FDA 510(k) Decisions During October, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K001163 10/23/2000 DMLC IV-ERGO 3D LINE USA, INC. KAREN H RIGAMONTI
K000886 10/05/2000 SPIROL EPIDURAL CATHETER ABBOTT LABORATORIES JILL N SACKETT
K001703 10/03/2000 PERCLOSE VASCULAR SUTURE DELIVERY DEVICE ABBOTT VASCULAR INC. DENISE C SUNGLETON
K002646 10/26/2000 ABX MICROS CRP ABX DIAGNOSTICS BRUCE DAVIS
K002909 10/13/2000 ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 ACRYMED, INC. BRUCE GIBBINS
K003022 10/13/2000 AERONEB PORTABLE NEBULIZER AEROGEN, INC. TRACI V.A. EDWARDS
K002871 10/13/2000 MODIFICATION TO YASARGIL ANEURYSM CLIPS AESCULAP, INC. JOYCE THOMAS
K003107 10/19/2000 M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K002967 10/18/2000 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K001493 10/25/2000 DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 AIR FORCE, INC. PIERO POLICICCHIO
K000963 10/20/2000 DA VINCHI EEG AND EMG/EP SYSTEMS AIRSEP CORP. PETER WEISENBORN
K002589 10/23/2000 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ALCON UNIVERSAL, LTD. MICHAEL E PFLEGER
K001578 10/13/2000 ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K002745 10/12/2000 VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K002746 10/11/2000 VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K003006 10/27/2000 TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION ARROW INTL., INC. THOMAS D NICKEL
K002355 10/10/2000 ATOM INFA WARMER V-505 ATOM MEDICAL CORP. SHEILA HEMEON-HEYER
K994321 10/25/2000 STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP AUTOMATIC LIQUID PACKAGING, INC. JOHN BRDA
K000632 10/19/2000 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE AVITRO LLC. JOHN BRDA
K001795 10/19/2000 THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD AVITRO LLC. JOHN BRDA
K002316 10/26/2000 PHOENIX DIGITAL EEG AXON SYSTEMS, INC. HOWARD BAILIN
K002557 10/06/2000 SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) AXYA MEDICAL, INC. HOWARD L SCHRAYER
K002823 10/17/2000 RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K003225 10/19/2000 SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K002376 10/26/2000 ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY BAYER CORP. WILLIAM J PIGNATO
K002389 10/23/2000 BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY BAYLIS MEDICAL CO., INC. KRIS SHAH
K002905 10/19/2000 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER BECKMAN COULTER, INC. MARA CALER
K002799 10/05/2000 PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 BECKMAN COULTER, INC. ANNETTE HELLIE
K002233 10/13/2000 BVI SLING BIO-VASCULAR, INC. DAISY P SIN
K002855 10/12/2000 BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER BIOCARE CORP. PAUL W MCDONALD
K002294 10/02/2000 BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 BIOCHECK, INC. ROBIN J HELLEN
K002325 10/30/2000 WUJIN #3 TIBIAL NAIL BIOLOGICALLY ORIENTED PROSTHESES ANGENA PAREKH
K001460 10/04/2000 VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 BIOMERIEUX, INC. JANET CONNOLLY
K002278 10/23/2000 BROOKER FEMORAL NAILS BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K002057 10/04/2000 BROOKER TIBIA NAILS BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K002772 10/04/2000 ASCENT XXL CLOSED BOX FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K002998 10/06/2000 BIOMET BI-POLAR SHOULDER SYSTEM BIOMET, INC. TRACY J BICKE;
K002423 10/20/2000 LACTOSORB PUSH SCREW BIOMET, INC. TRACY BICKEL
K002879 10/05/2000 MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. ERIC V HOHENSTEIN
K994281 10/20/2000 BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) BIOPRO (M) SDN BHD JAMES H LALE
K994276 10/20/2000 BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) BIOPRO (M) SDN BHD JAMES H LALE
