIPOLAR SYSTEM |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K012759 |
01/17/2002 |
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 |
HUTCHINSON TECHNOLOGY, INC. |
JOSEPH ORTNER |
| K013462 |
01/11/2002 |
HYDROFERA BACTERIOSTATIC WOUND DRESSING |
HYDROFERA, LLC. |
HEATHER H BOND |
| K022800 |
11/25/2002 |
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM |
HYPERION, INC. |
RADHA GOOLABSINGH |
| K023252 |
11/22/2002 |
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 |
ICN BIOMEDICALS, INC. |
CHARLES C.F. YU |
| K022817 |
11/22/2002 |
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II |
ICN PHARMACEUTICALS, INC. |
EDWARD F SMITH |
| K014130 |
01/08/2002 |
NLITE SYSTEM |
ICN PHOTONICS LTD. |
IAN MORTIMER |
| K013461 |
01/17/2002 |
NLITE SYSTEM,MODEL A00-1025 |
ICN PHOTONICS LTD. |
MIKE KIERMAN |
| K022821 |
11/15/2002 |
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E |
IDEATRICS, INC. |
JAMES W HELLER |
| K012349 |
01/29/2002 |
METAVISION CLINICAL INFORMATION SYSTEM |
IMDSOFT, LTD. |
T. WHIT ATHEY |
| K010378 |
01/28/2002 |
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ |
IMPLEX CORP. |
JOHN SCHALAGO |
| K023159 |
11/12/2002 |
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE |
INDUSTRIAL CLOTHINGS, LTD. |
UMAIR AHMED |
| K022504 |
11/18/2002 |
IDI-STREP B ASSAY |
INFECTIO DIAGNOSTIC, INC. |
Judi Smith |
| K021867 |
11/19/2002 |
INSOUND XT SERIES HEARING AID |
INSOUND MEDICAL INC. |
SUSAN WHICHARD |
| K021789 |
11/20/2002 |
QUICKLAB RSV |
INTEGRATED BIOTECHNOLOGY CORP. |
SALLY A BOOTH |
| K022159 |
11/07/2002 |
PISTON SYRINGE & HYPODERMIC NEEDLE |
INTERNATIONAL MEDSURG CONNECTION |
MICHELE H VOVOLKA |
| K013783 |
01/18/2002 |
AUTION MAX AX-4280 URINALYSIS SYSTEM |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
CYNTHIA J.M NOLTE |
| K014145 |
01/17/2002 |
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K023585 |
11/21/2002 |
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000 |
INTRAVASCULAR INCORPORATED |
STEVE APERAVICH |
| K022574 |
11/12/2002 |
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 |
INTUITIVE SURGICAL, INC. |
USHA S KREADEN |
| K013416 |
01/10/2002 |
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUI |
| K023589 |
11/19/2002 |
STORM TDX POWER WHEELCHAIR |
INVACARE CORP. |
RAE ANN FARROW |
| K013518 |
01/18/2002 |
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K022931 |
11/04/2002 |
HYALURONIDASE SOLUTION |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K013667 |
01/28/2002 |
BCC GAMMA CAMERA |
IS2 RESEARCH, INC. |
VICTOR WOODBURN |
| K014008 |
01/24/2002 |
HEMOCHRON JR. CITRATE APTT CUVETTE |
ITC, INC. |
JOHN CLAY |
| K014082 |
01/30/2002 |
D.SIGN 53, MODEL NA1012204 |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K013584 |
01/28/2002 |
EXCITE SELF ETCH |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K023616 |
11/04/2002 |
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K013912 |
01/18/2002 |
CREATINE KINASE (CK-NAC) |
JAS Diagnostics, Inc. |
David Johnston |
| K022900 |
11/14/2002 |
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES |
JOHN O. BUTLER CO. |
KEVIN G YOST |
| K022916 |
11/21/2002 |
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 |
K-JUMP HEALTH CO., LTD. |
JONATHAN S KAHAN |
| K021467 |
11/04/2002 |
AUTOCON II 400 ELECTROSURGICAL GENERATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K022853 |
11/25/2002 |
ENDOTACK |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K013838 |
01/16/2002 |
KSEA CLEARVISION LENS IRRIGATION SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K013500 |
01/14/2002 |
KAVO POLYLUX II |
KAVO AMERICA |
JENNIFER POTTALA |
| K010790 |
01/29/2002 |
CORTISOL LIA |
KMI DIAGNOSTICS, INC. |
MARK A KOWAL |
| K013052 |
01/16/2002 |
KONICA LASER IMAGER, DRYPRO MODEL 751/752 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
KOJIICHI KUBO |
| K022057 |
11/22/2002 |
KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX |
KYUNG GI MEDICAL IND. CO., LTD |
BYUNG DOO JEE |
| K022686 |
11/25/2002 |
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE |
LAP SURGICAL SYSTEMS, LLC |
DONALD WENNER |
| K022708 |
11/12/2002 |
KLARITY |
LARSON PRODUCTS, INC. |
PETER M LARSON |
| K013303 |
01/23/2002 |
