| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K993881 |
11/16/1999 |
GENX CULTURE DISH |
INTL., INC. |
MICHAEL D CECCHI |
| K993884 |
11/16/1999 |
GENX MICROTOOLS |
INTL., INC. |
MICHAEL D CECCHI |
| K993888 |
11/16/1999 |
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS |
A & D ENGINEERING, INC. |
JERRY WANG |
| K994039 |
11/29/1999 |
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB |
ABBOTT LABORATORIES |
JERRY JENNINGS |
| K993774 |
11/08/1999 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K993923 |
11/18/1999 |
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
JANICE E BROWN |
| K993946 |
11/19/1999 |
PEGASYS ULTRA |
ADAC LABORATORIES |
JANICE BROWN |
| K993775 |
11/08/1999 |
STERRAD BI TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K994055 |
11/30/1999 |
STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K993907 |
11/17/1999 |
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K993887 |
11/16/1999 |
ALATECH LATEX CONDOM |
ALATECH HEALTHCARE, LLC. |
WAYNE L GAINEY |
| K993833 |
11/12/1999 |
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K993871 |
11/15/1999 |
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K993795 |
11/09/1999 |
CONVERTORS SURGICAL DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K993873 |
11/15/1999 |
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD |
ALPHATEC MFG., INC. |
JASON BLAIN |
| K993961 |
11/22/1999 |
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K993796 |
11/09/1999 |
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K993857 |
11/15/1999 |
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR |
ANSELL PERRY |
JAMES R CHATTERTON |
| K993933 |
11/18/1999 |
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K993966 |
11/23/1999 |
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K993691 |
11/01/1999 |
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K993837 |
11/12/1999 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K994006 |
11/24/1999 |
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) |
AVOCET MEDICAL, INC. |
JILL FALCONE |
| K993816 |
11/10/1999 |
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD |
BAXTER EDWARDS |
DIANE PETERSON |
| K993711 |
11/03/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) |
BAYER CORP. |
GABRIEL MURACA |
| K993867 |
11/15/1999 |
BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K993954 |
11/22/1999 |
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K993805 |
11/09/1999 |
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) |
BEST MANUFACTURING COMPANY |
DAVID C YOUNG |
| K994037 |
11/29/1999 |
THE 4.5MM DIAMETER BICON DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
| K993708 |
11/03/1999 |
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG |
BIOMAGNETIC TECHNOLOGIES, INC. |
EUGENE C HIRSCHKOFF |
| K993714 |
11/02/1999 |
MEMOGRAPH STAPLE, WARM SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K993824 |
11/12/1999 |
MSAS PROFESSIONAL |
BIOMERIDIAN, INT. |
JOE GALLOWAY |
| K993972 |
11/23/1999 |
DISPOSABLE INFUSION PUMP KIT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K993836 |
11/12/1999 |
GENERATION 4 BONE CEMENT |
BIOMET, INC. |
MARY VERSTYNEN |
| K994007 |
11/24/1999 |
MALLORY/HEAD SMOOTH FEMORAL COMPONENT |
BIOMET, INC. |
TINA LAKIN |
| K994038 |
11/29/1999 |
MODULAR REACH HIP |
BIOMET, INC. |
FRED MCCLURE |
| K993956 |
11/22/1999 |
TITANIUM PEDIATRIC FEMORAL NAIL |
BIOMET, INC. |
LONNIE WITHAM |
| K993945 |
11/19/1999 |
BIONIKE AQ PHENCYCLIDINE (PCP) TEST |
BIONIKE LABORATORIES, INC. |
CLEVE W LAIRD |
| K994060 |
11/30/1999 |
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE |
BIOPLATE, INC. |
ERIC V HOHENSTEIN |
| K994043 |
11/29/1999 |
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES |
BIOPRO (M) SDN BHD |
JAMES H LALE |
| K993685 |
11/01/1999 |
BIOPACK |
BIOSCAN, INC. |
BUTCH SMITH |
| K993686 |
11/01/1999 |
LIGHT PATCH |
BIOSCAN, INC. |
BUTCH SMITH |
| K993684 |
11/01/1999 |
SPINAL PAD |
BIOSCAN, INC. |
BUTCH SMITH |
| K993729 |
11/04/1999 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
SANDRA WILLIAMSON |
| K994008 |
11/24/1999 |
BIOSYS FETAL MONITOR, MODEL IFM-500 |
BIOSYS CO. LTD. |
GARY J ALLSEBROOK |
| K993875 |
11/15/1999 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM |
BOSTON MEDICAL TECHNOLOGIES, INC. |
CESIDIO TEMPESTA |
| K994032 |
11/26/1999 |
FLUORO-TEX CARDIOVASCULAR PATCH |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
| K993900 |
11/16/1999 |
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 |
BRONCUS TECHNOLOGIES, INC. |
JOHN D'ANGELO |
| K993840 |
11/12/1999 |
BARD UROFORCE BALLOON DILATION CATHETER |
C.R. BARD, INC. |
ANGELA L BUNN |
| K993892 |
11/16/1999 |
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 |
C.R. BARD, INC. |
MARION GORDON |
| K993818 |
11/10/1999 |
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K993671 |
11/01/1999 |
CANDELA SCLERO LONG PULSE DYE LASER |
CANDELA CORP. |
JOAN CLIFFORD |
| K994009 |
11/26/1999 |
CG-2100 ECG TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K993799 |
11/09/1999 |
CG-7000DX ECG RECORDER/TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K993834 |
11/12/1999 |
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C |
CARDIOFOCUS, INC. |
WILLIAM A KNAPE |
| K993771 |
11/08/1999 |
CARESIDE DIRECT BILIRUBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993978 |
11/24/1999 |
PR3 ULTRASOUND SYSTEM |
CAROLINA MEDICAL, INC. |
CARROLL L TURNER |
| K993860 |
11/15/1999 |
CATHETER INNOVATIONS IMPLANTABLE PORT |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K993911 |
11/16/1999 |
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K993828 |
11/12/1999 |
CERALAS D10 810NM DIODE LASER |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K993951 |
11/22/1999 |
SPOT ENDOSCOPIC MARKER |
CHEK-MED SYSTEMS |
ROB WHALEN |
| K993949 |
11/22/1999 |
SOLO-CARE BRAND HARD SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K993806 |
11/09/1999 |
DIALGUARD ENDOTOXIN REMOVAL DEVICE |
CLARIGEN, INC. |
EDIT HEGYI |
| K993710 |
11/03/1999 |
MODIFICATION OF PARAPOST CEMENT |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993835 |
11/12/1999 |
PARAPOST SYSTEM STERILIZABLE ORGANIZER |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993802 |
11/09/1999 |
SHARPVIEW IMAGE ENHANCEMENT SYSTEM |
CONTEXTVISION AB |
CONSTANCE BUNDY |
| K993948 |
11/22/1999 |
SIS WOUND DRESSING II |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
| K993720 |
11/03/1999 |
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K993679 |
11/01/1999 |
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN |
DADE MICROSCAN, INC. |
TREVOR WALL |
| K993957 |
11/22/1999 |
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR |
DAKO CORP. |
GRETCHEN M MURRAY |
| K993855 |
11/15/1999 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K993810 |
11/10/1999 |
CD HORIZON SPINAL SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K993717 |
11/03/1999 |
ENIGMA HI-BASE DENTURE BASE MATERIAL |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
| K993897 |
11/16/1999 |
CERGOGOLD |
DEGUSSA - NEY DENTAL, INC. |
ANDREW J PIETROBONO |
| K994012 |
11/26/1999 |
TEMPOFIT, MODEL 02693 |
DETAX GMBH & CO. KG |
BARRY HALE |
| K993920 |
11/18/1999 |
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K994035 |
11/29/1999 |
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K993952 |
11/22/1999 |
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K993669 |
11/01/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K993681 |
11/01/1999 |
DIGITEC TWO STAGE COMPRESSION KIT |
DIGITEC MEDICAL SERVICE CORP. |
JAMES J MCGINITY |
| K993666 |
11/01/1999 |
DISETRONIC PEN P100 |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K993738 |
11/04/1999 |
DISPOS-A-SCOPE |
DISPOS-A-SCOPE |
LAUREL NICHOLAS |
| K993826 |
11/12/1999 |
NARKOMED 6000 |
DRAEGER MEDICAL, INC. |
GALE E WINARSKY |
| K993919 |
11/18/1999 |
DYNATRON 900 |
DYNATRONICS CORP. |
JOHN S RAMSEY |
| K993822 |
11/12/1999 |
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K993886 |
11/16/1999 |
EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K993841 |
11/12/1999 |
CEMSTOP CEMENT RESTRICTOR |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K993943 |
11/19/1999 |
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K993797 |
11/09/1999 |
EC-7701 FLUID WARMING CABINET |
ENTHERMICS MEDICAL SYSTEMS, INC. |
EMALEE G MURPHY |
| K994011 |
11/26/1999 |
EP MEDSYSTEMS, EP-WORKMATE |
EP MEDSYSTEMS, INC. |
JOSEPH C GRIFFIN III |
| K994014 |
11/26/1999 |
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K993801 |
11/09/1999 |
GYNECARE LAPAROSCOPIC MORCELLATOR |
ETHICON, INC. |
GREGORY R JONES |
| K993736 |
11/04/1999 |
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT |
EXACTECH, INC. |
GARY J MILLER |
| K993820 |
11/12/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS |
FELDA RUBBER CORP. |
YUNUS LATIF |
| K993861 |
11/15/1999 |
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JOSEPH M AZARY |
| K993704 |
11/02/1999 |
GASTRO-INTESTINAL SYSTEM EN-410WM |
FUJINON, INC. |
GARY ADLER |
| K993965 |
11/23/1999 |
CRYO-HIT |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K993813 |
11/10/1999 |
LUMAGEM SCINTILLATION CAMERA |
GAMMA MEDICA |
BRADLEY E PATT |
| K993973 |
11/23/1999 |
FUJI II LC CAPSULE |
GC AMERICA, INC. |
TERRY L JORITZ |
| K993687 |
11/01/1999 |
UROVIEW 2800 |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K993751 |
11/05/1999 |
COROMETRICS MODEL 173 FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RICHARD CEHOVSKY |
| K993791 |
11/09/1999 |
CT PERFUSION OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K993792 |
11/09/1999 |
SMART VESSEL ANALYSIS (SMART VA) OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K993789 |
11/09/1999 |
CLINICAL BLOOD GAS MIXTURE |
GENERAL AIR SERVICE AND SUPPLY |
MICHAEL FISHER |
| K993757 |
11/05/1999 |
SOLAR 7/8000 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K993752 |
11/05/1999 |
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K994013 |
11/26/1999 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) |
GLOVCO (M) SDN. BHD. |
TAN CHWEE HOCK |
| K994048 |
11/26/1999 |
PORTABLE LIGHT CURING UNIT |
GREGORY S. JACOB, D.D.S. |
GREGORY S JACOB |
| K993732 |
11/04/1999 |
BVBLUE |
GRYPHUS DIAGNOSTICS, L.L.C. |
THOMAS M TSAKERIS |
| K993793 |
11/09/1999 |
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K993749 |
11/05/1999 |
GYRUS HYSTEROSCOPIC RESECTOSCOPE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K994023 |
11/26/1999 |
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 |
HAEMACURE CORP. |
ELAINE WHITMORE |
| K993678 |
11/01/1999 |
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES |
HAEMOSCOPE CORP. |
ELI COHEN |
| K993812 |
11/10/1999 |
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 |
11/24/1999 |
HARDYDISK AMIKACIN 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
| K993994 |
11/24/1999 |
HARDYDISK AZITHROMYCIN 15MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994046 |
11/29/1999 |
HARDYDISK CEFACLOR 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994051 |
11/30/1999 |
HARDYDISK DOXYCYCLINE, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994027 |
11/26/1999 |
ACTIVATOR PASTE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K993716 |
11/02/1999 |
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K993722 |
11/03/1999 |
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K993725 |
11/03/1999 |
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS |
HARTALEGA SDN BHD |
JUAN KAM HON |
| K993760 |
11/08/1999 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K994059 |
11/29/1999 |
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 |
HDC CORP. |
JAMES ABILLA |
| K993766 |
11/08/1999 |
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
HELAX AB |
E.S. MARTELL |
| K993932 |
11/18/1999 |
SOLITAIRE 2 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K993991 |
11/24/1999 |
HM-930 ELECTROSURGICAL UNIT |
HILL-MED, INC. |
JHOANA VASQUEZ |
| K994026 |
11/26/1999 |
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER |
| K993938 |
11/19/1999 |
THE HOMMED SENTRY, MODEL 1 SENTRY |
HOMMED LLC. |
HERSCHEL PEDDICORD |
| K994033 |
11/26/1999 |
HORTMANN ECHOMASTER OAE ANALYZER |
HORTMANN AG |
BRADFORD MELANCON |
| K993768 |
11/08/1999 |
CITATION TMZF HA STEM |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K993692 |
11/02/1999 |
DURACON INSET PATELLA, 25MM |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K993889 |
11/16/1999 |
EXETER CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K993670 |
11/01/1999 |
MODIFIED LONG LENGTH GAMMA NAIL |
HOWMEDICA OSTEONICS CORP. |
MARGARET CROWE |
| K993773 |
11/08/1999 |
HUMID-HEAT |
HUDSON RCJ AB |
CONSTANCE G BUNDY |
| K993695 |
11/02/1999 |
LIGA-LOOP SUTURE APPLICATOR |
HYSTERX, INC. |
JUDY F GORDON |
| K993673 |
11/01/1999 |
SNN FLUORO NAVIGATION SYSTEM |
I.S.G. TECHNOLOGIES, INC. |
DOLORES MCGIRR |
| K993742 |
11/04/1999 |
SUPER TISSUE |
I.Z.I. CORP. |
E.J. Smith |
| K993682 |
11/01/1999 |
MRI EQUIPMENT COVER |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K993936 |
11/19/1999 |
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE |
IMAGYN SURGICAL |
JULIE POWELL |
| K993693 |
11/02/1999 |
INVIGRA |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K993913 |
11/17/1999 |
TRUE |
INFINITY EXTRUSION & ENGINEERING, INC. |
DOUGLAS WILKINS |
| K994010 |
11/26/1999 |
INNOVAQUARTZ GENERAL SHAPE LASER FIBER |
INNOVAQUARTZ |
RANDY MCLELLAN |
| K993975 |
11/24/1999 |
ABSOLUTE ABSORBABLE INTERFERENCE SCREW |
INNOVASIVE DEVICES, INC. |
KATHLEEN MORAHAN |
| K994004 |
11/24/1999 |
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
| K993785 |
11/08/1999 |
ULTRACLIP TISSUE MARKER |
INRAD |
JOSEPH M MAZUREK |
| K993869 |
11/15/1999 |
INTER-OS BONE GENERATOR |
INTER-OS TECHNOLOGIES, L.L.C. |
RANDOLPH C ROBINSON |
| K993850 |
11/12/1999 |
URINALYSIS REAGENT STRIPS (10 PARAMETERS) |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
DENNIS S.L. HONG |
| K993808 |
11/10/1999 |
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 |
| K993904 |
11/17/1999 |
INTRASTENT DOUBLESTRUT LD |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
| K993783 |
11/08/1999 |
TETRIC FLOW |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K993878 |
11/15/1999 |
JE 2000 |
JACK'S ELECTRODES |
ANTHONY R.H. FENDER |
| K993853 |
11/12/1999 |
K-ASSAY MULTI-ANALYTE CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993804 |
11/09/1999 |
KSEA RIGID CULDOSCOPE AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K993745 |
11/05/1999 |
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 |
KATECHO, INC. |
WARREN R WALTERS |
| K993721 |
11/03/1999 |
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES |
LABORIE MEDICAL TECH CORP. |
DALE COLEMAN |
| K993668 |
11/01/1999 |
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
LAERDAL MEDICAL A/S |
MAGNE STEINSET |
| K993942 |
11/19/1999 |
LITESABER 2000 |
LASER DENTAL INNOVATIONS |
DAVID W SCHLERF |
| K993912 |
11/17/1999 |
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI |
LATEXX PARTNERS, INC. |
E.J. Smith |
| K993894 |
11/16/1999 |
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
| K993885 |
11/16/1999 |
ULTRABLATOR ELECTRODE |
LINVATEC CORP. |
LAURA SENEFF |
| K994028 |
11/26/1999 |
FLIPO XENON CURING LIGHT |
LOKKI |
HILLARD W WELCH |
| K993849 |
11/12/1999 |
TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE |
LONGBEST (XIAMEN) BALLS CO., LTD |
STONE CHEN |
| K993847 |
11/12/1999 |
TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES |
LONGBEST (XIAMEN) BALLS CO., LTD |
T.H. CHEN |
| K993883 |
11/15/1999 |
M-PACT CORNEAL LIGHT SHIELD |
M-PACT CORP. |
AL BOEDEKER |
| K993941 |
11/19/1999 |
UBAS |
MARUKIN DIAGNOSTICS |
GREG HOLLAND |
| K993815 |
11/10/1999 |
UNI-LASER 430 |
MEDART CORP. |
JAN K ENEMAERKE |
| K993758 |
11/05/1999 |
PROAIR 3000 COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
SHOSHANA FRIEDMAN |
| K994057 |
11/30/1999 |
SLENDAIR 4000 COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
SHOSHANA FRIEDMAN |
| K993740 |
11/04/1999 |
MAMEX |
MEDICAL SYSTEMS GROUP |
JEFFREY N MOELLER |
| K993764 |
11/08/1999 |
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH |
MEDIPACK MEDICAL PACKAGING MFG. CO. |
NORMAN F ESTRIN |
| K993761 |
11/08/1999 |
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K993763 |
11/08/1999 |
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K993765 |
11/08/1999 |
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K993896 |
11/16/1999 |
MCA-601, C-ARM MOBILE |
MEDISON RADIOLOGY SYSTEMS, INC. |
JOHN W LEE |
| K993728 |
11/04/1999 |
MEDRAD ENVISION CT INJECTOR SYSTEM |
MEDRAD, INC. |
JAN E DOBSCHA |
| K993735 |
11/04/1999 |
DOUBLE SPRINGERS |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K993733 |
11/04/1999 |
LOVE LOCKERS |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K993737 |
11/04/1999 |
MIGHTY MAN (DYNAMIC LINKERS) |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K993677 |
11/01/1999 |
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT |
MEDTRONIC VASCULAR |
MICHAEL HINGSON |
| K993893 |
11/16/1999 |
MEDX INTECAM INTERFACE |
MEDX, INC. |
FLOYD ROWAN |
| K993914 |
11/17/1999 |
PREMIER TOXINS A&B, MODEL 616096 |
MERIDIAN DIAGNOSTICS, INC. |
DAVID H WILLIS |
| K993821 |
11/12/1999 |
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT |
METRON MEDICAL AUSTRALIA PTY LTD |
R.H. HOPKINS |
| K993959 |
11/22/1999 |
ISOCENTRIC BEAM CHECKER |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K993960 |
11/22/1999 |
PERMA-DOC PHANTOM |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K993970 |
11/23/1999 |
MICRINS MICROSURGICAL SUTURE |
MICRINS SURGICAL, INC. |
BERNHARD TEITZ |
| K993823 |
11/12/1999 |
MED-4000 |
MICRO CURRENT TECHNOLOGY, INC. |
JAMES Y SUZUKI |
| K993843 |
11/12/1999 |
MDI RF TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K994029 |
11/26/1999 |
MDI SM TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K993971 |
11/23/1999 |
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM |
MICRO DETECT, INC. |
MEHDI ALEM |
| K993672 |
11/01/1999 |
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K993699 |
11/02/1999 |
THE STRIPPER |
MID-ATLANTIC DIAGNOSTICS, INC. |
TERRANCE J FORTINO |
| K993694 |
11/02/1999 |
MIKRO-TIP ANGIOGRAPHIC CATHETER |
MILLAR INSTRUMENTS, INC. |
MIRIELLE ARCE |
| K993848 |
11/12/1999 |
MILLENNIUM HUBER PLUS SAFETY INFUSION SET |
MILLENNIUM MEDICAL DISTRIBUTION, INC. |
CHRISTINE EMANUEL |
| K993698 |
11/02/1999 |
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
| K993719 |
11/03/1999 |
KAC-300 KNEE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993898 |
11/16/1999 |
KAC-63 KNEE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993776 |
11/08/1999 |
OBC-300 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993780 |
11/08/1999 |
QSC-300 SHOULDER ARRAY COILS |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993819 |
11/10/1999 |
QWH-300 WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993754 |
11/05/1999 |
HSV-1 ELISA IGG, MODEL EL0910G |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K993724 |
11/03/1999 |
HSV-2 ELISA IGG, MODEL EL0920G |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K993811 |
11/10/1999 |
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE |
MULTISAFE SDN BHD |
GOH SEOK HUEI |
| K993908 |
11/17/1999 |
NANMA AJUSTABLE CONSTRICTION RING |
NANMA MFG CO., LTD. |
E.J. Smith |
| K993906 |
11/17/1999 |
NANMA NON-ADJUSTABLE CONSTRICTION RING |
NANMA MFG CO., LTD. |
E.J. Smith |
| K993909 |
11/17/1999 |
NANMA VACUUM PUMP |
NANMA MFG CO., LTD. |
E.J. Smith |
| K993689 |
11/01/1999 |
AED CYSTOSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993688 |
11/01/1999 |
AED LAPAROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993921 |
11/18/1999 |
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 |
NDD MEDICAL TECHNOLOGIES |
OSCAR KAELIN |
| K993877 |
11/15/1999 |
NELSON WATER SYSTEMS FOR HEMODIALYSIS |
NELSON ENVIRONMENTAL TECHNOLOGIES, INC. |
BURKE A WEST |
| K993762 |
11/08/1999 |
I.CO.S SCREW |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K993910 |
11/17/1999 |
TAC' PIN |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K993939 |
11/19/1999 |
NICOLET EME LEGEND TC22 |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
| K993950 |
11/22/1999 |
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 |
NIEN MADE ELECTRNICS CORP. |
JAMES M DELANEY |
| K993890 |
11/16/1999 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K993675 |
11/01/1999 |
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM |
NOMOS CORP. |
FRANCIS X DOBSCHA |
| K993778 |
11/08/1999 |
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K993788 |
11/09/1999 |
R.TEST EVOLUTION |
NOVACOR DIV. |
LYNETTE L HOWARD |
| K993979 |
11/24/1999 |
MARSPO2, MODEL 2001 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN |
| K993712 |
11/03/1999 |
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K993854 |
11/15/1999 |
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES |
ORATEC INTERVENTIONS, INC. |
SHIELA RAMERMAN |
| K993967 |
11/23/1999 |
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 |
ORATEC INTERVENTIONS, INC. |
JENNIFER BRENNAN |
| K993926 |
11/18/1999 |
OMNIAXIAL CONNECTOR |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K993787 |
11/09/1999 |
APPRAISE-CARDIO SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K993779 |
11/08/1999 |
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K993781 |
11/08/1999 |
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K993782 |
11/08/1999 |
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) |
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. |
VIJAY MAHAL |
| K993756 |
11/05/1999 |
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K993918 |
11/18/1999 |
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K994022 |
11/26/1999 |
PARALLAX CRANIOSET |
PARALLAX MEDICAL, INC. |
SUSAN MARQUES |
| K993895 |
11/16/1999 |
OPTIRAD |
PERMEDICS, INC. |
GREG HOLLAND |
| K993794 |
11/09/1999 |
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS |
PLAYTIME PRODUCTS, INC. |
MARK ROSENGARTEN |
| K993874 |
11/15/1999 |
BOFOR REVISION COUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K994045 |
11/29/1999 |
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 |
PRIMUS CORP. |
JIM NOFFSINGER |
| K993750 |
11/05/1999 |
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO |
PROBLEM SOLVING CONCEPTS, INC. |
THOMAS M MCCLELLAND |
| K993870 |
11/15/1999 |
UNSCENTED INTERLABIAL MENSTRUAL PAD |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
| K993683 |
11/01/1999 |
PULPDENT UNO-DUO |
PULPDENT CORP. |
KENNETH J BERK |
| K993674 |
11/01/1999 |
POCKET ULTRASONIC PACHYMETER |
QUANTEL MEDICAL |
GEORGE MYERS |
| K993723 |
11/03/1999 |
CARDIASURE CARDIAC MARKERS CONTROL |
QUANTIMETRIX CORP. |
EVY K JOHNSON |
| K993777 |
11/08/1999 |
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES |
R-GROUP INTL. |
KERRY A KAHN |
| K993944 |
11/19/1999 |
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE |
RITA MEDICAL SYSTEMS |
ERIN DIGNAN-MAZZONE |
| K993829 |
11/12/1999 |
ACCU-CHEK SIMPLICITY SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K993706 |
11/02/1999 |
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K994017 |
11/26/1999 |
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994030 |
11/26/1999 |
ONTRAK TESTCUP 5, CAT. 07 6481 7 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994020 |
11/26/1999 |
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K993786 |
11/08/1999 |
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K993715 |
11/03/1999 |
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K994036 |
11/29/1999 |
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K993880 |
11/15/1999 |
SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
MAO-SHENG LEE |
| K993859 |
11/15/1999 |
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
MAO-SHENG LEE |
| K993876 |
11/15/1999 |
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K993947 |
11/22/1999 |
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY |
SIEMENS CORP. |
ALICIA JUERGENSEN |
| K993974 |
11/24/1999 |
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K993731 |
11/04/1999 |
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K993741 |
11/04/1999 |
EZ LDL CHOLESTEROL TEST SYSTEM |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K993963 |
11/22/1999 |
SIGMA MANUAL WHEELCHAIR |
SIGMA DISTRIBUTION & SUPPLY, INC. |
ARTHUR KESHISHYAN |
| K993851 |
11/12/1999 |
SODEM PERFORATOR DRIVE |
SODEMSYSTEMS |
DANIEL BACCINO |
| K993868 |
11/15/1999 |
THE SOUNDVASER DISSECTION SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K994019 |
11/26/1999 |
CAUTERY GRASPER/DISSECTOR |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K993825 |
11/12/1999 |
PARA TECH PLUS RETICS |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K994021 |
11/26/1999 |
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION |
STRIETER CLINICAL RESEARCH LABORATORIES, INC. |
JAMES F STRIETER |
| K993990 |
11/24/1999 |
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM |
STRYKER INSTRUMENTS |
KRISTYN R KELLEY |
| K994053 |
11/30/1999 |
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE |
STRYKER INSTRUMENTS |
SUSANNE VELAQUEZ |
| K993667 |
11/01/1999 |
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS |
SULZER MEDICA |
EDWARD E NEWTON |
| K993864 |
11/15/1999 |
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES |
SUPERMAX SDN BHD |
STANLEY THAI |
| K993865 |
11/15/1999 |
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES |
SUPERMAX SDN BHD |
STANLEY THAI |
| K993713 |
11/03/1999 |
RIM-FIX, ACETABULAR CUP |
SURGICAL IMPLANTS INC. |
DOUGLAS W STUART |
| K994015 |
11/26/1999 |
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HARR |
| K993700 |
11/02/1999 |
PHARMASEED, MODEL BT-103-2 |
SYNCOR INTERNATIONAL, INC. |
GARY GILMORE |
| K993701 |
11/02/1999 |
PHARMASEED, MODEL BT-125-2 |
SYNCOR INTERNATIONAL, INC. |
GARY GILMORE |
| K994016 |
11/26/1999 |
PHARMASEED, MODEL BT-103-3 |
SYNCOR PHARMACEUTICALS, INC. |
GARY GILMORE |
| K994018 |
11/26/1999 |
PHARMASEED, MODEL BT-125-3 |
SYNCOR PHARMACEUTICALS, INC. |
GARY GILMORE |
| K993755 |
11/05/1999 |
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 |
SYVA CO. |
PAUL L ROGERS |
| K993982 |
11/24/1999 |
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL |
SYVA CO. |
PAUL L ROGERS |
| K993987 |
11/24/1999 |
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL |
SYVA CO. |
PAUL L ROGERS |
| K993985 |
11/24/1999 |
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL |
SYVA CO. |
PAUL L ROGERS |
| K993984 |
11/24/1999 |
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL |
SYVA CO. |
PAUL L ROGERS |
| K993988 |
11/24/1999 |
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL |
SYVA CO. |
PAUL L ROGERS |
| K993980 |
11/24/1999 |
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL |
SYVA CO. |
PAUL L ROGERS |
| K994005 |
11/24/1999 |
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL |
SYVA CO. |
PAUL L ROGERS |
| K993986 |
11/24/1999 |
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL |
SYVA CO. |
PAUL L ROGERS |
| K993983 |
11/24/1999 |
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL |
SYVA CO. |
PAUL L ROGERS |
| K993981 |
11/24/1999 |
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL |
SYVA CO. |
PAUL L ROGERS |
| K993832 |
11/12/1999 |
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 |
TANDEM MEDICAL, INC. |
ALBERT MISAJON |
| K994024 |
11/26/1999 |
EXTENDED STRAIGHT ATTACHMENT |
TEAM TECHNOLOGIES, INC. |
BOB WALTON |
| K993772 |
11/08/1999 |
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR |
TERUMO MEDICAL CORP. |
GARRY A COURTNEY |
| K993976 |
11/24/1999 |
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR |
THE PROMETHEUS GROUP |
RICHARD HORTON |
| K993862 |
11/15/1999 |
MODUS SAGITTAL SPLIT PLATE |
THE STRAUMANN CO. |
LINDA JALBERT |
| K993917 |
11/17/1999 |
TOKUYAMA ONE-UP-BOND F |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K993680 |
11/01/1999 |
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
| K994041 |
11/29/1999 |
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS |
TORNIER, INC. |
DAVID W SCHLERF |
| K993803 |
11/09/1999 |
EXCELART WITH PIANISSIMO |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K993998 |
11/24/1999 |
NYLON |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994002 |
11/24/1999 |
PLAIN/CHROMIC CATGUT |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994000 |
11/24/1999 |
POLYESTER |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K994001 |
11/24/1999 |
POLYGLYCOLIC ACID |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K993997 |
11/24/1999 |
POLYPROPYLENE |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K993999 |
11/24/1999 |
SILK |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
MAIN M GHAZAL |
| K993839 |
11/12/1999 |
ENA PROFILE ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
WAYNE KVETKOSKY |
| K993856 |
11/15/1999 |
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
| K993846 |
11/12/1999 |
ULTRASEAL XT PLUS |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K993784 |
11/08/1999 |
UNIGRAFT |
UNICARE BIOMEDICAL |
STAN YANG |
| K993703 |
11/02/1999 |
CLEARVIEW EASY HCG PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K993996 |
11/24/1999 |
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE |
UNIVEC, INC. |
S LEVINSON |
| K994040 |
11/29/1999 |
PHASED ARRAY KNEE AND FOOT COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K994042 |
11/29/1999 |
SHARP 9000 PHASED ARRAY BRAIN COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K994054 |
11/30/1999 |
ISSA PHAROS |
VAMS TEC, D.O.O. |
DAVID W SCHLERF |
| K993872 |
11/15/1999 |
VANNA BATHING SYSTEM |
VANCARE, INC. |
JAMES A VANDERHEIDEN |
| K993995 |
11/24/1999 |
VEIN ENTRY INDICATOR DEVICE (VEID) |
VASCULAR TECHNOLOGIES LTD. |
AHAVA STEIN |
| K993953 |
11/22/1999 |
OVES CERVICAL CAP |
VEOS LTD. |
PEGGY S DANNENBAUM |
| K994044 |
11/29/1999 |
CLEEN-ABLE |
VITAL SIGNS, INC. |
ANTHONY MARTINO |
| K994056 |
11/30/1999 |
ADMIRA |
VOCO GMBH |
EVAN DICK |
| K993827 |
11/12/1999 |
UFI GEL HARD |
VOCO GMBH |
SHUOJIA DONG |
| K993934 |
11/18/1999 |
V QUICK PATCH |
VQ CORP. |
MICHAEL A PRICE |
| K993927 |
11/18/1999 |
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993924 |
11/18/1999 |
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993925 |
11/18/1999 |
WAKO L-TYPE UN TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993928 |
11/18/1999 |
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD |
WAKO CHEMICALS, USA, INC. |
TANYA MALLORY |
| K993697 |
11/02/1999 |
DELFIA NEONATAL IRT KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
| K993935 |
11/19/1999 |
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K993903 |
11/16/1999 |
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
| K993969 |
11/23/1999 |
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION |
WINCHESTER LABORATORIES LLC. |
HOWARD ROSE |
| K993852 |
11/12/1999 |
FIRST CHECK HOME DRUG TEST PANEL 4 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K993958 |
11/22/1999 |
IDX-60 INTRAORAL X-RAY |
X-CEL X-RAY CORP. |
WILLIAM W MORRIS |
