FDA 510(k) Decisions During January, 2001  

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. BRUCE F MACKLER
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
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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


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