FDA 510(k) Applications Received During July, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K012290 07/20/2001 RAPIDIA 3D MED CO., LTD. CYNTHIA J.M. NOLTE
K012281 07/20/2001 TRS-2000 POWER TILT/POWER RECLINE SYSTEM ACCELERATED REHAB DESIGNS, INC. RANDALL POTTER
K012106 07/06/2001 ACCUIMAGE SMARTGATE UPGRADE ACCUIMAGE DIAGNOSTICS CORP. GARY J ALLSEBROOK
K012300 07/20/2001 ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K012215 07/16/2001 QUIK-CHECK HOME PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K012252 07/18/2001 QUIK-CHECK OVULATION PREDICTOR ACON LABORATORIES, INC. FRAN WHITE
K012116 07/06/2001 ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING ACRYMED, INC. BRUCE GIBBINS
K012168 07/12/2001 ADVANCE MEDICAL DESIGNS FLUID POUCH ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K012190 07/13/2001 AOS MODULAR FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. GARY SOHNGEN
K012201 07/13/2001 PREMICRON NONABSORBABLE PET SURGICAL SUTURE AESCULAP, INC. STEVE REITZLER
K012219 07/16/2001 SCALPFIX CLIP SYSTEM AESCULAP, INC. LISA M MILLINGTON
K012093 07/05/2001 AETMED IMAGE PROCESSING SOFTWARE AETMED, S.P.A. COLLEEN HITTLE
K012094 07/05/2001 MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K012383 07/27/2001 GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K012335 07/24/2001 BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K012149 07/10/2001 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K012253 07/18/2001 SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. KELVIN BURROUGHS
K012080 07/03/2001 SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. KELVIN BURROUGHS
K012164 07/11/2001 'RAPIDONE'-METHADONE TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K012213 07/16/2001 GULLIVER AND CLASSE A AMERICAN DENTAL TECHNOLOGIES, INC. JOHN VICKERS
K012127 07/09/2001 PULSEMASTER ERBIUM DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. SHEILA HEMEON-HEYER
K012304 07/20/2001 ADC 656 ELECTRONIC STETHOSCOPE AMERICAN DIAGNOSTIC CORP. MARC BLITSTEIN
K012386 07/27/2001 ACTICLOT PROTEIN S, MODEL 843L AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K012342 07/24/2001 AMS SOFT-TISSUE APPROXIMATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K012189 07/12/2001 ANGELTOUCH VENTED IV ADMINISTRATION SET ANGIPLAST PRIVATE LTD. ASHIT B SHAH
K012140 07/10/2001 COM-PATCH APEX MEDICAL CORP. ALAN CHANG
K012429 07/31/2001 SURESET INFUSION SET, MODEL 8023 APPLIED DIABETES RESEARCH, INCORPORATED CHARLES H KYPER
K012103 07/05/2001 BANDVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD. SHOSHANA FRIEDMAN
K012374 07/26/2001 MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE R MANNING
K012369 07/26/2001 BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 ATYS MEDICAL CHRISTINE TURLAT
K012154 07/11/2001 AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE AURORA IMAGING TECHNOLOGY, INC. JAMES J ROGERS
K012136 07/09/2001 AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER AVITA CORPORATION ALLEN REICH
K012299 07/20/2001 MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K012435 07/31/2001 ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 BAUSCH & LOMB, INC. VANADA JOHNSON
K012337 07/24/2001 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP. KENNETH T EDDS
K012340 07/24/2001 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) BAYER CORP. KENNETH T EDDS
K012205 07/16/2001 GLUCOMETER DEX TEST SENSOR BAYER CORP. GEORGE M TANCOS
K012183 07/12/2001 BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY BAYER DIAGNOSTICS CORP. BARBARA PREISEL-SIMMONS
K012357 07/25/2001 CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K012208 07/16/2001 ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 BECKMAN COULTER, INC. DENISE THOMPSON
K012351 07/25/2001 BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY BECTON DICKINSON & CO. COLLEEN A ROHRBECK
K012104 07/05/2001 "SNOW LOTUS" POWDER-FREE LATEX SURGEON'S GLOVES BEIJING REAGENT LATEX PRODUCTS CO., LTD. WANG YANNAN
K012166 07/11/2001 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) BEST MANUFACTURING COMPANY DAVID C YOUNG
K012084 07/03/2001 SONOREAL 3D BIO MEDI COM COLLEEN HITTLE
K012384 07/27/2001 EAR MUFFINS BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K012348 07/24/2001 MAXIM RPG PS FEMORAL COMPONENT BIOMET, INC. MICHELLE MCKINLEY
K012431 07/31/2001 COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 BIONOSTICS, INC. KATHY STORRO
K012430 07/31/2001 MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 BIONOSTICS, INC. KATHY STORRO
K012334 07/24/2001 CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 BIONX IMPLANTS, INC. TUIJA ANNALA
K012221 07/16/2001 SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K012180 07/12/2001 A-WEAR BISCO, INC. STEVEN J DURAY
K012184 07/12/2001 BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K012365 07/26/2001 VAXCEL DIALYSIS CATHETER BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K012216 07/16/2001 NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC SCIMED, INC. CANDICE BURNS
K012113 07/06/2001 INDWELLING FECAL MANAGEMENT SYSTEM BOWEL MANAGEMENT SYSTEMS, LLC COLLEEN J HITTLE
K012345 07/24/2001 NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR BROMAC ASSISTIVE TECHNOLOGY DAVID K BROWN
K012206 07/13/2001 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K012132 07/09/2001 CHROMAGEN V3.0 READING AID SOFT CONTACT LENS CANTOR & NISSEL LTD. MARTIN DALSING
K012223 07/16/2001 CG-2211 SELFCHECK ECG TRANSMITTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K012187 07/12/2001 CG-3250 MINIRECEIVER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K012197 07/13/2001 POWERHEART CARDIAC RHYTHM MODULE CARDIAC SCIENCE, INC. SEW-WAH TAY
K012241 07/17/2001 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 CARDIONET, INC DONALD V CANAL
K012325 07/23/2001 CARDIOVENTION CORX SYSTEM, MODEL FG 0001 CARDIOVENTION, INC. TESSA YAMUT
K012126 07/06/2001 THE SALICEPT ORAL PATCH CARRINGTON LABORATORIES, INC. KENNETH M YATES
K012089 07/05/2001 CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM CATHEFFECTS, LLC. SHAWN FOJTIK
K012298 07/20/2001 THE INTUITIVE COLORIMETER CERIUM OPTICAL TECHNOLOGIES, INC. SOL AISENBERG
K012248 07/17/2001 CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE JERNON
K012138 07/10/2001 MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) CHROMAVISION MEDICAL SYSTEMS, INC. DAVID DAVIS
K012157 07/11/2001 CHURCHILL MEDICAL SYSTEMS STOPCOCK CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K012214 07/16/2001 CRYOPEN AND ACCESSORIES CIMEX BIOTECH, LLC. MICHAEL HAAS
K012153 07/11/2001 LOWSLEY SUPRAPUBIC TRACTOR CIRCON VIDEO WAYNE B STGRNER
K012265 07/19/2001 METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 CIRCON VIDEO WAYNE B STERNER
K012203 07/13/2001 CLAY-PARK LABS, INC. - LUBRICATING JELLY CLAY-PARK LABS, INC. GARY L YINGLING
K012317 07/23/2001 COALESCENT SURGICAL U-CLIP COALESCENT SURGICAL MICHAEL A DANIEL
K012087 07/03/2001 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS CORP. CHUCK RYAN
K012056 07/02/2001 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM CORDIS EUROPA N.V. CHUCK RYAN
K012090 07/05/2001 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS, A JOHNSON & JOHNSON CO. CHARLES J RYAN
K012377 07/26/2001 OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES CORIN U.S.A. JOEL BATTS
K012059 07/02/2001 8100/8500 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K012327 07/23/2001 CSIST DICOM GATEWAY/IMAGE MANAGER CSIST CARL ALLETO
