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 |
K001612 |
07/18/2000 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K001516 |
07/12/2000 |
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 |
K001533 |
07/31/2000 |
SURGIFLATOR-40 |
W.O.M. GMHB |
MICHAEL MCGRAIL |
K001931 |
07/24/2000 |
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K001934 |
07/24/2000 |
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
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 |
K001919 |
07/23/2000 |
WAKO AUTOKIT LP(A)/DADE DEMENSION |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K001921 |
07/23/2000 |
WAKO AUTOKIT LP(A)/EXPRESS 550 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K001265 |
07/13/2000 |
WELCH ALLYN INSTRUMENT INTERFACE MODULE |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
K001989 |
07/25/2000 |
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |