FDA 510(k) Decisions During July, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K002115 07/25/2000 A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. JERRY WANG
K001511 07/19/2000 O-LAS OPHTHALMIC PHOTODISRUPTOR A.R.C. LASER AG DANIEL HOEFER
K002126 07/20/2000 ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP ABBOTT LABORATORIES JILL SACKETT
K001616 07/27/2000 MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE ABBOTT LABORATORIES CHRISTINE L LIONHOOD
K002323 07/31/2000 ADVANCED UROSCIENCE INJECTION NEEDLE ADVANCED UROSCIENCE, INC. KAREN E PETERSON
K001234 07/11/2000 BIOINSULATED SILICONE PUNCTUM PLUG ADVANCED VISION SCIENCE KHALID MENTAK
K993248 07/12/2000 AMPLATZER SIZING BALLOON AGA MEDICAL CORP. JODI L LOCHER
K001214 07/10/2000 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ALCON UNIVERSAL, LTD. MICHAEL E PFLEGER
K001235 07/03/2000 OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 ALCON UNIVERSAL, LTD. RALPH H LARSON
K994398 07/27/2000 INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994404 07/05/2000 INSTANT-VIEW MORPHINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994409 07/10/2000 INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K001314 07/25/2000 MEDSCOPE ALL-PRO IMAGING CORP. JOSEPH CAREY
K001924 07/14/2000 COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K001739 07/27/2000 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K001383 07/05/2000 SUPREMCAST V AMERICAN DENT-ALL, INC. VACHAKAN H KHOIE
K001401 07/12/2000 AMT THERAPEUTIC TABLE, MODEL 748AMT AMT MFG., INC. BILL DEACON
K001306 07/20/2000 STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX ANDROMED, INC. JEAN DUMAS
K002101 07/31/2000 ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K001883 07/31/2000 LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM ANSELL HEALTHCARE, INC. LON D MCILVAIN
K002192 07/27/2000 DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 ANSELL PERRY JAMES R CHATTERTON
K001587 07/12/2000 19 GA PLASTIC REINFORCED EPIDURAL CATHETER ARROW INTL., INC. THOMAS D NICKEL
K001936 07/19/2000 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD ARTHROCARE CORP. BETTY M JOHNSON
K001904 07/17/2000 ARTHROCARE FLOW CONTROL UNIT ARTHROCARE CORP. BRUCE PROTHRO
K000869 07/19/2000 LA PERSONAL SCOOTER ASSEMBLED PRODUCTS CORP. GARY DARLING
K002003 07/13/2000 HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING ATL ULTRASOUND, INC. TERRENCE J SWEENEY
K002093 07/24/2000 ATRIUM LITE MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K001798 07/31/2000 DC TITAN AUSTENAL, INC. RONALD DUDEK
K001747 07/13/2000 MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001751 07/19/2000 MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001752 07/19/2000 MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001754 07/19/2000 MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001750 07/21/2000 MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001753 07/27/2000 MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001748 07/27/2000 MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K001539 07/31/2000 RENU MULTIPLUS MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K002211 07/28/2000 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K001063 07/07/2000 SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 BAXTER HEALTHCARE CORP. JASON SMITH
K981089 07/05/2000 TISSOMAT AND SPRAY SET BAXTER HEALTHCARE CORP. ANGELA BLACKSHERE
K001770 07/05/2000 BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A BCI, INC. DONALD ALEXANDER