K012282 07/20/2001 STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE CYPRESS MEDICAL PRODUCTS, LTD. ANTONIO L GIACCIO
K012233 07/16/2001 STRATUS CS TROPONIN I CALIBRATOR DADE BEHRING, INC. ELAINE H KINDELL
K012195 07/13/2001 STEAM STERILIZATION INTERGRATOR DANA PRODUCTS, INC. HARRY BALA
K012354 07/25/2001 SNOWPOST, SNOWLIGHT DANVILLE MATERIALS, INC. CRAIG R BRUNS
K012235 07/17/2001 DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMEDICAL, INC. BONNIE B VIVIAN
K012364 07/26/2001 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K012328 07/23/2001 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER DI-CHEM, INC. KEITH A BUCHHOLZ
K012301 07/20/2001 IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012311 07/23/2001 IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012312 07/23/2001 IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012077 07/02/2001 IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012075 07/02/2001 IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012053 07/02/2001 DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012398 07/27/2001 DIOMED 15 DIODE LASER DIOMED, LTD. MAUREEN O'CONNELL
K012307 07/23/2001 LUXACORE/LUXACORE DUAL DMG USA, INC. PAMELA PAPINEAU
K012316 07/23/2001 PERMACEM / PERMACEM DUAL DMG USA, INC. PAMELA PAPINEAU
K012139 07/10/2001 VAMOS ANESTHETIC GAS MONITOR DRAEGER MEDICAL, INC. JAMES J BRENNAN
K012177 07/12/2001 VENTVIEW, MODEL 8414095 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K012152 07/11/2001 DS30 HCY BLOOD COLLECTION TUBES DREW SCIENTIFIC LTD. ANDREW KENNEY
K012390 07/27/2001 NO STEP ON SITE DEUG TEST CUP DRUG FREE ENTERPRISES PERRY RUCKER
K012155 07/11/2001 KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS EASTMAN KODAK COMPANY ANNE ZAVERTNIK
K012423 07/30/2001 MUCOGRAFT ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K012211 07/16/2001 EFILM WORKSTATION EFILM MEDICAL, INC. KATHY CHIN
K012079 07/03/2001 GEODESIC EEG SYSTEM, MODEL 200 ELECTRICAL GEODESICS, INCORPORATED ROBERT S MCQUATE
K012289 07/20/2001 MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) ELEKTA ONCOLOGY SYSTEMS, LTD. PETER STEGAGNO
K012175 07/12/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K012333 07/24/2001 FLEXI-SITE SP02 EAR SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K012128 07/09/2001 PROTECTIV ACUVANCE IV CATHETER SYSTEM ETHICON ENDO-SURGERY, INC. KATIE FORDYCE
K012176 07/12/2001 ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 ETHICON ENDO-SURGERY, INC. RUTH A WOOD
K012306 07/23/2001 AUDIOSCAN VERIFIT, MODEL VF-1 ETYMONIC DESIGN, INC. WILLIAM A COLE
K012251 07/18/2001 OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES EXACTECH, INC. ROBERT PAXSON
K012141 07/10/2001 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB AHAVA STEIN
K012230 07/16/2001 PHEM-ALERT FEMTEK,LLC. JOEL S FADEN
K012373 07/26/2001 LIFERAY WL CASSETTE, LIFERAY KW CASSETTE FERRANIA S.P.A. MANNELA PAOLO
K012161 07/11/2001 FLEX-NAILS FIXANO SA FRANK FERGUSON
K012062 07/02/2001 PF2 FIXANO SA FRANK FERGUSON
K012078 07/02/2001 RADIOFIX FIXANO SA FRANK FERGUSON
K012178 07/12/2001 FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW FRESENIUS HEMOTECHNOLOGY, INC. TOM TROTTER
K012242 07/17/2001 FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K012134 07/09/2001 GC E-LIGHT GC AMERICA, INC. TERRY L JORITZ
K012200 07/13/2001 1.5T INFINITY TWINSPEED MR SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K012313 07/23/2001 CT COLONOGRAPHY/NAVIGATOR2 GE MEDICAL SYSTEMS, INC. LARRY KROGER
K012385 07/27/2001 HISPEED X/I SMART GANTRY OPTION GE MEDICAL SYSTEMS, INC. JOHN W JAECKLE
K012389 07/27/2001 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS, INC. JODI PARKER
K012411 07/30/2001 HP-ONE GI SUPPLY FRANK CARTER
K012198 07/13/2001 GIBBONS STERILE TROCAR KITS GIBBONS SURGICAL CORP. LISA CRISSON
K012258 07/18/2001 COMPANION MODEL 221, 321, 421 GOLDEN TECHNOLOGIES, INC. FRED KIWAK
K012050 07/02/2001 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER GUIDANT CORP. SABA MODJARRAD
K012310 07/23/2001 MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SUSAN CHEN
K012250 07/17/2001 RAICHEM MULTI-ANALYTE CALIBRATOR HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K012243 07/17/2001 MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL HEMATRONIX, INC. JAMES S AFRANKO
K012341 07/24/2001 TRANSLUX ENERGY HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K012239 07/17/2001 MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM HITACHI MEDICAL CORP. WALTER WEYBURNE
K012172 07/12/2001 DURACON PS LIPPED TIBIAL INSERT HOWMEDICA OSTEONICS MARY-CATHERINE DILLON
K012158 07/11/2001 MODIFICATION TO: LONG LENGTH GAMMA NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012162 07/11/2001 STRYKER PLATING SYSTEM BASIC FRAGMENT SET HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012060 07/02/2001 MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT HU-FRIEDY MFG. CO.,INC. KEITH DUNN
K012199 07/13/2001 DIGICAP HUMANA USA, INC. H.N. DUNNING
K012417 07/30/2001 HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012366 07/26/2001 NAVIGUS II TRAJECTORY GUIDE IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K012349 07/24/2001 METAVISION CLINICAL INFORMATION SYSTEM IMDSOFT, LTD. T. WHIT ATHEY
K012419 07/30/2001 CONFORM SHEETING, MODEL IGEL IMPLANTECH ASSOCIATES, INC. STEPHEN MEADE
K012095 07/05/2001 THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) IMPLEX CORP. ROBERT A POGGIE
K012271 07/19/2001 ACUTEVENTILATOR IMPOEX INTERNATIONAL, LTD. SIVERT CLAESSON
K012406 07/30/2001 ACCESS SEQUESTRATION SYSTEM INTERPORE CROSS INTL. PROISE REY-FESSLER
K012169 07/12/2001 ILT SUPPORT CATHETER .014", MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K012167 07/12/2001 MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR INVACARE CORP. RAE ANN FARROW
K012370 07/26/2001 SOLARA JR. MANUAL WHEELCHAIR INVACARE CORP. RAE ANN FARROW
K012358 07/25/2001 CHIBA NEEDLE ISPG, INC. LORETTA F LUHMAN
K012174 07/12/2001 ERIS LAYERING MATERIALS IVOCLAR NORTH AMERICA, INC. DONNA M HARTNETT
K012303 07/20/2001 JEL-20 J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K012332 07/23/2001 JAS CARBON DIOXIDE LIQUID REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K012231 07/16/2001 AVANTE MICRO CRYSTAL SYSTEM JENERIC/PENTRON, INC. ANNMARIE TENERO
K012124 07/06/2001 MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP JOHNSON & JOHNSON MEDICAL (CHINA) LTD. BEN TANG
K012422 07/30/2001 K-ASSAY D-DIMER CONTROLS KAMIYA BIOMEDICAL CO. DON TRAN
K012404 07/30/2001 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 KATECHO, INC. WARREN R WALTERS
K012308 07/23/2001 KAVO QUATTROCARE KAVO AMERICA JOHN WESTERMEIER
K012236 07/17/2001 STARS2000 POWER CANNULA KMI KOLSTER METHODS, INC. ALWIN H KOLSTER
K012436 07/31/2001 MODIFICATION TO ALLOY PRIMER KURARAY MEDICAL INC. MASAYA SASAKI
K012440 07/31/2001 MODIFICATION TO CLEARFIL LINER BOND 2V KURARAY MEDICAL INC. MASAYA SASAKI
K012432 07/31/2001 MODIFICATION TO CLEARFIL PHOTO BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012442 07/31/2001 MODIFICATION TO CLEARFIL SE BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012438 07/31/2001 MODIFICATION TO PANAVIA 21 KURARAY MEDICAL INC. MASAYA SASAKI
K012441 07/31/2001 PANAVIA F KURARAY MEDICAL INC. MASAYA SASAKI
K012275 07/19/2001 PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP LIMERICK, INC. PATRICIA KELLY
K012320 07/23/2001 POWERPRO BATTERY SYSTEM LINVATEC CORP. LAURA D SENEFF
K012413 07/30/2001 MACROPORE FX, PS, NS, LP MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K012117 07/06/2001 VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 MAINE STANDARDS CO. CHRISTINE BEACH
K012118 07/06/2001 VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 MAINE STANDARDS CO. CHRISTINE BEACH
K012119 07/06/2001 VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 MAINE STANDARDS CO. CHRISTINE BEACH
K012120 07/06/2001 VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 MAINE STANDARDS CO. CHRISTINE V BEACH
K012122 07/06/2001 VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 MAINE STANDARDS CO. CHRISTINE V BEACH
K012186 07/12/2001 MASTER & FRANK SURGICAL GOWNS (STERILE) MASTER & FRANK ENT. CO., LTD. JENNIFER REICH
K012336 07/24/2001 MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 MEDICAL DATA ELECTRONICS GREGORY R ALKIRE
K012352 07/25/2001 SQA, SPERM QUALITY ANALYZER MEDICAL ELECTRONIC SYSTEMS, LLC ERIKA B AMMIRATI
K012276 07/19/2001 TEMP 3 MEDICAL SOLUTIONS, INC. BRUCE HEYMANN
K012217 07/16/2001 M5T INSTANT FEVER THERMOMETER MEDISIM LTD. SHOSHANA FRIEDMAN
K012143 07/10/2001 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 MEDTRONIC CARDIAC SURGICAL PRODUCTS MELISSA HARRIGER
K012274 07/19/2001 MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K012428 07/31/2001 MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K012052 07/02/2001 MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 MEDTRONIC PS MEDICAL JEFF HENDERSON
K012081 07/03/2001 DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K012255 07/18/2001 MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K012225 07/16/2001 ATTAIN 6215 VENOGRAM BALLOON CATHETER MEDTRONIC VASCULAR KAREN REIDT
K012083 07/03/2001 ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 MEDTRONIC VASCULAR KAREN REIDT
K012130 07/09/2001 ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM MEDTRONIC VASCULAR KAREN REIDT
K012240 07/17/2001 MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE MERCAN AB JEFFREY O STULL
K012237 07/17/2001 MERTEX-PLUS REUSABLE SURGICAL DRAPE MERCAN AB JEFFERY O STULL
K012414 07/30/2001 PRIME ECG SYSTEM MERIDIAN MEDICAL TECHNOLOGIES, INC. JAMIL F LAHAM
K012110 07/06/2001 DRI ECSTASY ENZYME IMMUNOASSAY MICROGENICS CORP. SHERRIE RINNE
K012109 07/06/2001 DRI ECSTASY URINE CALIBRATORS MICROGENICS CORP. SHERRIE RINNE
K012145 07/10/2001 MICROPLEX COIL SYSTEM MICROVENTION, INC. VINCENT CUTARELLI
K012294 07/20/2001 WRISTORE FIXATOR MILLENNIUM MEDICAL TECHNOLOGIES, INC. DAVID W SCHLERF
K012353 07/25/2001 HNC-127 NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K012088 07/03/2001 NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT NASTECH PHARMACEUTICAL COMPANY, INC. PETER C APRILE
K012262 07/18/2001 BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012263 07/18/2001 MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012264 07/18/2001 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012259 07/18/2001 MEDFUSION 2001 & 2010, MODEL N7215IWC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012229 07/16/2001 SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012266 07/18/2001 SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012069 07/02/2001 MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT NEUROTRON MEDICAL, INC. WHITT ATHEY
K012367 07/26/2001 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K012123 07/06/2001 NIDOIL NIDACON INTERNATIONAL AB DANIEL KAMM
K012416 07/30/2001 CONFOSCAN 2 CONFOCAL MICROSCOPE NIDEK TECHNOLOGIES SRL CAROL PATTERSON
K012194 07/13/2001 BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 NIHON SEIMITSU SOKKI CO., LTD.
