FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K013491 |
11/19/2001 |
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 |
A & A MEDICAL, INC. |
JAY MANSOUR |
K013437 |
11/19/2001 |
SF SH CATHETER, MODEL R65-945 |
A & A MEDICAL, INC. |
JAY MANSOUR |
K002061 |
01/19/2001 |
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
K013393 |
11/09/2001 |
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H |
A-MED SYSTEMS, INC. |
CYNTHIA G ROYSTER |
K002717 |
01/08/2001 |
STERILE PISTON SYRINGE |
ABBOTT LABORATORIES |
THOMAS P SAMPONGA |
K010011 |
01/12/2001 |
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM |
ACCELERATED REHAB DESIGNS, INC. |
RANDALL POTTER |
K012824 |
11/09/2001 |
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011994 |
11/08/2001 |
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 |
ACRYMED, INC. |
BRUCE GIBBINS |
K012655 |
11/07/2001 |
CONGRUENT BONE PLATE SYSTEM |
ACUMED, INC. |
SHARI JEFFERS |
K013521 |
11/07/2001 |
GEMINI IMAGING SYSTEM |
ADAC LABORATORIES |
COLEEN A COLEMAN |
K013496 |
11/06/2001 |
MODIFICATION TO SKYLIGHT IMAGING SYSTEM |
ADAC LABORATORIES |
DAVID KOLESAR |
K003670 |
01/26/2001 |
PATIENT DRAPE, SURGICAL |
ADVANCE MEDICAL DESIGNS, INC. |
BILL GILL |
K002488 |
01/05/2001 |
KELO-COTE TOPICAL GEL |
ADVANCED BIO-TECHNOLOGIES, INC. |
DAVID BRYANT |
K013291 |
11/14/2001 |
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) |
ADVANCED DIAGNOSTICS, INC. |
STEVE HESLER |
K000852 |
01/19/2001 |
RENEW NEUROSTIMULATION SYSTEM |
ADVANCED NEUROMODULATION SYSTEMS |
RASHMI MOZA |
K003708 |
01/22/2001 |
ADVANTAGE THC/COCAINE TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
K011556 |
11/16/2001 |
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM |
AESCULAP, INC. |
LISA M MILLINGTON |
K003519 |
01/29/2001 |
YASARGIL PERMANENT ANEURYSM CLIPS |
AESCULAP, INC. |
JOYCE THOMAS |
K012750 |
11/14/2001 |
ADC PEDIATRIC |
AGFA CORP. |
T. WHIT ATHEY |
K012941 |
11/29/2001 |
DRYSTAR, MODEL 4500M |
AGFA CORP. |
T. WHIT ATHEY |
K003763 |
01/05/2001 |
2010 PLUS HOLTER FOR WINDOWS |
AGILENT TECHNOLOGIES |
GRETEL LUMLEY |
K003330 |
01/04/2001 |
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
K013087 |
11/13/2001 |
SINGLE DOSE DISPENSING PIN, MODEL 2201 |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
K002937 |
11/05/2001 |
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
K003768 |
01/05/2001 |
MONARCH II IOL DELIVERY SYSTEM |
ALCON RESEARCH, LTD. |
SHERRI J LAKOTA |
K011192 |
11/26/2001 |
COMPRESSIBLE LIMB SLEEVE |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K012605 |
11/07/2001 |
REPROCESSED ATHROSCOPICS BURS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K012603 |
11/07/2001 |
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K012652 |
11/08/2001 |
REPROCESSED DYONICS ARTHROSCOPIC BURS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K012635 |
11/07/2001 |
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K012611 |
11/07/2001 |
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
K012630 |
11/09/2001 |
REPROCESSED LINVATEC ARTHROSCOPIC BURS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
K012613 |
11/07/2001 |
REPROCSSED LINVATEC SHAVERS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
K003031 |
01/05/2001 |
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML |
ALPHA VISTA, INC. |
HELMUT WEBER |
K003202 |
01/10/2001 |
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II |
ALTUS MEDICAL |
MICHAEL LEVERNIER |
K012484 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE |
AMEDITECH, INC. |
JOHN WU |
K012585 |
11/16/2001 |
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE |
AMEDITECH, INC. |
JOHN WU |
K012483 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN OPIATES |
AMEDITECH, INC. |
JOHN WU |
K012582 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN PCP |
AMEDITECH, INC. |
JOHN WU |
K012164 |
11/20/2001 |
'RAPIDONE'-METHADONE TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K013180 |
11/26/2001 |
RAPIDONE-ECSTASY TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K003509 |
01/02/2001 |
FLEXICAST |
AMERICAN DENT-ALL, INC. |
VACHAKAN H KHOIE |
K012304 |
11/01/2001 |
ADC 656 ELECTRONIC STETHOSCOPE |
AMERICAN DIAGNOSTIC CORP. |
MARC BLITSTEIN |
K003901 |
01/17/2001 |
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K003771 |
01/16/2001 |
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
K013604 |
11/13/2001 |
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
K013603 |
11/13/2001 |
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
K003895 |
01/17/2001 |
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 |
ANSELL PERRY |
JAMES R CHATTERTON |
K002624 |
01/22/2001 |
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
STEVEN CREES |
K002621 |
01/22/2001 |
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
STEVEN CREES |
K012918 |
11/27/2001 |
APEX MODULAR ALUMINA FEMORAL HEAD |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
K012429 |
11/06/2001 |
SURESET INFUSION SET, MODEL 8023 |
APPLIED DIABETES RESEARCH, INCORPORATED |
CHARLES H KYPER |
K002915 |
01/08/2001 |
FLEXIBLE OCCLUSION SYSTEM |
APPLIED MEDICAL |
ANIL BHALANI |
K003368 |
01/19/2001 |
ACROTHERM |
AQUARIUS MEDICAL CORP. |
CHRISTINA M FLEMING |
K003227 |
01/08/2001 |
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B |
ARTHREX, INC. |
VERNON BROWN |
K013463 |
11/15/2001 |
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K012872 |
11/20/2001 |
RESORBABLE SCREW ANCHOR |
ARTHROTEK, INC. |
SARA B SHULTZ |
K002513 |
01/04/2001 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
K001259 |
01/12/2001 |
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
K013682 |
11/28/2001 |
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
K001859 |
01/11/2001 |
PENILE CONSTRICTOR RING |
BASIC SOLUTIONS, LLC. |
JAY H GELLER |
K013232 |
11/20/2001 |
CYBERCASES BY BAUSCH & LOMB |
BAUSCH & LOMB, INC. |
KIM S DEVITTO |
K012873 |
11/19/2001 |
DOCUMENTING LASER SLIT LAMP, DP 2010 |
BAUSCH & LOMB, INC. |
PENNI L PANNELL |
K011796 |
11/01/2001 |
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
K011963 |
11/20/2001 |
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY |
BAYER CORP. |
KENNETH T EDDS |
K000884 |
01/19/2001 |
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY |
BECTON DICKINSON BIOSCIENCES |
COLLEEN ROHRBECK |
K013073 |
11/08/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
K012746 |
11/14/2001 |
ICE BATON |
BEHIVE LTD |
MARY MCNAMARA-CULLINANE |
K010607 |
11/28/2001 |
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 |
BENLAN, INC. |
BILL LIM |
K012521 |
11/30/2001 |
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST |
BINAX, INC. |
PAMELA ANGELL |
K003827 |
01/08/2001 |
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION |
BIO-PLEXUS, INC. |
PAUL A TENTHOREY |
K003176 |
01/04/2001 |
BIOEMG II AND BIOJVA |
BIO-RESEARCH ASSOCIATES, INC. |
JOHN C RADKE |
K012829 |
11/02/2001 |
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS |
BIOCARE CORP. |
BRUCE A MACFARLAND |
K003948 |
01/29/2001 |
EPI-DERM SILICONE GEL SHEETING |
BIODERMIS CORP. |
JEFF S SCHLEUING |
K003385 |
01/25/2001 |
TWILITE, TWILITE WHITE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K003253 |
01/12/2001 |
BIOMET'S MINIMALLY CONSTRAINED ELBOW |
BIOMET, INC. |
SARA A BAILEY |
K012798 |
11/16/2001 |
INTEX SCREW |
BIOMET, INC. |
DALENE T BINKLEY |
K003273 |
01/11/2001 |
LACTOSORB SCREW ANCHOR |
BIOMET, INC. |
MARY VERSTYNEN |
K010027 |
01/12/2001 |
MAXIM KNEE SYSTEM |
BIOMET, INC. |
DALENE T BINKLEY |
K011328 |
11/21/2001 |
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH |
BIONET COMPANY LTD |
MIN SOO HAN |
K003756 |
01/03/2001 |
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES |
BIONX IMPLANTS, INC. |
DAVID W ANDERSON |
K003970 |
01/12/2001 |
CONTOUR LABRAL NAIL, MODEL 533520A |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
K013546 |
11/21/2001 |
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
K012908 |
11/28/2001 |
BIOPLATE RESORBABLE BONE SCREW |
BIOPLATE, INC. |
ERIC V HOHENSTEIN |
K012910 |
11/20/2001 |
THE BIOPLATE MANDIBLE FIXATION SYSTEM |
BIOPLATE, INC. |
BRUCE F MACKLER |
K002426 |
01/26/2001 |
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
K994060 |
01/24/2001 |
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE |
BIOPLATE, INC. |
ERIC V HOHENSTEIN |
K013083 |
11/21/2001 |
CARTO XP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
AMY WALTERS |
K003380 |
01/29/2001 |
BIOTEQUE VAGINAL DILATOR |
BIOTEQUE AMERICA, INC. |
DENIS DORSEY |
K003454 |
01/18/2001 |
A1-CS-SB Y-ADAPTER, MODEL 124 871 |
BIOTRONIK, INC. |
JON BURMBAUGH |
K003072 |
01/09/2001 |
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES |
BIOTRONIK, INC. |
Jon Brumbaugh |
K010002 |
01/22/2001 |
CONTOUR POLARIS URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
LINDA J VARROSO |
K011909 |
11/28/2001 |
ULTRA-THIN SDS BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
K012752 |
11/15/2001 |
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
K013124 |
11/07/2001 |
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
K003917 |
01/26/2001 |
MODIFICATION TO FLUOROTEX II SURGICAL MESH |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
K003906 |
01/26/2001 |
MODIFICATION TO FLUROTEX SURGICAL MESH |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
K003956 |
01/05/2001 |
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 |
C.R. BARD, INC. |
BETH A ZIS |
K003793 |
01/05/2001 |
BARD LUMINEXX BILIARY STENT |
C.R. BARD, INC. |
CAROL VIERLING |
K003186 |
01/09/2001 |
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT |
C.R. BARD, INC. |
BETH A ZIS |
K003289 |
01/05/2001 |
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU |
C.R. BARD, INC. |
GEORGE C ABERNATHY |
K003492 |
01/18/2001 |
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K013565 |
11/21/2001 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K013564 |
11/21/2001 |
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K010038 |
01/24/2001 |
NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE |
CAMBRIDGE MARKETING, INC. |
JOSEPH B DUNN |
K003541 |
01/25/2001 |
DENLASER, MODEL 800 |
CAO GROUP, INC. |
TRACY S BEST |
K012197 |
11/16/2001 |
POWERHEART CARDIAC RHYTHM MODULE |
CARDIAC SCIENCE, INC. |
Sew-Wah Tay |
K011439 |
11/02/2001 |
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRIAN PARK |
K011861 |
11/06/2001 |
BERNOULLI VENTILATOR MANAGEMENT SYSTEM |
CARDIOPULMONARY CORP. |
JOHN LAVIOLA |
K013402 |
11/14/2001 |
VISULAS 532S |
CARL ZEISS, INC. |
KENNETH M NICOLL |
K003791 |
01/23/2001 |
CAVEX TEMPORARY CEMENT |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K013472 |
11/28/2001 |
TOTAL O2 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
K003467 |
01/29/2001 |
CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
DAVE HERNON |
K012951 |
11/09/2001 |
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE |
CIRCON VIDEO |
WAYNE B STERNER |
K012925 |
11/07/2001 |
DUR-8, MODELS DUR-8 |
CIRCON VIDEO |
WAYNE STERNER |
K012929 |
11/19/2001 |
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 |
CIRCON VIDEO |
WAYNE STERNER |
K012942 |
11/05/2001 |
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
K013332 |
11/20/2001 |
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K002338 |
01/29/2001 |
LIQUIDERM LIQUID ADHESIVE BANDAGE |
CLOSURE MEDICAL CORP. |
W. THOMAS STEPHENS |
K013480 |
11/16/2001 |
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR |
COBE CARDIOVASCULAR, INC. |
SHAWN RIEDEL |
K012763 |
11/15/2001 |
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
K003481 |
01/19/2001 |
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 |
CODONICS, INC. |
GARY J ALLSEBROOK |
K003339 |
01/08/2001 |
COLLAGEN PERIODONTAL MEMBRANE |
COLLAGEN MATRIX, INC. |
SHU-TUNG LI |
K010034 |
01/24/2001 |
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- |
COOK, INC. |
LISA WEBB |
K010601 |
11/16/2001 |
FANELLI BILIARY STENT |
COOK, INC. |
LISA HOPKINS |
K001985 |
01/25/2001 |
INTRODEUCE DOUBLE LUMEN INTRODUCER |
COOK, INC. |
APRIL LAVENDER |
K011812 |
11/08/2001 |
SPECTRUM VENTRICULAR CATHETER |
COOK, INC. |
APRIL LAVENDER |
K003964 |
01/19/2001 |
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B |
CORDIS CORP. |
KAREN WILK |
K003925 |
01/08/2001 |
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
K013581 |
11/28/2001 |
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER |
CORDIS, A JOHNSON & JOHNSON CO. |
CHUCK RYAN |
K012563 |
11/02/2001 |
DEEP GRAY |
CORTECHS LABS, INC. |
JEFFREY M ANDERS |
K001174 |
01/11/2001 |
COSMED QUARK |
COSMED S.R.L. |
ROBERT SCHIFF |
K013274 |
11/16/2001 |
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE |
CP MEDICAL |
MARY ANN GREENAWALT |
K003485 |
01/11/2001 |
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE |
CYBERCARE TECHNOLOGIES, INC. |
GORDON J PETERS |
K012790 |
11/16/2001 |
CYNOSURE PHOTOGENICA ER |
CYNOSURE, INC. |
GEORGE CHO |
K012806 |
11/19/2001 |
CYNOSURE PHOTOGENICA VL |
