FDA 510(k) Applications Received During March, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K000741 03/07/2000 EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 138 MEDICAL SUPPLIES, INC. SUSAN D GOLDSTEIN-FALK
K000968 03/27/2000 3181 DUO DELIVERY SYSTEM A-DEC, INC. LOVENA STANDRIDGE
K000966 03/27/2000 4631 DUO DELIVERY SYSTEM A-DEC, INC. LOVENA STANDRIDGE
K000967 03/27/2000 4635 ASSISTANT'S INSTRUMENTATION A-DEC, INC. LOVENA STANDRIDGE
K000961 03/24/2000 AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K000821 03/14/2000 ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION ABBOTT LABORATORIES JILL SACKETT
K000886 03/20/2000 SPIROL EPIDURAL CATHETER ABBOTT LABORATORIES JILL N SACKETT
K001044 03/31/2000 ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM ACME SPINE, LLC. TIMOTHY WILLIAMS
K000908 03/21/2000 SKYLIGHT IMAGING SYSTEM ADAC LABORATORIES JANICE E BROWN
K000932 03/23/2000 ARACHNOPHLEBECTOMY NEEDLE ADVANCED MEDICAL PRODUCTS, INC. CHARLES H KYPER
K000852 03/15/2000 RENEW NEUROSTIMULATION SYSTEM ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K000792 03/10/2000 CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX ADVANCED RENAL TECHNOLOGIES, INC. ROBIN CALLAN
K000775 03/09/2000 HEART 2005 AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K000822 03/14/2000 AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR AGILENT TECHNOLOGIES, GMBH EGON PFEIL
K000854 03/16/2000 VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K000963 03/24/2000 DA VINCHI EEG AND EMG/EP SYSTEMS AIRSEP CORP. PETER WEISENBORN
K001013 03/29/2000 MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY AIRSEP CORP. PETER WEISENBORN
K000813 03/13/2000 FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM ALLEGIANCE HEALTHCARE COPORATION ERICA SETHI
K000697 03/01/2000 MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K000788 03/10/2000 APEX MODULAR HIP STEM APEX SURGICAL, LLC. EDWARD J CHEAL
K000748 03/08/2000 TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K000729 03/06/2000 ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL ARROW INTL., INC. WILLIAM PAQUIN
K000778 03/10/2000 ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 ARTHROCARE CORP. BRUCE PROTHRO
K000740 03/07/2000 ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S ASAHI IRYOKI CO. LTD MIKE PAWLUK
K000869 03/17/2000 LA PERSONAL SCOOTER ASSEMBLED PRODUCTS CORP. GARY DARLING
K000964 03/27/2000 STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 AUTOMATIC LIQUID PACKAGING, INC. JOHN BRDA
K000947 03/23/2000 ULTRASTIM ELECTRODE, MODEL US4040 AXELGAARD MFG. CO., LTD. DAN JEFFERY
K000960 03/24/2000 BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 BARZELL-WHITMORE MAROON BELLS, INC. ART WARD
K000903 03/21/2000 ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM BAYER CORP. FREDRICK CLERIE
K000921 03/22/2000 BAYER ADVIA IMS SYSTEM; 200 + 3 BAYER CORP. FREDRICK CLERIE
K000829 03/14/2000 GATIFLOXACIN, 5 UG, BBL SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BRADFORD SPRING
K000762 03/08/2000 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BRADFORD SPRING
K000897 03/21/2000 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE BD Biosciences CINDY MORROW
K000716 03/03/2000 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN COULTER, INC. ANGELA M BYLAND
K000884 03/20/2000 BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY BECTON DICKINSON BIOSCIENCES COLLEEN ROHRBECK
K000962 03/24/2000 PICO SMOKERLYZER, MODEL EC-50 BEDFONT SCIENTIFIC LTD. MARTIN FOXLEY
K000799 03/13/2000 BELMONT UNIT, MODEL 2000 SERIES BELMONT EQUIPMENT CORP. JOHN E COLLINS
K000814 03/13/2000 FINGER PULSE METER BHS INTL., INC. CHRIS REDDING
K000875 03/20/2000 ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 BIO-RAD ELIZABETH PLATT
K000874 03/20/2000 URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 BIO-RAD ELIZABETH PLATT
K001022 03/30/2000 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 BIOCHECK, INC. ROBIN J HELLEN
K000978 03/27/2000 ANATOMIC TOTAL KNEE PROSTHESIS BIOMET, INC. LONNIE WITHAM
K001010 03/29/2000 ASCENT KNEE REVISION FEMORAL STEM BIOMET, INC. TINA LAKIN
K000764 03/09/2000 PEDIATRIC FIXATION RODS BIOMET, INC. PATRICIA SANDBORN BERES
K000760 03/08/2000 REACH FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K000836 03/14/2000 BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM BIONX IMPLANTS, INC. TUIJA ANNALA
K001046 03/31/2000 BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS BIOPRO, INC. CHERYL WARSINSKE
K000931 03/22/2000 AU5 ULTRASOUND IMAGING SYSTEM BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K000763 03/09/2000 PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 BIOTRONIK, GMBH & CO. Jon Brumbaugh
K000798 03/13/2000 TALON BALLOON DILATION CATHETER BOSTON SCIENTIFIC CORP. TERRY A MCGOVERN
K000743 03/07/2000 BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 BOSTON SCIENTIFIC SCIMED, INC. DEBORAH A FRANK
K000956 03/24/2000 MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS BOSTON SCIENTIFIC SCIMED, INC. MELANIE RASKA
K000904 03/21/2000 PENADAPT 10 BUFFALO FILTER CO., INC. KATHLEEN H SELOVER
K000981 03/27/2000 CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX C-MIX ART WARD
K000983 03/27/2000 CERAMIX PORCELAIN SYSTEM C-MIX ART WARD
K000830 03/14/2000 CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K001034 03/31/2000 MODEL APS ALTERNANS PROCESSING SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K000959 03/24/2000 CRITERION 60 OR PM 60 CARADYNE, LTD. PAUL DRYDEN
K000834 03/14/2000 CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO CASTELLINI S.P.A. GIULIANO LANZARINI
K000837 03/13/2000 PUMA DENTAL CHAIR AND UNIT CASTELLINI S.P.A. GIULIANO LANZARINI
K001050 03/31/2000 CALCIJECT CENTRIX, INC. SCOTT COHN
K000770 03/09/2000 PROVIEW MEDICAL IMAGE DISPLAY MODULE CERNER CORP. SHELLEY LOOBY
K000890 03/20/2000 CHAD THERAPEUTICS OXYMATIC MODEL 401 CHAD THERAPEUTICS, INC. OSCAR J SANCHEZ
K000859 03/17/2000 OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 CHARLES A. SMITH CHARLES A SMITH
K001042 03/31/2000 COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHEE YONG FOO
K000810 03/13/2000 QUALITROL LIPID CONTROL, LEVELS 1 AND 2 CONSOLIDATED TECHNOLOGIES OF WISCONSIN RUSTY SEWELL
K000855 03/16/2000 GUNTHER TULIP VENA CAVA MREYE FILTER SET COOK, INC. MARY GOSSARD
K000753 03/08/2000 CORDIS 13F CATHETER SHEATH INTRODUCER CORDIS CORP. ARIEL MACTAVISH
K000715 03/02/2000 ENVOY AND VISTA BRITE TIP CORDIS CORP. DENNIS S GRIFFIN
K001033 03/31/2000 AGILITY STEERABLE GUIDEWIRE CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K000920 03/22/2000 REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K001020 03/30/2000 8100 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K000973 03/27/2000 BEHRING COAGULATION SYSTEM (BCS) DADE BEHRING, INC. REBECCA S AYASH
K000815 03/13/2000 AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) DATEX-OHMEDA JOEL C KENT
K000882 03/20/2000 DATEX-OHMEDA CS/3 TELEMETRY SYSTEM DATEX-OHMEDA JOEL KENT
K000706 03/02/2000 DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR DATEX-OHMEDA, INC. DANIEL KOSEDNAR
K000892 03/20/2000 DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES DATEX-OHMEDA, INC. JOEL KENT
K001003 03/29/2000 Z-NET DEMITE LIMITED WILLIAM H.E. VON OEHSEN
K000894 03/20/2000 C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO DENTAL VENTURES OF AMERICA, INC. ANTHONY SIRAGUSA
K000996 03/28/2000 TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND DENTSPLY INTL. P. JEFFERY LEHN
K001021 03/30/2000 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 DIDECO S.P.A. BARRY SALL
K000982 03/27/2000 A100 AESTHETIC DIODE LASER DIOMED, INC. MAUREEN O'CONNELL
K000704 03/02/2000 DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) DMC MEDICAL LTD. CHARMAINE HENDERSON
K000878 03/20/2000 HONIGUM DMG USA, INC. PAMELA PAPINEAU
K000951 03/23/2000 LUXAFORM DMG USA, INC. PAMELA PAPINEAU
K001030 03/30/2000 RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S DYMEDIX, INC. Gary Syring
K001037 03/31/2000 MODIFICATION TO EBI SPINELINK SYSTEM EBI, L.P. JONAS WILF
K000958 03/24/2000 ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOKING
K000900 03/21/2000 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOCKING
K001024 03/30/2000 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. DE LOS SANTOS
K000766 03/09/2000 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K000820 03/13/2000 AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 ENDOSONICS CORP. CHRISTINA KICHULA
K000831 03/14/2000 STAT-SHELL DISPOSABLE SP02 SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K000943 03/23/2000 CEMEX SYSTEM GUN APPLICATION VERSION EXACTECH, INC. GARY J MILLER
K000919 03/22/2000 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 EXCEL TECH. LTD. DEBBIE DAVY
K000898 03/21/2000 EEG WITH VIDEO, MODEL EX-NW EXCEL TECH. LTD. DEBBIE DAVY
K000896 03/20/2000 POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K000891 03/20/2000 STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K000702 03/01/2000 BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K000746 03/08/2000 FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K001016 03/29/2000 GE LOGIQ 700 GE MEDICAL SYSTEMS ALLEN SCHUH
K000802 03/13/2000 SPIRAL IMAGING OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K000695 03/01/2000 GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K001029 03/30/2000 GEIGER NEEDLE ADAPTER, MODEL 406 GEIGER MEDICAL TECHNOLOGIES, INC. JOHN BOTTJER
K000779 03/10/2000 APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K000861 03/17/2000 CRANIOCAP GILLETTE CHILDREN'S SPECIALTY HEALTHCARE LINDA VALERI
K000736 03/07/2000 LA JOIE GOOMI EHWA, INC. MANOH PARK
K000793 03/13/2000 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER GUIDANT CORP. BYRON LAMBERT
K001047 03/31/2000 GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K001049 03/31/2000 GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K000801 03/13/2000 PC COATED FLUOROPLASTIC VENT TUBES GYRUS ENT L.L.C. ALICIA FARAGE
K000858 03/16/2000 WEHRS INCUS-STAPES GYRUS ENT L.L.C. ALICIA FARAGE
K000913 03/22/2000 POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) HANDSAFE PRODUCTS SDN. BHD. NG KOK HWA
K000995 03/28/2000 NARKOMAT, MODEL 2000 HEYER AMERICA, INC. ART WARD
K001019 03/30/2000 TI500 GLOBE-TROTTER TRANSPORT SYSTEM HILL-ROM AIR-SHIELDS JAMES G CARPENTER
K000957 03/24/2000 HOFFMANN II EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K000965 03/27/2000 MULTI-AXIAL CROSS (MAC) CONNECTOR HOWMEDICA OSTEONICS CORP. TERRY SHERIDAN POWELL
K000915 03/22/2000 PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 HUMAGEN FERTILITY DIAGNOSTICS, INC. CINDY SHOWALTER
K000725 03/06/2000 HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) HWA TEH INDUSTRIAL SDN. BHD. K. KARUNAKARAN
K000911 03/21/2000 MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 HYSTERX, INC. JUDY F GORDON
K001039 03/31/2000 THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP IMPLEX CORP. JOHN SCHALAGO
K000730 03/06/2000 IMPOAID IMPOAID, INC. ELAIN DUNCAN
K000733 03/06/2000 QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K000732 03/06/2000 QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K000976 03/27/2000 DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) INSTRUMENTARIUM IMAGING, INC. MAX LINDERT
K000876 03/20/2000 SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP INTERPORE CROSS INTL. LYNN M RODARTI
K000864 03/17/2000 INTRASTENT DOUBLESTRUT XS STENT INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K000939 03/23/2000 HTF-HEPES INVITROCARE, INC. ROBERT E LOVINS
K000940 03/23/2000 HUMAN SERUM ALBUMIN (HSA) INVITROCARE, INC. ROBERT E LOVINS
K000938 03/23/2000 IVC ONE MEDIUM INVITROCARE, INC. ROBERT E LOVINS
K000937 03/23/2000 IVC TWO MEDIUM INVITROCARE, INC. ROBERT E LOVINS
K000989 03/28/2000 SPERM WASH MEDIUM, CAT# 2003/2005 INVITROCARE, INC. RPBERT E LOVINS
K000777 03/09/2000 SAMPLOK ITL CORPORATION, PTY LTD. KENNETH A PALMER
K000738 03/07/2000 WHEELCHAIR, MODELS H001A, 4422 JACKSON COMPANY LLC. DEBORAH WEIMAN
K000845 03/15/2000 MODIFICATION TO JMS A.V. FISTULA NEEDLE SET JMS CO., LTD. KEISUKE URATOMI
K000843 03/15/2000 MODIFICATION TO JMS APHERESIS NEEDLE JMS CO., LTD. KEISUKE URATOMI
K001023 03/30/2000 FREEDOM, MODEL 4660 JOHNSON & JOHNSON CONSUMER COMPANIES, INC. JOSEPH KICEINA
K000806 03/13/2000 KARL STORZ HYSTEROMAT II KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K000769 03/09/2000 KSEA MANHES PNEUMOTROCAR KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K000870 03/20/2000 KM-10 TENS ELECTRODE KATECHO, INC. WARREN R WALTERS
K000805 03/13/2000 KAVO K.E.Y. LASER 1242 KAVO AMERICA JOHN FRANZ
K001043 03/31/2000 KAWASUMI LABORATORY BLOOD DRAWING KIT KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K000948 03/23/2000 OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. ROGER GRAY
K000950 03/23/2000 EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 LABOTECT LABOR-TECHNIK GOTTINGEN ANGELIKA ALBRECHT
K001031 03/30/2000 URANUS, COMFORTOUCH LASER SYSTEM LASER MAX MEDICAL TECHNOLOGIES CORP. PAUL Y FANG
K000707 03/02/2000 LEICA COLPOSCOPE LEICA MICROSCOPY SYSTEMS LTD. SUSAN D GOLDSTEIN-FALK
K000987 03/27/2000 VFSS IMAGER, MODEL SIS-300 LIFECARE IMAGING INTL., LTD. RICHARD A ADAMS
K000997 03/28/2000 ZORTRAN DETECTOR LUCENT MEDICAL SYSTEMS CINDY PESTKA
K000826 03/14/2000 PRODIGY LATERAL VIEW SOFTWARE LUNAR CORP. JAMES P RASKOB
K000992 03/28/2000 MACROPOREDX DISTRACTOR SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K000696 03/01/2000 MACROPOREMX MANDIBULAR FIXATION SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K000985 03/27/2000 MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS MATANG MFG. SDN. BHD. KOK-KEE HON
K001006 03/29/2000 THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE MDS NORDION E S MARTELL
K000714 03/02/2000 VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET MED-PRO TECHNOLOGIES, INC. ART WARD
K000824 03/14/2000 PERCUTANEOUS INTRODUCER, MODEL 10383-XXX MEDAMICUS, INC. DENNIS MADISON
K000825 03/14/2000 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER MEDI-DYNE, INC. NORMAN HALL
K000926 03/22/2000 EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER MEDICA CORP. Photios Makris
K000724 03/06/2000 MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 MEDICA S.R.L. JAMES DELANEY
K000929 03/22/2000 PROLITE PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K000693 03/01/2000 UMECO OPTIMA MULTILINE LASER SYSTEM MEDICAL LASER SOLUTIONS LLC. IAIN D MILLER
K000712 03/02/2000 PORTABLE INTENSIVE CARE UNIT, MODEL PIC MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K000744 03/07/2000 MEDTRONIC AVE BRIDGE X3 STENT MEDTRONIC AVE, INC. SUSAN WALTON
K000776 03/10/2000 MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP MEDTRONIC CARDIAC SURGICAL PRODUCTS JAMES BALUN
K000991 03/28/2000 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K000955 03/24/2000 PLACER MODEL 6232 STEERABLE STYLET MEDTRONIC VASCULAR MIKE JOHNSON
K000728 03/06/2000 MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE MEDTRONIC XOMED DAVID TIMLIN
K000767 03/09/2000 MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 MEMCATH TECHNOLOGIES LLC. MARC JAKER
K000887 03/20/2000 DRX HBA1C METRIKA, INC. JOEAL M BLATT
K000885 03/20/2000 DRX HBA1C - FOR PRESCRIPTION HOME USE METRIKA, INC. JOEL M BLATT
K000934 03/23/2000 MDI SCL-70 TEST MICRO DETECT, INC. MEHDI ALEM
K000969 03/27/2000 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K000927 03/22/2000 ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 MISONIX, INC. ALBERT F CLANCY JR.
K000936 03/23/2000 VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS MARY P LEGRAW
K000844 03/15/2000 ABSOLUTE HCG PREGNANCY TEST MIZUHO USA, INC. BENEDICT ZIN
K000902 03/21/2000 KLINIDRAPE REINFORCED SURGICAL GOWNS MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K000906 03/21/2000 KLINIDRAPE SURGICAL DRAPES MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K000901 03/21/2000 KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K000935 03/23/2000 KFA-63 KNEE AND FOOT ARRAY MRI DEVICES CORP. THOMAS SCHUBERT
K000999 03/28/2000 MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K000865 03/17/2000 QUIK-CAP NEUROSCAN DAVID B JONES
K000812 03/13/2000 NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) NEUROSOFT, INC. DAVID B JONES
K000975 03/27/2000 LIPIDURE REWETTING DROPS NOF CORP. ANN KUROWSKI
K000710 03/02/2000 MD 10, SEM, SM 12, CBM NOUVAG AG MARGIT ESCHBAUMER
K000895 03/20/2000 STAT PROFILE PHOX PLUS ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K000718 03/03/2000 CHROMOSTREAK NOVAMED LTD. GERALD M SLUTZKY
K000794 03/13/2000 MODIFICATION TO MARSPO2, MODEL 2001 NOVAMETRIX MEDICAL SYSTEMS, INC. ROBERT H SCHIFFMAN
K000977 03/27/2000 COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS OLSON MEDICAL SALES, INC. GARY A COURTNEY
K000998 03/23/2000 OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES OPTISONIC, INC. JOHN M SZABOCSIK
K000990 03/28/2000 OPUS 10 DENTAL DIODE LASER OPUSDENT LTD. SHOSHANA FRIEDMAN
K000847 03/15/2000 ORALUBE ORASYSTEMS BERNARD SESSMAN
K000848 03/15/2000 TDK HANDPIECES ORASYSTEMS BERNARD SESSMAN
K000846 03/15/2000 TKD SCALERS ORASYSTEMS BERNARD SESSMAN
K001008 03/29/2000 TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K000797 03/13/2000 OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 ORTHOPAEDIC BIOSYSTEMS, LTD. MELODY F MARTIN
K000817 03/13/2000 OMEGA II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K001032 03/30/2000 RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY OTSUKA PHARMACEUTICAL CO., LTD. JAMES W HARRIS
K000739 03/07/2000 EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. WILLIAM JACKSON
K000930 03/22/2000 GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K000928 03/22/2000 QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K000838 03/14/2000 DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) P.T. HEALTHCARE GLOVINDO ELLEN HUTAPEA
K000722 03/03/2000 UNIPOLAR NEEDLES PAJUNK GMBH BURK A BRANDT
K000952 03/24/2000 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR PAMITEX INDUSTRIES SDN BHD SAID AWANG
K000828 03/14/2000 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE PAMITEX INDUSTRIES SDN BHD SAID AWANG
K000694 03/01/2000 PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) PECTOFIX, INC. ERIC BANNON
K000819 03/13/2000 PHILIPS CT SECURA MV PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FRANK GIANELLI
K000832 03/14/2000 STEROTACTIC LOCALIZATION DEVICE (SLD) PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER A LTMAN
K000734 03/07/2000 PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 PIONEER SURGICAL TECHNOLOGY AMY MOMMAERTS
K000771 03/09/2000 DIMAX 2 PLANMECA OY BOB PIENKOWSKI
K000795 03/13/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY DEBRA L.B. KETCHUM
K001366 03/31/2000 PROSTEC 125I BRANCHYTHERAPY SNAPSEED PROSTEC LLC. AL WEISENBORN
K000888 03/20/2000 SANSIBAR CPAP SYSTEM PRYM MEDICAL LTD. SHOSHANA FRIEDMAN
K000851 03/15/2000 PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR PSYCHEMEDICS CORP. WILLIAM THISTLE
K000754 03/08/2000 QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT QUANTASE LTD. R. STEWART CAMPBELL
K001009 03/29/2000 RANDOX C-REACTIVE PROTEIN RANDOX LABORATORIES, LTD. P. ARMSTRONG
K000979 03/27/2000 REDI-SCREEN REDWOOD BIOTECH, INC. JANIS FREESTONE
K000783 03/10/2000 DIRECT TIBC CALIBRATOR REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K000781 03/10/2000 DIRECT TIBC KIT REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K001048 03/23/2000 LIGHT BOND (QUICK CURE) RELIANCE ORTHODONTIC PRODUCTS, INC. KATHRYN B PATTERSON
K000994 03/28/2000 BIPAP DUET LX BI-LEVEL SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K000705 03/02/2000 RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 RESPIRONICS, INC. DAVID J VANELLA
K001017 03/29/2000 RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC RETRAX SAFETY SYSTEMS, INC. DAVID GARVIN
K001025 03/30/2000 LIFECARD CF COMPACT RECORDER REYNOLDS MEDICAL LTD. GEORGE MYERS
K000752 03/08/2000 RHIGENE MESACUP2 TEST- RNP RHIGENE, INC. DAVE KOLESAR
K000750 03/08/2000 RHIGENE MESACUP2 TEST- SCL-70 RHIGENE, INC. DAVE KOLESAR
K000755 03/08/2000 RHIGENE MESACUP2 TEST- SM RHIGENE, INC. DAVE KOLESAR
K000749 03/08/2000 RHIGENE MESACUP2 TEST- SSA RHIGENE, INC. DAVE KOLESAR
K000751 03/08/2000 RHIGENE MESACUP2 TEST- SSB RHIGENE, INC. DAVE KOLESAR
K000808 03/13/2000 RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE RICH-MAR CORP. DAVID RICHARDS
K000905 03/21/2000 URETHROTOME 8667.XXX AND 8670.XXX RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K001014 03/29/2000 ELECSYS ANTI-TPO CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K001015 03/29/2000 ELECSYS THYROGLOBULIN CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K000784 03/10/2000 THE CARDIAC READER SYSTEM ROCHE DIAGNOSTICS CORP. SUSAN D GOLDSTEIN-FALK
K000723 03/06/2000 HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) ROCHESTER MEDICAL CORP. MARY WILEN
K000889 03/20/2000 SENOJ IMPLANT SYSTEM SENOJ BIOCARE, INC. PENNY WOLLUM
K000700 03/01/2000 SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR SENSIDYNE, INC. HOWARD MILLS
K000868 03/17/2000 NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES SGMP CO., LTD. CHEAH CHOR HEE
K000867 03/17/2000 POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR SGMP CO., LTD. CHEAH CHOR HEE
K000872 03/20/2000 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K000953 03/24/2000 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K000860 03/17/2000 FUTURA SAFETY SYRINGE SHEILA W. PICKERING SHEILA W PICKERING
K000942 03/23/2000 CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 SIMS DELTEC, INC. LISA STONE
K000842 03/15/2000 CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM SIMS DELTEC, INC. LISA STONE
K000811 03/13/2000 NLITE SYSTEM, SLS MODEL NUMBER A00-1025 SLS BIOPHILE LTD. MICHAEL KIERNAN
K000717 03/03/2000 SMITH & NEPHEW SUTURELOK, MODEL 7207321 SMITH & NEPHEW, INC. NICHOLAS CONDAKES
K000720 03/03/2000 SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE SOMNUS MEDICAL TECHNOLOGIES, INC. STEVEN J OJALA
K000893 03/20/2000 AC POWERED THERMAL CAUTERY UNIT STARION INSTRUMENTS BRIAN GRIGSBY
K000941 03/23/2000 STERLTECH WATER PURIFIER STERLTECH, INC. JOHN R NOLL
K000945 03/23/2000 PARA 12 PLUS RETICS STRECK LABORATORIES, INC. PAUL KITTELSON
K000954 03/24/2000 KERR GEL ETCHANT SYBRON DENTAL SPECIALTIES, INC. ORLANDO TADEO, JR.