K002033 07/26/2000 BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K001375 07/25/2000 ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) BEST MANUFACTURING COMPANY DAVID C YOUNG
K001891 07/12/2000 MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C BIO/DATA CORP. RODNEY W SCARPELLI
K001374 07/27/2000 PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K002106 07/27/2000 NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER BIOMET, INC. TRACY J BICKEL
K001350 07/26/2000 PATIENT MATCHED TITANIUM ALLOY TROCHLEA BIOMET, INC. PATRICIA SANDBORN BERES
K001271 07/14/2000 SAMARCO SPIDER PLATES BIOMET, INC. MARY VERSTYNEN
K001376 07/20/2000 TI-MAX PROTRUSIO CAGE BIOMET, INC. TRACY J BICKEL
K001378 07/28/2000 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 BIONX IMPLANTS, INC. TUIJA ANNALA
K001530 07/21/2000 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. ERIC V HOHENSTEIN
K993685 07/18/2000 BIOPACK BIOSCAN, INC. BUTCH SMITH
K993686 07/18/2000 LIGHT PATCH BIOSCAN, INC. BUTCH SMITH
K993684 07/19/2000 SPINAL PAD BIOSCAN, INC. BUTCH SMITH
K001390 07/21/2000 BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES BIOSENSE WEBSTER, INC. MARIA D OCHOA
K001894 07/06/2000 MODIFICATION TO E-SCAN BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K001608 07/25/2000 BLAINE SCARCARE PATCH BLAINE LABS, INC. ROBERT BLAINE
K001391 07/24/2000 BONUS MECHANICAL WHEELCHAIR BONUS ENT. CORP. JEFF TEPERMEYSTER
K002084 07/19/2000 MICROVASIVE LITHOTRIPTOR FLEXPROBE II BOSTON SCIENTIFIC CORP. ROBERT J MICHALIK
K001596 07/06/2000 LIFERX BOWDENGS TECHNOLOGIES, LLC. JEFFERY BOWDEN
K994413 07/13/2000 BRAINSCAN BRAINLAB AG STEFAN VILSMEIER
K994032 07/07/2000 FLUORO-TEX CARDIOVASCULAR PATCH BRIDGER BIOMED, INC. BRUCE G RUEFER
K992182 07/18/2000 CA GUARD, LTD. PSP (PORT SITE PROTECTOR) CA GUARD, LTD. FRANK M LEWIS
K001371 07/07/2000 CARDEON ASCENDING BALLOON CANNULA (ABC) CARDEON CORP. JANE BEGGS
K000837 07/11/2000 PUMA DENTAL CHAIR AND UNIT CASTELLINI S.P.A. GIULIANO LANZARINI
K001296 07/17/2000 SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM CAVENDISH SCOTT, INC. PAUL TRESE
K001050 07/21/2000 CALCIJECT CENTRIX, INC. SCOTT COHN
K001822 07/07/2000 THE V-BAG CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K001110 07/05/2000 CRYSTAL-EEG MODEL 15 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K001111 07/07/2000 PANORET, MODEL 1000A CMT MEDICAL TECHNOLOGIES, LTD. ILAN SHARON
K001698 07/17/2000 MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 COGENT LIGHT TECHNOLOGIES, INC. ED CURRIE
K001746 07/19/2000 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) COHERENT STAR ILIRIJA ENCINAS
K993420 07/19/2000 CONTROL SOLUTIONS INC, MODEL CS3101 CONTROL SOLUTIONS, INC. JOHN HAYDEN
K001087 07/20/2000 PTA BALLOON CATHETER COOK, INC. KAREN BRADBURN
K001135 07/03/2000 6F & 7F INTRODUCING CATHETERS (MODIFICATION) CORDIS CORP. DENNIS S GRIFFIN
K000062 07/07/2000 CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT CORDIS CORP. KAREN WILK
K001843 07/18/2000 S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. ELENA JUGO
K000647 07/13/2000 DATEX-OHMEDA NETWORK AND CENTRAL DATEX-OHMEDA, INC. JOEL KENT
K001317 07/21/2000 ARIA DEL MAR MEDICAL SYSTEMS, LLC. ED CRESPIN
K001372 07/27/2000 E-Z LINK CROSS CONNECTOR DEPUY ACROMED KAREN F JURCZAK
K001340 07/26/2000 STACKABLE CAGE SYSTEM DEPUY ACROMED KAREN JURCZAK
K001778 07/07/2000 POROCOAT PRODIGY HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K001982 07/26/2000 TRI-LOCK HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K001707 07/07/2000 DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K001388 07/28/2000 DATA MASTER PERFUSION MONITORING SYSTEM DIDECO ROSINA ROBINSON