CYNOSURE, INC. |
GEORGE CHO |
K013114 |
11/09/2001 |
BCS SYSTEM |
DADE BEHRING, INC. |
REBECCA S AYASH |
K011852 |
11/15/2001 |
DIMENSION HAIC ASSAY, MODEL DF105 |
DADE BEHRING, INC. |
Cathy Craft |
K013126 |
11/09/2001 |
N LP(A) STANDARD SY |
DADE BEHRING, INC. |
REBECCA S AYASH |
K003696 |
01/25/2001 |
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD |
DADE BEHRING, INC. |
LAURENCE A POTTER |
K003619 |
01/09/2001 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K012885 |
11/08/2001 |
NEUROMOVE NM900 |
DAN MED, INC. |
THOMAS SANDGAARD |
K013326 |
11/02/2001 |
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B |
DATASCOPE CORP. |
JOANN WOLF |
K012531 |
11/02/2001 |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX |
DATEX-OHMEDA |
JOEL KENT |
K003323 |
01/22/2001 |
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 |
DAVOL, INC. |
PAULA E BULGER |
K013049 |
11/29/2001 |
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE |
DENNIS R. BAILEY, DDS |
DENNIS R BAILEY |
K003921 |
01/24/2001 |
DYRACT CEM LCI COMPOMER |
DENTSPLY INTL. |
P. JEFFREY LEHN |
K003518 |
01/09/2001 |
RAPIDD HIGHSPEED DENTAL HANDPIECE |
DENTSPLY INTL. |
P. JEFFREY LEHN |
K012720 |
11/08/2001 |
TULSA CONTRA ANGLES |
DENTSPLY INTL. |
P. JEFFREY LEHN |
K003451 |
01/02/2001 |
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T |
DENVER BIOMEDICALS, INC. |
BONNIE VIVIAN |
K012773 |
11/16/2001 |
DISCOVERY FACET SCREW FIXATION SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K003822 |
01/08/2001 |
ISOLA CLOSED DUAL ROD CONNECTOR |
DEPUY ACROMED |
FRANK MAAS |
K013441 |
11/16/2001 |
ISOLA POLYAXIAL WASHER |
DEPUY ACROMED |
LISA GILMAN |
K013382 |
11/07/2001 |
MODIFICATION TO: STACKABLE CAGE SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K013222 |
11/07/2001 |
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K003286 |
01/18/2001 |
SYMPHONY GRAFT DELIVERY SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
K012738 |
11/14/2001 |
SYMPHONY GRAFT DELIVERY SYSTEM (GDS) |
DEPUY ACROMED |
KAREN F JURCZAK |
K012916 |
11/27/2001 |
FRONTIER ANTERIOR SCOLIOSIS SYSTEM |
DEPUY ACROMED, INC. |
LISA GILMAN |
K011048 |
11/13/2001 |
BSM BONE SUBSTITUTE MATERIAL |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
K003397 |
01/29/2001 |
COLLES C SERIES FRAME STERILE PACK |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K013350 |
11/07/2001 |
MODIFICATION TO DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K013503 |
11/16/2001 |
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K013566 |
11/20/2001 |
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K011586 |
11/16/2001 |
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
K013499 |
11/16/2001 |
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS |
DIOMED, INC. |
MARY MCNAMARA-CULLINANE |
K013782 |
11/20/2001 |
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
DAVID E CHADWICK |
K011322 |
11/19/2001 |
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE |
DORNIER MEDTECH AMERICA, INC. |
BRIAN WALSH |
K003579 |
01/22/2001 |
NARKOMED MRI-2, MODEL NM-MRI-2 |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
K012917 |
11/28/2001 |
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B |
DYNAREX CORP. |
JOHN GAGLIARDI |
K003154 |
01/05/2001 |
MIZAR, BASIS BE, SANDMAN DIGITAL |
EB NEURO, S.P.A. |
COLLEEN HITTLE |
K012516 |
11/27/2001 |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
K003898 |
01/04/2001 |
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K010003 |
01/31/2001 |
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K013540 |
11/20/2001 |
EBI XFIX ACCESS PELVIC FIXATOR |
EBI, L.P. |
MICHAEL TAGGART |
K013378 |
11/08/2001 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
MICHAEL T TAGGART |
K003764 |
01/02/2001 |
MODIFICATION TO EBI SPINELINK SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K013631 |
11/20/2001 |
EFILM VIDEO |
EFILM MEDICAL, INC. |
JOSEPH A THOMAS |
K013152 |
11/09/2001 |
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
K003688 |
01/22/2001 |
VIEW READING STATION |
ELECTROMED INTL., LTD. |
JEAN-LUC DES GROSEILLIERS |
K013255 |
11/07/2001 |
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF |
ELLMAN INTL., INC. |
FRANK LIN |
K003250 |
01/25/2001 |
FMP METAL/METAL ACETABULAR INSERT |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
K013431 |
11/15/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
K013403 |
11/14/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
K003151 |
01/08/2001 |
MICROPOBE SERIES OF LASERS AND ACCESSORIES |
ENDO OPTIKS, INC. |
KEITH HERTZ |
K012725 |
11/08/2001 |
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
K012977 |
11/02/2001 |
VARICES INJECTION NEEDLE |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
K001121 |
11/29/2001 |
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) |
ENGINEERED MEDICAL TECHNOLOGY, INC. |
DON SCHMIELEY |
K003348 |
01/12/2001 |
E.N.S.I. RETRACTABLE SAFETY SYRINGE |
ENSI-MED INTERNATIONAL PTY. LTD. |
NAP CURIE |
K002457 |
01/12/2001 |
!NSURE FECAL OCCULT BLOOD TEST |
ENTERIX INC. |
ROBERT C BRUCE |
K003462 |
01/04/2001 |
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 |
ERBE USA, INC. |
JOHN TARTAL |
K003297 |
01/18/2001 |
MAMMOTOME HAND HELD PROBE, MODEL MHH8 |
ETHICON ENDO-SURGERY, INC. |
DENNIS HAHN |
K003487 |
01/24/2001 |
STIMATE N601 TENS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
DORA HSU YANG |
K012920 |
11/28/2001 |
MOLDED CRANIAL HELMET |
FAIRVIEW ORTHOPEDIC LABORATORY |
ROSS C D'EMANUELE |
K003453 |
01/18/2001 |
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS |
FONAR CORP. |
LUCIANO BONANNI |
K011174 |
11/07/2001 |
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
K003498 |
01/04/2001 |
FRESENIUS OPTIFLUX 200A |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K002638 |
01/17/2001 |
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT |
FUTURE DIAGNOSTICS B.V. |
DAVE D SMITH |
K003957 |
11/01/2001 |
DIACLEAR ULTRAFILTER |
GAMBRO RENAL PRODUCTS |
SUZANNE DENNIS |
K003817 |
01/16/2001 |
PATTERN RESIN |
GC AMERICA, INC. |
TERRY L JORITZ |
K013481 |
11/02/2001 |
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION |
GE MEDICAL SYSTEMS |
JODI PARKER |
K013561 |
11/08/2001 |
LIGHTSPEED 4.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K003575 |
01/17/2001 |
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K012875 |
11/20/2001 |
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY KROGER |
K012718 |
11/13/2001 |
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOELLE NEIDER |
K003573 |
01/23/2001 |
DIFFUSION TENSOR IMAGING OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K003931 |
01/18/2001 |
VIVID 7 WITH SONOPAC, MODEL FB0008XX |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
K001624 |
01/25/2001 |
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 |
GEBAUER CO. |
DENISE E SPELLMAN |
K010042 |
01/30/2001 |
CT PERFUSION 2 |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
K002450 |
01/12/2001 |
GENUA MENOPAUSE MONITOR TEST KIT |
GENUA 1944, INC. |
Gary Lehnus |
K003223 |
01/12/2001 |
GEON DIGITAL CLINICAL THERMOMETER |
GEON CORP. |
ALLEN REICH |
K003441 |
01/02/2001 |
CASTLE MODEL 233HC STEAM STERILIZER |
GETINGE/CASTLE, INC. |
FREDERICK R CATT |
K013731 |
11/27/2001 |
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 |
GIMMI GMBH |
DAGMAR S MASER |
K013136 |
11/26/2001 |
ANEURYSM CLIPS |
GISTLSTRASSE |
DIETER VON SEPPELIN |
K003872 |
01/23/2001 |
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K010054 |
01/26/2001 |
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K010078 |
01/29/2001 |
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K013536 |
11/30/2001 |
EMTRAC; DELPHIN; SEMTRAC 2000 SET |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
K013497 |
11/09/2001 |
FAS SET #4551 |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
K013501 |
11/30/2001 |
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
K003556 |
01/17/2001 |
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K003536 |
01/12/2001 |
HARDYDISK NAFCILLIN, 1 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K003537 |
01/12/2001 |
HARDYDISK RIFAMPIN, 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K003690 |
01/25/2001 |
HARDYDISK SULFISOXAZOLE |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K003686 |
01/12/2001 |
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K003554 |
01/19/2001 |
HARDYDISK TRIMETHOPRIM 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K012785 |
11/16/2001 |
TWINTRODE ELC 134 ELECTRODE |
HEALTH TRONICS SURGICAL SERVICES, INC. |
PETER WEIMAN |
K013573 |
11/09/2001 |
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
K013709 |
11/16/2001 |
HILL-ROM PRIMAVIEW MONITOR SYSTEM |
HILL-ROM, INC. |
TIMOTHY M DAVIS |
K012779 |
11/02/2001 |
ICONNECTION 3D |
HINNOVATION, INC. |
YI ISABELLE SUN |
K003231 |
01/12/2001 |
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 |
HOME MEDICAL SERVICES |
C.A. TEKLINSKI |
K003258 |
01/12/2001 |
MS-ONE, MODEL MS-1 |
HOME WELLNESS WEST |
C.A. TEKLINSKI |
K002235 |
01/23/2001 |
HORIZONS ERCP CANNULA |
HORIZONS INTL. CORP. |
RAFIC SALEH |
K002236 |
01/23/2001 |
HORIZONS PAPILLOTOME |
HORIZONS INTL. CORP. |
RAFIC SALEH |
K012776 |
11/16/2001 |
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
K003848 |
01/11/2001 |
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K013468 |
11/16/2001 |
LONG LENGTH DYAX NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K013524 |
11/14/2001 |
TROCHANTERIC DYAX NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K003736 |
01/18/2001 |
MRI LINE MARKER |
I.Z.I. CORP. |
HELEN ZINREICH |
K003513 |
01/11/2001 |
TAXOL ADMINISTRATION SET |
ICU MEDICAL, INC. |
SALVADORE F PALOMARES |
K001097 |
01/18/2001 |
ACTIVE ARRAY CATHETER, MODEL CS-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
K013432 |
11/29/2001 |
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
K013285 |
11/14/2001 |
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
K013283 |
11/14/2001 |
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
K013531 |
11/07/2001 |
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
K004013 |
01/25/2001 |
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY |
IMPLEX CORP. |
JOHN SCHALAGO |
K012964 |
11/09/2001 |
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
K012962 |
11/09/2001 |
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
K012664 |
11/09/2001 |
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
K012665 |
11/09/2001 |
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
K003959 |
01/22/2001 |
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA |
INOVA DIAGNOSTICS, INC. |
BRY C MYERS |
K011196 |
11/08/2001 |
IQUANTIFY, VERSION 1.0 |
INSIGHTFUL CORPORATION |
BRADLEY T WYMAN |
K002011 |
01/22/2001 |
GLUTARTEST 1 REAGENT STRIP |
INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
WEN H WU |
K003406 |
01/12/2001 |
GUARDED NEEDLE 2000 |
INTERNATIONAL MEDICAL DEVICE PARTNERS, INC. |
JAMES R GREENWOOD |
K010989 |
11/07/2001 |
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 |
INTERPORE CROSS INTL. |
LYNN R RODARTI |
K990800 |
01/08/2001 |
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS |
INTERVASCULAR, INC. |
JAMES S MILLER |
K003997 |
01/24/2001 |
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
K012833 |
11/16/2001 |
INTUITIVE SURGICAL BIPOLAR FORCEPS |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUI |
K011479 |
11/30/2001 |
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
INVERNESS MEDICAL INNOVATIONS, INC. |
CAROL A ADILETTO |
K003751 |
01/17/2001 |
HYALURONIDASE REAGENT, MODEL CAT#2212 |
INVITROCARE, INC. |
ROBERT E LOVINS |
K003278 |
01/17/2001 |
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K010739 |
11/06/2001 |
WATCH-PAT 100 |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
GEORGE MYERS |
K003407 |
01/26/2001 |
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K012877 |
11/21/2001 |
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER |
IVOCLAR USA, INC. |
ANDERJEET GULATI |
K003693 |
01/29/2001 |
DIRECT BILIRUBIN |
JAS Diagnostics, Inc. |
DAVID JOHNSON |
K003603 |
01/10/2001 |
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE |
JELENKO CO. |
RAPHAEL JUDKINS |
K003683 |
01/11/2001 |
AVANTE CURELIGHT |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K003042 |
01/22/2001 |
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT |
JOE B. GOLDBERG, O.D. |
JOE B GOLDBERG |
K003938 |
01/18/2001 |
TRAK BACK II |
JOMED, INC. |
CHRISTINA KICHULA |
K012774 |
11/16/2001 |
JOSTRA ARTERIAL PERFUSION CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
K012617 |
11/06/2001 |
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... |
JOSTRA AG |
KATHLEEN JOHNSON |
K012492 |
11/02/2001 |
KADANCE 2000 |
KADA RESEARCH, INC. |
HARVEY KNAUSS |
K012527 |
11/01/2001 |
KSEA SIALOENDOSCOPES AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K012815 |
11/13/2001 |
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
K003883 |
01/23/2001 |
MOLINA ORBITAL MALAR DISTRACTOR |
KLS-MARTIN L.P. |
MIKE TEAGUE |
K012236 |
11/19/2001 |
STARS2000 POWER CANNULA |
KMI KOLSTER METHODS, INC. |
ALWIN H KOLSTER |
K012830 |
11/20/2001 |
LERMAN & SON CRANIAL ORTHOSIS HELMET |
LERMAN & SON |
MAX LERMAN |
K003226 |
01/12/2001 |
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
K013117 |
11/29/2001 |
RESECTION ABLATOR |
LINVATEC CORP. |
LAURA D SENEFF |
K012545 |
11/05/2001 |
ARAMIS DERMATLOGIC LASER |
LUMEDICS, LTD. |
JONATHAN S KAHAN |
K001577 |
01/11/2001 |
OUTBACK CATHETER |
LUMEND, INC. |
PHIL HOPPER |
K003862 |
01/12/2001 |
MADA WHEELCHAIRS |
MADA MEDICAL PRODUCTS, INC. |
JEFFREY W ADAM |
K003982 |
01/26/2001 |
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR |
MAGNETIC RESONANCE EQUIPMENT CORP. |
G. RONALD MORRIS |
K013119 |
11/16/2001 |
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
K013265 |
11/20/2001 |
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
K012844 |
11/08/2001 |
MAROSIS PACS |
MAROTECH, INC |
CARL ALLETTO |
K013443 |
11/29/2001 |
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 |
MAXTER GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
K013239 |
11/20/2001 |
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES |
MED GEN, INC. |
THEODORE BARASH |
K003682 |
01/26/2001 |
MEDCOMP Z-CATH |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
K003783 |
01/12/2001 |
MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER |
MEDICAL DEPOT, INC. |
ART WARD |
K012624 |
11/08/2001 |
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
K002822 |
01/31/2001 |
VERTEX SYSTEM |
MEDICAL POSITIONING, INC. |
CAROL PATTERSON |
K013627 |
11/16/2001 |
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
A. ROBERT DEPALMA |
K012944 |
11/20/2001 |
POWER DRIVE |
MEDITEAM AB |
THOMAS STJERNKVIST |
K003055 |
01/26/2001 |
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K002968 |
01/23/2001 |
MEDLINE STERILIZATION WRAP |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K013082 |
11/16/2001 |
MEDSTAR 100 INTERFERENTIAL STIMLATOR |
MEDNET SERVICES, INC. |
DAVID L MATHEWS |
K013081 |
11/20/2001 |
MEDSTAR 150 |
MEDNET SERVICES, INC. |
DAVID L MATHEWS |
K002930 |
01/22/2001 |
INSTACCULT |
MEDTEK DIAGNOSTICS, LLC. |
LIANE F GOSSET |
K002331 |
01/17/2001 |
PROFILE-ER |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K002445 |
01/31/2001 |
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES |
MEDTRONIC PHYSIO-CONTROL CORP. |
BOB ZITO |
K003928 |
01/17/2001 |
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K010579 |
11/21/2001 |
STENT SUPPORT GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
K012953 |
11/30/2001 |
GIOTTO IMAGE |
MEDX, INC. |
FLOYD R ROWAN |
K013331 |
11/30/2001 |
LYMPHA PRESS PLUS DEVICE |
MEGO AFEK |
AHAVA STEIN |
K003387 |
01/09/2001 |
AUROFILM NP |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K013264 |
11/29/2001 |
MICRO STAMPING LIGATING CLIP |
MICRO STAMPING CORP. |
JOHN GAGLIARDI |
K001802 |
01/09/2001 |
VENODYNE DVT ADVANTAGE MODEL 610 |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
K002056 |
01/11/2001 |
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 |
MICRUS CORP. |
TOM HOLDYCH |
K010771 |
11/27/2001 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
K010366 |
11/28/2001 |
DISPOSABLE STORAGE CAP |
MOLDED PRODUCTS INC. |
ELISE JOHNSTON |
K011070 |
11/07/2001 |
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR |
MOOR INSTRUMENTS LTD. |
DAVID BOGGETT |
K003476 |
01/12/2001 |
MPS ACACIA PAIN KIT |
MPS ACACIA |
FERGIE F FERGUSON |
K013602 |
11/20/2001 |
HNC-63-INT NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K013508 |
11/20/2001 |
HRH-127-ALLEGRA HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K013399 |
11/13/2001 |
MODEL MES-9000/EMG SYSTEM |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
K012801 |
11/14/2001 |
N2000 BASE STATION, N2001 NURSE STATION |
NEPTEC DESIGN GROUP, LTD. |
CHARLES H KYPER |
K012823 |
11/14/2001 |
MODIFICATION TO HANDMASTER |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
JONATHAN S HAHAN |
K003508 |
01/17/2001 |
NC-STAT |
NEUROMETRIX, INC. |
JAMES R VEALE |
K010819 |
11/08/2001 |
3CC NMT SAFETY SYRINGE |
NEW MEDICAL TECHNOLOGY LTD. |
MIKE MALANDRAKIS |
K003563 |
01/02/2001 |
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE |
NING BO YUJIANG RUBBER & PLASTIC CO. |
JANNA P TUCKER |
K003394 |
01/30/2001 |
APPALEAD GW+03XXXXXXR SERIES |
NIPRO MEDICAL CORP. |
CARY GOLDSMITH |
K001879 |
11/20/2001 |
INFUSION IV SET |
NIRVI INTL. USA |
DARSHANA HATHI |
K013133 |
11/13/2001 |
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 |
NORDIX, INC. |
MARIAN LISAK |
K004007 |
01/25/2001 |
DR180+OXY |
NORTHEAST MONITORING, INC. |
RODNEY L CAMBRE |
K013185 |
11/28/2001 |
TCM ENDO III |
NOUVAG AG |
COLLEEN BOSWELL |
K003902 |
01/11/2001 |
MULTITRACK ANGIOGRAPHIC CATHETER |
NUMED, INC. |
NICHELLE R LAFLESH |
K003972 |
01/11/2001 |
NUMED GHOST II PTA CATHETERS |
NUMED, INC. |
NICHELL LAFLESH |
K001283 |
01/17/2001 |
LIFEMATE HEMOFILTRATION SYSTEM |
NXSTAGE MEDICAL, INC. |
JEFFREY BURBANK |
K003136 |
01/06/2001 |
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
RICHARD E LIPPMAN |
K002231 |
01/30/2001 |
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K011652 |
11/07/2001 |
BODY FAT ANALYZER, MODEL HBF-306 |
OMRON HEALTHCARE, INC. |
OSAMU SHIRASAKI |
K002375 |
01/26/2001 |
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
K002163 |
01/11/2001 |
MICROSTREAM EXTERNAL BATTERY CHARGER |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K011536 |
11/14/2001 |
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K013845 |
11/29/2001 |
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K012751 |
11/14/2001 |
HEALOS BONE GRAFT MATERIAL |
ORQUEST, INC. |
KRISTINE F LAHMAN |
K013339 |
11/08/2001 |
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS |
Oscor Inc. |
MILA DOSKOCIL |
K012626 |
11/02/2001 |
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR |
OSI MEDICAL, INC. |
JON WERNER |
K011043 |
11/30/2001 |
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) |
OSMETECH |
JOHN PLANT |
K003316 |
01/19/2001 |
OTI CERAMIC FEMORAL HEAD SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K003199 |
01/10/2001 |
TRIAD II MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K003155 |
01/04/2001 |
VERTEBRAL BODY REPLACEMENT |
OSTEOTECH, INC. |
KIM THURMAN |
K013362 |
11/13/2001 |
AUTOJECT 2 |
OWEN MUMFORD USA, INC. |
ROBERT SHAW |
K011308 |
11/29/2001 |
MULTISTIM |
PAJUNK GMBH |
LYNETTE HOWARD |
K012771 |
11/14/2001 |
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX |
PAJUNK GMBH |
MARTIN HANGER |
K003460 |
01/25/2001 |
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
K013796 |
11/26/2001 |
LIVESURE METHADONE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K012647 |
11/09/2001 |
TONOPORT V |
PAR MEDIZINTECHNIK GMBH |
LOTHAR ENGEL |
K013489 |
11/29/2001 |
KP + LFM |
PDS HEALTHCARE PRODUCTS, INC. |
JIM LEWIS |
K003775 |
01/12/2001 |
PORTABLE BREAST COMPRESSION DEVICE |
PEM TECHNOLOGIES |
T. WHIT ATHEY |
K002381 |
01/11/2001 |
PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES |
PENTAFERTE S.R.L. |
VITTORIO SERVIDORI |
K011899 |
11/06/2001 |
PF 5050 PRESSURE UNIT, MODEL PF 5050 |
PERIMED AB |
BJORN BAKKEN |
K003459 |
01/22/2001 |
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K013470 |
11/14/2001 |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
MIKE HUDON |
K013427 |
11/29/2001 |
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
K013199 |
11/28/2001 |
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
K012987 |
11/07/2001 |
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
K003292 |
01/05/2001 |
260 CORVUS |
PIE MEDICAL |
COLLEEN J HITTLE |
K012846 |
11/20/2001 |
ZIPPY, MODEL I88WA |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
K013220 |
11/20/2001 |
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
POLY VUE TECHNOLGIES, INC. |
MARTIN DALSING |
K013068 |
11/20/2001 |
BIOSCANNER 2000 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K013203 |
11/16/2001 |
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K012670 |
11/09/2001 |
BOSS 2000-3 VACUUM ERECTION DEVICE |
POS-T-VAC, INC. |
DENNIS L BELL |
K012672 |
11/09/2001 |
BOSS-2000-2 VACUUM ERECTION DEVICE |
POS-T-VAC, INC. |
DENNIS L BELL |
K003284 |
01/17/2001 |
PHLEBOPUMP, MODEL 1000 |
PREVENT PRODUCTS, INC. |
CAROL A GARCIA |
K012794 |
11/05/2001 |
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
K012761 |
11/01/2001 |
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
K991618 |
01/24/2001 |
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR |
PROPPER MFG. CO., INC. |
JOHN D DYCKMAN |
K011933 |
11/02/2001 |
GLYCOSAL II HBA 1C TEST |
PROVALIS DIAGNOSTICS LTD. |
THOMAS M TSAKERIS |
K010868 |
11/06/2001 |
PSYCHEMEDICS RIA COCAINE ASSAY |
PSYCHEMEDICS CORP. |
THOMAS CAIRNS |
K012498 |
11/01/2001 |
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM |
PULSE METRIC, INC. |
ROBERT DUFFY |
K003904 |
01/24/2001 |
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES |
PURNABINA SDN BHD |
LIEW YOON FONG |
K003576 |
01/25/2001 |
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 |
QUINTON, INC. |
DAVID HIMES |
K003874 |
01/12/2001 |
CBC-4K HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
KENNETH EDDS |
K003991 |
01/16/2001 |
CD-CAL PLUS CALIBRATOR |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
K002067 |
01/11/2001 |
RADIANALYZER, MODEL 12710 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K012850 |
11/19/2001 |
RECORDING AND STIMULATING ELECTRODE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
K013711 |
11/26/2001 |
BACTI-SWAB DRY |
REMEL CO. |
ROBERT E BOOTH |
K003164 |
01/08/2001 |
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K010060 |
01/23/2001 |
RITA STARBURST XLI ELECTROSURGICAL DEVICE |
RITA MEDICAL SYSTEMS |
ERIN MAZZONE |
K003426 |
01/23/2001 |
ALGINATE IMPRESSION MATERIAL |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K003427 |
01/24/2001 |
ZINC PHOSPHATE CEMENT |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K003745 |
01/16/2001 |
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET |
RLN SYSTEMS, INC. |
J. LEE REA |
K003967 |
01/12/2001 |
CA 125 II CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K003969 |
01/12/2001 |
ELECSYS CA 125 II CALSET |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K003174 |
01/17/2001 |
ELECSYS DHEA-S |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K003409 |
01/26/2001 |
ELECSYS FSH CALSET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K003941 |
01/25/2001 |
ELECSYS HCG STAT CLASET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K011684 |
11/30/2001 |
INFLUENZA A/B RAPID TEST, CAT NO 2158 663 |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
K013373 |
11/02/2001 |
OMNI C ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBETT |
K012396 |
11/05/2001 |
ONTRAK TESTCARD 9 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
K013278 |
11/15/2001 |
TINA-QUANT APOLIPOPROTEIN A-1 VER.2 |
ROCHE DIAGNOSTICS CORP. |
HELEN TORNEY |
K013206 |
11/16/2001 |
TINA-QUANT APOLIPOPROTEIN B VER.2 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K013207 |
11/13/2001 |
TINA-QUANT APOLIPOPROTEIN B VER.2 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K013249 |
11/16/2001 |
TINA-QUANT APOLIPOPROTEIN VER.2 |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
K012361 |
11/29/2001 |
TINA-QUANT COMPLEMENT C3C TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
K012359 |
11/29/2001 |
TINA-QUANT COMPLEMENT C4 TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
K011122 |
11/16/2001 |
BALLPEN SPINAL NEEDLE W/WO INTRODUCER |
RUSCH INTL. |
JULIE A BEAUMONT |
K010596 |
11/21/2001 |
RUSCH BRONCHUS BLOCKER KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
K011121 |
11/16/2001 |
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS |
RUSCH INTL. |
JULIE A BEAUMONT |
K013266 |
11/27/2001 |
RUSCH POLYFLEX STENT KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
K012767 |
11/01/2001 |
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL |
S & C POLYMER GMBH |
CHRISTIAN BOTTCHER |
K013440 |
11/16/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
K013444 |
11/16/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
K003484 |
01/19/2001 |
NETRA WORKSTATION AND NETRAMD SOFTWARE |
SCIMAGE, INC. |
MICHAEL PETER |
K012552 |
11/05/2001 |
SCITON IMAGE HAIR REMOVAL LASER |
SCITON, INC. |
PETER N ALLEN |
K012546 |
11/02/2001 |
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM |
SEDECAL USA, INC. |
DANIEL KAMM |
K003934 |
01/26/2001 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
SELTOM PACIFIC SDN. BHD. |
S. SEAGARAN |
K012819 |
11/16/2001 |
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 |
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
JAY MANSOUR |
K012115 |
11/30/2001 |
SERIM BLOOD LEAK TEST STRIP-2 |
SERIM RESEARCH CORP. |
PATRICA RUPCHOCK |
K003675 |
01/09/2001 |