K012058 07/02/2001 STAT PROFILE PHOX PLUS L ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K012165 07/11/2001 OLDELFT THORASCAN MODEL NUMBER 180T NUCLETRON CORP. LISA DIMMICK
K012096 07/05/2001 DISPOSABLE VITRECTOMY LENS OCULAR INSTRUMENTS, INC. RAYMOND GRAHAM
K012425 07/30/2001 BIOMEDICS UV MULTIFOCAL OCULAR SCIENCES PUERTO RICO, INC. RICHARD LIPPMAN
K012402 07/27/2001 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. WILLIAM E PATTON
K012227 07/16/2001 MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 ONCOLOGY DATA SYSTEMS, INC. GREGORY G MILLER
K013110 07/11/2001 ANISEIKONIA INSPECTOR OPTICAL DIAGNOSTICS, INC. JOYCE DE WIT
K012125 07/06/2001 OPUS MAGNUM ANCHOR & INSERTER OPUS MEDICAL, INC. MARK RITCHART
K012395 07/27/2001 MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K012391 07/27/2001 MAC-LINE CO2 NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K012394 07/27/2001 ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K012129 07/09/2001 ORTHO DEVELOPMENT ORION-I EMF SYSTEM ORTHO DEVELOPMENT CORP. CAROL FREASIER
K012254 07/18/2001 VBR OSTEOTECH, INC. KIM THURMAN
K012392 07/27/2001 DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 PACE MEDICAL ROBERT C MACE
K012407 07/30/2001 PACEART TX3 CARDIAC EVENT RECORDER PACEART, INC. GEORGE MYERS
K012133 07/09/2001 LIVESURE BARBITURATES SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K012131 07/09/2001 LIVESURE BENZODIAZEPINES SCREEN TESTS PAN PROBE BIOTECH, INC. ALICE H YU
K012107 07/05/2001 LIVESURE PHENECYCLINE (PCP) SCREEN TESTS PAN PROBE BIOTECH, INC. ALICE H YU
K012360 07/25/2001 LC TEMPORARY FILLING PARKELL, INC. NELSON J GENDUSA
K012150 07/10/2001 PATTON ENDO-BAG PATTON MEDICAL CORP. MICHAEL T PATTON
K012279 07/19/2001 PATTON TRIPOL PATTON MEDICAL CORP. MICHAEL T PATTON
K012057 07/02/2001 CASCADE BATH, MODEL 6900 PENNER MANUFACTURING, INC. VICKIE J BRADY
K012061 07/02/2001 SUPERIOR BATH, MODEL 6300 PENNER MANUFACTURING, INC. VICKIE BRADY
K012238 07/17/2001 DOSERIGHT PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. FRANK GIANELLI
K012163 07/11/2001 POLYTITER SYSTEM POLYMEDCO, INC. HELLEN LANDICHO
K012108 07/06/2001 MEDPOR COATED TEAR DRAIN POREX SURGICAL, INC. HOWARD MERCER
K012350 07/25/2001 MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL POREX SURGICAL, INC. HOWARD MERCER
K012142 07/10/2001 THE QUIET SLEEPER PRECISION DENTAL LABORATORIES, INC. SHARON LAMONT
K012160 07/11/2001 COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 PREMIER DENTAL PRODUCTS CO. BARRY HALE
K012439 07/31/2001 DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM RADCO DATA AB DANIEL KAMM
K012315 07/23/2001 LEVEEN ELECTRODE RADIOTHERAPEUTICS CORP. KIRSTEN VALLEY
K012112 07/06/2001 RANDOX DIGITOXIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K012978 07/06/2001 RANDOX GENTAMICIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K012319 07/23/2001 RANDOX HUMAN ASSSAYED DRUG CONTROL RANDOX LABORATORIES, LTD. P. ARMSTRONG
K012318 07/23/2001 RANDOX THERAPEUTIC DRUG CALIBRATOR RANDOX LABORATORIES, LTD. P ARMSTRONG
K012323 07/23/2001 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K012309 07/23/2001 RIWO SYSTEM TRAYS RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K012324 07/23/2001 ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP. MIKE FLIS
K012210 07/16/2001 MODIFICATION TO ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K012399 07/27/2001 MODIFICATION TO ELECSYS FSH II CALSET ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K012287 07/20/2001 MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K012286 07/20/2001 MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K012396 07/27/2001 ONTRAK TESTCARD 9 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K012361 07/25/2001 TINA-QUANT COMPLEMENT C3C TEST SYSTEM ROCHE DIAGNOSTICS CORP. HELEN T TORNEY
K012359 07/25/2001 TINA-QUANT COMPLEMENT C4 TEST SYSTEM ROCHE DIAGNOSTICS CORP. HELEN T TORNEY
K012371 07/26/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K012393 07/27/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K012397 07/27/2001 URISYS 2400 URINE TEST STRIP ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K012121 07/06/2001 SECUREGUARD RETRACTABLE SAFETY SYRINGE SAFEGARD MEDICAL PRODUCTS, INC. MIKE DAYTON
K012283 07/20/2001 SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE SAFEGARD MEDICAL PRODUCTS, INC. PATRICK GRANT, JR.