K002133 10/12/2000 NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JODI LYNN GREENNIZEN
K002802 10/05/2000 RAPID EXCHANGE TAPERTOME BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K002078 10/02/2000 BETA GLUCAN GEL (MACROPRO GEL) BRENNEN MEDICAL, INC. PHILLIP LAWIN
K002077 10/02/2000 GLUCANPRO CREAM BRENNEN MEDICAL, INC. PHILLIP LAWIN
K002094 10/06/2000 BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE C.R. BARD, INC. MARION GORDON
K002684 10/11/2000 COMPOSIX E/X MESH C.R. BARD, INC. RUTH C FORSTADT
K994320 10/20/2000 CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES CANTOR & SILVER LTD. MARTIN DALSING
K002590 10/31/2000 CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K002296 10/02/2000 CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 CERAMOPTEC, INC. CAROL J MORELLO
K002546 10/31/2000 CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE CIVCO MEDICAL INSTRUMENTS CO., INC. J. WILLIAM JONES
K003057 10/13/2000 AUTOSTAT II ENA-4 PROFILE ELISA COGENT DIAGNOTICS LTD. DANIELLE KNIGHT
K003054 10/13/2000 AUTOSTAT II ENA-6 PROFILE ELISA COGENT DIAGNOTICS LTD. DANIELLE KNIGHT
K002147 10/13/2000 FOCUS COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K000855 10/18/2000 GUNTHER TULIP VENA CAVA MREYE FILTER SET COOK, INC. MARY GOSSARD
K003159 10/30/2000 CORDIS SLALOM PTA BALLOON CATHETER CORDIS CORP. CHUCK RYAN
K002188 10/30/2000 SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, CORE-VENT CORP. WILL FISHER
K002479 10/19/2000 BIOMESH P1 AND BIOMESH PLUG AND PATCH COUSIN BIOTECH S.A.R.L HOWARD M HOLSTEIN
K002715 10/31/2000 ECAT PET SCANNER CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K002898 10/17/2000 CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST CURON MEDICAL, INC. THOMAS C WEHMAN
K001668 10/19/2000 GLOBAL SPINAL FIXATION SYSTEM D.K.M. CO.,LTD. ANDREW PAENG
K002551 10/11/2000 EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL DADE BEHRING, INC. PAUL L ROGERS
K002974 10/11/2000 EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL DADE BEHRING, INC. PAUL L ROGERS
K002804 10/05/2000 N PROTEIN STANDARD SL DADE BEHRING, INC. REBECCA S AYASH
K002949 10/20/2000 MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC DATASCOPE CORP. JOANNE WOLF
K002478 10/05/2000 S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 DATEX-OHMEDA, INC. JOEL C KENT
K001990 10/23/2000 DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES DEPILASE GROUP LTD. MARIO LUCA RUSSO
K002883 10/13/2000 PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K002980 10/23/2000 MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. PATRICIA FLOOD
K002229 10/20/2000 WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC. ROSINA ROBINSON
K002631 10/23/2000 ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH SCOTT PEASE
K002484 10/04/2000 EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL ELECTRO MEDICAL SYSTEMS SA SHEILA HEMEON-HEYER
K002959 10/16/2000 MODIFICATION TO ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K002437 10/02/2000 ENDIUS ENDOSCOPIC ACCESS SYSTEM ENDIUS, INC. SUSAN FINNERAN
K002396 10/13/2000 ENDOCARE PERCUTANEOUS ACCESS SET ENDOCARE, INC. VINCENT CUTARELLI
K002913 10/17/2000 HEADBAND FOR BAHA ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE G BUNDY
K002431 10/24/2000 ELRAN 01 SYSTEM ENVISION ADVANCED MEDICAL SYSTEM LTD GERARD J PRUD'HOMME
K002534 10/18/2000 EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 EUPALAMUS, LLC. ANNE LAURITZEN
K003060 10/31/2000 PLASMAKINETIC GENERATOR EVEREST MEDICAL CORP. DAVID KAY
K002332 10/06/2000 EEG SPIKE AND EVENT DETECTOR MODULE EXCEL TECH. LTD. DEBBIE DAVY
K001884 10/25/2000 DIRECT CROWN FLEXIBLE DIMENSIONS LLC. CAROL PATTERSON
K002198 10/17/2000 FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS FLUORO SCAN IMAGING SYSTEMS, INC. WILLIAM J ENGEL