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES |
SHANGHAI CHINASTAR CORP. |
LEE HUNG TE CHE |
K013261 |
11/29/2001 |
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
TONY T K CHENG |
K003392 |
01/25/2001 |
CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 |
SHL TELEMEDICINE INTERNATIONAL LTD. |
ALROY IRIT |
K011473 |
11/16/2001 |
SNAZZY2 |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
K003628 |
01/23/2001 |
MAGNETOM RHAPSODY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
K013522 |
11/07/2001 |
SOMATOM P30 CT SYSTEMS |
SIEMENS MEDICAL SYSTEMS, INC. |
PRAVEEN NADKARNI |
K013544 |
11/15/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
K013545 |
11/15/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
K013696 |
11/28/2001 |
SILMED NASAL SEPTAL BUTTON |
SILMED, INC. |
RAMA GUNDLAPALLI |
K012517 |
11/01/2001 |
CEREC3 VITABLOCKS |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
K013306 |
11/02/2001 |
MINIME NASAL MASK, MODEL P/N 50220 |
SLEEPNET CORPORATION |
PAUL R CHIESA |
K012853 |
11/16/2001 |
SMART GLOVE STERILE NITRILE EXAM GLOVE |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
K012856 |
11/16/2001 |
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K011985 |
11/02/2001 |
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT |
SMITH & NEPHEW, INC. |
TIM CRABTREE |
K012724 |
11/08/2001 |
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K003358 |
01/19/2001 |
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) |
SMV AMERICA |
PAULA MCLEAN |
K013469 |
11/20/2001 |
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
K013467 |
11/20/2001 |
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
K003990 |
01/24/2001 |
SOFRADIM PARIETEX SURGICAL MESHES |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
K011487 |
11/21/2001 |
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS |
SOMANETICS CORP. |
RONALD A WIDMAN |
K013170 |
11/13/2001 |
SCANTAC MEMBRANE OR SCANTAC STRIP |
SONOTECH, INC. |
MARGARET J LARSON |
K012753 |
11/13/2001 |
SORING GMBH SONOCA 180/190 |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
K013394 |
11/08/2001 |
LIFTLOC SAFETY INFUSION SET |
SPECIALIZED HEALTH PRODUCTS, INC. |
Mark Nelson |
K003351 |
01/24/2001 |
PARSFIX CABLE-SCREW SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
K012881 |
11/26/2001 |
C3 ANTERIOR CERVICAL PLATE SYSTEM |
SPINE VISION, INC |
DAVID W MULLIS, JR |
K001528 |
01/18/2001 |
PC FLOW + |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
JAMES R VEALE |
K003367 |
01/04/2001 |
ORION PLATINUM |
SRS MEDICAL SYSTEMS, INC. |
LEE BRODY |
K003127 |
01/04/2001 |
REGAIN DESKTOP |
SRS MEDICAL SYSTEMS, INC. |
LEE BRODY |
K012880 |
11/16/2001 |
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) |
SSN GLOVES (M) SDN BHD |
CLINTON A TECK LEONG |
K012896 |
11/16/2001 |
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) |
SSN GLOVES (M) SDN BHD |
CLINTON A TECK LEONG |
K003729 |
01/03/2001 |
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), |
ST. JUDE MEDICAL |
ANGELA BYLAND |
K013548 |
11/09/2001 |
STANDARD IMAGING IVB 1000 WELL CHAMBER |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
K012578 |
11/07/2001 |
REPROCESSED ENDOSCOPIC TROCAR |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K012571 |
11/07/2001 |
REPROCESSED HARMONIC |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K012598 |
11/07/2001 |
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS |
STERILMED, INC. |
PATRICK F FLEISCHHACKER |
K012682 |
11/08/2001 |
REPROCESSED LASER PROBE |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K012579 |
11/08/2001 |
REPROCESSED PHACO TIPS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K012536 |
11/02/2001 |
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K012679 |
11/08/2001 |
REPROCESSED RF ARTHROSCOPY PROBES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
K003577 |
01/29/2001 |
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT |
STERIS Corporation |
RAYMOND URSICK |
K011788 |
11/05/2001 |
EVERSTICK |
STICK TECH LTD. |
WILLIAM M TROETEL |
K011799 |
11/05/2001 |
EVERSTICKNET |
STICK TECH LTD. |
WILLIAM M TROETEL |
K003333 |
01/04/2001 |
STICK |
STICK TECH LTD. |
WILLIAM M TROETEL |
K003334 |
01/08/2001 |
STICK NET |
STICK TECH LTD. |
WILLIAM M TROETEL |
K001961 |
01/25/2001 |
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE |
STOECKERT INSTRUMENTE |
LYNNE LEONARD |
K002273 |
01/29/2001 |
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE |
STOECKERT INSTRUMENTE |
BARBARA WATSON |
K013316 |
11/06/2001 |
SICKLE-CHEX |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
K002652 |
01/26/2001 |
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII |
STRYKER CORP. |
SUZANNE VELAZQUEZ |
K012991 |
11/29/2001 |
NEPTUNE WASTE MANAGEMENT STSTEM |
STRYKER INSTRUMENTS |
SUZANNE VELAZQUEZ |
K003111 |
01/04/2001 |
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES |
STRYKER INSTRUMENTS |
NICOLE PETTY |
K004027 |
01/24/2001 |
STRYKER REMOTE SURGICAL PLANNING SYSTEM |
STRYKER INSTRUMENTS |
NICOLE PETTY |
K010073 |
01/19/2001 |
SPLINE DENTAL IMPLANT SYSTEM |
SULZER CALCITEK, INC. |
FOSTER BOOP |
K002007 |
01/25/2001 |
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS |
SULZER CARBOMEDICS, INC. |
LISA O'CONNER |
K013227 |
11/19/2001 |
SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT |
SULZER DENTAL, INC. |
FOSTER BOOP |
K012739 |
11/14/2001 |
CONVERGE ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K003832 |
01/04/2001 |
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K003269 |
01/04/2001 |
UNICONDYLAR INTERPOSITIONAL SPACER |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K003422 |
01/19/2001 |
EDTA ROOT CANAL CLEANSER |
SUPER GLIDE, INC. |
VICTOR L RATKUS |
K001678 |
01/25/2001 |
PVA FOAM EMBOLIZATION PARTICLES |
SURGICA CORP. |
LOU MATSON |
K011195 |
11/06/2001 |
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HAAR |
K003748 |
01/26/2001 |
TIANXIE |
SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. |
HENRY WOO |
K001896 |
01/08/2001 |
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC |
SUZUKEN CO., LTD. |
CAROLANN KOTULA |
K003658 |
01/04/2001 |
TEMP-BOND NE 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K002932 |
01/04/2001 |
PHACOGARD |
SYNTEC, INC. |
JIM EASLEY |
K003393 |
01/17/2001 |
MAXILLARY DISTRACTOR |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K000560 |
01/09/2001 |
SYNTHES (USA) RESORBABLE TACK SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
K003341 |
01/22/2001 |