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER |
LATEXX MANUFACTURING SDN.BHD. |
TEOH CHOH SHEE |
| K023503 |
11/14/2002 |
SKINTACT ECG ELECTRODE |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K013421 |
01/08/2002 |
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES |
LIFEGUARD MEDICAL PRODUCTS, INC. |
CRAIG JOHNSON |
| K012275 |
01/07/2002 |
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP |
LIMERICK, INC. |
PATRICIA KELLY |
| K022827 |
11/22/2002 |
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR |
LINVATEC CORP. |
LAURA D SENEFF |
| K014162 |
01/15/2002 |
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND |
LOBOB LABORATORIES, INC. |
DANIEL J MANELLI |
| K011562 |
01/16/2002 |
LUMEND PERCUTANEOUS CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K014117 |
01/11/2002 |
MODIFICATION TO OUTBACK CATHETER |
LUMEND, INC. |
PHIL HOPPER |
| K021565 |
11/14/2002 |
LUTHER SAFETY HUBER NEEDLE SET |
LUTHER RESEARCH PARTNERS |
GREY HOLLAND |
| K023352 |
11/22/2002 |
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K023054 |
11/13/2002 |
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE |
MANDALA HEALTH CARE, LLC |
DASHIMA DOVCHIN |
| K022719 |
11/13/2002 |
PHYSICAL MONITORING REGISTRATION UNIT |
MARYROSE CUSIMANO, PH.D./PHIL REASTON |
MARYROSE CUSIMANO |
| K013498 |
01/17/2002 |
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
MAXTER GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K013554 |
01/17/2002 |
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
MAXTER GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K023236 |
11/12/2002 |
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
MAXXIM MEDICAL |
ROY E MOSER |
| K023390 |
11/26/2002 |
MY BREAST FRIEND, BREAST SELF-EXAM PAD |
MBF SALES, LLC |
EDUARDO MARCH |
| K021247 |
11/08/2002 |
PNEUMOPERITONEUM INSUFFLATION NEEDLE |
MECTRA LABS, INC. |
CHARLES E ALLGOOD |
| K022982 |
11/15/2002 |
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB |
MED-LOGICS, INC. |
MARK MOYER |
| K013120 |
01/24/2002 |
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 |
MEDAMICUS, INC. |
DENNIS S MADISON |
| K010549 |
01/18/2002 |
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) |
MEDI-GLOBE CORP. |
SCOTT KARLER |
| K022948 |
11/04/2002 |
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L |
MEDICAL ACTION INDUSTRIES, INC. |
SHARON SUESS GRAHAM |
| K013366 |
01/08/2002 |
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR |
MEDICAL BIO CARE SWEDEN AB |
CONNIE W HOY |
| K013365 |
01/08/2002 |
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS |
MEDICAL BIO CARE SWEDEN AB |
CONNIE W HOY |
| K023573 |
11/21/2002 |
WIZAIR COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
ARAVA HACOHEN |
| K014294 |
01/25/2002 |
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 |
MEDICAL DATA ELECTRONICS |
GREGORY ALKIRE |
| K022712 |
11/12/2002 |
HAND DRILL, MODEL 11-9901-7 |
MEDICAL DESIGN LLC. |
PAUL JOHN AXT |
| K022751 |
11/04/2002 |
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS |
MEDICAL DEVICE SERVICES |
MARK ALDANA |
| K022753 |
11/14/2002 |
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS |
MEDICAL DEVICE SERVICES |
MARK ALDANA |
| K013391 |
01/11/2002 |
BODYFIX |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
CHRISTIAN MULLER |
| K012766 |
01/23/2002 |
PORTABLE INTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K013725 |
01/30/2002 |
MEDITRON II THESTERTHOSCOPE SYSTEM |
MEDITRON AS |
CHARLES H KYPER |
| K023432 |
11/04/2002 |
MEDLINE ASEP PLUS SURGICAL DRAPES |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
| K023538 |
11/01/2002 |
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER |
MEDPORT, INC. |
FRAN WHITE |
| K023596 |
11/08/2002 |
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL |
MEDRAD, INC. |
JIM FERGUSON |
| K013620 |
01/22/2002 |
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION |
MEDSTONE INTL., INC. |
RON BERGESON |
| K014205 |
01/14/2002 |
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) |
MEDTRONIC AVE, INC. |
KEVIN DRISCO |
| K011471 |
11/08/2002 |
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K014269 |
11/21/2002 |
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K014223 |
01/25/2002 |
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM |
MEDTRONIC PERCUSURGE, INC. |
MATT MOON |
| K013913 |
11/15/2002 |
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM |
MEDTRONIC PERCUSURGE, INC. |
MATTHEW J MOON |
| K023570 |
11/19/2002 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K014267 |
01/25/2002 |
BUTTERFLY PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K023555 |
11/22/2002 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K013665 |
01/29/2002 |
PYRAMID ANTERIOR PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K021980 |
11/19/2002 |
HIP MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K012937 |
01/25/2002 |
KNEE MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K023402 |
11/06/2002 |
8F LAUNCHER GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K013392 |
01/25/2002 |
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 |
MEDTRONIC VASCULAR |
SCOTT CANDY |
| K014165 |
01/22/2002 |
STIMULUS - DISSECTION INSTRUMENTS |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
| K021576 |
11/04/2002 |
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 |
MERCURY MEDICAL |
RONALD RUPENSKI |
| K014225 |
01/17/2002 |
BREATHTEK - UBIT UBT FOR H. PYLORI |
MERETEK DIAGNOSTICS, INC. |
DENISE E SPELLMAN |
| K013769 |
01/22/2002 |
V-GNATHOS SUPRA |
METALOR TECHNOLOGIES USA |
BRUCE A BARTON |
| K013506 |
01/03/2002 |
YELLOW SPECIAL |
METALOR TECHNOLOGIES USA |
BRUCE BARTON |
| K011238 |
01/08/2002 |
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM |
METRACOR TECHNOLOGIES, INC. |
GEORGE F MCHUGH |
| K012744 |
01/23/2002 |
INTRAORAL LENS OPTION TO SPECTROSHADE |
MHT OPTIC RESEARCH AG |
MARKUS ANGST |
| K013485 |
01/17/2002 |
MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K013695 |
01/08/2002 |
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
| K013311 |
01/03/2002 |
MODIFICATION TO: POCKETVIEW ECG SOFTWARE |
MICROMEDICAL INDUSTRIES, LTD. |
STEPHEN CRESSWELL |
| K022768 |
11/13/2002 |
AMT POLYAXIAL PEDICLE SCREW |
MICRON PRECISION ENGINEERING, INC. |
FRANK E BAILEY |
| K011826 |
01/24/2002 |
EPS320 CARDIAC STIMULATOR |
MICROPACE PTY. LTD. |
MICHAEL CEJNAR |
| K022903 |
11/27/2002 |
CHILLBUSTER |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
| K013228 |
01/18/2002 |
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR |
MINNESOTA MINING AND MFG. CO. |
TIERNEY NORSTED |
| K013417 |
01/10/2002 |
MISONIX IRRIGATION SYSTEM MOEDL BC20P |
MISONIX, INC. |
ALBERT F CLANCY |
| K012789 |
01/17/2002 |
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 |
MORAX |
BOREK JANIK |
| K013752 |
01/30/2002 |
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) |
MORGAN SCIENTIFIC, INC. |
PATRICK MORGAN |
| K023426 |
11/21/2002 |
TRX VERTICAL POSITIONER |
MOTION CONCEPTS |
DAVID CIOLFE |
| K020540 |
11/01/2002 |
REGENECARE WOUND GEL |
MPM MEDICAL, INC. |
PAUL R MILLER |
| K013514 |
01/02/2002 |
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K013163 |
01/22/2002 |
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES |
N.S. UNI-GLOVES SDN. BHD. |
ROBERT D VANDER LEEK |
| K014121 |
01/11/2002 |
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 |
NELLCOR PURITAN BENNETT, INC. |
ANTHONY MULLIN |
| K011564 |
01/03/2002 |
NEOLEAD |
NEOTECH PRODUCTS, INC. |
ARNOLD M HEYMAN |
| K023413 |
11/08/2002 |
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
| K013459 |
01/17/2002 |
MODIFICATION OF NC-STAT |
NEUROMETRIX, INC. |
SHIELA HEMEON-HEYER |
| K013167 |
01/30/2002 |
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 |
NEWCARE PRODUCTS, LLC. |
T. WHIT ATHEY |
| K022597 |
11/01/2002 |
K-FIX |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K023562 |
11/13/2002 |
MODIFICATION TO CLASSIC GREAT TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K023206 |
11/08/2002 |
SPERM CRYOPROTEC |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K013694 |
11/19/2002 |
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) |
NIDEK, INC. |
CAROL PATTERSON |
| K013319 |
01/03/2002 |
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K022746 |
11/22/2002 |
STAT PROFILE CRITICAL CARE XPRESS ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K013729 |
01/15/2002 |
STAT PROFILE PHOX BASIC ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K014124 |
01/16/2002 |
NUMED COEFFICIENT PTV CATHETERS |
NUMED, INC. |
NICHELLE R LAFLASH |
| K013601 |
01/03/2002 |
NUMED MULLINS PTA CATHETER |
NUMED, INC. |
NICHELLE R LAFLESH |
| K023283 |
11/13/2002 |
1075LD HUSH-SLUSH |
O.R. SOLUTIONS, INC. |
STEVE HANNES |
| K023282 |
11/13/2002 |
ORS-3000LD |
O.R. SOLUTIONS, INC. |
STEVE HANNES |
| K013617 |
01/30/2002 |
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K014078 |
01/08/2002 |
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM |
ON SITE GAS SYSTEMS, INC. |
C. BARTON GULLONG |
| K022777 |
11/19/2002 |
MANUAL TOUCHE SYSTEM |
ONUX MEDICAL, INC. |
RUTHANN DEPIETRO |
| K014100 |
01/08/2002 |
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND |
OPUSDENT LTD. |
ARAVA HACOHEN |
| K013622 |
01/31/2002 |
NUCLEOTOMY INTRADISCAL CATHETER |
ORATEC INTERVENTIONS, INC. |
LINDA GUTHRIE |
| K013575 |
01/25/2002 |
KPS-I, THE KIDNEY PERFUSION SOLUTION |
ORGAN RECOVERY SYSTEMS, INC. |
STANLEY J HARRIS |
| K013899 |
01/24/2002 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE A SHULMAN |
| K021679 |
11/19/2002 |
ORIA SPINAL CLIP SYSTEM |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K022047 |
11/04/2002 |
PHLEBOTEST 2000 |
OSBORN MEDICAL CORP. |
BILL DAVIS |
| K013429 |
01/11/2002 |
ACTAEON PROBE |
OSTEOBIOLOGICS, INC. |
MARK Q NIEDERAUER |
| K022779 |
11/20/2002 |
OTI UNICONDULAR INTERPOSITIONAL SPACER |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K022887 |
11/26/2002 |
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K022886 |
11/25/2002 |
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K012486 |
01/16/2002 |
OSTEOMED BIORESORBABLE FIXATION SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K014209 |
01/18/2002 |
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS |
PADPRO LLC. |
DANIEL KAMM |
| K013513 |
01/17/2002 |
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE |
PAIN CONCEPTS, INC. |
RUSSELL PFLUEGER |
| K011783 |
01/24/2002 |
MULTI-SNARE SET |
PFM PRODUKTE FUR DIE MEDIZIN AG |
SALVADORE F PALOMARES |
| K023433 |
11/13/2002 |
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 |
PHARMACIA DIAGNOSTICS GMBH & CO. KG |
MICHAEL LINSS |
| K013425 |
01/14/2002 |
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K014157 |
01/17/2002 |
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K014191 |
01/07/2002 |
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 |
PHILIPS MEDICAL SYSTEMS |
STEVE SINGLAR |
| K023698 |
11/19/2002 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K023674 |
11/29/2002 |
PHILIPS DRUG CALCULATOR SOFTWARE |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K020715 |
11/08/2002 |
PHILIPS M5066A AND M5068A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K023749 |
11/19/2002 |
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) |
PHILIPS MEDICAL SYSTEMS |
J.P. OUELLETTE |
| K022899 |
11/22/2002 |
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K013894 |
01/18/2002 |
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K014181 |
01/15/2002 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
PHILIPS MEDICAL SYSTEMS, INC. |
MIKE HUDON |
| K014159 |
01/18/2002 |
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K013858 |
01/22/2002 |
INFINION 0.6T MR IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE C PRASCHAN |
| K023268 |
11/15/2002 |
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
| K022539 |
11/19/2002 |
PHFW-10 |
PIHSIANG MACHINERY MFG. CO. LTD. |
CHRIS TINSLEY |
| K013656 |
01/16/2002 |
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
| K022594 |
11/01/2002 |
PLAYTEX BREAST PUMP |
PLAYTEX PRODUCTS, INC. |
PAUL A SIRACUSA |
| K023416 |
11/08/2002 |
MODIFICATION TO VKS KNEE SYSTEM |
PLUS ORTHOPEDICS |
LOUISE FOCHT |
| K023558 |
11/15/2002 |
PTS PANELS LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K013174 |
01/04/2002 |
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, |
PORGES S.A. |
BERNARD ISMAEL |
| K022675 |
11/07/2002 |
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K022868 |
11/08/2002 |
PRIMAGARD SURGICAL EQUIPMENT DRAPES |
PRIMELINE MEDICAL PRODUCTS, INC. |
BRENDA LEE |
| K023117 |
11/08/2002 |
PRIMAGARD SURGICAL GOWNS |
PRIMELINE MEDICAL PRODUCTS, INC. |
BRANDA LEE |
| K023266 |
11/08/2002 |
PRIMAGARD SURGICAL GOWNS |
PRIMELINE MEDICAL PRODUCTS, INC. |
DAVID POWER |
| K014084 |
01/07/2002 |
NYCOCARD CRP CONTROL |
PRIMUS CORP. |
JIM NOFFSINGER |
| K022634 |
11/06/2002 |
CO-AXIAL INTRODUCER NEEDLE |
PROMEX, INC. |
JOSEPH L MARK |
| K011185 |
01/24/2002 |
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY |
PSYCHEMEDICS CORP. |
WILLIAM R TISTLE |
| K013478 |
01/10/2002 |
DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM |
PULSE METRIC, INC. |
ROBERT DUFFY |
| K011005 |
11/01/2002 |
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS |
PURE WATER SOLUTIONS, INC. |
JOHN BOWER |
| K012943 |
01/18/2002 |
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE |
QUANTECH LTD. |
ROBIN J HELLEN |
| K023008 |
11/13/2002 |
UNIVERSAL SYSTEM, MODEL QV-800 |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
| K013898 |
01/22/2002 |
R&D RET-LINE KIT |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K023003 |
11/20/2002 |
IMAGECHECKER-CT WORKSTATION |
R2 TECHNOLOGY, INC. |
Kathy O'Shaughnessy |
| K022682 |
11/05/2002 |
RANDOX C-REACTIVE PROTEIN CALIBRATOR |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K011648 |
01/15/2002 |
RANDOX CARBAMAZEPINE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K012112 |
01/11/2002 |
RANDOX DIGITOXIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K021897 |
11/26/2002 |
RANDOX HAEMOGLOBIN A1C |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K011771 |
01/17/2002 |
RANDOX THEOPHYLLINE |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K011649 |
01/15/2002 |
RANDOX VALPROIC ACID |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K020026 |
01/30/2002 |
RAVEN BACTERIAL SPORE STRIPS |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K023306 |
11/27/2002 |
MIRAGE FULL FACE MASK SERIES 2 |
RESMED LTD. |
ROGER KOTTER |
| K023284 |
11/27/2002 |
MIRAGE FULL FACE MASK SERIES 2 |
RESMED LTD. |
ROGER KOTTER |
| K023244 |
11/27/2002 |
MIRAGE FULL FACE MASK SERIES 2 |
RESMED LTD. |
ROGER KOTTER |
| K023350 |
11/06/2002 |
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
| K011597 |
01/11/2002 |
SMARTMONITOR 2, MODEL 4000 |
RESPIRONICS GEORGIA, INC. |
BETSY CORTELLONI |
| K012554 |
01/29/2002 |
REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K013859 |
01/29/2002 |
RHODIA BITE REGISTRATION MATERIAL |
RHODIA INC. |
ALAIN MORIN |
| K013881 |
01/25/2002 |
RIBBOND - TRIAXIAL |
RIBBOND, INC. |
SHOSHANA RUDO DRIVER |
| K013771 |
01/18/2002 |
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE |
RICH-MAR CORP. |
DAVID RICHARDS |
| K013770 |
01/18/2002 |
MODIFICATION TO: WINNER ST-2 STIMULATOR |
RICH-MAR CORP. |
DAVID RICHARDS |
| K010033 |
01/10/2002 |
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K011846 |
01/18/2002 |
BIOTECH POWERED WHEELCHAIR, C650PW |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
JEN KE-MIN |
| K023296 |
11/25/2002 |
COBAS INTEGRA ONLINE DAT II COCAINE II |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K020883 |
11/29/2002 |
ELECSYS PROBNP CALCHECK |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K022516 |
11/19/2002 |
ELECSYS PROBNP IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
ROBERT A GREGG |
| K013757 |
01/08/2002 |
ROCHE ACETAMINOPHEN |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K013583 |
01/17/2002 |
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K013539 |
01/17/2002 |
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K023601 |
11/19/2002 |
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K022861 |
11/26/2002 |
SAFETOUCH |
RUSIN MEDICAL DEVICES |
JAMES D RUSIN |
| K023199 |
11/04/2002 |
CERANUM 50 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K023200 |
11/04/2002 |
CERANUM 76 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K023197 |
11/05/2002 |
CERANUM 82 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K023198 |
11/01/2002 |
CERANUM 90 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K023196 |
11/01/2002 |
LUCIUS 76 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K013439 |
01/14/2002 |
ANTERIOR CERVICAL PLATE SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
| K013447 |
01/15/2002 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DREOGE |
| K013555 |
01/23/2002 |
SCI-PHARM POST SECURE |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K012804 |
01/17/2002 |
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS |
SCOTT E ALLEN CP |
SCOTT E ALLEN |
| K014055 |
01/28/2002 |
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING |
SEAL POLYMER INDUSTRIES BHD. |
CHUN C FONG |
| K013560 |
01/16/2002 |
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 |
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
JAY MANSOUR |
| K013641 |
01/29/2002 |
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS |
SENORX, INC. |
AMY BOUCLY |
| K013585 |
01/28/2002 |
MEDIPORT 2000 MOBILE |
SERVOX MEDIZINTECHNIK GMBH |
MARTIN HERBERG |
| K013384 |
01/07/2002 |
SHARGHP A.V. FISTULA NEEDLE SET |
SHARGH PHARMACEUTICAL CO., INC. |
ARMAND HAMEDANI |
| K013793 |
01/22/2002 |
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K013794 |
01/22/2002 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K013795 |
01/22/2002 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K013523 |
01/07/2002 |
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 |
SHIRE BIOLOGICS INC. |
ANGELA ROGERS |
| K013927 |
01/28/2002 |
MINI SHOPPER |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
| K010923 |
01/23/2002 |
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E |
SIEMENS ELEMA AB |
DIANE WURZBURGER |
| K013515 |
01/10/2002 |
INFINITY EXPLORER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K014213 |
01/17/2002 |
SIEMENS INFINITY GATEWAY SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K023569 |
11/04/2002 |
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K022036 |
11/05/2002 |
SIEMENS VIRTUAL SIMULATION (VSIM) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SEAN M CURRY |
| K023720 |
11/20/2002 |
SONOLINE ANTARES ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDI HOFFMAN |
| K023571 |
11/20/2002 |
6 CHANNEL BODY COIL |
SIEMENS MEDICAL SYSTEMS, INC. |
JAMIE YIEH |
| K023687 |
11/22/2002 |
SOMATOM EMOTION 6 CT SYSTEMS |
SIEMENS MEDICAL SYSTEMS, INC. |
PRAVEEN NADKARNI |
| K023155 |
11/25/2002 |
ALOCLAIR ORAL RINSE |
SINCLAIR PHARMACEUTICALS, LTD. |
DENISE SWIFT |
| K021585 |
11/13/2002 |
STELLAR SERIES SURGICAL LIGHTS WITH HERMES |
SKYTRON, DIV. THE KMW GROUP, INC. |
KARI OGREEN |
| K011842 |
01/08/2002 |
SABRE COMPAC |
SLE LIMITED |
FRANK FERGUSON |
| K023680 |
11/19/2002 |
BIOBUCK CEMENT RESTRICTOR |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K013870 |
01/17/2002 |
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K023417 |
11/07/2002 |
SURETAC III, MODELS 7209900, 7209901 |
SMITH & NEPHEW, INC. |
JASON BILOBRAM |
| K023066 |
11/25/2002 |
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) |
SODEM SYSTEMS |
CAROLE BURNIER |
| K014299 |
01/30/2002 |
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH |
SORBA MEDICAL SYSTEMS, INC. |
JILL BARNEY |
| K023636 |
11/22/2002 |
BLOCKING TRAY |
SOUTHEASTERN RADIATION PRODUCTS, INC. |
RICHARD SWEAT |
| K023647 |
11/27/2002 |
CADENCE PEEK CEMEENT RESTRICTOR |
SPINAL CONCEPTS, INC. |
AUDREY SWEARINGEN |
| K023644 |
11/25/2002 |
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
AUDREY SWEARINGEN |
| K013196 |
01/30/2002 |
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM |
SPINAL INNOVATIONS, LLC. |
KENNETH RUSSELL |
| K022644 |
11/06/2002 |
RETRO REPAIR KIT, MODEL PRRK5 |
SPIRE BIOMEDICAL, INC. |
DONALD FICKETT |
| K023635 |
11/18/2002 |
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN |
SRI/SURGICAL EXPRESS, INC. |
JACK A HAMILTON |
| K013773 |
01/24/2002 |
SAFE |
SSN MEDICAL PRODUCTS SDN. BHD. |
ANG TECK LEONG |
| K014037 |
01/04/2002 |
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
| K014161 |
01/15/2002 |
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
| K992099 |
01/18/2002 |
BIO SPA INTELLIGENT |
STARBENE |
JUDITH NIZTZSCHMAMN |
| K014049 |
01/09/2002 |
EPOCA CODR STEM AND HEAD |
STELKAST COMPANY |
DONALD A STEVENS |
| K023765 |
11/29/2002 |
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K013450 |
01/14/2002 |
NOTTA AMBULATORY RECORDER |
STELLATE SYSTEMS |
GEORGE PAPAGIANNIS |
| K022843 |
11/01/2002 |
GAYHEART CORNEAL EXCISION DEVICE |
STEPHENS INSTRUMENTS |
ARCHANA JOHNSON |
| K022835 |
11/01/2002 |
STEPHENS DISPOSABLE FORCEPS |
STEPHENS INSTRUMENTS |
ARCHANA JOHNSON |
| K022842 |
11/01/2002 |
STEPHENS DISPOSABLE HOOKS |
STEPHENS INSTRUMENTS |
ARCHALA JOHNSON |
| K022840 |
11/01/2002 |
STEPHENS DISPOSABLE SCISSORS |
STEPHENS INSTRUMENTS |
ARCHANA JOHNSON |
| K022836 |
11/01/2002 |
STEPHENS DISPOSABLE SPECULUM |
STEPHENS INSTRUMENTS |
ARCHANA JOHNSON |
| K021363 |
11/27/2002 |
ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
GARY RAUVOLA |
| K012684 |
01/18/2002 |
REPROCESSED ELECTROSURGICAL ELECTRODE |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K014062 |
01/17/2002 |
SIMPLICITY EASY ACCESS INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K014061 |
01/17/2002 |
SIMPLICITY STARPLUS SOFT INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K023622 |
11/21/2002 |
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 |
STOCKERT INSTRUMENTE GMBH |
LYNNE LEONARD |
| K022309 |
11/08/2002 |
STRYKER POWERED WHEELED STRETCHER |
STRYKER CORP. |
LYNETTE GABRIEL |
| K013775 |
01/08/2002 |
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM |
STRYKER LEIBINGER |
ROBIN L ROWE |
| K013494 |
01/18/2002 |
3.75MM AND 5.0MM SPLINE TWIST IMPLANT |
SULZER DENTAL, INC. |
FOSTER BOOP |
| K014050 |
11/13/2002 |
HEX-LOCK TEMPORARY ABUTMENT |
SULZER DENTAL, INC. |
SEAN HARIRI |
| K014136 |
01/17/2002 |
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K014140 |
11/18/2002 |
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET |
SUNDER BIOMEDICAL TECH. CO., LTD. |
TONY HUNG |
| K021925 |
11/08/2002 |
SUNPEX TECHNOLOGIES MODEL SE 01 |
SUNPEX TECHNOLOGY CO., LTD. |
LEONARD FRIER |
| K014134 |
01/22/2002 |
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) |
SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. |
JANNA P TUCKER |
| K013589 |
01/08/2002 |
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K014021 |
01/28/2002 |
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K011190 |
01/08/2002 |
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) |
SURX, INC. |
ALAN CURTIS |
| K022643 |
11/05/2002 |
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 |
SWEMED LAB INTERNATIONAL AB |
HOWARD M HOLSTEIN |
| K013460 |
01/17/2002 |
SWIFT LOW PROFILE CUP (PRO CUP) |
SWIFT DELIVERY PRODUCTS |
RICHARD G LINDSAY |
| K013609 |
01/16/2002 |
NEXUS 2 CLEAR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013510 |
01/18/2002 |
POINT 4 MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013529 |
01/09/2002 |
POINT 4 TRANSLUCENT MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013647 |
01/16/2002 |
REVOLUTION FORMULA 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K022784 |
11/13/2002 |
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
| K013072 |
11/26/2002 |
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) |
SYNTHES |
THOMAS M MARGUIRE |
| K011583 |
01/30/2002 |
SPIKED WASHER |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K013415 |
01/11/2002 |
SYNTHES ANKLE ARTHRODESIS PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
| K022791 |
11/13/2002 |
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K023675 |
11/26/2002 |
SYNTHES CERVIFIX/ AXON |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K022012 |
11/01/2002 |
SYNTHES LOW PROFILE NEURO SYSTEM |
SYNTHES (USA) |
MATTHEW M HULL |
| K023458 |
11/07/2002 |
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) |
TAIJECT MEDICAL DEVICE CO., LTD. |
JIM-SON CHOU |
| K022652 |
11/21/2002 |
ALPHATRAC, MODEL A 205 |
TEFTEC CORP. |
THOMAS E FINCH III |
| K022783 |
11/19/2002 |
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM |
TENSYS MEDICAL, INC. |
STUART L GALLANT |
| K023056 |
11/26/2002 |
CIRCUIT TUBINGS WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
KAZUHITO INOUE |
| K013578 |
01/22/2002 |
PUMP TUBING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K022918 |
11/27/2002 |
ADAPTERS WITH X-COATING |
Terumo Cardiovascular Systems Corporation |
KAZUHITO INOUE |
| K014182 |
01/03/2002 |
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS |
TETRAD CORP. |
CHARLES F HOTTINGER |
| K023767 |
11/29/2002 |
UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K021402 |
11/05/2002 |
THERMAGE THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K013639 |
01/29/2002 |
THERMAGE THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K022593 |
11/01/2002 |
THOMAS MEDICAL ELECTRODES |
THOMAS MEDICAL, INC. |
THOMAS J ZINNANTI |
| K023645 |
11/13/2002 |
SPI EASY DENTAL IMPLANT ABUTMENT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K023606 |
11/19/2002 |
TILITE YG AND TILITE YGS |
TISPORT |
RICHARD S FORMAN |
| K013625 |
01/17/2002 |
PERMACOL |
TISSUE SCIENCE LABORATORIES, PLC |
HOWARD M HOLSTEIN |
| K013673 |
01/28/2002 |
HI-ART SYSTEM |
TOMO THERAPY INC |
KENNETH D BUROKER |
| K023760 |
11/22/2002 |
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K023511 |
11/05/2002 |
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K022655 |
11/07/2002 |
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH |
TRIMEDYNE, INC. |
GLENN D YEIK |
| K014233 |
01/24/2002 |
CAPTIAM SYPHILIS-G ASSAY |
TRINITY BIOTECH, PLC |
FIONA CAMPBELL |
| K012580 |
01/17/2002 |
ERCHONIA PL2000 |
TUCO INNOVATIONS, INC. |
KEVIN WALL |
| K023039 |
11/07/2002 |
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 |
TUTA HEALTHCARE PTY LIMITED |
OMID SOURESRAFIL |
| K020886 |
11/01/2002 |
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US |
TYCO HEALTHCARE NANCY |
MOUSTAFA ANKI |
| K023699 |
11/27/2002 |
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K020804 |
11/19/2002 |
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SARAH HUBENY |
| K013671 |
01/08/2002 |
L-25 ABSORBABLE SURIGCAL SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ROBERT ZOTT |
| K013594 |
01/22/2002 |
BODY ARRAY COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K013592 |
01/08/2002 |
EXTREMITY COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K022007 |
11/04/2002 |
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K013595 |
01/22/2002 |
PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K012480 |
01/22/2002 |
VANGUARD REPROCESSED INFLATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012293 |
01/18/2002 |
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
DEBORAH L JENSEN |
| K023507 |
11/08/2002 |
MODIFICATION TO GELBFISH VASCULAR DILATORS |
VASCUMETRIX, LLC |
NICK RAIBLE |
| K011625 |
01/23/2002 |
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) |
VASOCOR, INC. |
WALTER M ROSEBROUGH |
| K013477 |
01/17/2002 |
TOCO LITE, MODEL TD-01 |
VENTREX, INC. |
ROBERT GUTHRIE |
| K014224 |
01/23/2002 |
PRECISION PLUS TUNA OFFICE SYSTEM |
VIDAMED, INC. |
YI CHEN |
| K020888 |
11/07/2002 |
FUNDUS AUTOIMAGER |
VISUAL PATHWAYS, INC. |
GERALD (GARY) F BUCK |
| K022021 |
11/01/2002 |
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT |
VITAL SCIENTIFIC N.V. |
ISRAEL M STEIN |
| K013091 |
01/25/2002 |
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM |
VON ZEPPELIN GMBH |
DIETER VON ZEPPELIN |
| K020140 |
01/28/2002 |
VOXAR'S CALCIUM SCORING PRODUCT |
VOXAR LIMITED |
CONRAD CMIN |
| K003311 |
01/11/2002 |
NUTRISAFE PUR ENTERAL FEEDING TUBE |
VYGON CORP. |
ROBERT SCHIFF |
| K021477 |
11/08/2002 |
PRECLUDE MVP DURA SUBSTITUTE |
W. L. GORE & ASSOCIATES, INC. |
TIMOTHY J RYNN |
| K023679 |
11/18/2002 |
GORE 3.0T TORSO ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACY WOLF |
| K013648 |
01/08/2002 |
VIABAHN ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYNN |
| K014148 |
01/17/2002 |
SELF-DRILLING RADIOGRAPHIC MARKER |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K023530 |
11/26/2002 |
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) |
WESTCON CONTACT LENS CO., INC. |
CAROL NOBLE |
| K013983 |
01/28/2002 |
WIENER LAB. ALP 405 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K022962 |
11/01/2002 |
WIENER LAB. BILIRRUBINA TOTAL AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K022629 |
11/05/2002 |
WMT-TCP BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K020019 |
01/23/2002 |
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) |
WRP ASIA PACIFIC SDN. BHD. |
YUE W CHOW |
| K014147 |
01/14/2002 |
80 CHANNEL EEG |
XLTEK |
SONJA MARKEZ |
| K014146 |
01/14/2002 |
84 CHANNEL EEG |
XLTEK |
SONJA MARKEZ |
| K023590 |
11/08/2002 |
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K013385 |
01/09/2002 |
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE |
ZIMMER, INC. |
STEPHEN MCKELVEY |