K002490 10/03/2000 INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER FONAR CORP. LUCIANO BONANNI
K003065 10/31/2000 SEEDNET, MODEL EP6T5, EP5E5 GALIL MEDICAL LTD. JONATHAN S KAHAN
K994390 10/26/2000 GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER GAMBRO HEALTHCARE JEFFREY R SHIDEMAN
K002978 10/10/2000 LIGTHSPEED 3.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K002611 10/31/2000 SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K000638 10/30/2000 RESPONDER 3000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH KLAUS RUDOLF
K002341 10/23/2000 THERMAL CAUTERY UNIT, MODEL 150 GEIGER MEDICAL TECHNOLOGIES, INC. JOHN BOTTJER
K002957 10/18/2000 SOLAR SPO2 MODULE WITH MASIMO SET GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K002542 10/23/2000 REUSABLE CANNULA GENICON, LC GARY HABERLAND
K001125 10/04/2000 GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING GEUDER GMBH HILLARD W WELCH
K000861 10/30/2000 CRANIOCAP GILLETTE CHILDREN'S SPECIALTY HEALTHCARE LINDA VALERI
K002777 10/05/2000 VACUETTE WITH PPACK GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K002676 10/30/2000 ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER GUIDANT CARDIAC AND VASCULAR SURGERY KRISTEN HONL
K002143 10/12/2000 DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SUSAN SILAVIN, PH.D.
K002702 10/26/2000 NEUROTOLOGY DRAPE, MODEL TBD GYRUS ENT L.L.C. GREG SREDIN
K003214 10/31/2000 SMITH & NEPHEW PISTONS GYRUS ENT L.L.C. JEFFREY W COBB
K002737 10/12/2000 SMITH & NEPHEW PORPS & TORPS GYRUS ENT L.L.C. ALICIA FARAGE
K002074 10/04/2000 AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES H&C MEDICAL DEVICES SPA ATTILIO CASTELLI
K003219 10/25/2000 HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A JAMES DELANEY
K003221 10/25/2000 HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A JAMES DELANEY
K002367 10/26/2000 HARDY DISK CEFTIZOXIME, 30MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002661 10/26/2000 HARDYDISK CEFOTETAN, 30MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002656 10/25/2000 HARDYDISK CEFUROXIME, 30MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002369 10/26/2000 HARDYDISK GENTAMICIN, 120MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002664 10/26/2000 HARDYDISK LEVOFLOXACIN, 5MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002660 10/26/2000 HARDYDISK LOMEFLOXACIN, 10MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002663 10/19/2000 HARDYDISK NETILMICIN, 30MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002368 10/25/2000 HARDYDISK STREPTOMYCIN, 300MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K994059 10/13/2000 CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 HDC CORP. JAMES ABILLA
K002882 10/13/2000 HL168B HEALTH & LIFE CO., LTD. PAUL YANG
K003012 10/25/2000 RAICHEM PHOSPORUS REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K000995 10/11/2000 NARKOMAT, MODEL 2000 HEYER AMERICA, INC. ART WARD
K002420 10/17/2000 HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K002921 10/18/2000 SUREONE INSULIN SYRINGE HOSUK CO., LTD. Y. H KIM
K002505 10/05/2000 XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K002858 10/13/2000 XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K002213 10/03/2000 BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID HUNTER RESEARCH LABORATORIES, INC. BARBARA PEDIGO
K001387 10/05/2000 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-STAT CORP. PAUL VANDERWERF
K001096 10/25/2000 BURR HOLE COVER, MODEL XX IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K002330 10/18/2000 NAVIGUS PEEL AWAY INTRODUCER IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K002125 10/11/2000 PINS AND WIRES IMPLANT RESOURCE, INC. AL LIPPINCOTT
K000730 10/19/2000 IMPOAID IMPOAID, INC. ELAIN DUNCAN
