FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K021817 |
07/11/2002 |
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
K021874 |
07/12/2002 |
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 |
ABBOTT LABORATORIES |
FRANK POKROP |
K022200 |
07/29/2002 |
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 |
ABX DIAGNOSTICS |
TIM LAWTON |
K020657 |
07/29/2002 |
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE |
ACCULASER, INC. |
PATSY J TRISLER |
K012018 |
07/16/2002 |
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 |
ACMI CORPORATION |
FRANK J FUCILE |
K021526 |
07/17/2002 |
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K021321 |
07/17/2002 |
WRIST FUSION PLATE |
ACUMED, INC. |
CARRIE MCMICHAEL |
K021497 |
07/09/2002 |
CYPRESS ULTRASOUND SYSTEM |
ACUSON CORP. |
BOB LEIKER |
K021966 |
07/02/2002 |
Q LAB SOFTWARE |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
SARAH BAXTER |
K022073 |
07/24/2002 |
HEARTLINE RECEIVING STATION |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
K021327 |
07/25/2002 |
ORTHOPILOT HTO MODULE |
AESCULAP, INC. |
GEORGE KELLER |
K021313 |
07/22/2002 |
SEARCH EVOLUTION TOTAL KNEE SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
K021417 |
07/02/2002 |
AART CHIN IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021839 |
07/16/2002 |
AART GLUTEAL IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021419 |
07/02/2002 |
AART MALAR IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021418 |
07/02/2002 |
AART NASAL IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021337 |
07/03/2002 |
AART PECTORALIS IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021820 |
07/16/2002 |
AART SILICONE CARVING BLOCK |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
K021383 |
07/17/2002 |
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL |
AGION TECHNOLOGIES, LLC. |
PAUL C FORD |
K002741 |
07/03/2002 |
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK |
ALBERT BROWNE LTD. |
CYNTHIA J.M.NOLTE |
K013713 |
07/15/2002 |
ARM AUTOMATIC REPROCESSING MACHINE |
ALCAVIS INTERNATIONAL INCORPORATED |
LUDOVICO GIAVOTTO |
K021566 |
07/02/2002 |
INFINITI |
ALCON LABORATORIES, INC. |
MICHAEL BUENGER |
K020818 |
07/05/2002 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K020668 |
07/10/2002 |
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
K020356 |
07/23/2002 |
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM |
ALPHATEC MFG., INC. |
ELLEN A HICKS |
K021114 |
07/23/2002 |
'RAPIDTEC' 5A MULTIPLE DIP TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K020527 |
07/09/2002 |
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 |
AMERICAN OPTISURGICAL, INC. |
NANETTE CANEPA |
K010065 |
07/02/2002 |
CRANIAL STEREOTACTIC EQUIPMENT |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K013418 |
07/09/2002 |
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY |
ASAHI MEDICAL CO., LTD |
DAVID L WEST |
K021809 |
07/18/2002 |
V-2100G ADVANCED INFANT INCUBATOR |
ATOM MEDICAL CORP. |
SHEILA HEMEON-HEYER |
K022125 |
07/30/2002 |
PROVOX FREEHANDS HME, MODEL 7710 |
ATOS MEDICAL AB |
EDDY ABERG |
K021473 |
07/09/2002 |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
K014246 |
07/16/2002 |
AVID-NIT NERVE STIMULATION NEEDLES |
AVID N.I.T., INC. |
SCOTT HENDERSON |
K013420 |
07/19/2002 |
CHEMWELL, ALSO KNOWN AS PROJECT 2900 |
AWARENESS TECHNOLOGY, INC. |
GLEN VAN SLOOTEN |
K021516 |
07/23/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
K021094 |
07/03/2002 |
INTROCAN SAFETY IV CATHETER |
B. BRAUN MEDICAL, INC. |
PATRICIA D WILSON |
K021488 |
07/08/2002 |
SURECAN SAFETY HUBER NEEDLE INFUSION SETS |
B. BRAUN MEDICAL, INC. |
SHERI L MASGNUNG |
K021958 |
07/03/2002 |
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H |
BACCHUS VASCULAR, INC. |
GREG MATHINSON |
K013892 |
07/11/2002 |
LUTZ NEEDLE |
BALLARD MEDICAL PRODUCTS |
SYDNEE F MCMILLAN |
K020073 |
07/12/2002 |
MEDICAL ADMINISTRATOR |
BARCO NV |
