| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K993888 |
12/20/1999 |
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS |
A & D ENGINEERING, INC. |
JERRY WANG |
| K991541 |
12/28/1999 |
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 |
A-MED SYSTEMS, INC. |
ROBERTA THOMPSON |
| K991246 |
12/16/1999 |
FRUCTOSAMINE, MODEL FR 106-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K994039 |
12/22/1999 |
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB |
ABBOTT LABORATORIES |
JERRY JENNINGS |
| K992531 |
12/20/1999 |
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM |
ACCUMETRICS, INC. |
FRANCES E HARRISON |
| K993774 |
12/07/1999 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K993317 |
12/01/1999 |
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
| K993203 |
12/01/1999 |
ACON ONE STEP PREGNANCY TEST STRIP (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
| K992631 |
12/15/1999 |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER |
ACUSON CORP. |
HOWARD M HOLSTEIN |
| K993544 |
12/22/1999 |
SPACE-OR RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA CULLINANE |
| K991401 |
12/15/1999 |
ATR 3000, ATR 2000, IMPLANT-PRO |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. |
CAROL A PATTERSON |
| K992995 |
12/09/1999 |
AROMATIC AND FLAVORED TONGUE DEPRESSOR |
AGA PLASTIC IND. COM. LTDA. |
SUSAN D GOLDSTEIN-FALK |
| K993276 |
12/14/1999 |
SIMPLIFY D-DIMER, MODEL DCGK1 |
AGEN BIOMEDICAL LTD. |
RUSSEL RICHARDS |
| K993907 |
12/06/1999 |
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K993887 |
12/20/1999 |
ALATECH LATEX CONDOM |
ALATECH HEALTHCARE, LLC. |
WAYNE L GAINEY |
| K993833 |
12/10/1999 |
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K990643 |
12/07/1999 |
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
AMAURY SANCHEZ |
| K993796 |
12/21/1999 |
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K993135 |
12/01/1999 |
IMPLANTABLE CLIP FOR GENERAL SURGERY |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K993650 |
12/28/1999 |
URETERAL ACCESS SHEATH SET - NEW MODELS |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K992232 |
12/21/1999 |
FIRST RESPONSE 1-STEP PREGNANCY |
ARMKEL, LLC. |
Maureen Garner |
| K993283 |
12/29/1999 |
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C |
ARNOLD & RICHTER CINE TECHNIK |
THOMAS POPP |
| K990398 |
12/01/1999 |
PLATELETWORKS |
ARRAY MEDICAL, INC. |
DAVID CARVILLE |
| K992581 |
12/09/1999 |
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K993837 |
12/16/1999 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K992502 |
12/21/1999 |
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY |
AXIS |
RONALD G LEONARDI |
| K993711 |
12/16/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) |
BAYER CORP. |
GABRIEL MURACA |
| K993309 |
12/06/1999 |
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY |
BAYER CORP. |
William J Pignato |
| K993571 |
12/16/1999 |
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 |
BAYER CORP. |
THOMAS F FLYNN |
| K993353 |
12/06/1999 |
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA JR |
| K993577 |
12/01/1999 |
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
MONICA E GIGUERE |
| K993500 |
12/02/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K994149 |
12/27/1999 |
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K993107 |
12/21/1999 |
BIO-RAD HOMOCYSTEINE BY HPLC |
BIO-RAD |
Patricia M Klimley |
| K991756 |
12/10/1999 |
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE |
BIO-RESEARCH ASSOCIATES, INC. |
LONNIE WITHAM |
| K993529 |
12/29/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
BIOGRAFIK (MALAYSIA) SDN BHD |
SHUKUR BIN HASRAN |
| K993708 |
12/03/1999 |
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG |
BIOMAGNETIC TECHNOLOGIES, INC. |
EUGENE C HIRSCHKOFF |
| K993033 |
12/16/1999 |
INTRAY GC |
BIOMED DIAGNOSTICS, INC. |
ROBERT D HALL |
| K992355 |
12/20/1999 |
LACTOSORB TRAUMA PLATING SYSTEM |
BIOMET, INC. |
TRACY J BICKEL |
| K994038 |
12/22/1999 |
MODULAR REACH HIP |
BIOMET, INC. |
FRED MCCLURE |
| K993956 |
12/20/1999 |
TITANIUM PEDIATRIC FEMORAL NAIL |
BIOMET, INC. |
LONNIE WITHAM |
| K993945 |
12/07/1999 |
BIONIKE AQ PHENCYCLIDINE (PCP) TEST |
BIONIKE LABORATORIES, INC. |
CLEVE W LAIRD |
| K993074 |
12/10/1999 |
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K993073 |
12/06/1999 |
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K993729 |
12/03/1999 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
SANDRA WILLIAMSON |
| K993118 |
12/17/1999 |
BIOTEQUE A.V. FISTULA NEEDLE SET |
BIOTEQUE CORP. |
ALLEN REICH |
| K993139 |
12/17/1999 |
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K993449 |
12/20/1999 |
BIRD V.I.P. GOLD/STERLING |
BIRD PRODUCTS CORP. |
DARRYL SHELBY |
| K993591 |
12/28/1999 |
BLADEWORKS DISPOSABLE ALK TUBING |
BLADE WORKS, INC. |
GARY MOCNIK |
| K993115 |
12/17/1999 |
MULTITAK SS |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K993232 |
12/30/1999 |
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
RONALD W BENNETT |
| K991139 |
12/22/1999 |
GUGLIELMI DETACHABLE (GDC) |
BOSTON SCIENTIFIC, TARGET |
JIM LEATHLEY |
| K993464 |
12/10/1999 |
BARDEX I.C. PEDIATRIC FOLEY CATHETER |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
| K994009 |
12/21/1999 |
CG-2100 ECG TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K993799 |
12/10/1999 |
CG-7000DX ECG RECORDER/TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K993634 |
12/02/1999 |
CARESIDE ANALYZER |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993771 |
12/27/1999 |
CARESIDE DIRECT BILIRUBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K990058 |
12/15/1999 |
QMS MAPPING SYSTEM,MODEL 2000 |
CATHDATA, INC. |
RICHARD KEEN |
| K993860 |
12/03/1999 |
CATHETER INNOVATIONS IMPLANTABLE PORT |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K993375 |
12/20/1999 |
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
COLIN ALDERSLEY |
| K993001 |
12/03/1999 |
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED |
COBE CARDIOVASCULAR, INC. |
LYNN LEONARD |
| K993304 |
12/06/1999 |
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K993255 |
12/06/1999 |
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993710 |
12/21/1999 |
MODIFICATION OF PARAPOST CEMENT |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993835 |
12/16/1999 |
PARAPOST SYSTEM STERILIZABLE ORGANIZER |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K992121 |
12/20/1999 |
EMBOLIZATION COIL SYSTEM |
COOK, INC. |
LISA WEBB |
| K994068 |
12/23/1999 |
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA JUGO |
| K993299 |
12/07/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K993102 |
12/02/1999 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
TREVOR WALL |
| K983746 |
12/09/1999 |
MICROSTREP PLUS PANEL |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K993855 |
12/15/1999 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K993296 |
12/15/1999 |
TRIP TONOMETRY CATHETER, 14F |
DATEX-OHMEDA, INC. |
JOEL KENT |
| K993717 |
12/22/1999 |
ENIGMA HI-BASE DENTURE BASE MATERIAL |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
| K993099 |
12/15/1999 |
BREMER HALO SYSTEM TITANIUM SKULL PIN |
DEPUY ACROMED |
FRANK MASS |
| K993030 |
12/29/1999 |
MODIFICATION TO ISOLA SPINAL SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
| K993952 |
12/16/1999 |
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K992552 |
12/16/1999 |
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K994110 |
12/21/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN/AMERICAN STANDARD COMPANIES |
JUDITH J SMITH |
| K993681 |
12/21/1999 |
DIGITEC TWO STAGE COMPRESSION KIT |
DIGITEC MEDICAL SERVICE CORP. |
JAMES J MCGINITY |
| K994197 |
12/29/1999 |
DISENTRONIC PENFINE INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K994186 |
12/30/1999 |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K991714 |
12/10/1999 |
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K992209 |
12/10/1999 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
T. WHIT ATHEY |
| K992949 |
12/27/1999 |
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST |
DRUG DETECTION DEVICES, LTD. |
BRUCE CHRISTIE |
| K984564 |
12/02/1999 |
ETHYL CHLORIDE DISPENSER |
DUKAL CORP. |
ED RASOM |
| K993822 |
12/10/1999 |
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K993886 |
12/14/1999 |
EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K992479 |
12/02/1999 |
ENSITE 3000 SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
JAMES W BULLOCK |
| K992211 |
12/22/1999 |
SPO2 WRAP SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K992092 |
12/22/1999 |
STAT-SHELL DISPOSABLE SPO2 SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K993566 |
12/06/1999 |
PROMPTFLOW |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K993054 |
12/09/1999 |
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
| K991439 |
12/20/1999 |
POLLER CALIBRANTS |
EUROPEAN CONCERTED ACTION ON ANTICOAGULATION |
L. POLLER |
| K993820 |
12/02/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS |
FELDA RUBBER CORP. |
YUNUS LATIF |
| K993450 |
12/29/1999 |
LATEX SURGICAL GLOVES, PRE-POWDERED |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH PEREIRA |
| K993095 |
12/09/1999 |
FRIALIT-2 SELECT COMPONENTS |
FRIADENT GMBH |
CAROL PATTERSON |
| K993687 |
12/21/1999 |
UROVIEW 2800 |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K993645 |
12/21/1999 |
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K994075 |
12/27/1999 |
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K993202 |
12/17/1999 |
EIM-107 PREP-CHECK |
GENERAL DEVICES |
MICHAEL SMITH |
| K993752 |
12/03/1999 |
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K993127 |
12/02/1999 |
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) |
GLOVESWORLD INDUSTRIES SDN. BHD. |
BIEN LONG NIEN |
| K992456 |
12/21/1999 |
GRADILEIDEN V TEST |
GRADIPORE LTD. |
RHONDA PILGRIM |
| K993386 |
12/20/1999 |
LATEX EXAMINATION POWDERED GLOVES |
GREAT GLOVE SDN BHD |
K.M. LEE |
| K990079 |
12/23/1999 |
FASTSEAL CHEST WOUND DRESSING |
GREENFIELD MEDICAL TECHNOLOGIES, INC. |
DONALD R GORSUCH |
| K991964 |
12/20/1999 |
EIS THREADED SCREW FRACTURE FIXATION |
GROUPE LEPINE |
DOUGLAS W STUART |
| K994166 |
12/27/1999 |
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K993749 |
12/03/1999 |
GYRUS HYSTEROSCOPIC RESECTOSCOPE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K993812 |
12/21/1999 |
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K |
HARDY DIAGNOSTICS |
MELISSA M TAYLOR |
| K993993 |
12/27/1999 |
HARDYDISK AMIKACIN 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
| K993994 |
12/21/1999 |
HARDYDISK AZITHROMYCIN 15MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K991492 |
12/02/1999 |
LC COMPOSITE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K993716 |
12/21/1999 |
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K990807 |
12/03/1999 |
HL148 & HL168 |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K993766 |
12/08/1999 |
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
HELAX AB |
E.S. MARTELL |
| K993330 |
12/30/1999 |
THERMOCHEM-HT SYSTEM |
HEMOCLEANSE, INC. |
STEPHEN R ASH |
| K993602 |
12/15/1999 |
PRE-VISION FILL |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K993932 |
12/22/1999 |
SOLITAIRE 2 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K992977 |
12/01/1999 |
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A |
HEWLETT-PACKARD CO. |
WARREN R WALTERS |
| K993169 |
12/20/1999 |
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A |
HEWLETT-PACKARD CO. |
SHEILA W PICKERING, PHD. |
| K992595 |
12/08/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K993692 |
12/02/1999 |
DURACON INSET PATELLA, 25MM |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K990849 |
12/20/1999 |
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K993402 |
12/20/1999 |
OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K983637 |
12/10/1999 |
ACTIFRESH 400 LENS |
HYDRON LTD. |
JULIAN B HOLLOWAY |
| K993673 |
12/21/1999 |
SNN FLUORO NAVIGATION SYSTEM |
I.S.G. TECHNOLOGIES, INC. |
DOLORES MCGIRR |
| K993338 |
12/29/1999 |
INTEGRATED DIGITAL MEDICAL RECORD (IDMR) |
IBM ISRAEL LTD. |
ELI M ORBACH |
| K993936 |
12/27/1999 |
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE |
IMAGYN SURGICAL |
JULIE POWELL |
| K992759 |
12/06/1999 |
COLON ALERT TEST |
IMMUNOSTICS, INC. |
VINCENT P LASTELLA |
| K993532 |
12/15/1999 |
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) |
IMPAX TECHNOLOGY, INC. |
PAULA PFEIFLE |
| K993693 |
12/29/1999 |
INVIGRA |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K994010 |
12/17/1999 |
INNOVAQUARTZ GENERAL SHAPE LASER FIBER |
INNOVAQUARTZ |
RANDY MCLELLAN |
| K993975 |
12/20/1999 |
ABSOLUTE ABSORBABLE INTERFERENCE SCREW |
INNOVASIVE DEVICES, INC. |
KATHLEEN MORAHAN |
| K993808 |
12/06/1999 |
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K991074 |
12/21/1999 |
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST |
INTRACEL CORP. |
SHERYL RUPPEL |
| K993153 |
12/17/1999 |
INTRALASE 600C LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K993413 |
12/15/1999 |
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL |
INVACARE CORP. |
EDWAED A KROLL |
| K992298 |
12/09/1999 |
IRIDERM, MODEL APEX 800 |
IRIDEX CORP. |
BRAD RENTON |
| K991878 |
12/10/1999 |
LUMA-CATH STEERABLE EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K991339 |
12/06/1999 |
TYRODE'S SOLUTION-ACIDIFIED |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K993783 |
12/13/1999 |
TETRIC FLOW |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K993482 |
12/06/1999 |
K-ASSAY FIBRINOGEN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993853 |
12/27/1999 |
K-ASSAY MULTI-ANALYTE CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993539 |
12/15/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K992954 |
12/21/1999 |
KEELER CRYO MASTER & PROBES |
KEELER INSTRUMENTS, INC. |
EUGENE R VAN ARSDALE |
| K980760 |
12/21/1999 |
KLS-MARTIN MMF SCREW |
KLS-MARTIN L.P. |
PATRICK J LAMB |
| K993668 |
12/20/1999 |
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
LAERDAL MEDICAL A/S |
MAGNE STEINSET |
| K993096 |
12/20/1999 |
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR |
LIFESTREAM TECHNOLOGIES, INC. |
JACKSON B CONNOLLY |
| K993339 |
12/10/1999 |
ENDOPEARL WITH THREADER |
LINVATEC CORP. |
LAURA SENEFF |
| K993883 |
12/21/1999 |
M-PACT CORNEAL LIGHT SHIELD |
M-PACT CORP. |
AL BOEDEKER |
| K990110 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990112 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990113 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990111 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990115 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K983250 |
12/12/1999 |
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR |
MAGNETIC RESONANCE EQUIPMENT CORP. |
G.RONALD MORRIS |
| K984088 |
12/06/1999 |
OPTISTAR MR INJECTOR SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
BRIDGET DRAKE |
| K993008 |
12/06/1999 |
QUANTITATIVE SENTINEL SYSTEM |
MARQUETTE MEDICAL SYSTEMS, INC. |
MARIA VITUG FOUTS |
| K993572 |
12/13/1999 |
CERADIUM V NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
| K993530 |
12/15/1999 |
SYSTEM 2100 |
MATH SOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K990173 |
12/21/1999 |
PATHFINDER II ANGIOGRAPHIC CATHETER |
MAXXIM MEDICAL |
EDDIE MONROE |
| K991441 |
12/28/1999 |
CADENCE DOPPLER ULTRASOUND SYSTEM |
MEDASONICS, INC. |
WILLIAM E MCKAY |
| K992943 |
12/10/1999 |
VIT ENHANCER |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
LINDA M UPTON |
| K993764 |
12/16/1999 |
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH |
MEDIPACK MEDICAL PACKAGING MFG. CO. |
NORMAN F ESTRIN |
| K993761 |
12/28/1999 |
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K992111 |
12/16/1999 |
VERDICT -II OPIATES 2000 |
MEDTOX DIAGNOSTICS, INC. |
|
| K993226 |
12/10/1999 |
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 |
MEMCATH TECHNOLOGIES LLC. |
MARC JAKER |
| K993308 |
12/13/1999 |
MENTOR EVACARE VAGINAL PESSARIES |
MENTOR CORP. |
DONNA A CRAWFORD |
| K993914 |
12/10/1999 |
PREMIER TOXINS A&B, MODEL 616096 |
MERIDIAN DIAGNOSTICS, INC. |
DAVID H WILLIS |
| K993475 |
12/09/1999 |
AUROFLUID M, ALLOY NO. 5315 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993474 |
12/02/1999 |
DELTAPAL, ALLOY NO. 5161 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993506 |
12/08/1999 |
PAGALINOR 4 , ALLOY NO. 5440 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993505 |
12/08/1999 |
V-DELTA SPECIAL, ALLOY NO. 5154 |
METALOR DENTAL USA CORP. |
KENNITH A PUTNEY |
| K993508 |
12/06/1999 |
V-SUPRA PLUS, ALLOY NO. 5025 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993507 |
12/06/1999 |
V-SUPRAGOLD, ALLOY NO. 5024 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993821 |
12/09/1999 |
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT |
METRON MEDICAL AUSTRALIA PTY LTD |
R.H. HOPKINS |
| K993575 |
12/29/1999 |
RESOLVE QUICKANCHOR |
MITEK PRODUCTS |
PAULA E BULGER |
| K993327 |
12/16/1999 |
TALON ANCHOR SNAP-PAK |
MITEK PRODUCTS |
PAULA E BULGER |
| K993261 |
12/02/1999 |
TALON ANCHOR SNAP-PAK |
MITEK PRODUCTS |
PAULA A BULGER |
| K992148 |
12/29/1999 |
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT |
MORAX |
BOREK JANIK |
| K992074 |
12/23/1999 |
MPM REGENECARE WOUND GEL |
MPM MEDICAL, INC. |
RICHARD A HAMER |
| K993776 |
12/03/1999 |
OBC-300 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993819 |
12/03/1999 |
QWH-300 WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K991656 |
12/02/1999 |
AED ARTHROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993689 |
12/15/1999 |
AED CYSTOSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993688 |
12/06/1999 |
AED LAPAROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993130 |
12/17/1999 |
ULTRA-GARMENT ELECTRODE |
NEWWAVE MEDICAL LLC. |
ROBERT ARMSTRONG |
| K993643 |
12/28/1999 |
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 |
NEXAN TELEMED LTD. |
KENNETH PALMER |
| K991882 |
12/08/1999 |
NEXFLEX TOTAL KNEE SYSTEM |
NEXMED, INC. |
JASON BLAIN |
| K992188 |
12/06/1999 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 |
NICHOLS INSTITUTE DIAGNOSTICS |
JAMES A RYBSKI |
| K993890 |
12/01/1999 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K993359 |
12/21/1999 |
RAPTOR TREATMENT PLANNING SYSTEM |
NOMOS CORP. |
WILLIAM O CHISHKO |
| K993104 |
12/02/1999 |
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR |
NOVA BIOMEDICAL CORP. |
PAUL W MAC DONALD |
| K993062 |
12/10/1999 |
CHEST DRAINAGE TUBING |
OLSON MEDICAL SALES, INC. |
GARRY A COURTNEY |
| K990416 |
12/23/1999 |
OMNICORDER BIOSCAN SYSTEM |
OMNICORDER TECHNOLOGIES, INC. |
MARK FAUCI |
| K993445 |
12/06/1999 |
OMNISONIC ENDOSCOPIC DEFLECTOR |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
| K993628 |
12/15/1999 |
OMNISONICS ULTRASONIC PROBES |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
| K993854 |
12/06/1999 |
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES |
ORATEC INTERVENTIONS, INC. |
SHIELA RAMERMAN |
| K993967 |
12/17/1999 |
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 |
ORATEC INTERVENTIONS, INC. |
JENNIFER BRENNAN |
| K993576 |
12/14/1999 |
BACT/ALERT MP PROCESS BOTTLE |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K993423 |
12/15/1999 |
BACT/ALERT SA |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K993421 |
12/14/1999 |
BACT/ALERT SN |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K994145 |
12/22/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K993926 |
12/17/1999 |
OMNIAXIAL CONNECTOR |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K990899 |
12/21/1999 |
HEMOCHEK-A1C SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K993379 |
12/16/1999 |
PALL SUPOR AEF FILTER |
PALL CORP. |
LEONARD S BERMAN |
| K993621 |
12/29/1999 |
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K993486 |
12/22/1999 |
PARAGON LENS CARRIER |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K993487 |
12/22/1999 |
PARAGON LENS VIAL |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K991562 |
12/28/1999 |
PASCAL MEDICAL AB MENIETT 20 |
PASCAL MEDICAL AB |
JEFFREY R SIDEMAN |
| K994237 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9063 |
PHAMATECH |
CARL A MONGIOVI |
| K994233 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9068 |
PHAMATECH |
CARL A MONGIOVI |
| K994219 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9073 |
PHAMATECH |
CARL A MONGIOVI |
| K994220 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9078 |
PHAMATECH |
CARL A MONGIOVI |
| K994234 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9083 |
PHAMATECH |
CARL A MONGIOVI |
| K994236 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9133 |
PHAMATECH |
CARL A MONGIOVI |
| K994093 |
12/16/1999 |
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C |
PHAMATECH |
CARL A MONGIOVI |
| K993388 |
12/01/1999 |
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K990329 |
12/07/1999 |
PHILIPS EASYVISION WORKSTATION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K993227 |
12/21/1999 |
PHILIPS INTURIS DICOM RECORDER |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K993590 |
12/21/1999 |
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS JR. |
| K983860 |
12/27/1999 |
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K994045 |
12/21/1999 |
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 |
PRIMUS CORP. |
JIM NOFFSINGER |
| K991575 |
12/03/1999 |
PRIMUS STEAM STERILIZERS |
PRIMUS STERILIZER CO., INC. |
JEFF REED |
| K993435 |
12/06/1999 |
MANUAL BONE MARROW BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K993683 |
12/13/1999 |
PULPDENT UNO-DUO |
PULPDENT CORP. |
KENNETH J BERK |
| K993271 |
12/02/1999 |
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS |
QUALITY LATEX CORP. SDN BHD |
SHARENE WAN |
| K990258 |
12/21/1999 |
QUANTECH TOTAL B-HCG ASSAY |
QUANTECH LTD. |
ROBIN HELLEN |
| K992482 |
12/27/1999 |
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) |
RADIANCY, LTD. |
JONATHAN S KAHAN |
| K993594 |
12/15/1999 |
CONFORMAX MMLC VR1 |
RADIONICS, INC. |
NANCY MACDONALD |
| K993443 |
12/17/1999 |
RTD ARM ASSISTIVE ROBOTIC DEVICE |
REHABILITATION TECHNOLOGIES DIVISION |
RICHARD M MAHONEY |
| K993103 |
12/10/1999 |
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARA |
| K993944 |
12/02/1999 |
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE |
RITA MEDICAL SYSTEMS |
ERIN DIGNAN-MAZZONE |
| K990390 |
12/10/1999 |
HEPARIN IV FLUSH SYRINGE, 10 U/ML \ |
ROCAP DIV. OF SABRATEK CORP. |
AVIA TONEY |
| K990308 |
12/10/1999 |
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML |
ROCAP DIV. OF SABRATEK CORP. |
AVIA TONEY |
| K993829 |
12/09/1999 |
ACCU-CHEK SIMPLICITY SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K993048 |
12/20/1999 |
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
| K974503 |
12/01/1999 |
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K993542 |
12/29/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K993432 |
12/20/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K993063 |
12/09/1999 |
RUSCH BRILLANT SILICONE FOLEY |
RUSCH INTL. |
JULIE A BEAUMONT |
| K993651 |
12/23/1999 |
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
SC HENNIG ENTERPRISES EUROPE SRL |
GEORGE O'NEIL |
| K992939 |
12/09/1999 |
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K993631 |
12/09/1999 |
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K994036 |
12/20/1999 |
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K993947 |
12/21/1999 |
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY |
SIEMENS CORP. |
ALICIA JUERGENSEN |
| K993731 |
12/23/1999 |
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K992711 |
12/06/1999 |
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K992712 |
12/06/1999 |
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K993106 |
12/09/1999 |
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) |
SMITH & NEPHEW, INC. |
JANET JOJNSON GREEN |
| K993289 |
12/20/1999 |
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K994175 |
12/21/1999 |
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE |
SODEM SYSTEMS |
DANIEL BACCINO |
| K993851 |
12/27/1999 |
SODEM PERFORATOR DRIVE |
SODEMSYSTEMS |
DANIEL BACCINO |
| K993142 |
12/27/1999 |
ELITE CUSTOM |
SOMA BLUE, INC. |
JOHN M MITCHELL |
| K993143 |
12/27/1999 |
VITALITY SYSTEM |
SOMA BLUE, INC. |
JOHN M MITCHELL |
| K994096 |
12/20/1999 |
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K993868 |
12/21/1999 |
THE SOUNDVASER DISSECTION SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K981655 |
12/03/1999 |
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR |
SPACELABS MEDICAL, INC. |
NANCY GERTLAR |
| K990959 |
12/27/1999 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
PAMELA SNYDER |
| K993454 |
12/03/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K993457 |
12/02/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K992587 |
12/22/1999 |
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM |
STELLAR BIO SYSTEMS, INC. |
JOHN BREWER |
| K992384 |
12/01/1999 |
CPAP/PRO CPAP INTERFACE |
STEVENSON INDUSTRIES, INC. |
DAVID W SCHLERF |
| K991835 |
12/20/1999 |
HANG UPS POWER II |
STL INTL., INC. |
ROGER C TEETER |
| K992635 |
12/20/1999 |
INTERFACE MODULE IDDD |
STOECKERT INSTRUMENTE |
MARY MCNAMARA-CULLINANE |
| K991706 |
12/07/1999 |
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE |
STRYKER CORP. |
NICOLE PETTY |
| K994053 |
12/20/1999 |
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE |
STRYKER INSTRUMENTS |
SUSANNE VELAQUEZ |
| K993288 |
12/29/1999 |
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM |
SULZER CARBOMEDICS, INC. |
EDWARD E NEWTON |
| K993569 |
12/01/1999 |
APR METASUL ACETABULAR INSERT |
SULZER MEDICA |
MITCHELL A DHORITY |
| K993043 |
12/02/1999 |
MS-30 FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K990503 |
12/09/1999 |
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS |
SULZERMEDICA |
EDWARD E NEWTON |
| K993485 |
12/27/1999 |
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K992626 |
12/16/1999 |
SURE-WAY REUSABLE SHARPS CONTAINER |
SURE-WAY SYSTEMS, INC. |
GARY CHILCOTT |
| K992927 |
12/29/1999 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ANGELIQUE DESTRUEL |
| K993072 |
12/10/1999 |
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) |
SURVIVALINK CORP. |
Sew-Wah Tay |
| K992008 |
12/23/1999 |
PHARMASEED, MODEL BT-125-1 |
SYNCOR PHARMACEUTICALS, INC. |
GARY GILMORE |
| K994187 |
12/21/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K993314 |
12/06/1999 |
SYNTHES LIGHT GUIDE |
SYNTHES (USA) |
JONATHAN GILBERT |
| K993755 |
12/21/1999 |
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 |
SYVA CO. |
PAUL L ROGERS |
| K994101 |
12/21/1999 |
E. HISTOLYTICA II |
TECHLAB, INC. |
DAVID M LYERLY |
| K992402 |
12/22/1999 |
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH |
TELEMED SYSTEMS, INC. |
JOHN A CHAVES |
| K992390 |
12/22/1999 |
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD |
TELEMED SYSTEMS, INC. |
JOHN A CHAVES |
| K991465 |
12/10/1999 |
DRUG STOP |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
| K993562 |
12/29/1999 |
POWDER FREE LATEX STERILE SURGICAL GLOVES |
TG MEDICAL SDN BHD |
T.S. PUON |
| K993727 |
12/21/1999 |
BINDAZYME ANTI-DSDNA EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993612 |
12/21/1999 |
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981783 |
12/20/1999 |
C3 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981785 |
12/20/1999 |
C4 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K982100 |
12/20/1999 |
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981784 |
12/21/1999 |
IGM MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981915 |
12/20/1999 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993862 |
12/29/1999 |
MODUS SAGITTAL SPLIT PLATE |
THE STRAUMANN CO. |
LINDA JALBERT |
| K993209 |
12/23/1999 |
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY |
THERMOLASE CORP. |
GERALD FELDMAN, MPH, MBA |
| K993452 |
12/20/1999 |
GREEN POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K993605 |
12/20/1999 |
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
| K993680 |
12/13/1999 |
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
| K992992 |
12/03/1999 |
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DIANA THORSON |
| K991697 |
12/21/1999 |
UNI-GOLD H. PYLORI |
TRINITY BIOTECH, PLC |
Erika B Ammirati |
| K993333 |
12/16/1999 |
CLEARPLAN EASY II HOME PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K993703 |
12/02/1999 |
CLEARVIEW EASY HCG PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K993123 |
12/17/1999 |
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B |
UNITED PACIFIC CO., LTD. |
DANIEL YE HUA |
| K984168 |
12/07/1999 |
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K993381 |
12/21/1999 |
TONGUE STABILIZER DEVICE |
UNIVERSITY OF OTAGO |
CHRISTINA M LAJOIE |
| K992368 |
12/09/1999 |
LEMAITRE EMBOLECTOMY CATHETER |
VASCUTECH, INC. |
TRENT G KAMKE |
| K993597 |
12/15/1999 |
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 |
VIDAR SYSTEMS CORP. |
MARY "PENNIE" DRINKARD |
| K993468 |
12/16/1999 |
WAKO L-TYPE GOT TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K992681 |
12/16/1999 |
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K992676 |
12/16/1999 |
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K993157 |
12/17/1999 |
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 |
WECK CLOSURE SYSTEMS |
BRIAN YOUNG |
| K993935 |
12/21/1999 |
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K993969 |
12/30/1999 |
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION |
WINCHESTER LABORATORIES LLC. |
HOWARD ROSE |
| K993342 |
12/23/1999 |
DUCPREP BREAST ASPIRATOR, MODEL PMPO2 |
WINDY HILL TECHNOLOGY, INC. |
ANGELA B SOITO |
| K983907 |
12/09/1999 |
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R |
WOODSIDE BIOMEDICAL, INC. |
CAROL L PATTERSON |
| K993371 |
12/20/1999 |
SADDLE SHAPED PATELLA |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K993214 |
12/02/1999 |
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
OOI SOO KANG |
| K993215 |
12/02/1999 |
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
OOI SOO KANG |
| K993962 |
12/21/1999 |
PENSIL TRAUMA, MODEL WWS6100 |
WUESTEC MEDICAL, INC. |
BRENDA S. D. DAVIS |
| K993655 |
12/21/1999 |
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
XOMED, INC. |
MARTIN D SARGENT |
| K993112 |
12/09/1999 |
XOMED ENT RF SYSTEM |
XOMED, INC. |
MARTIN D SARGENT |
| K993424 |
12/23/1999 |
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP |
Y-CLIP ASSOCIATES |
GEORGE YU |