K000252 10/17/2000 INSIGHT 4000 ENDOSCOPE INSIGHT INSTRUMENTS MFG., INC. K. PETER LULOH
K002467 10/13/2000 COALIZA PROTEIN S-FREE INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K002592 10/06/2000 INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. PROSIE REY-FESSLER
K002284 10/24/2000 VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX INVACARE CORP. EDWARD A KROLL
K001522 10/18/2000 TRANSQ3 IOMED, INC. W. TIM MILLER
K002645 10/19/2000 JEL BIOS PURE J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K002826 10/24/2000 EQUITY JENSEN INDUSTRIES, INC. JOHN SLANSKI
K002673 10/11/2000 EZ-COMFORT TRANSPORTER 2000 SERIES JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. JAMES CHU
K002669 10/11/2000 EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. JAMES CHU
K002671 10/11/2000 EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. JAMES CHU
K002670 10/11/2000 EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. JAMES CHU
K002857 10/05/2000 ELS CANNULA (KIT), MODEL M1210-88,M1510-88 JOSTRA AG KATHLEEN JOHNSON
K002558 10/25/2000 K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE KAMIYA BIOMEDICAL CO. COLIN GETTY
K002788 10/23/2000 KSEA NEURO-FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002700 10/18/2000 KSEA UNIMAT 12 KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K001408 10/30/2000 KSEA VASCULAR FIBERSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002152 10/10/2000 TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION KLS-MARTIN L.P. ART WARD
K001742 10/06/2000 RESUSCI INFLATE-A-SHIELD CPR BARRIER LAERDAL MEDICAL CORP. CYNTHIA J NOLTE
K001179 10/27/2000 SUPER NOVA, ACUBEAM LIGHT FORCE THERAPY, INC. KIM PETERSON
K002523 10/06/2000 ADVANTAGE DRIVE SYSTEM LINVATEC CORP. LAURA D SENEFF
K002566 10/19/2000 LUMALITE CURE LIGHT, MODEL 2100 LUMALITE, INC. JOSEPH M FOREHAND
K000696 10/19/2000 MACROPOREMX MANDIBULAR FIXATION SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K002943 10/23/2000 WHEELCHAIR, MECHANICAL SERIES MODEL 3100 MADA MEDICAL PRODUCTS, INC. JEFFERY W ADAM
K993094 10/23/2000 AERO-CLICK MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH TORSTEN SCHLICHTHOLZ
K002104 10/10/2000 COMBINED PHYSIOLOGICAL MONITORING SYSTEM MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF MARYROSE CUSIMANO
K002751 10/05/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K002939 10/06/2000 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER MASIMO CORP. JAMES J CRONIN
K002933 10/19/2000 STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL PALLIE STODDARD
K000929 10/17/2000 PROLITE PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K000620 10/30/2000 PBN FALLOPIAN TUBE CATHETER SYSTEM MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K002130 10/30/2000 NIR BILIARY STENT MEDINOL LTD. NASR SALMAN
K003121 10/20/2000 MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS MEDISON AMERICA, INC. GARY J ALLSEBROK
K002372 10/25/2000 ACCESS ALERT GAUGE MEDISYSTEMS CORP. FREDRIC SWINDLER
K002577 10/26/2000 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS MEDIVANCE, INC. ROBERT A KLINE
K003091 10/24/2000 MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K002140 10/10/2000 MENICON PROGENT REMOVER MENICON CO. LTD. BEVERLEY D VENUTI
K002310 10/25/2000 CARDIOBEEPER CB12/12, MODEL CB12/12 MERIDIAN MEDICAL TECHNOLOGIES LTD. GERARD LYNN
K002289 10/04/2000 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K002358 10/19/2000 MDI GLIADIN A TEST MICRO DETECT, INC. MEHDI ALEM
K002359 10/19/2000 MDI GLIADIN G TEST MICRO DETECT, INC. MEHDI ALEM
K003090 10/18/2000 MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM MIDMARK CORP. MIKE SNYDER
K000927 10/10/2000 ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 MISONIX, INC. ALBERT F CLANCY JR.
K003076 10/27/2000 MITEK CUFFTACK MITEK PRODUCTS CHRISTINE KUNTZ-NASSIF
K002191 10/12/2000 CARRIAZO BARRAQUER II MICROKERATOME MORIA, INC. DAVID CONRAD
K002850 10/05/2000 MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002686 10/18/2000 ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E NELLCOR PURITAN BENNETT, INC. CHERYL NORTON
K001811 10/25/2000 NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM NEU-ION, INC. LEE A HEIKKINEN
K002888 10/20/2000 NICHOLS ADVANTAGE THYROGLOB NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K001693 10/24/2000 LIFE SCOPE P, MODEL BSM-4100 SERIES NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K002690 10/11/2000 MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 NONIN MEDICAL, INC. RICHARD P BENNETT
K002808 10/31/2000 ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002810 10/31/2000 ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002811 10/31/2000 ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002613 10/19/2000 MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K001464 10/02/2000 DISPOSABLE H-PE MICROKERATOME BLADES OASIS YVONNE FERNANDEZ
K002443 10/18/2000 COLLAGEN WOUND DRESSING OASIS RESEARCH, LLC. JAMES CHRISTENSEN
K002510 10/18/2000 SMARTLENS ODC OPHTHALMIC DEVELOPMENT CO. AG KEVIN WALLS
K002982 10/25/2000 OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K002918 10/25/2000 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K002922 10/16/2000 OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) OMNIGRACE (THAILAND) LTD. WILLIAM E PATTON
K000848 10/05/2000 TDK HANDPIECES ORASYSTEMS BERNARD SESSMAN
K003104 10/20/2000 BACT/ALERT CSR ORGANON TEKNIKA CORP. REBECCA A RIVAS
K000739 10/24/2000 EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. WILLIAM JACKSON
K002622 10/23/2000 BIOSLEEP OXFORD BIOSIGNALS LIMITED PAULINE A HOBDAY
K000838 10/23/2000 DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) P.T. HEALTHCARE GLOVINDO ELLEN HUTAPEA
K002497 10/10/2000 MODEL 4810 ANALYZER OUTPUT ADAPTER PACE MEDICAL ROBERT C MACE
K002496 10/10/2000 MODEL 4815 ADAPTER PACE MEDICAL ROBERT C MACE
K002204 10/18/2000 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V PACE MEDICAL ROBERT C MACE
K002228 10/06/2000 PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-"X" & Z-13175-"X" PARADIGM MEDICAL INDUSTRIES, INC. TRACY S BEST
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K002471 10/19/2000 JETCAN HUBER NEEEDLE SET PFM PRODUKTE FUR DIE MEDIZIN AG SALVADORE F PALOMARES
K002556 10/31/2000 CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 PHARMACIA & UPJOHN CO. TONI D ELLIOTT
K001552 10/19/2000 TREPCHEK TREPONEMAL ANTIBODY EIA PHOENIX BIOTECH CORP. GARY LEHNUS
K002880 10/26/2000 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC PIE MEDICAL COLLEEN J HITTLE
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K000666 10/13/2000 TC-PLUS SOLUTION KNEE PLUS ORTHOPEDICS HARTMUT LOCH
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K002675 10/25/2000 MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM PRODUCT DEVELOPMENT INDUSTRIES, INC. RODOLFO A CARBALLO
K002500 10/23/2000 X-POSURE SYSTEM VERSION 2 RAD PRONOSCO A/S JONATHAN KAHAN
K002881 10/11/2000 VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 PULMONETIC SYSTEMS, INC. ROBERT HANKINS
K001646 10/20/2000 PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION PURITAN BENNETT CORP. MARY E FUNK
K003094 10/25/2000 FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER QUALIGEN, INC. DOROTHY DEINZER
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K001741 10/23/2000 RADIONICS RF DISC CATHETER ELECTRODE SYSTEM RADIONICS, INC. KRISTINE CANAVAN
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K001603 10/05/2000 REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) REPROMEDIX CORP. HAN-SOO KIM
K001606 10/05/2000 REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) REPROMEDIX CORP. HAN-SOO KIM
K000418 10/24/2000 PDT DOSECALCULATOR, MODEL 80000 RETINALABS.COM FRANK TIGHE
K003232 10/26/2000 RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K001468 10/23/2000 ELECSYS CA 15-3 TEST SYSTEM ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K002760 10/05/2000 ELECSYS DHEA-S CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K001719 10/10/2000 Q-LUX PLASMA 100 LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. STERLING CHENG
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K001295 10/25/2000 PIPER RTEK MEDICAL SYSTEMS, LLC. ROBERT C JACKSON
K002836 10/03/2000 MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE SAGE BIOPHARMA GREG HOLLAND
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K002936 10/17/2000 MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM SECTRA-IMTEC AB HERMAN OOSTERWIJK
K002867 10/12/2000 INVERNESS MEDICAL OVULATION PREDICTOR TEST SELFCARE, INC. CAROL A ADILETTO
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K002876 10/11/2000 JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM SUITER MEDICAL L.L.C. JAMES P SUITER
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K002446 10/23/2000 RE-ENTRANT CHAMBER, MODEL 1008 OR 44D SUN NUCLEAR CORP. THOMAS L POWERS
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K002345 10/11/2000 SURGI-VISION URETHRAL COIL SURGI-VISION, INC. NANCY E TAYLOR
K000246 10/20/2000 RADIOCAMERAS EXTRACRANIAL SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER WHITE
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K003061 10/30/2000 SYNTHES USS (10.0MM SIDE OPENING SCREWS) SYNTHES JONATHAN GILBERT
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K002361 10/31/2000 SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM SYNTHES (USA) BONNIE J SMITH
K002729 10/06/2000 SYNTHES PROXIMAL HUMERAL NAIL SYNTHES (USA) THOMAS M MAGUIRE
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K002564 10/26/2000 SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD. JAY H GELLER
K002563 10/26/2000 SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD. JAY H GELLER
K002350 10/05/2000 REFACTO LABORATORY STANDARD THE GENETICS INSTITUTE MARYANN KRANE
K000317 10/27/2000 SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM TISSUE MEDICAL LASERS, INC. DWIGHT ZURAWSKI
K000003 10/02/2000 TORNIER TOTAL ELBOW PROSTHESIS TORNIER DAVID W SCHLERF
K002424 10/27/2000 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIANA THORSON
K002531 10/26/2000 EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 TOSHIBA AMERICA MRI, INC. KEN NEHMER
K002522 10/25/2000 OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. BRUCE CLARK
K001835 10/11/2000 IRV2000 INDIVIDUAL RECREATIONAL VEHICLE TRAC ABOUT, INC. KEVIN WALLS
K991296 10/06/2000 TUTOPATCH TUTOGEN MEDICAL U.S., INC. PJ PARDO
K002408 10/17/2000 AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS UNILENS CORP., USA CHARLOTTE B COUECOU
K002318 10/11/2000 UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES UNITED CHAIR MFG., LLC. DOUGLAS A HANBY
K003010 10/19/2000 SPIRIT ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. DANIEL YE HUA
K002483 10/25/2000 POWER 5000 GENERAL PURPOSE COIL USA INSTRUMENTS, INC. RONY THOMAS
K002482 10/17/2000 VISION 9000 PHASED ARRAY TORSO COIL USA INSTRUMENTS, INC. RONY THOMAS
K002562 10/13/2000 PACIFIER THERMOMETER MODELS VT-901F, VT901C VALEO CORP. MARIAN HARDING COCHRAN
K001972 10/27/2000 ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK VISICU, INC. CAROL PATTERSON
K991124 10/20/2000 VISIJET HYDROKERATOME, MODEL 50 VISIJET, INC. JUDY F GORDON
K002519 10/19/2000 VITREA 2, VERSION 2.1 VITAL IMAGES, INC. ROBERT C SAMEC
K002983 10/11/2000 C.T.M. POWER CHAIR, MODEL HS-5600 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K001519 10/06/2000 ACTICOAT 7 DRESSING WESTAIM BIOMEDICAL, INC. STEVE CHARTIER
K002975 10/24/2000 DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K002897 10/11/2000 TITANIUM MIDDLE EAR PROSTHESES XOMED, INC. DAVID TIMLIN
K002828 10/17/2000 XPS NITRO SYSTEM XOMED, INC. MARTIN D SARGENT


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