FRANK FERGUSON |
K020828 |
07/24/2002 |
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER CORP. |
KENNETH T EDDS |
K021428 |
07/05/2002 |
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM |
BAYER CORP. |
KENNETH T EDDS |
K020792 |
07/11/2002 |
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K021151 |
07/13/2002 |
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K020616 |
07/17/2002 |
BAYER RAPIDPOINT 405 SYSTEM |
BAYER DIAGNOSTICS CORP. |
THOMAS F FLYNN |
K020794 |
07/11/2002 |
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K021475 |
07/19/2002 |
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET |
BD |
PASQUALE AMATO |
K022161 |
07/29/2002 |
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K021572 |
07/19/2002 |
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K022130 |
07/29/2002 |
BD VACUTAINER PLUS PST II TUBE |
BECTON DICKINSON & CO. |
JING ZHANG |
K021582 |
07/13/2002 |
BACTEC MGIT 960 PZA KIT |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
K022129 |
07/25/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
K020921 |
07/11/2002 |
NO-POKES NEEDLE SAFETY DEVICE |
BEMIS MFG. CO. |
JOHN B HOWELL |
K021304 |
07/23/2002 |
PROLITE PULSED LIGHT SYSTEM |
BIG SKY LASER TECHNOLOGIES, INC. |
PATRICK MAINE |
K021895 |
07/01/2002 |
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
K014019 |
07/11/2002 |
NEUROTECH MEDISTIM PLUS, TYPE 291 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
K014020 |
07/11/2002 |
NT MEDITENS PLUS, TYPE 290 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
K022041 |
07/16/2002 |
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 |
BIO-RAD LABORATORIES, INC. |
MARIA ZEBALLOS |
K021326 |
07/18/2002 |
VIDAS TESTOSTERONE (TES), MODEL 30 418 |
BIOMERIEUX, INC. |
KELLY ROWLAND |
K021254 |
07/17/2002 |
LACTOSORB MINI INTERFERENCE SCREW |
BIOMET ORTHOPEDICS, INC. |
SARA B SHULTZ |
K022094 |
07/25/2002 |
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING |
BIOMET, INC. |
TRACY J BICKEL |
K021071 |
07/01/2002 |
PCCS GRAFT DELIVERY SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
K021927 |
07/12/2002 |
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
K021828 |
07/01/2002 |
SMALL HAMMER TOE PIN |
BIOMET, INC. |
SARA B SHULTZ |
K021697 |
07/12/2002 |
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE |
BIONOSTICS, INC. |
KATHLEEN STORRO |
K021624 |
07/12/2002 |
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 |
BIONOSTICS, INC. |
KATHLEEN STORRO |
K022033 |
07/19/2002 |
STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM |
BIOPLATE, INC. |
BRUCE F MACKLER |
K021317 |
07/01/2002 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
BIOSITE INCORPORATED |
JEFFERY R DAHLEN |
K013634 |
07/09/2002 |
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK |
BIOTEQUE CORP. |
JENNIFER REICH |
K013873 |
07/11/2002 |
COBRA CARDIAC ELECTROSURGICAL SYSTEM |
BOSTON SCIENTIFIC CORP. |
ANDREA L RUTH |
K014297 |
07/09/2002 |
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
K021901 |
07/09/2002 |
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
SHERRY L SPARROW |
K014256 |
07/19/2002 |
KOLIBRI IGS SYSTEMS |
BRAINLAB AG |
STEFAN VILSMEIER |
K022355 |
07/30/2002 |
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
K021165 |
07/01/2002 |
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES |
BROMAC ASSISTIVE TECHNOLOGY |
DAVID K BROWN |
K021736 |
07/16/2002 |
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 |
C.R. BARD, INC. |
BRAIN A KANERVIKO |
K022149 |
07/16/2002 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K022152 |
07/16/2002 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K020222 |
07/29/2002 |
WISORB MALLEOLAR SCREW |
CAMBRIDGE SCIENTIFIC, INC. |
DEBRA J TRANTOLO |
K021236 |
07/17/2002 |
SURGERY AND ACCESSORIES |
CAMTRONICS, LTD. |
SCOTT PEASE |
K021180 |
07/02/2002 |
CANDELA VBEAM PULSED DYE LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
K022174 |