K000972 03/27/2000 SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS SYNTHES (USA) BONNIE J SMITH
K000742 03/07/2000 SYNTHES ANTERIOR CSLP SYSTEM SYNTHES SPINE JONATHAN GILBERT
K000731 03/06/2000 MODIFICATION TO RTA RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD. JONATHAN S KAHAN
K000816 03/13/2000 SHARP BRAND ACUPUNCTURE NEEDLES TCM SUPPLY CORP. WILLIAM HUNG LEE
K000701 03/01/2000 HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER THE BINDING SITE, LTD. JAY H GELLER
K001026 03/30/2000 3D-MSPECT THE REAGENTS OF THE UNIVERSITY OF MICHIGAN SHEILA HEMEON-HEYER
K000944 03/23/2000 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. KEITH MULLOWNEY
K000745 03/08/2000 SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM TILLOTSON HEALTHCARE CORP. THOMAS N TILLOTSON
K000849 03/15/2000 SOFTFORM FACIAL IMPLANT TISSUE TECHNOLOGIES, INC. JESSE KRAMER
K001035 03/31/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K001036 03/31/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K000747 03/07/2000 UNIVEC TWO PIECE SYRINGE UNIVEC, INC. S. LEVINSON
K000993 03/28/2000 LIBERTY 9000 BREAST COIL USA INSTRUMENTS, INC. RONY THOMAS
K000974 03/27/2000 FOWLER ENDOCURETTE, MODEL CUR-XXX UTAH MEDICAL PRODUCTS, INC. KEVIN L CORNWELL
K000922 03/22/2000 PROTON VISION VARIAN ASSOC., INC. LINDA S NASH
K000796 03/13/2000 MAGIC MOBILITY 4 X 4 WHEELCHAIR VESTIL MANUFACTURING CORP. RICK MICHAEL
K000881 03/20/2000 PERFADEX SOLUTION FOR ORGAN PRESERVATION VITROLIFE SWEDEN AB KARL A POSSELT
K001004 03/29/2000 WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K001005 03/29/2000 WAKO HDL-C/LDL-C CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K001002 03/29/2000 WAKO LIPASE CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K000768 03/09/2000 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K000827 03/14/2000 UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED WALTER ABENDSCHEIN, M.D. WALTER ABENDSCHEIN
K001012 03/29/2000 DIGITAL INTEGRATION SYSTEM, DIS2000 WELLINGTON MEDICAL SYSTEMS, INC. SCOTT AUGUST
K000719 03/03/2000 NEOCARE 20 MICRON BLOOD FILTER WHATMAN, INC. RANDALL D BATH
K001041 03/31/2000 AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K000971 03/27/2000 PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K000737 03/07/2000 COAXIAL DILATOR SET XENTEK MEDICAL, INC. JIM EDDINGS
K000727 03/06/2000 BUFFLIGHT CLT SURGICAL LASER SYSTEM Y-BEAM TECHNOLOGIES, INC. JUDY F GORDON
K000880 03/20/2000 THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K000879 03/20/2000 THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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