K001794 07/12/2000 EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. JON CAPAROTTA
K001357 07/20/2000 MODIFICATION TO OMEGA 21 SYSTEM EBI, L.P. JONAS WILF
K001407 07/24/2000 SURGITRON IEC II ELLMAN INTL., INC. FRANK LIN
K001194 07/11/2000 STERICHEK TOTAL CHLORINE REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. DAVID A MORRIS
K001502 07/12/2000 AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO ERICH JAEGER GMBH LARRY MURDOCK
K001494 07/07/2000 MODIFICATION TO PROMPT L-POP ESPE DENTAL AG ANDREAS PETERMANN
K001625 07/10/2000 PRONOVA NONABSORBABLE SUTURE, USP ETHICON, INC. PETER M CECCHINI
K001166 07/07/2000 ULTRA V THERAPEUTIC ULTRASOUND EXCEL TECH. LTD. CAMERON MAHON
K001715 07/05/2000 POWDERED PATIENT EXAMINATION GLOVES, LATEX FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K001527 07/27/2000 FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES FOTONA D.D. MOJCA VALJAVEC
K001873 07/28/2000 HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR ELLINSFELD
K994266 07/06/2000 FDTENS 2010 FUJI DYNAMICS LIMITED TORU HORIUCHI
K994265 07/06/2000 MEDISANA DIGITAL TENS FUJI DYNAMICS LIMITED TORU HORIUCHI
K001156 07/07/2000 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET GAMBRO RENAL PRODUCTS BENITA BRADFORD
K001730 07/17/2000 GC FUJICEM GC AMERICA, INC. TERRY L JORITZ
K001518 07/05/2000 GRADIA GC AMERICA, INC. TERRY L JORITZ
K001359 07/18/2000 DASH 3000/4000 PATIENT MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K001268 07/17/2000 GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K001902 07/10/2000 BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD GYRUS ENT L.L.C. ALICIA FARAGE
K001728 07/27/2000 HARDY DISK CLARITHROMYCIN, 15MCG HARDY DIAGNOSTICS MELISSA TRAYLOR
K001959 07/26/2000 POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) HARTALEGA SDN BHD NURU AISYAH KONG
K001242 07/13/2000 ISOLETTE INFANT INCUBATOR, MODEL C2HS HILL-ROM AIR-SHIELDS JAMES G CARPENTER
K001334 07/06/2000 HITACHI AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K001886 07/12/2000 APEX FIXATION PINS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K001385 07/27/2000 HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K001844 07/19/2000 MODIFICATION TO CENTAUR SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001957 07/25/2000 MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K001419 07/27/2000 SOLAR SHOULDER OFFSET HUMERAL HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K001228 07/07/2000 EXTERNAL FIXATION ANCHOR PIN IMMEDICA, INC. ROY BOGERT
K001092 07/26/2000 GENERIC BLOOD GLUCOSE TEST STRIP INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K001349 07/27/2000 CARDIOVISE ECG INTERPRETATIVE SOFTWARE INOVISE MEDICAL, INC. DEBRA A OLSON
K001729 07/13/2000 FOCUS INSTRUMENTARIUM CORP. DOUG WOODS
K990144 07/11/2000 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM INTUITIVE SURGICAL, INC. MICHAEL DANIEL
K001777 07/24/2000 MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS INVACARE CORP. EDWARD A KROLL
K983667 07/05/2000 IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE IONICS MEDICAL CORP. M. LAINE MASHBURN
K001583 07/13/2000 ISLAND BIOSURGICAL BNS KIT #3 ISLAND BIOSURGICAL, LLC. HUNTER A MCKAY
K001469 07/05/2000 R&D PROJECT DW269#25 IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K001218 07/05/2000 CORRECT PLUS JENERIC/PENTRON, INC. ANNMARIE TENERO
K001623 07/11/2000 SCULPTURE FLOW JENERIC/PENTRON, INC. ANNMARIE TENERO
K001361 07/19/2000 JILCO TRACTION-FLEXION CHAIR JILCO ENTERPRISES DAVID K LEONARD
K001690 07/31/2000 PROTECTIV SAFETY BLOOD COLLECTION NEEDLE JOHNSON & JOHNSON MEDICAL, INC. DORENE MARKWIESE
K001445 07/26/2000 SMILIE PC JULIE ALLIANCE Claude Berthoin
K001630 07/19/2000 KSEA BIPOLAR COAGULATING ELECTRODES KARL STORZ ENDOSCOPY KEVIN KENNAN
K001362 07/17/2000 KARL STORZ 3D VIDEO SYSTEM KARL STORZ IMAGING, INC. TERRY FERNANDEZ
K001426 07/21/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K001423 07/21/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K001424 07/21/2000 KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K994214 07/19/2000 GEM KNEE SYSTEM KINAMED, INC. JOEL SLOMOFF
K000580 07/24/2000 ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 KLS-MARTIN L.P. ART WARD
K001129 07/06/2000 PROLONG, MODELS PL50, PL100, PL150 LIFE-TECH INTL., INC. JEFF KASOFF
K000610 07/21/2000 RESOLUTION CHOLESTEROL MONITOR LIFESTREAM TECHNOLOGIES, INC. JACK CONNOLLY
K001964 07/18/2000 OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION LOBOB LABORATORIES, INC. DANIEL J MANELLI
K001756 07/06/2000 LUNAR REPORT GENERATOR II LUNAR CORP. JAMES P RASKOB
K001812 07/10/2000 PEDIATRIC REFERENCE DATA LUNAR CORP. JAMES P RASKOB
K994158 07/24/2000 MACROSORBOS PROTECTIVE SHEET MACROPORE BIOSURGERY, INC. FLOYD G LARSON
K001845 07/05/2000 MALLINCKRODT, GOODKNIGHT 418S MALLINCKRODT DEVELOPPEMENT FRANCE MOUSTAFA ANKI
K001275 07/13/2000 RETCAM II MASSIE RESEARCH LABORATORIES, INC. BERT MASSIE
K001758 07/05/2000 DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) MEDICAL ANALYSIS SYSTEMS, INC. SCOT D KINGHORN
K991279 07/20/2000 MEDI-CULT UNIVERSAL IVF-MEDIUM MEDICULT A/S RONALD G LEONARDI
K001831 07/11/2000 NEEDLELESS TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. BRUCE F MACKLER
K001165 07/05/2000 POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MEDIPURE CORPORATION (M) SDN. BHD. LEE SON HONG
K994141 07/21/2000 CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 MEDTRONIC AVE, INC. SHELLY TRIMM
K001255 07/11/2000 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K000887 07/26/2000 DRX HBA1C METRIKA, INC. JOEAL M BLATT
K001370 07/17/2000 ACCUSONIC PLUS, MODEL AP-100 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K001966 07/20/2000 REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND MICRO THERAPEUTICS, INC. MARIBELLE AGUINALDO
K000902 07/11/2000 KLINIDRAPE REINFORCED SURGICAL GOWNS MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K000901 07/05/2000 KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K001217 07/11/2000 INSIDE VIEW MONADNOCK OPTICS, INC. LEONARD J BONNELL
K001619 07/26/2000 MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K001497 07/26/2000 MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K993909 07/19/2000 NANMA VACUUM PUMP NANMA MFG CO., LTD. E.J. Smith
K001911 07/07/2000 IM-9A MICROINJECTORS NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001912 07/07/2000 IM-9B MICROINJECTORS NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001910 07/07/2000 IM-9C MICROINJECTORS NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001324 07/11/2000 SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) NEURO SCAN LABS DAVID B JONES
K001231 07/11/2000 THE KALIX IMPLANT NEWDEAL S.A. NORMAN F ESTRIN
K990119 07/27/2000 EPI-STAR SURGICAL LASER SYSTER NIDEK, INC. JERRY TSUTSUMI
K001251 07/07/2000 SNIPER, MODEL OR-3872XX SERIES NIPRO MEDICAL CORP. JACK FRAUTSCHI
K001369 07/26/2000 RESPIEVENTS, VERSION 4.2 NON-INVASIVE MONITORING SYSTEMS, INC. MARVIN A SACKNER, M.D.
K001930 07/20/2000 MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 NONIN MEDICAL, INC. RICHARD P BENNETT
K001288 07/20/2000 DR180-II NORTHEAST MONITORING, INC. RODNEY L CAMBRE
K001328 07/17/2000 INTRODUCER SHEATH NOVASYS MEDICAL, INC. THOMAS C WEHMAN
K001804 07/12/2000 NUMED Z-5 ATRIOSEPTOSTOMY CATHETER NUMED, INC. NICHELLE LAFLESH
K001323 07/25/2000 NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW NUVASIVE, INC. LAETITIA BERNARD
K001848 07/03/2000 OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 OMRON HEALTHCARE, INC. OSAMU SHIRASAKI
K992414 07/21/2000 PROTON BEAM THERAPY SYSTEM (PBTS) OPTIVUS TECHNOLOGY, INC. RENEE J THIBEAULT
K001885 07/20/2000 VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. MARLENE SHULMAN
K001167 07/07/2000 OPI BAND ORTHOMERICA PRODUCTS, INC. WILLIAM H.E. VON OEHSEN
K001032 07/24/2000 RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY OTSUKA PHARMACEUTICAL CO., LTD. JAMES W HARRIS
K001890 07/24/2000 SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR) OTTO BOCK ORTHOPAEDISCHE INDUSTRIE, KG. E. P. BERT HARMAN
K993527 07/06/2000 LOOP ELECTRODE, BALL ELECTRODE PALM MEDICAL USA, INC. MARK J KAHN
K001516 07/12/2000 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K001612 07/18/2000 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K001386 07/17/2000 ACCUSET SENSOR, MODEL 2000 PELVICARE, INC. WALTER D WALLACH
K001716 07/19/2000 REDON SET PFM PRODUKTE FUR DIE MEDIZIN AG SALVADORE F PALOMARES
K001942 07/25/2000 SL-PLUS AND SLR-PLUS STEMS PLUS ORTHOPEDICS HARTMUT LOCH
K000586 07/03/2000 BIOSCANNER TRIGLYCERIDES TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K001418 07/05/2000 ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S PROCERA SANDVIK, INC. MARTIN STERNER
K000124 07/10/2000 SENSATION -VACUUM ASSIST DEVICES PROSURG, INC. LEE BUI
K993674 07/13/2000 POCKET ULTRASONIC PACHYMETER QUANTEL MEDICAL GEORGE MYERS
K001117 07/05/2000 COMFORT STIM R & D MEDICAL PRODUCTS, INC. JAMES TRAN
K001236 07/17/2000 RIZA BAND STRETCHER (RBS)-60000 R-MED, INC. EROL D RIZA
K001950 07/26/2000 OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. KEVIN J O'CONNELL
K001906 07/13/2000 ELECSYS INSULIN CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K993706 07/24/2000 ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K001421 07/12/2000 ONTRAK TESTCUP 501, MODEL 3016633 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K001356 07/10/2000 ONTRAK TESTCUP PRO-5, MODEL 1986678 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K001143 07/07/2000 RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER ROCHESTER MEDICAL CORP. MARY WILEN
K001298 07/18/2000 J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR ROLL-ABILITY (PTY) LTD. KEITH F MYBURGH
K001446 07/21/2000 LIGHT-CURED ORTHODONTIC BAND CEMENT SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K001723 07/19/2000 COOL-TEC ELECTRODES SEEDLING ENTERPRISES. LLC. PAMELA PAPINEAU
K002049 07/27/2000 INVERNESS MEDICAL EARLY PREGNANCY TEST SELFCARE, INC. CAROL A ADILETTO
K002175 07/31/2000 NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR SGMP CO., LTD. JANNA P TUCKER
K002176 07/31/2000 NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE SGMP CO., LTD. JANNA P TUCKER
K001432 07/05/2000 DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PM PLASTICS ENT. CO., LTD. CHANG T SUN
K001837 07/11/2000 NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K001836 07/26/2000 NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K001863 07/11/2000 SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. JAMES CHU
K001861 07/11/2000 SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. JAMES CHU
K993741 07/03/2000 EZ LDL CHOLESTEROL TEST SYSTEM SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K001318 07/20/2000 CPAP SYSTEM, MODEL 102001 SIMS PORTEX, INC. BRIAN D FARIAS
K001466 07/26/2000 VOCOM SILICONE SYSTEM SMITH & NEPHEW, INC. ALICIA E FARAGE
K001745 07/27/2000 MODIFICATION TO PROVIDENT HIP SYSTEM STELKAST COMPANY DONALD A STEVENS
K001536 07/27/2000 INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K001320 07/07/2000 SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K993328 07/18/2000 SURGILIGHT, INC EXCIMER LASER SURGILIGHT, INC. TIMOTHY J SHEA
K001876 07/21/2000 TAKE 1 BITE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K994016 07/14/2000 PHARMASEED, MODEL BT-103-3 SYNCOR PHARMACEUTICALS, INC. GARY GILMORE
K994018 07/17/2000 PHARMASEED, MODEL BT-125-3 SYNCOR PHARMACEUTICALS, INC. GARY GILMORE
K001276 07/17/2000 MEDICAL IMAGE MERGE (MIM) SYNTERMED, INC. KENNETH F VAN TRAIN
K994161 07/28/2000 SYNTHES BIORESORBABLE SUTURE ANCHOR SYNTHES (USA) SHERI L MUSGNUNG
K001864 07/20/2000 SYNTHES CERVIFIX SYSTEM SYNTHES SPINE JONATHAN GILBERT
K990365 07/26/2000 GASTRIC LAVAGE VALVE T-MED VAC CORPORATION LANIS P PFOLSGROF
K001772 07/06/2000 LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA TARACAN PTY. LTD. KEITH DEGENHARDT
K001337 07/05/2000 DANIELS SHARPSMART REUSABLE SHARPS CONTAINER THE DANIELS CORP. FLOYD G LARSON
K001515 07/31/2000 PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 THE PROMETHEUS GROUP RICHARD HORTON
K000944 07/19/2000 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. KEITH MULLOWNEY
K001524 07/12/2000 FORMA SCIENTIFIC DIRECT HEAT INCUBATORS THERMOQUEST CORP. RICHARD L MILLER
K002071 07/24/2000 SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES TISSUE TECHNOLOGIES, INC. JESSE KRAMER
K000050 07/27/2000 TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES TOP QUALITY MFG., INC. ART WARD
K001932 07/20/2000 TORNIER CEMENT RESTRICTOR TORNIER DAVID W SCHLERF
K001573 07/18/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K001558 07/24/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K001137 07/05/2000 AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) TRUDELL MEDICAL INT'L TOM HOLBROOK
K993205 07/20/2000 BOOKER BOX, MODEL PAD 5010 TZ MEDICAL, INC. BYRON KAHLER
K001450 07/18/2000 AUTO SUTURE MICRO SURGICLIP CLIP APPLIER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER A GRAHAM
K993996 07/17/2000 UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE UNIVEC, INC. S LEVINSON
K001582 07/17/2000 LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE USA INSTRUMENTS, INC. RONY THOMAS
K001541 07/21/2000 MINICAM VIDEO DENTAL CONCEPTS, INC. Claude Berthoin
K001430 07/05/2000 RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K002046 07/21/2000 MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC. HOWARD M HOLSTEIN
K001789 07/06/2000 SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
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K001931 07/24/2000 WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET WAKO CHEMICALS, USA, INC. TONYA MALLORY
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K001933 07/24/2000 WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO WAKO CHEMICALS, USA, INC. TONYA MALLORY
K001929 07/24/2000 WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA WAKO CHEMICALS, USA, INC. TONYA MALLORY
K001920 07/23/2000 WAKO AUTOKIT LP(A)/ RA,500/1000, WAKO CHEMICALS, USA, INC. TONYA MALLORY
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K001265 07/13/2000 WELCH ALLYN INSTRUMENT INTERFACE MODULE WELCH ALLYN, INC. DAVID KLEMENTOWSKI
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