07/29/2002 |
MODIFICATION TO CARDEON AEGIS CATHETER |
CARDEON CORP. |
JANE BEGGS |
K020486 |
07/01/2002 |
CARESIDE GGT |
CARESIDE, INC. |
KENNETH B ASARCH |
K020484 |
07/03/2002 |
CARESIDE LDH |
CARESIDE, INC. |
KENNETH B ASARCH |
K020735 |
07/12/2002 |
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES |
CATHAY INTERNATIONAL, LTD. |
ANNE JEN |
K021146 |
07/02/2002 |
D/SENSE 1-STEP |
CENTRIX, INC. |
JOHN DISCKO |
K020475 |
07/05/2002 |
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
K021387 |
07/31/2002 |
POLAR WAND |
CHEK-MED SYSTEMS |
ROB WHALEN |
K021611 |
07/12/2002 |
QAB2A IGG ELISA KIT HRP |
CHESHIRE DIAGNOSTICS LTD. |
NEIL B STRINGER |
K021610 |
07/12/2002 |
QAB2A IGM ELISA KIT HRP |
CHESHIRE DIAGNOSTICS LTD. |
NEIL B STRINGER |
K012600 |
07/03/2002 |
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
K012609 |
07/03/2002 |
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
K012622 |
07/03/2002 |
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
K021407 |
07/03/2002 |
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
K021830 |
07/02/2002 |
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM |
COBE CARDIOVASCULAR, INC. |
SHAWN RIEDEL |
K021653 |
07/29/2002 |
CODMAN BACTISEAL EVD CATHETER SET |
Codman & Shurtleff, Inc. |
KATHY WUNDER |
K013434 |
07/09/2002 |
VP-2000/1000 |
COLIN CORP. |
KENICHI SAKURADO |
K020004 |
07/24/2002 |
CLINDATALINK VERSION 1.0 FOR SPIROMETRY |
COMPLEWARE CORP. |
KAY WEILER |
K021899 |
07/10/2002 |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 |
CONCENTRIC MEDICAL, INC. |
KEVIN MACDONALD |
K021079 |
07/01/2002 |
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX |
CONMED CORP. |
CHARLES M HART |
K021616 |
07/11/2002 |
DELIGHT DENTAL ER: YAG LASER SYSTEM |
CONTINUUM ELECTRO-OPTICS, INC. |
TOM HANEY |
K013182 |
07/01/2002 |
TRIPLE LUMEN CENTRAL VENOUS CATHETER |
COOK, INC. |
LISA HOPKINS |
K021961 |
07/02/2002 |
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
K021191 |
07/12/2002 |
AUTOALIGN |
CORTECHS LABS, INC. |
JEFFREY M ANDERSON |
K021311 |
07/13/2002 |
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL |
CP MEDICAL |
MARY ANN GREENAWALT |
K021676 |
07/12/2002 |
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTONIO L GIACCIO |
K020413 |
07/17/2002 |
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K021199 |
07/12/2002 |
PRIMECHAIR |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K021279 |
07/19/2002 |
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE |
DATEX-OHMEDA |
JOEL C KENT |
K021376 |
07/24/2002 |
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE |
DATEX-OHMEDA |
JOEL C KENT |
K022190 |
07/24/2002 |
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K021335 |
07/11/2002 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
LISA GILMAN |
K021499 |
07/24/2002 |
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
K022118 |
07/22/2002 |
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K021394 |
07/09/2002 |
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K021869 |
07/01/2002 |
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP |
DIROS TECHNOLOGY, INC. |
LESLIE W ORGAN |
K021356 |
07/16/2002 |
THE DIVACUP MENSTRUAL SOLUTION |
DIVA INTERNATIONAL INC |
FRANCINE CHAMBERS |
K021959 |
07/11/2002 |
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 |
DOLPHIN MEDICAL INC. |
JON WERNER |
K021601 |
07/10/2002 |
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER |
DUTECK INDUSTRIAL CO., LTD. |
YI-LANG LIN |
K011329 |
07/26/2002 |
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER |
E. BENSON HOOD LAB, INC. |
LEWIS MARTEN |
K021903 |
07/10/2002 |
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE |
EASTMAN KODAK COMPANY |
PATRICIA B LANZONI |
K021829 |
07/02/2002 |
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM |
EASTMAN KODAK COMPANY |
CAROL RYERSON |
K022109 |
07/12/2002 |
EIZO, MODEL FC-2091 |
EIZO NANAO CORPORATION |
YUUICHI SEKI |
K021385 |
07/12/2002 |
ATAC PAK BUN REAGENT |
ELAN DIAGNOSTICS |
WYNN STOCKING |
K022119 |
07/25/2002 |
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE |
ELECTRO MEDICAL SYSTEMS SA |
MARY MCNAMARA-CULLINANE |
K021520 |
07/15/2002 |
EMT-CPAP |
EMERGENCY MEDICAL TECHOLOGY |
GREG HOLLAND |
K020114 |
07/12/2002 |
3D KNEE |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
K021881 |
07/29/2002 |
ENDIUS TITLE SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
K013728 |
07/30/2002 |
TRACH VOX |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
K020926 |
07/12/2002 |
EXTENSION SET, MODELS 1911-512 |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER B LAKE |
K022029 |
07/30/2002 |
QUINCKE SPINAL NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER B LAKE |
K022148 |
07/23/2002 |
INJEX 30 NEEDLE FREE INJECTION SYSTEM |
EQUIDYNE SYSTEMS, INC. |
JIM BARLEY |
K020431 |
07/03/2002 |
FIBIOCORE |
EST. ANTHOGYR |
CLAUDE ANTHOINE |
K021075 |
07/12/2002 |
MECHANICAL DAILY USE WHEELCHAIR |
FIRST WORLD SERVICES, INC. |
LEONARD FRIER |
K021429 |
07/29/2002 |
HERPESELECT 1 ELISA IGG, MODEL EL0910G |
FOCUS TECHNOLOGIES, INC. |
MICHAEL J WAGNER |
K021602 |
07/26/2002 |
FOSSA URETERAL STONE SWEEPER |
FOSSA INDUSTRIES, INC. |
PAMELA PAPINEAU |
K013263 |
07/29/2002 |
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST |
FRED HUTCHINSON CANCER RESEARCH CENTER |
SHELBY J HALL |
K021318 |
07/02/2002 |
XIVE DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
K021261 |
07/03/2002 |
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
K021990 |
07/18/2002 |
GALT MEDICAL GUIDEWIRE |
GALT MEDICAL CORP. |
DAVID CATLIN |
K014255 |
07/02/2002 |
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
THOMAS ENGLISH |
K021780 |
07/29/2002 |
ADVANTAGE SIM 6.0 |
GENERAL ELECTRIC MEDICAL SYSTEMS |
LARRY A KROGER |
K021366 |
07/03/2002 |
MAC-LAB/CARDIOLAB EP/COMBOLAB |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LISA LEE MICHELS |
K021316 |
07/25/2002 |
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR |
GENZYME CORP. |
BARABRA PIZZA |
K021730 |
07/05/2002 |
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
K021757 |
07/29/2002 |
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
K021882 |
07/11/2002 |
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
K021824 |
07/02/2002 |
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 |
GUIDANT CORP. |
MARTHA MURARI |
K020585 |
07/13/2002 |
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT |
GYRUS MEDICAL, INC. |
FREDERICK G MADES |
K021525 |
07/12/2002 |
TOPCUT |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
K021466 |
07/24/2002 |
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE |
HAYES MEDICAL, INC. |
WILLIAM J GRIFFIN |
K022049 |
07/19/2002 |
MODIFICATION TO RAICHEM CALCIUM REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
K021194 |
07/29/2002 |
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
K011741 |
07/23/2002 |
CRIT-LINE MONITOR III TQA (CLM TQA) |
HEMAMETRICS |
MATTHEW L HAYNIE |
K021314 |
07/02/2002 |
SCEPTRE-VS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
ROBERT H MCCARTHY |
K021998 |
07/12/2002 |
HORIZONS CYTOLOGY BRUSH |
HORIZONS INTL. CORP. |
RAFIC SALEH |
K022077 |
07/25/2002 |
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K021911 |
07/02/2002 |
TRIDENT CROSSFIRE POLYUETHYLENE LINERS |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
K020042 |
07/30/2002 |
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE |
HYCARE INTL. CO., LTD. |
JANNA P TUCKER |
K020433 |
07/11/2002 |
FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER |
IDT TECHNOLOGY LIMITED |
JAMES J ROGERS |
K021967 |
07/17/2002 |
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 |
IMPLEX CORP. |
ROBERT A POGGIE |
K021970 |
07/12/2002 |
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) |
IMPLEX CORP. |
ROBERT A POGGIE |
K021437 |
07/19/2002 |
SECURE SOFT |
IMTEC CORP. |
BRAD VANCE |
K021984 |
07/02/2002 |
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT |
INCEPTIO MEDICAL TECHNOLOGIES, LC |
ROSINA ROBINSON |
K021280 |
07/17/2002 |
INION HEXALON BIODEGRADABLE ACL/PCL SCREW |
INION LTD. |
HANNA MARTTILA |
K021482 |
07/30/2002 |
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K020399 |
07/02/2002 |
RESPERATE; MODEL RR-150 |
INTERCURE LTD. |
JONATHAN S KAHAN |
K021636 |
07/17/2002 |
ALBUMIN REAGENT |
INTERSECT SYSTEMS, INC. |
JOAN CATHEY |
K021322 |
07/24/2002 |
ENDOSSOUS IMPLANTS |
INTRA-LOCK INTERNATIONAL |
JEFFERY SAKOFF |
K021638 |
07/26/2002 |
ILT ADVANCING MECHANISM, MODEL A115AMI |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K021243 |
07/11/2002 |
ILT TORQUER, MODEL 114TR1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K020386 |
07/02/2002 |
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 |
INVACARE CORP. |
EDWARD A KNOLL |
K021685 |
07/23/2002 |
VENTURE HOMEFILL II WITH OXYGEN CONSERVER |
INVACARE CORP. |
EDWARD A KROLL |
K021358 |
07/05/2002 |
EMBRYO BIOPSY MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K021941 |
07/02/2002 |
SAMPLOK LUER KIT |
ITL CORPORATION, PTY LTD. |
WILIAM L MOBBS |
K021892 |
07/25/2002 |
BRIGHT GOLD |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
K022085 |
07/25/2002 |
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL |
J & S MEDICAL ASSOC., INC. |
PAUL MACDONNELL |
K021671 |
07/19/2002 |
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K021851 |
07/17/2002 |
DIGITAL CLINICAL THERMOMETER, MODEL KD-193 |
K-JUMP HEALTH CO., LTD. |
JONATHAN S KAHAN |
K021660 |
07/25/2002 |
K-ASSAY LP(A) ASSAY |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
K021438 |
07/16/2002 |
INSEMINATION CATHETER, MODEL 320301 |
LABOTECT LABOR-TECHNIK GOTTINGEN |
ANGELIKA ALBRECHT |
K021831 |
07/01/2002 |
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB |
LACRIMEDICS, INC. |
JERRY HENDERSON |
K020021 |
07/02/2002 |
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL HARDIMAN |
K021164 |
07/01/2002 |
MACROPORE OS TRAUMA |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
K020474 |
07/23/2002 |
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 |
MAKRITE INDUSTRIES, INC. |
JOSEPH Z ZDROK |
K022116 |
07/26/2002 |
ELPH INJECTION SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
ELLIS ROGERS |
K021231 |
07/30/2002 |
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT |
MATRITECH, INC. |
MELODIE R DOMURAD |
K021678 |
07/12/2002 |
HEMADERM COTAINING HEMADEX CLOTTING BEADS |
MEDAFOR, INC. |
PHILIP B JARVI |
K021515 |
07/16/2002 |
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER |
MEDICA CORP. |
DEAN HONKONEN |
K022141 |
07/30/2002 |
VERDICT-II |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K022026 |
07/19/2002 |
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) |
MEDTRONIC AVE, INC. |
KEVIN DRISKO |
K021461 |
07/22/2002 |
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K021061 |
07/25/2002 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K021170 |
07/09/2002 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
K020247 |
07/22/2002 |
COLORADO 2 SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K020986 |
07/22/2002 |
MASTERGRAFT RESORBABLE CERAMIC |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K021705 |
07/24/2002 |
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K022015 |
07/18/2002 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K022070 |
07/22/2002 |
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K020017 |
07/12/2002 |
MEDX 1000 SERIES |
MEDX ELECTRONICS, INC. |
ROBIN WILEY |
K020119 |
07/22/2002 |
VECTORSONIC, MODEL VU-200 |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVE TORMAN |
K021275 |
07/18/2002 |
MICOMED POSTERIOR DOUBLEROD SYSTEM |
MICOMED ORTHO GMBH |
CORRINE M TAFLINGER |
K020434 |
07/29/2002 |
MICROPLEX COIL SYSTEM (MCS) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
K021914 |
07/09/2002 |
MICROPLEX COIL SYSTEMS (MCS) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
K013205 |
07/02/2002 |
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 |
MILLAR INSTRUMENTS, INC. |
MONICA R MONTANEZ |
K021084 |
07/03/2002 |
LIGHT SABER SPINAL NEEDLE |
MINRAD, INC. |
KIM S DEVITO |
K022027 |
07/22/2002 |
CALIBRATING MATERIAL, BUFFERS, STANDARD |
MISSION DIAGNOSTICS |
LINDA STUNDTNER |
K021883 |
07/01/2002 |
BIOFASTIN RC THREADED SUTURE ANCHOR |
MITEK WORLDWIDE |
RUTH C FORSTADT |
K021264 |
07/30/2002 |
TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT |
MOTION CONCEPTS |
DAVID CIOLFE |
K021968 |
07/26/2002 |
CERALOY SOLDER |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
K021969 |
07/30/2002 |
CHROLOY |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
K021965 |
07/26/2002 |
CHROLOY SOLDER |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
K022296 |
07/30/2002 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
CHERRIE COVAL-GOLDSMITH |
K021196 |
07/01/2002 |
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 |
NEURON THERAPEUTICS, INC. |
JUDY P WAYS |
K020046 |
07/25/2002 |
MULTIGAS UNIT, MODEL AG-920RA |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K022121 |
07/29/2002 |
PSG INPUT BOX, MODEL JE-912AK |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K021713 |
07/25/2002 |
STAT PROFILE PHOX PLUS C ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K021336 |
07/25/2002 |
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
K021442 |
07/30/2002 |
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR |
OEMEDIC INTERNATIONAL, INC. |
Kevin Walls |
K021604 |
07/29/2002 |
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
OHIO MEDICAL INSTRUMENT CO., INC. |
CHARLES E DINKLER II |
K021179 |
07/05/2002 |
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K021581 |
07/12/2002 |
HEMOSORB |
ON SITE GAS SYSTEMS, INC. |
FRANCIS X HURSEY |
K020172 |
07/22/2002 |
OPUS MAGNUM ANCHOR & INSTRUMENT SET |
OPUS MEDICAL, INC. |
JIM HART |
K021918 |
07/25/2002 |
CLARREN HELMET (ORTHOMERICA) |
ORTHOMERICA PRODUCTS, INC. |
DEANNA FISH |
K021207 |
07/09/2002 |
STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
DEANNA FISH |
K021919 |
07/03/2002 |
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO |
ORTHOTEC,LLC |
KAREN E WARDEN |
K021221 |
07/01/2002 |
O&P CRANICAL MOLDING HELMET |
ORTHOTIC & PROSTHETIC LAB, INC. |
THOMAS MALONE |
K021822 |
07/23/2002 |
R120 MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K020968 |
07/15/2002 |
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K011891 |
07/30/2002 |
PANAG |
PANAG INTERNATIONAL |
PETER KALABAKAS |
K022169 |
07/25/2002 |
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES |
PARALLAX MEDICAL, INC. |
RICHARD M RUEDY |
K022038 |
07/15/2002 |
SPI ONETIME DENTAL IMPLANT |
PAXMED INTERNATIONAL |
FLOYD G LARSON |
K020456 |
07/09/2002 |
EASI 12 LEAD ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
K021453 |
07/03/2002 |
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A |
PHILIPS MEDICAL SYSTEMS |
RICHARD J PETERSEN |
K021778 |
07/17/2002 |
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B |
PHILIPS MEDICAL SYSTEMS |
DAVE OSBORN |
K022303 |
07/30/2002 |
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER |
PHILIPS ULTRASOUND, INC. |
PAUL SMOLENSKI |
K021592 |
07/15/2002 |
PHFW-10 |
PIHSIANG MACHINERY MFG. CO. LTD. |
CHRIS TINSLEY |
K022120 |
07/24/2002 |
MPF ACETABULAR CUP GENERATION 2 |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K020852 |
07/03/2002 |
POLY-CHEM GLUCOSE |
POLYMEDCO, INC. |
HELEN LANDICHO |
K022001 |
07/12/2002 |
MPOWER, MODEL 712 SERIES |
POSITRON CORP. |
IRENE C ALBRIGHT |
K021524 |
07/19/2002 |
LIGHT CURE DENTAL DAM |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
K012974 |
07/23/2002 |
PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 |
PRIZM MEDICAL, INC. |
CATHRYN N CAMBRIA |
K020005 |
07/16/2002 |
INFANT FEEDING TUBES |
PROMEDIC, INC. |
PAUL DRYDEN |
K011220 |
07/01/2002 |
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
GARY CURTIS |
K013843 |
07/16/2002 |
AUTOSET SPIRIT CPAP SYSTEM |
RESMED CORP. |
ROGER KOTTER |
K013909 |
07/08/2002 |
S7 ELITE CP AP SYSTEM |
RESMED CORP. |
ROGER KOTTER |
K022018 |
07/05/2002 |
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 |
RHIGENE, INC. |
YUSUKE KOBE |
K022171 |
07/23/2002 |
ACCU-CHEK COMPACT SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K021512 |
07/16/2002 |
COBAS INTEGRA ONLINE DAT II METHADONE II |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
K021827 |
07/03/2002 |
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K021505 |
07/16/2002 |
ONLINE DAT II METHADONE II |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
K020704 |
07/12/2002 |
ROCHE ONLINE GENTAMICIN |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K021517 |
07/24/2002 |
ABP FOR WINDOWS |
ROZINN ELECTRONICS, INC. |
MARK ROSOFF |
K020714 |
07/01/2002 |
RUSCH FLONEIL; FLOCATH INTROGEL |
RUSCH INTL. |
KARENANN J BROZOWSKI |
K021764 |
07/23/2002 |
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED |
RUSCH INTL. |
RICK LYKINS |
K014208 |
07/02/2002 |
SSIR SYSTEM |
RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC. |
JOYCE HEINRICH |
K022053 |
07/12/2002 |
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 |
SEBIA |
BOREK JANIK |
K020227 |
07/30/2002 |
SELICOR, MODELS A100 & D100 |
SELICOR, INC. |
JAMES B BINGHAM |
K020665 |
07/30/2002 |
HI-OX |
SENSORMEDICS CORP. |
EARL W DRAPER |
K022087 |
07/11/2002 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. |
PETER WANG |
K012770 |
07/23/2002 |
INFINITY MICRO2+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
K022013 |
07/16/2002 |
LUNGCARE CT SOFTWARE PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRAVEEN P NADKARNI |
K021063 |
07/01/2002 |
GREAT TOE IMPLANT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
K021534 |
07/02/2002 |
IQ NASAL MASK, MODEL 50160 REV. D |
SLEEPNET CORPORATION |
PAUL R CHIESA |
K021521 |
07/02/2002 |
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
K012193 |
07/11/2002 |
AMC ANTIMICROBIAL PIN/WIRE SLEEVE |
SMITH & NEPHEW, INC. |
JEFF F DOERZBACHER |
K021202 |
07/13/2002 |
ULTRAQUIET |
SOUND TECHNIQUE SYSTEM, LLC |
HOWARD M HOLSTEIN |
K022000 |
07/19/2002 |
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) |
SPIRE BIOMEDICAL INC |
DONALD FICKETT |
K020409 |
07/18/2002 |
STEAMPLUS STERILIZATION TEST |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
K021908 |
07/09/2002 |
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL |
STELKAST COMPANY |
DONALD A STEVENS |
K012574 |
07/18/2002 |
REPROCESSED FEMORAL COMPRESSION DEVICE |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K020103 |
07/24/2002 |
PRISMAFLO |
STIHLER ELECTRONIC GMBH |
RICHARD C LANZILLOTO |
K013689 |
07/02/2002 |
RE-ENTRANT CHAMBER |
SUN NUCLEAR CORP. |
JIM MIXON |
K012437 |
07/16/2002 |
DEVILBISS SLEEP RECORDER MODEL # RM60 |
SUNRISE MEDICAL HHG, INC. |
JIM FROEHLICH |
K012644 |
07/29/2002 |
REPROCESSED TROCARS AND CANNULAS |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
ROBERT S MCQUATE |
K020882 |
07/26/2002 |
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K021253 |
07/05/2002 |
ULTRASONIC TIPS WITH DIAMOND COATING |
SYBRON ENDO/ANALYTIC |
COLLEEN BOSWELL |
K021991 |
07/18/2002 |
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE |
SYNCRO MEDICAL INNOVATIONS, INC. |
SABRY A GABRIEL |
K021149 |
07/09/2002 |
AURORA DS |
SYNERON MEDICAL LTD. |
AMIR WALDMANN |
K022255 |
07/25/2002 |
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
K021408 |
07/29/2002 |
RESORBABLE CRANIAL CLAMPS |
SYNTHES (USA) |
MATTHEW M HULL |
K021458 |
07/24/2002 |
SYNTHES IN-SITU BENDER/CUTTER |
SYNTHES (USA) |
MATTHEW M HULL |
K011037 |
07/01/2002 |
VERTEBRAL SPACER |
SYNTHES (USA) |
JONATHAN GILBERT |
K013061 |
07/01/2002 |
BIOTOUCH MASSAGE THERAPY SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
ERIC MCKEE |
K021849 |
07/16/2002 |
TAGG DISPOSABLE VAGINAL SPECULUM |
TAGG INDUSTRIES |
TERRY L SHIRLEY |
K021185 |
07/12/2002 |
NERVUS MONITOR |
TAUGAGREINING HF |
E.J. Smith |
K022083 |
07/16/2002 |
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER |
THE BINDING SITE, LTD. |
JAY H GELLER |
K020910 |
07/19/2002 |
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF |
THE ELECTRODE STORE, INC. |
CARL YOUNGMANN |
K022165 |
07/18/2002 |
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 |
THERALIGHT, INC. |
RAYMOND HARTMAN |
K013768 |
07/03/2002 |
POWERED MUSCLE STIMULATOR |
THERATECH, INC. |
CAROLANN KOTULA |
K021436 |
07/30/2002 |
TTECH MODEL 200E + TENS DEVICE |
THERATECH, INC. |
SUSAN D GOLDSTEIN-FALK |
K022108 |
07/25/2002 |
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 |
THERMO DMA, INC. |
THOMAS DOLLAR |
K021007 |
07/05/2002 |
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL |
TILLOTSON HEALTHCARE CORP. |
FRANK W PERRELLA |
K022020 |
07/02/2002 |
JUSTWO MODEL TME-601 ROOT APEX LOCATOR |
TOEI ELECTRIC CO., LTD. |
DANIEL KAMM |
K013906 |
07/17/2002 |
HLS NOETOS SYSTEM |
TORNIER |
Mireille Lemery |
K022050 |
07/09/2002 |
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K021504 |
07/25/2002 |
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 |
TUTTNAUER USA CO. LTD. |
TODD H HALPERN |
K021825 |
07/01/2002 |
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM |
UNITED STATES SURGICAL |
TINA RIDEOUT |
K021330 |
07/25/2002 |
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
K012688 |
07/31/2002 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
K022225 |
07/25/2002 |
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM |
VECTOR MEDICAL, INC. |
ERIN MCGURK |
K012543 |
07/15/2002 |
VISION SCIENCES ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEU |
K022046 |
07/23/2002 |
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL |
VITAL SCIENTIFIC N.V. |
ISRAEL M STEIN |
K021844 |
07/19/2002 |
ADMIRA PROTECT |
VOCO GMBH |
GERALD W SHIPPS |
K021842 |
07/29/2002 |
ADMIRA SEAL |
VOCO GMBH |
GERALD W SHIPPS |
K021041 |
07/30/2002 |
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES |
W.A. RUBBERMATE CO., LTD. |
LARA N SIMMONS |
K021224 |
07/12/2002 |
ENDOCERVICAL BLOCK NEEDLE |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
K021681 |
07/23/2002 |
MICROPAQ, MODELS 402, 404 |
WELCH ALLYN PROTOCOL, INC. |
DON M ABBEY |
K021124 |
07/02/2002 |
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER |
WFR/AQUAPLAST CORP. |
J DAMON KIRK |
K021926 |
07/25/2002 |
AUROPAL 60 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K021332 |
07/03/2002 |
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K011591 |
07/19/2002 |
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
K020337 |
07/29/2002 |
READI-STRAND; MODEL PSSTRAND |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
K021349 |
07/01/2002 |
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K021346 |
07/02/2002 |
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROGER D BROWN |
K021119 |
07/05/2002 |
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KK LEONG |
K021159 |
07/03/2002 |
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
K. K LEONG |
K021784 |
07/24/2002 |
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K014119 |
07/25/2002 |
WU'S 3-WHEELED NEO SCOOTER, WT-M3 |
WU'S TECH CO., LTD. |
Ke-Min Jen |
K013763 |
07/30/2002 |
WU'S 4-WHEELED NEO SCOOTER, WT-L4 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
K013926 |
07/18/2002 |
QIZHOU ACUPUNCTURE NEEDLE |
WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO |
GONG BO |
K021641 |
07/26/2002 |
XTD THROMBECTOMY CATHETER, XX CM |
XTRAK MEDICAL INC. |
DEBBIE IAMPIETRO |
K022164 |
07/26/2002 |
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM |
ZETA DEVELOPMENT LABORATORIES |
MARK T FUKUHARA |
K014070 |
07/30/2002 |
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES |
ZIMMER, INC. |
KAREN CAIN |