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS |
SYVA CO., DADE BEHRING, INC. |
PAUL L ROGER |
K003375 |
01/28/2001 |
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX |
TECNILATEX S.A. |
JOSE M VAZQUEZ MARTIN |
K013526 |
11/15/2001 |
CAPIOX RX HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K012812 |
11/14/2001 |
CAROTID GUIDING SHEATH |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
K013550 |
11/20/2001 |
CLIRANS E-SERIES DIALYZER |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K012854 |
11/21/2001 |
RENAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
K003313 |
01/11/2001 |
FILAC FAS TEMP ELECTRONIC THERMOMETER |
THE KENDALL COMPANY |
KELLY J ROWLAND |
K003511 |
01/24/2001 |
KENDALL-LTP TURNER SAVE-A-LINE |
THE LUDLOW COMPANY, LP |
KATHLEEN M MURPHY |
K012882 |
11/14/2001 |
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 |
THERMOELASTIC TECHNOLOGIES, INC. |
ART WARD |
K002719 |
01/26/2001 |
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
K013324 |
11/29/2001 |
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
K002863 |
01/04/2001 |
PALFIQUE ESTELITE LV |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K013608 |
11/15/2001 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DIANA THORSON |
K013633 |
11/13/2001 |
SSA-770A, APLIO ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K003583 |
01/17/2001 |
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 |
TRACE AMERICA, INC. |
THOMAS DOLLAR |
K013368 |
11/20/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K013195 |
11/07/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K012921 |
11/02/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K013075 |
11/26/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K012818 |
11/20/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX |
TRIAGE MEDICAL INC |
GREG H HOLLAND |
K012817 |
11/20/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED |
TRIAGE MEDICAL INC |
GREG HOLLAND |
K011709 |
11/08/2001 |
UNI-GOLD STREP A TEST KIT |
TRINITY BIOTECH, PLC |
FIONA CAMPBELL |
K012070 |
11/27/2001 |
ORALLITE COMPREHENSIVE EXAM TRAY |
TRYLON CORP. |
MARTIN L LONKY |
K003479 |
01/18/2001 |
U-SYSTEMS ULTRASOUND SYSTEM USI-2000 |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
K003457 |
01/09/2001 |
UNIGRAFT |
UNICARE BIOMEDICAL |
STAN YANG |
K013372 |
11/09/2001 |
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST |
UNIPATH LTD. |
STEVEN H ARMSTRONG |
K003237 |
01/10/2001 |
U2 HIP STEM, TI POROUS COATED |
UNITED ORTHOPEDIC CORP. |
MELLEN LIU |
K002791 |
01/29/2001 |
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM |
UNIX ELECTRONIC CO. LTD. |
GUENTER GINSBERG |
K003753 |
01/04/2001 |
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE |
URESIL CORP. |
CHARLES P GILL |
K012620 |
11/09/2001 |
SE-200 |
V.T.S.,INC. |
DENNIS L BELL |
K012619 |
11/09/2001 |
VT-1 |
V.T.S.,INC. |
DENNIS L BELL |
K012700 |
11/07/2001 |
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
K012698 |
11/09/2001 |
VANGUARD REPROCESSED PHACOEMULSIFICATION |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
K012544 |
11/15/2001 |
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM |
VASCULAR ARCHITECTS, INC. |
JEAN M CAILLOUETTE |
K003639 |
01/23/2001 |
VITREA 2 CT PERFUSION OPTION |
VITAL IMAGES, INC. |
ROBERT C SAMEC |
K012662 |
11/09/2001 |
SE-100 VACUUM ERECTION DEVICE |
VTS, INC. |
DENNIS L BELL |
K012639 |
11/09/2001 |
SE-300 VACUUM THERAPY SYSTEM |
VTS, INC. |
DENNIS L BELL |
K013810 |
11/27/2001 |
CARDIOVASCULAR ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACEY D WOLF |
K011175 |
11/01/2001 |
W.O.M. LASER U100 |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
K003342 |
01/22/2001 |
WAKO CRP-UL, CRP-UL CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLOY |
K013557 |
11/16/2001 |
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW |
WALTER LORENZ SURGICAL, INC. |
TRACY J BICKEL |
K003415 |
01/03/2001 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE |
WANG & LI, INC. |
ANN D MCGONIGLE |
K994292 |
01/02/2001 |
WATER PURIFICATION SYSTEM |
WATER & POWER TECHNOLOGIES, INC. |
BARRY PEARCE |
K003396 |
01/11/2001 |
BURN JEL PLUS |
WATER-JEL TECHNOLOGIES, LLC. |
MICHAEL PISANI |
K001543 |
01/29/2001 |
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 |
WELCH ALLYN, INC. |
ZORAN PSENICNIK |
K003376 |
01/25/2001 |
WELCH ALLYN 11800 OPTHALMOSCOPE |
WELCH ALLYN, INC. |
COLIN WOLFF |
K012831 |
11/01/2001 |
BIO PORTADUR, ORDER-NO.:2017 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012826 |
11/01/2001 |
BIOPORTA G, MODEL 2052 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012841 |
11/20/2001 |
DUO PAL 6, ORDER-NO.: 2154 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012827 |
11/01/2001 |
PORTA AURIUM, MODEL 2067 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012834 |
11/01/2001 |
PORTA GEO TI MODEL #2004 |
WIELAND EDELMETALLE GMBH & CO. |
GEHARD POLZER |
K012835 |
11/01/2001 |
PORTA MAXIMUM, MODEL# 2066 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012828 |
11/01/2001 |
PORTA SMK 82, MODEL 2032 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
K012843 |
11/02/2001 |
PORTADUR P 2, MODEL #2031 |
WIELAND EDELMETALLE GMBH & CO. |
GEHARD POLZER |
K013101 |
11/16/2001 |
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K013102 |
11/13/2001 |
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K013145 |
11/27/2001 |
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K013097 |
11/13/2001 |
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K013095 |
11/16/2001 |
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K012326 |
11/08/2001 |
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K011561 |
11/20/2001 |
SEREINE EXTRA STRENGTH DAILY CLEANER |
WILSA, INC. |
SALLY COOK |
K012591 |
11/02/2001 |
ADVANCE UNICONDYLAR KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K010072 |
01/26/2001 |
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE W CHOW |
K003653 |
01/26/2001 |
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K002269 |
01/04/2001 |
ELECTROSURGICAL PROBES AND DEVICES-GELTX |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
K002603 |
01/08/2001 |
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER |
ZCV ,INC. |
JING ZHANG |
K012147 |
11/02/2001 |
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE |
ZEVEX, INC. |
SUSAN P SCHMIDT |
K001775 |
01/12/2001 |
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM |
ZOE MEDICAL, INC. |
PAUL M FITZMEYER |