K012232 07/16/2001 INSIGHT, MODEL S980000 SANDHILL SCIENTIFIC, INC. LEWIS WARD
K012226 07/16/2001 MONITORING SYSTEM,MODEL ARGUS PB-1000 SCHILLER AG MARKUS BUETLER
K012054 07/02/2001 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 SEIN ELECTRONICS CO., LTD. WON. KY KIM
K012085 07/03/2001 SOMNO STAR & SERIES SLEEP SYSTEM SENSORMEDICS CORP. LINDA MURDOCK
K012115 07/06/2001 SERIM BLOOD LEAK TEST STRIP-2 SERIM RESEARCH CORP. PATRICA RUPCHOCK
K012339 07/24/2001 ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K012424 07/30/2001 SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM SHIMADZU CORP. MICHAEL FISHBACK
K012202 07/13/2001 NUMARIS 4VA15A SIEMENS MEDICAL CORP. JAMIE YIEH
K012410 07/30/2001 INFINITY HBA KIT, MODELS 537-A, 537-B SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K012277 07/19/2001 PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE SIMS PORTEX LTD. STEVEN OGILVIE
K012068 07/02/2001 WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S SIMS PORTEX LTD. CLAIRE MULLINS
K012378 07/26/2001 3D HUMERAL HEADS SMITH & NEPHEW, INC. DAVID HENLEY
K012193 07/12/2001 AMC ANTIMICROBIAL PIN/WIRE SLEEVE SMITH & NEPHEW, INC. JEFF F DOERZBACHER
K012314 07/23/2001 DYONICS ELECTROBLADE RESECTOR SMITH & NEPHEW, INC. TIM CRABTREE
K012170 07/12/2001 DIGORA PCT SOREDEX PALODEX GROUP OY KAI LANER
K012427 07/31/2001 PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT SPECIALITES SEPTODONT PETER S REICHERTZ
K012268 07/19/2001 TRIMAX STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K012362 07/25/2001 MODIFICATION TO VASCULAR CLOSURE DEVICE STD MFG., INC. STEPHEN M PALUMBO
K012330 07/23/2001 SIMPLICITY EURO QD INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K012387 07/27/2001 STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM STETHOGRAPHICS, INC. HARVEY KNAUSS
K012270 07/19/2001 STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM STRYKER ENDOSCOPY ALISA MILLER
K012380 07/26/2001 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY STRYKER LEIBINGER ROBIN L ROWE
K012055 07/02/2001 3.25MM SPLINE TWIST IMPLANT SULZER DENTAL, INC. FOSTER BOOP
K012066 07/02/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K012347 07/24/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC. MARCIA R ELLIS
K012173 07/12/2001 DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM SULZER SPINE-TECH KRISTYN M BENSON
K012305 07/23/2001 MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM SULZER SPINE-TECH JANELL A COLLEY
K012437 07/31/2001 DEVILBISS SLEEP RECORDER MODEL # RM60 SUNRISE MEDICAL HHG, INC. JIM FROEHLICH
K012405 07/30/2001 EXTRUDE MODIFIED SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012322 07/23/2001 OPTIBOND 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012082 07/03/2001 OPTIBOND SOLO PLUS ACTIVATOR SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012321 07/23/2001 POINT 4 FLOWABLE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012105 07/05/2001 POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM SYMMETRY MEDICAL, INC. D. DARIN MARTIN
K012415 07/30/2001 AURIS AEP SYNAPSYS, INC. JULIEN CHAUSSY
K012114 07/06/2001 SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM SYNTHES (USA) MATTHEW M HULL
K012372 07/26/2001 SYSMEX UF-50 SYSMEX CORP. CHRIS STUKEL
K012257 07/18/2001 EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 SYVA CO. SUSAN L COLLINS
K012086 07/03/2001 AQUARIUSNET SERVER TERARECON, INC. DAVID W SCHLERF
K012191 07/13/2001 TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES TERATECH CORP. CHARLES F HOTTINGER
K012209 07/16/2001 CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K012355 07/25/2001 IMAGE-X SYSTEM TG GROUP, INC. WAYNE LEBEAU
K012296 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T THE BINDING SITE, LTD. JAY H GELLER
K012291 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA THE BINDING SITE, LTD. JAY GELLER
K012292 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB THE BINDING SITE, LTD. JAY H GELLER
K012295 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T THE BINDING SITE, LTD. JAY H GELLER
K012218 07/16/2001 LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES THE LUDLOW COMPANY LP KATHLEEN M TREMBLAY
K012073 07/02/2001 OLYMPUS SPRAY CATHETER PW-6C-1 THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K012074 07/02/2001 XBO1-824-18/19/20 BIOPSY FORCEPS THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K012278 07/19/2001 THEKEN SMALL CEMENT RESTRICTOR THEKEN SURGICAL,LLC RANDY THEKEN
K012207 07/16/2001 ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K012212 07/16/2001 MODIFICATION TO AEQUALIS SHOULDER SYSTEM TORNIER IRENE GOSSET
K012099 07/05/2001 MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K012151 07/10/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K012379 07/26/2001 PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM TREX ENTERPRISES CORP. PETER J MARTIN
K012280 07/19/2001 TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 TRIAGE MEDICAL INC GREG HOLLAND
K012368 07/26/2001 AEROPEP TRUDELL MEDICAL INTL. TOM HOLBROOK
K012070 07/02/2001 ORALLITE COMPREHENSIVE EXAM TRAY TRYLON CORP. MARTIN L LONKY
K012220 07/16/2001 TAO EMBRYO TRANSFER CATHETER SYSTEM TTJ BIOMEDICAL, LLC. RICHARD JORTBERG
K012067 07/02/2001 CLINCARE LATEX SURGEON'S GLOVE TTK HEALTHCARE LTD. ELI J CARTER
K012196 07/13/2001 ULTRACELL ABSORBENT STICK ULTRACELL MEDICAL TECHNOLOGIES, INC. COLLEEN MARTIN
K012097 07/05/2001 VORTEX ULTRAVISUAL MEDICAL SYSTEMS GARY J ALLSEBROOK
K012144 07/10/2001 CYTOFLEX UNICARE BIOMEDICAL, INC. STAN YANG
K012071 07/02/2001 ENT LASERVISION UNION MEDICAL USA ANNIE VELEZ
K012273 07/19/2001 SPIRAL RADIUS 90-D SST SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER SCHUCK
K012346 07/24/2001 VANGUARD REPROCESSED ARTHROSCOPIC BLADES VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012403 07/30/2001 VANGUARD REPROCESSED COMPRESSION GARMENT VANGUARD MEDICAL CONCEPTS, INC. MICHAEL SAMMON
K012344 07/24/2001 VANGUARD REPROCESSED PULSE OXIMETER SENSORS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012293 07/20/2001 VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT VASCULAR SOLUTIONS, INC. DEBORAH L JENSEN
K012256 07/18/2001 GELBISH VASCULAR DILATOR VASCUMETRIX, LLC MIKE HAMMONS
K012171 07/12/2001 MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS VISICU, INC. MICHAEL BRESLOW
K012072 07/02/2001 VOXAR VC, MODEL 1.0 VOXAR LIMITED CONRAD CHIN
K012284 07/20/2001 WH ACCU TEST PREGNANCY TEST W.H.P.M., INC. FRAN WHITE
K012098 07/05/2001 PRECLUDE PERICARDIAL MEMBRANE W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
K012409 07/30/2001 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS WALTER LORENZ SURGICAL, INC. SHERYL MALMBERG
K012156 07/11/2001 IMAGINE H.E. WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012065 07/02/2001 WIENER LAB. CREATININA CINETICA AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K012260 07/18/2001 WIENER LAB. UREA UV CINETICA AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K012329 07/23/2001 WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K012326 07/23/2001 WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K012091 07/05/2001 PRO-FEMUR WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K012135 07/09/2001 POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K012147 07/10/2001 DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE ZEVEX, INC. SUSAN P SCHMIDT


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact