| 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 |
| K990297 |
01/29/1999 |
ETEST MINOCYCLINE |
AB BIODISK |
ANNE BOLMSTROM |
| 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 |
| K990035 |
01/06/1999 |
RF |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K990241 |
01/25/1999 |
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP |
ACCUIMAGE DIAGNOSTICS CORP. |
GARY J ALLSEBROOK |
| K990140 |
01/19/1999 |
NORMED BONE TRANSPORT |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| 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 |
| K990090 |
01/11/1999 |
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K990089 |
01/11/1999 |
SILKAM NONABSORBABLE SILK SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K990088 |
01/11/1999 |
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K990093 |
01/11/1999 |
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW |
AGILENT TECHNOLOGIES |
DUDLEY HARRIS |
| 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 |
| K990198 |
01/21/1999 |
AMIB7 |
ALLIANCE MEDICAL, INC. |
JAMES RIEDL |
| K993873 |
11/15/1999 |
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD |
ALPHATEC MFG., INC. |
JASON BLAIN |
| K990010 |
01/04/1999 |
ALTHIN MEDICAL AB ALTRACART II |
ALTHIN MEDICAL AB |
ULF LUNDGREN |
| K990253 |
01/27/1999 |
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 |
AMBA MEDICAL LTD. |
MIKE CAUDWELL |
| 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 |
| K990037 |
01/06/1999 |
NEPTUNE WASTE MANAGEMENT SYSTEM |
AMERICAN IMMUNO TECH |
ESTHER SALTZ |
| 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 |
| K990092 |
01/11/1999 |
AVL OMNI MODULAR ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| 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 |
| K990284 |
01/29/1999 |
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| 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 |
| K990042 |
01/06/1999 |
SILON DUAL-DRESS |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K990106 |
01/12/1999 |
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K990317 |
01/29/1999 |
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990017 |
01/04/1999 |
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 |
BIO-RAD |
ELIZABETH PLATT |
| K990162 |
01/19/1999 |
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990282 |
01/29/1999 |
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990161 |
01/19/1999 |
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990150 |
01/19/1999 |
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990149 |
01/19/1999 |
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 |
BIO-RAD |
ELIZABETH PLATT |
| K990277 |
01/28/1999 |
O-RING ABUTMENT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
DIANA M EASTON |
| K990219 |
01/22/1999 |
MODIFICATION OF MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
ANDREW KIMMEL |
| 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 |
| K990230 |
01/25/1999 |
ELECTRO-NERVE STIMULATOR TENS, MODEL LX |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K993824 |
11/12/1999 |
MSAS PROFESSIONAL |
BIOMERIDIAN, INT. |
JOE GALLOWAY |
| K990290 |
01/29/1999 |
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| 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 |
| K990291 |
01/29/1999 |
LACTOSORB BONE PIN |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K994007 |
11/24/1999 |
MALLORY/HEAD SMOOTH FEMORAL COMPONENT |
BIOMET, INC. |
TINA LAKIN |
| K990032 |
01/06/1999 |
MODULAR PROTUSIO CUP |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
| 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 |
| K990280 |
01/28/1999 |
BIONIKE AQ BARBITURATE TEST |
BIONIKE, 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 |
| K990156 |
01/19/1999 |
MULTITAK SS BUTTONS |
BONUTTI RESEARCH |
PATRICK BALSMANN |
| K993875 |
11/15/1999 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM |
BOSTON MEDICAL TECHNOLOGIES, INC. |
CESIDIO TEMPESTA |
| K990295 |
01/29/1999 |
BONE ANCHOR SYSTEM III (BAS III) |
BOSTON SCIENTIFIC CORP. |
Lorraine M Hanley |
| 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 |
| K990066 |
01/08/1999 |
CCD CAMERA, MODEL 9000 |
CAMTRONICS, LTD. |
ROBERT KRIEDERMANN |
| 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 |
| K990024 |
01/05/1999 |
CARESIDE ALKALINE PHOSPHATASE |
CARESIDE, INC. |
KENNETH B ASARCH |
| K990025 |
01/04/1999 |
CARESIDE AMYLASE |
CARESIDE, INC. |
KENNETH B ASARCH |
| K990009 |
01/04/1999 |
CARESIDE AST |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993771 |
11/08/1999 |
CARESIDE DIRECT BILIRUBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K990036 |
01/06/1999 |
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993978 |
11/24/1999 |
PR3 ULTRASOUND SYSTEM |
CAROLINA MEDICAL, INC. |
CARROLL L TURNER |
| K990058 |
01/07/1999 |
QMS MAPPING SYSTEM,MODEL 2000 |
CATHDATA, INC. |
RICHARD KEEN |
| 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 |
| K990239 |
01/25/1999 |
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| 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 |
| K990011 |
01/04/1999 |
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
CONTINENTAL SOFT LENS, INC. |
KIM MCQUARRIE |
| K993948 |
11/22/1999 |
SIS WOUND DRESSING II |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
| K990072 |
01/11/1999 |
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C |
COOK UROLOGICAL, INC. |
DEBBIE SCHMIDT |
| K993720 |
11/03/1999 |
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K990127 |
01/13/1999 |
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K990172 |
01/19/1999 |
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA |
COULTER CORP. |
MARION S GAIDE |
| K990251 |
01/27/1999 |
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 |
DADE BEHRING, INC. |
CATHY P CRAFT |
| K990255 |
01/27/1999 |
DIMENSION DRUG CALIBRATOR II, MODEL DC49B |
DADE BEHRING, INC. |
CATHY P CRAFT |
| 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 |
| K990132 |
01/14/1999 |
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
| K990278 |
01/28/1999 |
DAUM NEUROCUT NEUROBIOPSYNEEDLE |
DAUM CORP. |
E.J. Smith |
| 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 |
| K990027 |
01/05/1999 |
OMNICORDER, MODEL 464 |
DEL MAR AVIONICS |
RAPHAEL HENKIN |
| K990087 |
01/11/1999 |
DMD DIGITAL X-RAY SYSTEM |
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. |
STEVE BRODY |
| K990120 |
01/13/1999 |
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K990148 |
01/19/1999 |
STACKABLE CAGE SYSTEM |
DEPUY MOTECH ACROMED |
WILLIAM CHRISTIANSON |
| 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 |
| K990222 |
01/25/1999 |
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K990138 |
01/19/1999 |
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K993669 |
11/01/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K990248 |
01/26/1999 |
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION |
DICOMIT IMAGING SYSTEMS CORP. |
TERRY CALLAHAN |
| K990023 |
01/05/1999 |
HYBRID CAPTURE II CT-ID TEST |
DIGENE CORP. |
MARK DEL VECCHIO |
| K990049 |
01/07/1999 |
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 |
DIGIDENT LTD. |
MARY MCNAMARA-CULLINAME |
| K993681 |
11/01/1999 |
DIGITEC TWO STAGE COMPRESSION KIT |
DIGITEC MEDICAL SERVICE CORP. |
JAMES J MCGINITY |
| K990014 |
01/04/1999 |
DIOSCAN |
DIOMED, INC. |
MAUREEN O'CONNELL |
| K990259 |
01/27/1999 |
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K993666 |
11/01/1999 |
DISETRONIC PEN P100 |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K993738 |
11/04/1999 |
DISPOS-A-SCOPE |
DISPOS-A-SCOPE |
LAUREL NICHOLAS |
| K990212 |
01/22/1999 |
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K990019 |
01/04/1999 |
DRG MEDIUM SCREW SYSTEM |
DOLPHIN MEDICAL TECHNOLOGIES, INC. |
MARK G URBANSKI |
| K993826 |
11/12/1999 |
NARKOMED 6000 |
DRAEGER MEDICAL, INC. |
GALE E WINARSKY |
| K990159 |
01/19/1999 |
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 |
DYNAMIC TECHNOLOGY CORP. |
YAW C YANG |
| K993919 |
11/18/1999 |
DYNATRON 900 |
DYNATRONICS CORP. |
JOHN S RAMSEY |
| K990122 |
01/13/1999 |
INDEPENDENCE 624 |
EAGLE PARTS & PRODUCTS, INC. |
CHARLES B WALKER JR. |
| 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 |
| K990146 |
01/19/1999 |
SURGITRON |
ELLMAN INTL., INC. |
FRANK LIN |
| 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 |
| K990271 |
01/28/1999 |
ENDOSONICS TRAK BACK DEVICE |
ENDOSONICS CORP. |
RICHARD HEBERT |
| 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 |
| K990082 |
01/11/1999 |
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
JEFFREY SECUNDA |
| K990008 |
01/04/1999 |
ERCO-RIBBON -C |
ERCONS, INC. |
YAKOV ALTSHULER |
| K990006 |
01/04/1999 |
ERCO-VAC -C |
ERCONS, INC. |
YAKOV ALTSHULER |
| K994014 |
11/26/1999 |
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K990028 |
01/05/1999 |
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE |
ETHICON ENDO-SURGERY, INC. |
CHUCK TABRI |
| 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 |
| K990197 |
01/20/1999 |
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM |
EXACTECH, INC. |
GARY J MILLER |
| K990205 |
01/21/1999 |
DIGISCOPE OPHTHALMIC CAMERA |
EYE TEL IMAGING, INC. |
KEVIN T QUINN |
| K990091 |
01/11/1999 |
S.P.A.R STERILE AMBULATORY RESERVOIR |
FAULDING PHARMACEUTICAL CO. |
HEIKE MAASER |
| K993820 |
11/12/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS |
FELDA RUBBER CORP. |
YUNUS LATIF |
| K990174 |
01/19/1999 |
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV |
FISMA, INC. |
TRACY S BEST |
| K990243 |
01/25/1999 |
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
| 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 |
| K990039 |
01/06/1999 |
GAMBRO DQM 200 |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
| 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 |
| K990226 |
01/25/1999 |
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| 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 |
| K990068 |
01/08/1999 |
SOLAR 9500 INFORMATION MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K990062 |
01/08/1999 |
SAPHLIFT |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
Ruth Forstadt |
| 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 |
| K990079 |
01/11/1999 |
FASTSEAL CHEST WOUND DRESSING |
GREENFIELD MEDICAL TECHNOLOGIES, INC. |
DONALD R GORSUCH |
| 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 |
| K990228 |
01/25/1999 |
GUTHRIE PRIME POWDER-FREE |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K993793 |
11/09/1999 |
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K990213 |
01/22/1999 |
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET |
GYRUS ENT L.L.C. |
JEFF COBB |
| 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 |
| K990293 |
01/29/1999 |
ALADDIN II MONITORING OXYGEN/AIR MONITOR |
HAMILTON MEDICAL, INC. |
TIMOTHY Y COWART |
| K990184 |
01/20/1999 |
AUTOMARQER |
HAMILTON THORNE RESEARCH |
DIARMAID DOUGLAS-HAMILTON |
| 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 |
| K990283 |
01/29/1999 |
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES |
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 |
| K990143 |
01/19/1999 |
GLUMA ONE BOND |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K993932 |
11/18/1999 |
SOLITAIRE 2 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K990125 |
01/13/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| 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 |
| K990209 |
01/21/1999 |
NOVAC7 |
HITESYS S.P.A. |
WALTER E GUNDAKER |
| 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 |
| K990152 |
01/19/1999 |
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER |
HOWMEDICA OSTEONICS CORP. |
KATE SUTTON |
| K990059 |
01/08/1999 |
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS |
HOWMEDICA OSTEONICS CORP. |
KATE SUTTON |
| 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 |
| K990242 |
01/25/1999 |
TOPOGRAPHIC IMAGING MARKER |
I.Z.I. MEDICAL PRODUCTS 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 |
| K990193 |
01/21/1999 |
IODINE BRACHYTHERAPY SEEDS, MODEL 3000 |
IMPLANT SCIENCES CORP. |
HOWARD L SCHRAYER |
| K990183 |
01/20/1999 |
IMPLEX ALUMINA FEMORAL HEAD |
IMPLEX CORP. |
ROBERT POGGIE |
| K993693 |
11/02/1999 |
INVIGRA |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K993913 |
11/17/1999 |
TRUE |
INFINITY EXTRUSION & ENGINEERING, INC. |
DOUGLAS WILKINS |
| K990160 |
01/19/1999 |
MICROTAC-BONE ANCHOR SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K990095 |
01/12/1999 |
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
INFLUENCE, INC. |
PETER BICK |
| 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 |
| K990052 |
01/07/1999 |
TEL-ECHO SYSTEM |
INNOVATIVE MEDICAL SOLUTIONS, INC. |
LAWRENCE E SIEB,JR |
| 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 |
| K990086 |
01/11/1999 |
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM |
INTEGRA LIFESCIENCES CORP. |
JUDITH E O'GRADY |
| 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 |
| K990131 |
01/14/1999 |
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K990057 |
01/07/1999 |
SYNERGY ADJUSTABLE LENGTH ROD |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| 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 |
| K990221 |
01/22/1999 |
INTRACOIL PERIPHERAL STENT |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
| K993904 |
11/17/1999 |
INTRASTENT DOUBLESTRUT LD |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
| K990144 |
01/19/1999 |
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL DANIEL |
| K990188 |
01/20/1999 |
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 |
INTUITIVE SURGICAL, INC. |
JOHN N ZORICH, JR. |
| K990157 |
01/19/1999 |
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K990077 |
01/11/1999 |
D-SIGN III (R&D PROJECT DW264#7) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990078 |
01/11/1999 |
D-SIGN IV (R&D PROJECT DW265#37) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990182 |
01/20/1999 |
D-SIGN V (R&D PROJECT DW267#17) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990235 |
01/25/1999 |
D-SIGN VI (R&D PROJECT DW266#9) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K993783 |
11/08/1999 |
TETRIC FLOW |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990056 |
01/07/1999 |
JELDENT MULTICRYL |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K993878 |
11/15/1999 |
JE 2000 |
JACK'S ELECTRODES |
ANTHONY R.H. FENDER |
| K990236 |
01/25/1999 |
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
LINDA G HILL |
| K990002 |
01/04/1999 |
QUICKRAY DSX 730 |
JULIE ALLIANCE |
CLAUDE D BERHOIN |
| K990229 |
01/25/1999 |
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 |
JUSTEC MEDICAL PRODUCTS, INC. |
JEFFREY L ROTHMAN |
| K993853 |
11/12/1999 |
K-ASSAY MULTI-ANALYTE CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K990004 |
01/04/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K993804 |
11/09/1999 |
KSEA RIGID CULDOSCOPE AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K990154 |
01/19/1999 |
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
| K993745 |
11/05/1999 |
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 |
KATECHO, INC. |
WARREN R WALTERS |
| K990240 |
01/25/1999 |
ELECTROGLOTTOGRAPH |
KAY ELEMETRICS CORP. |
WILLIAM D HARBESON |
| K990155 |
01/19/1999 |
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 |
KAY SEE DENTAL MFG. CO. |
CLARK SMITH |
| K990257 |
01/27/1999 |
KEELER PULSAIR 3000 NON CONTACT TONOMETER |
KEELER INSTRUMENTS, INC. |
EUGENE R VAN ARSDALE |
| K990139 |
01/19/1999 |
KENSTONE |
KENDA USA |
LONNIE WELLS |
| K990094 |
01/12/1999 |
KMI WRIST FUSION SYSTEM |
KINETIKOS MEDICAL, INC. |
MICHAEL COLLINS |
| K990073 |
01/11/1999 |
CALCITONIN |
KMI DIAGNOSTICS, INC. |
GOTTFRIED KELLERMAN |
| K990060 |
01/08/1999 |
MACH 7 |
KREATIV, INC. |
JOSEPH FOREHAND |
| K990040 |
01/06/1999 |
CLEARFIL SE BOND |
KURARAY CO. |
KOJI FUJITA |
| K993721 |
11/03/1999 |
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES |
LABORIE MEDICAL TECH CORP. |
DALE COLEMAN |
| K990041 |
01/06/1999 |
UROSTYM BIOFEEDBACK AND STIMULATION PROBES |
LABORIE MEDICAL TECH CORP. |
DALE COLEMAN |
| K990224 |
01/25/1999 |
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET |
LABTICIAN OPHTHALMICS, INC. |
R. DAVID SCULATI |
| K993668 |
11/01/1999 |
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
LAERDAL MEDICAL A/S |
MAGNE STEINSET |
| K990270 |
01/28/1999 |
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K990285 |
01/29/1999 |
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K990268 |
01/28/1999 |
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K993942 |
11/19/1999 |
LITESABER 2000 |
LASER DENTAL INNOVATIONS |
DAVID W SCHLERF |
| K990227 |
01/25/1999 |
ULTRASHAPER KERATOME |
LASERSIGHT TECHNOLOGIES, INC. |
MICHAEL P DAYTON |
| 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 |
| K990043 |
01/06/1999 |
SMOOTHLASE ALEXANDRITE LASER SYSTEM |
LEISEGANG MEDICAL, INC. |
LORNA K LINVILLE |
| K993894 |
11/16/1999 |
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
| K990141 |
01/19/1999 |
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 |
LIGHT DIAGNOSTICS |
CINDY PENNY |
| K990075 |
01/11/1999 |
LPULSA SYL-9000 OPHTHALMIC YAG LASER |
LIGHT-MED (USA), INC. |
THOMAS V KEELEY |
| K990194 |
01/21/1999 |
BIOBUTTON |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K993885 |
11/16/1999 |
ULTRABLATOR ELECTRODE |
LINVATEC CORP. |
LAURA SENEFF |
| K990044 |
01/06/1999 |
LOBOB UNIVERSAL CONTACT LENS CLEANER |
LOBOB LABORATORIES, INC. |
DANIEL J MANELLI |
| 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 |
| K990238 |
01/25/1999 |
LONGPORT MODEL LDS -1 |
LONGPORT, INC. |
MICHAEL G FARROW |
| K990067 |
01/08/1999 |
SHEER GLYDE DAMS |
LOUISE C. MYERS |
LOUISE C MYERS |
| K993883 |
11/15/1999 |
M-PACT CORNEAL LIGHT SHIELD |
M-PACT CORP. |
AL BOEDEKER |
| K990110 |
01/13/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990112 |
01/13/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990113 |
01/13/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990111 |
01/13/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990115 |
01/13/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K993941 |
11/19/1999 |
UBAS |
MARUKIN DIAGNOSTICS |
GREG HOLLAND |
| K990173 |
01/19/1999 |
PATHFINDER II ANGIOGRAPHIC CATHETER |
MAXXIM MEDICAL |
EDDIE MONROE |
| K990034 |
01/06/1999 |
WILSON-COOK COLONIC Z-STENT |
MED INSTITUTE, INC. |
NEAL E FEARNOT |
| K993815 |
11/10/1999 |
UNI-LASER 430 |
MEDART CORP. |
JAN K ENEMAERKE |
| K990220 |
01/22/1999 |
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM |
MEDI-GLOBE CORP. |
MICHELLE L FIELDS |
| 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 |
| K990185 |
01/20/1999 |
MDILOG, MODEL MDC-512 |
MEDTRAK TECHNOLOGIES, INC. |
LINDA L NELSON |
| K993677 |
11/01/1999 |
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT |
MEDTRONIC VASCULAR |
MICHAEL HINGSON |
| K990104 |
01/12/1999 |
MEDTRONIC MODEL 7495 EXTENSION KIT |
MEDTRONIC VASCULAR |
LISA L PRITCHARD |
| K993893 |
11/16/1999 |
MEDX INTECAM INTERFACE |
MEDX, INC. |
FLOYD ROWAN |
| K990263 |
01/27/1999 |
IMMUNOCARD STAT! E. COLI O157:H7 |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K993914 |
11/17/1999 |
PREMIER TOXINS A&B, MODEL 616096 |
MERIDIAN DIAGNOSTICS, INC. |
DAVID H WILLIS |
| K990264 |
01/27/1999 |
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS |
METRO OPTICS OF AUSTIN, INC. |
MARTIN DALSING |
| K993821 |
11/12/1999 |
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT |
METRON MEDICAL AUSTRALIA PTY LTD |
R.H. HOPKINS |
| K990210 |
01/21/1999 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP |
MEXPO INTL., INC. |
TIM THAI |
| 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 |
| K990168 |
01/19/1999 |
MICROLIFE IT2CA1 |
MICROLIFE SYSTEMS AG |
SCOT J DUBE |
| K990266 |
01/28/1999 |
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE |
MICROMEDICAL INDUSTRIES, LTD. |
DEAN E SYNDER |
| K993699 |
11/02/1999 |
THE STRIPPER |
MID-ATLANTIC DIAGNOSTICS, INC. |
TERRANCE J FORTINO |
| K990189 |
01/20/1999 |
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER |
MIDMARK CORP. |
JAMES RILE |
| 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 |
| K990153 |
01/19/1999 |
VIRGO MRI SYSTEM |
MILLENNIUM TECHNOLOGY SERVICES |
DAVID W SCHLERF |
| K990202 |
01/21/1999 |
SUGITA TITANIUM ANEURYSM CLIP |
MIZUHO AMERICA, INC. |
T.WHIT ATHEY |
| K993698 |
11/02/1999 |
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
| K990250 |
01/26/1999 |
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 |
MORAX |
BOREK JANIK |
| 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 |
| K990177 |
01/19/1999 |
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR |
NELLCOR PURITAN BENNETT, INC. |
CHERYL ROSENBERG |
| 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 |
| K990119 |
01/13/1999 |
EPI-STAR SURGICAL LASER SYSTER |
NIDEK, INC. |
JERRY TSUTSUMI |
| K993950 |
11/22/1999 |
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 |
NIEN MADE ELECTRNICS CORP. |
JAMES M DELANEY |
| K990031 |
01/05/1999 |
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K990063 |
01/08/1999 |
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K993890 |
11/16/1999 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K990281 |
01/28/1999 |
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
NISSEL LTD. |
JOHN M SZABOCSIK |
| 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 |
| K990180 |
01/20/1999 |
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| K990179 |
01/20/1999 |
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| K990178 |
01/20/1999 |
BURNFREE PAIN RELIEVING GEL, MODEL 4B |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| 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 |
| K990237 |
01/24/1999 |
TROCAR SYSTEM ACCORDING TO HASSON |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K990055 |
01/07/1999 |
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 |
OMEGA MEDICAL IMAGING, INC. |
DOUGLAS M COON |
| K990292 |
01/29/1999 |
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN |
OPHTHALMIC CONSULTANTS, INC. |
JOHN E LINCOLN |
| K990064 |
01/08/1999 |
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM |
OPHTHALMIC TECHNOLOGIES, INC. |
GEORGE MYERS |
| 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 |
| K990061 |
01/08/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K990016 |
01/04/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K990026 |
01/05/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| 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 |
| K990003 |
01/04/1999 |
J-SERIES OMEGA TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K990158 |
01/19/1999 |
OSTEONICS COMBINATION SCREW RING/BLOCKER |
OSTEONICS CORP. |
KATE SUTTON |
| K990203 |
01/21/1999 |
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| 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 |
| K990046 |
01/07/1999 |
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| 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 |
| K990249 |
01/26/1999 |
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 |
PHAMATECH |
CARL MONGIOVI |
| K990256 |
01/27/1999 |
CRX WORLD SHUNT |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| 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 |
| K990261 |
01/27/1999 |
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K990045 |
01/06/1999 |
BERACLAMP, MODEL BC-1 |
POAMAX L.L.C. |
MICHAEL J PALMER |
| K990247 |
01/26/1999 |
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K990276 |
01/28/1999 |
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER |
POROUS MEDIA CORP. |
ROCHELLE M MICKSCHL |
| K990296 |
01/28/1999 |
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) |
PRECISION BIOLOGIC |
SANDY MORRISON |
| 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 |
| K990234 |
01/25/1999 |
QUALISYS PSA IMMUNOASSAY |
QUALISYS DIAGNOSTICS, INC. |
GRACE KWAN |
| K990258 |
01/27/1999 |
QUANTECH TOTAL B-HCG ASSAY |
QUANTECH LTD. |
ROBIN HELLEN |
| 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 |
| K990071 |
01/11/1999 |
IMAGEFUSION 2.0 |
RADIONICS, INC. |
NANCY C MACDONALD |
| K990216 |
01/22/1999 |
MAGNETIC TIBC KIT |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K990199 |
01/21/1999 |
SMARTRECORDER, MODEL 2500 |
RESPIRONICS, INC. |
BETSY CORTELLONI |
| K990147 |
01/19/1999 |
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K990050 |
01/07/1999 |
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| 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 |
| K990108 |
01/13/1999 |
LC FLOWFILL |
S & C POLYMER GMBH |
JURGEN ENGELRECHT |
| K990118 |
01/13/1999 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
DEBBIE DE LOS SANTOS |
| K990208 |
01/21/1999 |
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT |
SCIENCE INCORPORATED |
RALPH E HOGANCAMP |
| K993715 |
11/03/1999 |
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K990206 |
01/21/1999 |
SERIM BLOOD LEAK TEST STRIP |
SERIM RESEARCH CORP. |
ROBERT J CARRICO |
| K990101 |
01/12/1999 |
PAIN CONTROL INFUSION PUMP |
SGARLATO LABORATORIES, INC. |
THOMAS SGARLATO |
| 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 |
| K990186 |
01/20/1999 |
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD |
FRANK LIU |
| K990117 |
01/13/1999 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K990081 |
01/11/1999 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K990267 |
01/28/1999 |
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K990175 |
01/19/1999 |
SHEATHES (NON-LATEX), STERILE |
SHEATHING TECHNOLOGIES, INC. |
LAWRENCE S POLAYES |
| 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 |
| K990083 |
01/11/1999 |
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K990192 |
01/21/1999 |
BIOPSY-DIGIT |
SITCO, INC. |
ROBERT H MCCARTHY |
| K990233 |
01/25/1999 |
ST-302 INFRAREX |
SKYLARK DEVICE CO., LTD. |
GEORGE K. C CHEN |
| K993851 |
11/12/1999 |
SODEM PERFORATOR DRIVE |
SODEMSYSTEMS |
DANIEL BACCINO |
| K990103 |
01/12/1999 |
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE |
SORIN BIOMEDICAL, INC. |
LYNNE LEONARD |
| K993868 |
11/15/1999 |
THE SOUNDVASER DISSECTION SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K990005 |
01/04/1999 |
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
PEPPER A CHASTAIN |
| K994019 |
11/26/1999 |
CAUTERY GRASPER/DISSECTOR |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K990246 |
01/26/1999 |
STERI-PAK LF BOWIE-DICK TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
LON BRUSO |
| 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 |
| K990038 |
01/06/1999 |
HUMMER TRAK SYSTEM |
Stryker Endoscopy |
DAVID HIMES |
| 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 |
| K990136 |
01/14/1999 |
ANATOMICA GLENOID COMPONENT |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K990137 |
01/14/1999 |
ANATOMICA HUMERAL STEM/HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K990142 |
01/19/1999 |
HT, MODEL HT PB |
SULZER OSCOR, INC. |
MILA DOSKOCIL |
| 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 |
| K990214 |
01/22/1999 |
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K994015 |
11/26/1999 |
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HARR |
| K990225 |
01/25/1999 |
ENDO ANALYZER, MODEL 8005, MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990252 |
01/27/1999 |
SOLO PLUS ORTHO |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| 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 |
| K990100 |
01/04/1999 |
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE |
TE ME NA S.A.R.L. |
JOE HARMS |
| K990020 |
01/04/1999 |
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC |
TE ME NA S.A.R.L. |
DONALD F RYAN |
| K994024 |
11/26/1999 |
EXTENDED STRAIGHT ATTACHMENT |
TEAM TECHNOLOGIES, INC. |
BOB WALTON |
| K990015 |
01/04/1999 |
ELECTRODE NEEDLES |
TECHNOMED EUROPE |
HARRY KNUTH |
| K993772 |
11/08/1999 |
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR |
TERUMO MEDICAL CORP. |
GARRY A COURTNEY |
| K990288 |
01/29/1999 |
FREE FLOW SAFETY DEVICE, MODEL MG 245052 |
TEVA MEDICAL, LTD. |
MARYANN MELUS |
| 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 |
| K990129 |
01/13/1999 |
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR |
THERAPY LINK, INC. |
CRAIG SEYL |
| 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 |
| K990134 |
01/14/1999 |
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K993803 |
11/09/1999 |
EXCELART WITH PIANISSIMO |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K990260 |
01/27/1999 |
OPART |
TOSHIBA AMERICA MRI, INC. |
HSU CHANG |
| K990007 |
01/04/1999 |
OPART, MODEL MRT-600 |
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 |
| K990262 |
01/27/1999 |
CLEARPLAN EASY HOME PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K993703 |
11/02/1999 |
CLEARVIEW EASY HCG PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K990223 |
01/25/1999 |
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR |
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 |
| K990085 |
01/11/1999 |
MILLENNIUM MLC -120 |
VARIAN ASSOC., INC. |
LINDA S NASH |
| K993995 |
11/24/1999 |
VEIN ENTRY INDICATOR DEVICE (VEID) |
VASCULAR TECHNOLOGIES LTD. |
AHAVA STEIN |
| K990123 |
01/13/1999 |
PVR-100/VASOGRAM |
VASOCOR, INC. |
JEFF RAINES |
| K990098 |
01/12/1999 |
VENTLAB VERIFY II |
VENTLAB CORP. |
E J SMITH |
| 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 |
| K990145 |
01/19/1999 |
WILSON-COOK BIPOLAR PROBE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K990130 |
01/14/1999 |
WILSON-COOK PANCREATIC WEDGE STENT |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K990231 |
01/25/1999 |
WILTEK HOT BIOPSY FORCEPS |
WILTEK MEDICAL, INC. |
JON S WILSON |
| 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 |
| K990030 |
01/05/1999 |
ADVANCED REVISION PRODUCT LINE EXTENSION |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K993958 |
11/22/1999 |
IDX-60 INTRAORAL X-RAY |
X-CEL X-RAY CORP. |
WILLIAM W MORRIS |
| K990013 |
01/04/1999 |
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
E J SMITH |
| K990207 |
01/21/1999 |
GLIADIN IGA ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK K KOPNITSKY |
| K990204 |
01/21/1999 |
GLIADIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K990135 |
01/13/1999 |
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE |
ZIMMER, INC. |
KAREN CAIN |
| K990170 |
01/19/1999 |
HOLTER 2000 |
ZYMED MEDICAL INSTRUMENTATION |
GRETEL LUMLEY |
