| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K993888 |
12/20/1999 |
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS |
A & D ENGINEERING, INC. |
JERRY WANG |
| K991541 |
12/28/1999 |
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 |
A-MED SYSTEMS, INC. |
ROBERTA THOMPSON |
| K991246 |
12/16/1999 |
FRUCTOSAMINE, MODEL FR 106-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K984236 |
02/10/1999 |
AARON ESU FOOT-CONTROL ADAPTER #A1205A |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K984239 |
02/10/1999 |
SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K983890 |
02/18/1999 |
SYSTEM U3 |
AB BIODISK |
ANNE BOLSTROM |
| K984144 |
02/09/1999 |
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID |
AB BIODISK |
ANNE BOLMSTROM |
| K984087 |
02/08/1999 |
SYSTEM U3 FOR AMPICILLIN |
AB BIODISK |
ANNE BOLMSTROM |
| K984108 |
02/03/1999 |
ABBOTT ARCHITECT B12 |
ABBOTT LABORATORIES |
LAURA L GRANITZ |
| K984301 |
02/05/1999 |
ABBOTT ARCHITECT FOLATE |
ABBOTT LABORATORIES |
LAURA L GRANITZ |
| K994039 |
12/22/1999 |
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB |
ABBOTT LABORATORIES |
JERRY JENNINGS |
| K983070 |
02/16/1999 |
CK |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K990373 |
02/22/1999 |
FACT PLUS ONE STEP PREGNANCY TEST |
ABBOTT LABORATORIES |
KATHERINE M WORTLEY |
| K984489 |
02/16/1999 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K992531 |
12/20/1999 |
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM |
ACCUMETRICS, INC. |
FRANCES E HARRISON |
| K993774 |
12/07/1999 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K984058 |
02/11/1999 |
ACIST INJECTOR SYSTEM, MODEL CL100 H |
ACIST MEDICAL SYSTEMS |
KATE ANDERSON |
| K993317 |
12/01/1999 |
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
| K993203 |
12/01/1999 |
ACON ONE STEP PREGNANCY TEST STRIP (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
| K992631 |
12/15/1999 |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER |
ACUSON CORP. |
HOWARD M HOLSTEIN |
| K993544 |
12/22/1999 |
SPACE-OR RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA CULLINANE |
| K991401 |
12/15/1999 |
ATR 3000, ATR 2000, IMPLANT-PRO |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. |
CAROL A PATTERSON |
| K984109 |
02/12/1999 |
AESCULAP AXIAL CLIP APPLIER |
AESCULAP, INC. |
LIA S JONES |
| K984124 |
02/01/1999 |
AESCULAP XENON LIGHT SOURCE |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
| K990088 |
02/10/1999 |
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K992995 |
12/09/1999 |
AROMATIC AND FLAVORED TONGUE DEPRESSOR |
AGA PLASTIC IND. COM. LTDA. |
SUSAN D GOLDSTEIN-FALK |
| K993276 |
12/14/1999 |
SIMPLIFY D-DIMER, MODEL DCGK1 |
AGEN BIOMEDICAL LTD. |
RUSSEL RICHARDS |
| K993907 |
12/06/1999 |
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K983626 |
02/05/1999 |
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II |
ALARIS MEDICAL SYSTEMS, INC. |
GARY N MILLS |
| K993887 |
12/20/1999 |
ALATECH LATEX CONDOM |
ALATECH HEALTHCARE, LLC. |
WAYNE L GAINEY |
| K984616 |
02/04/1999 |
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K984613 |
02/04/1999 |
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION |
ALBERT BROWNE LTD. |
CYNTHIA NOLTE |
| K984080 |
02/16/1999 |
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K984077 |
02/16/1999 |
INSTANT-VIEW PREGNANCY COMBO TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K984079 |
02/16/1999 |
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K984075 |
02/16/1999 |
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K984076 |
02/16/1999 |
INSTANT-VIEW PREGNANCY URINE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K993833 |
12/10/1999 |
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K990300 |
02/10/1999 |
SUPRASHIELD EXPRESS STERILIZATION WRAP |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K990643 |
12/07/1999 |
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
AMAURY SANCHEZ |
| K984275 |
02/01/1999 |
THE GOLDEN TIP ELECTRO-SURGICAL PROBE |
AMADA SURGICAL |
SUSAN D GOLDSTEIN-FALK |
| K993796 |
12/21/1999 |
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K984525 |
02/26/1999 |
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K983614 |
02/04/1999 |
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) |
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
TARANI DEVI |
| K984558 |
02/26/1999 |
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K984559 |
02/26/1999 |
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K993135 |
12/01/1999 |
IMPLANTABLE CLIP FOR GENERAL SURGERY |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K993650 |
12/28/1999 |
URETERAL ACCESS SHEATH SET - NEW MODELS |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K984208 |
02/22/1999 |
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD |
ARGENTUM INTERNATIONAL LLC. |
A. BART FLICK |
| K992232 |
12/21/1999 |
FIRST RESPONSE 1-STEP PREGNANCY |
ARMKEL, LLC. |
Maureen Garner |
| K993283 |
12/29/1999 |
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C |
ARNOLD & RICHTER CINE TECHNIK |
THOMAS POPP |
| K990398 |
12/01/1999 |
PLATELETWORKS |
ARRAY MEDICAL, INC. |
DAVID CARVILLE |
| K992581 |
12/09/1999 |
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K983368 |
02/17/1999 |
CARE BAND ANTIBACTERIAL BANDAGES |
ASO CORP. |
JOAN RUBENDALL |
| K993837 |
12/16/1999 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K992502 |
12/21/1999 |
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY |
AXIS |
RONALD G LEONARDI |
| K983005 |
02/04/1999 |
PERFUSOR COMPACT |
B. BRAUN MEDICAL, INC. |
GARY A GULYAS |
| K984084 |
02/01/1999 |
BARDEX LUBRI-SIL FOLEY CATHETER |
BARD MEDICAL DIV. |
DONNA J WILSON |
| K984136 |
02/16/1999 |
BARDEX LUBRI-SIL I.C. FOLEY CATHETER |
BARD MEDICAL DIV. |
DONNA J WILSON |
| K984381 |
02/19/1999 |
BURETROL SOLUTION SETS |
BAXTER HEALTHCARE CORP. |
JUDY KANNENBERG |
| K993711 |
12/16/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) |
BAYER CORP. |
GABRIEL MURACA |
| K993309 |
12/06/1999 |
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY |
BAYER CORP. |
William J Pignato |
| K993571 |
12/16/1999 |
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 |
BAYER CORP. |
THOMAS F FLYNN |
| K993353 |
12/06/1999 |
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA JR |
| K993577 |
12/01/1999 |
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
MONICA E GIGUERE |
| K993500 |
12/02/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K984244 |
02/23/1999 |
ORL-E-92 SURGICAL DRILL SYSTEM |
BIEN AIR USA, INC. |
CAROL PATTERSON |
| K990106 |
02/26/1999 |
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K994149 |
12/27/1999 |
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K984604 |
02/02/1999 |
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984625 |
02/02/1999 |
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 |
BIO-RAD |
ELIZABETH PLATT |
| K993107 |
12/21/1999 |
BIO-RAD HOMOCYSTEINE BY HPLC |
BIO-RAD |
Patricia M Klimley |
| K984594 |
02/02/1999 |
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 |
BIO-RAD |
ELIZABETH PLATT |
| K991756 |
12/10/1999 |
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE |
BIO-RESEARCH ASSOCIATES, INC. |
LONNIE WITHAM |
| K993529 |
12/29/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
BIOGRAFIK (MALAYSIA) SDN BHD |
SHUKUR BIN HASRAN |
| K990219 |
02/24/1999 |
MODIFICATION OF MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
ANDREW KIMMEL |
| K993708 |
12/03/1999 |
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG |
BIOMAGNETIC TECHNOLOGIES, INC. |
EUGENE C HIRSCHKOFF |
| K993033 |
12/16/1999 |
INTRAY GC |
BIOMED DIAGNOSTICS, INC. |
ROBERT D HALL |
| K984408 |
02/12/1999 |
130 MODIFIED INTEGRAL FEMORAL COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K984154 |
02/11/1999 |
APF POROUS COATED LINE EXTENSION |
BIOMET, INC. |
FRED MCCLURE |
| K992355 |
12/20/1999 |
LACTOSORB TRAUMA PLATING SYSTEM |
BIOMET, INC. |
TRACY J BICKEL |
| K984296 |
02/18/1999 |
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT |
BIOMET, INC. |
DARLENE HUFZIGER BINKLEY |
| K990032 |
02/18/1999 |
MODULAR PROTUSIO CUP |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
| K994038 |
12/22/1999 |
MODULAR REACH HIP |
BIOMET, INC. |
FRED MCCLURE |
| K984209 |
02/03/1999 |
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
| K993956 |
12/20/1999 |
TITANIUM PEDIATRIC FEMORAL NAIL |
BIOMET, INC. |
LONNIE WITHAM |
| K993945 |
12/07/1999 |
BIONIKE AQ PHENCYCLIDINE (PCP) TEST |
BIONIKE LABORATORIES, INC. |
CLEVE W LAIRD |
| K982721 |
02/17/1999 |
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
JONATHAN S KAHAN |
| K993074 |
12/10/1999 |
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K993073 |
12/06/1999 |
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K993729 |
12/03/1999 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
SANDRA WILLIAMSON |
| K982298 |
02/03/1999 |
OPTICOAT T4 EIA KIT |
BIOTECX LABORATORIES, INC. |
MOHAN MEHRA |
| K993118 |
12/17/1999 |
BIOTEQUE A.V. FISTULA NEEDLE SET |
BIOTEQUE CORP. |
ALLEN REICH |
| K993139 |
12/17/1999 |
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K983650 |
02/17/1999 |
BIPORE BALLOON DILATATION CATHETER |
BIPORE, INC. |
DURMUS KOCH |
| K993449 |
12/20/1999 |
BIRD V.I.P. GOLD/STERLING |
BIRD PRODUCTS CORP. |
DARRYL SHELBY |
| K993591 |
12/28/1999 |
BLADEWORKS DISPOSABLE ALK TUBING |
BLADE WORKS, INC. |
GARY MOCNIK |
| K982034 |
02/19/1999 |
E-FAX SYSTEM |
BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS |
J. HARVEY KNAUSS |
| K983047 |
02/05/1999 |
ACCU-CHEK HQ SYSTEM |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K984419 |
02/02/1999 |
ELECSYS IGE CALCHECK |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K984326 |
02/08/1999 |
ELECYS IGE ASSAY |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K993115 |
12/17/1999 |
MULTITAK SS |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K982363 |
02/23/1999 |
OASIS THROMBECTOMY CATHETER SYSTEM |
BOSTON SCIENTIFIC CORP. |
LAURA MONDANO |
| K993232 |
12/30/1999 |
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
RONALD W BENNETT |
| K991139 |
12/22/1999 |
GUGLIELMI DETACHABLE (GDC) |
BOSTON SCIENTIFIC, TARGET |
JIM LEATHLEY |
| K993464 |
12/10/1999 |
BARDEX I.C. PEDIATRIC FOLEY CATHETER |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
| K984601 |
02/04/1999 |
CANDELA GENTLELASE II DERMATOLOGICAL LASER |
CANDELA CORP. |
JAY CAPLAN |
| K994009 |
12/21/1999 |
CG-2100 ECG TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K993799 |
12/10/1999 |
CG-7000DX ECG RECORDER/TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K990429 |
02/24/1999 |
MODIFICATION OF VENTURI VENTILATOR |
CARDIOPULMONARY CORP. |
JOHN LAVIOLA |
| K984025 |
02/10/1999 |
CARE TENS |
CARE REHAB, INC. |
CHRISTIAN HUNT |
| K990025 |
02/08/1999 |
CARESIDE AMYLASE |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993634 |
12/02/1999 |
CARESIDE ANALYZER |
CARESIDE, INC. |
KENNETH B ASARCH |
| K993771 |
12/27/1999 |
CARESIDE DIRECT BILIRUBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K982151 |
02/09/1999 |
STERITITE PROCESS INDICATOR ACCESSORIES |
CASE MEDICAL, INC. |
MARCIA FRIEZE |
| K990058 |
12/15/1999 |
QMS MAPPING SYSTEM,MODEL 2000 |
CATHDATA, INC. |
RICHARD KEEN |
| K993860 |
12/03/1999 |
CATHETER INNOVATIONS IMPLANTABLE PORT |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K983950 |
02/03/1999 |
CERALAS DIODE LASER SYSTEM (MODEL H) |
CERAMOPTEC, INC. |
JOHNATHAN S KAHAN |
| K982317 |
02/01/1999 |
VECTRA COMBO |
CHATTANOOGA GROUP, INC. |
CHERYL G DYER |
| K982324 |
02/01/1999 |
VECTRA PRO MODELS 2 AND 4 |
CHATTANOOGA GROUP, INC. |
CHERYL G DYER |
| K982321 |
02/01/1999 |
VECTRA STIM MODELS 200 AND 400 |
CHATTANOOGA GROUP, INC. |
CHERYL G DYER |
| K981913 |
02/12/1999 |
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY |
Chembio Diagnostic Systems, Inc. |
RAYMOND DATTWYLER |
| K993375 |
12/20/1999 |
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
COLIN ALDERSLEY |
| K993001 |
12/03/1999 |
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED |
COBE CARDIOVASCULAR, INC. |
LYNN LEONARD |
| K993304 |
12/06/1999 |
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K993255 |
12/06/1999 |
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993710 |
12/21/1999 |
MODIFICATION OF PARAPOST CEMENT |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K993835 |
12/16/1999 |
PARAPOST SYSTEM STERILIZABLE ORGANIZER |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K984228 |
02/02/1999 |
IS ANTI-TPO IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983054 |
02/10/1999 |
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K983642 |
02/01/1999 |
COOK MINI-INCUBATOR |
COOK OB/GYN |
BRENDA DAVIS |
| K983596 |
02/05/1999 |
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING |
COOK OB/GYN |
DEBBIE SCHMITT |
| K983595 |
02/08/1999 |
TRANSMYOMETRIAL EMBRYO TRANSFER SET |
COOK OB/GYN |
BRENDA DAVIS |
| K992121 |
12/20/1999 |
EMBOLIZATION COIL SYSTEM |
COOK, INC. |
LISA WEBB |
| K982333 |
02/12/1999 |
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY |
COOK, INC. |
APRIL LAVENDER |
| K983534 |
02/26/1999 |
7F HYDROLYSER THROMBECTOMY CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K994068 |
12/23/1999 |
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA JUGO |
| K990127 |
02/10/1999 |
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K983334 |
02/19/1999 |
NITRILE POWDER FREE EXAMINATION GLOVES |
CRANBERRY (M) SDN. BHD. |
CHONG YOON TAT |
| K984187 |
02/18/1999 |
CROSSTEX NON-WOVEN SPONGES |
CROSSTEX INTL. |
SUSAN D GOLDSTEIN-FALK |
| K990255 |
02/16/1999 |
DIMENSION DRUG CALIBRATOR II, MODEL DC49B |
DADE BEHRING, INC. |
CATHY P CRAFT |
| K993299 |
12/07/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K993102 |
12/02/1999 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
TREVOR WALL |
| K983746 |
12/09/1999 |
MICROSTREP PLUS PANEL |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K993855 |
12/15/1999 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K993296 |
12/15/1999 |
TRIP TONOMETRY CATHETER, 14F |
DATEX-OHMEDA, INC. |
JOEL KENT |
| K984128 |
02/09/1999 |
ENIGMA DENTURE TEETH |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
| K993717 |
12/22/1999 |
ENIGMA HI-BASE DENTURE BASE MATERIAL |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
| K984134 |
02/12/1999 |
NATURA DENTURE TEETH |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CYDE E INGERSOLL |
| K982867 |
02/19/1999 |
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 |
DAVOL, INC., SUB. C.R. BARD, INC. |
ROBIN DRAGO |
| K990027 |
02/09/1999 |
OMNICORDER, MODEL 464 |
DEL MAR AVIONICS |
RAPHAEL HENKIN |
| K984339 |
02/18/1999 |
MEDART 455 SCANNER SYSTEM |
DEL MAR TECHNOLOGIES, INC. |
JAN K ENEMAERK |
| K983106 |
02/09/1999 |
1ST IMPRESSION |
DEN-MAT CORP. |
W R GLACE |
| K990120 |
02/01/1999 |
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K993099 |
12/15/1999 |
BREMER HALO SYSTEM TITANIUM SKULL PIN |
DEPUY ACROMED |
FRANK MASS |
| K993030 |
12/29/1999 |
MODIFICATION TO ISOLA SPINAL SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
| K993952 |
12/16/1999 |
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K990222 |
02/26/1999 |
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K981831 |
02/16/1999 |
IS EBV-EA-D IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
NORMAN JENKINS |
| K981829 |
02/16/1999 |
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
NORMAN JENKINS |
| K992552 |
12/16/1999 |
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K994110 |
12/21/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN/AMERICAN STANDARD COMPANIES |
JUDITH J SMITH |
| K993681 |
12/21/1999 |
DIGITEC TWO STAGE COMPRESSION KIT |
DIGITEC MEDICAL SERVICE CORP. |
JAMES J MCGINITY |
| K990014 |
02/26/1999 |
DIOSCAN |
DIOMED, INC. |
MAUREEN O'CONNELL |
| K994197 |
12/29/1999 |
DISENTRONIC PENFINE INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K994186 |
12/30/1999 |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K990259 |
02/12/1999 |
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K991714 |
12/10/1999 |
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K983438 |
02/08/1999 |
MAX IT |
DOREA, INC. |
RICHARD V MOSES,JR. |
| K984349 |
02/04/1999 |
DORNIER MEDILAS R |
DORNIER |
CAROL WERNECKE |
| K992209 |
12/10/1999 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
T. WHIT ATHEY |
| K982003 |
02/11/1999 |
DS30 HCY HOMOCYSTEINE ASSAY KIT |
DREW SCIENTIFIC LTD. |
ANDREW KENNEY |
| K992949 |
12/27/1999 |
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST |
DRUG DETECTION DEVICES, LTD. |
BRUCE CHRISTIE |
| K984564 |
12/02/1999 |
ETHYL CHLORIDE DISPENSER |
DUKAL CORP. |
ED RASOM |
| K984276 |
02/10/1999 |
DISPOSABLE ELECTROSURGERY GROUNDING PAD |
E & M ENGINEERING, INC. |
ROGER STRUBE |
| K993822 |
12/10/1999 |
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K993886 |
12/14/1999 |
EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K983983 |
02/03/1999 |
EDI VERIS SYSTEM |
ELECTRO-DIAGNOSTIC IMAGING, INC. |
SHEILA W PICKERING |
| K980631 |
02/02/1999 |
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA |
EMBOL-X, INC. |
JEAN CHANG |
| K982663 |
02/26/1999 |
STIMULAN- CALCIUM SULFATE BONE VOID FILLER |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K983144 |
02/24/1999 |
FLEXPOSURE RETRACTOR |
ENDIUS, INC. |
MARY MCNAMARA-CULLINANE |
| K992479 |
12/02/1999 |
ENSITE 3000 SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
JAMES W BULLOCK |
| K984544 |
02/18/1999 |
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S |
ENTERIC PRODUCTS, INC. |
JEFFREY PEACOCK |
| K984150 |
02/22/1999 |
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER |
EP MEDSYSTEMS |
JOSEPH C GRIFFIN, III |
| K992211 |
12/22/1999 |
SPO2 WRAP SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K992092 |
12/22/1999 |
STAT-SHELL DISPOSABLE SPO2 SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K990008 |
02/24/1999 |
ERCO-RIBBON -C |
ERCONS, INC. |
YAKOV ALTSHULER |
| K990006 |
02/24/1999 |
ERCO-VAC -C |
ERCONS, INC. |
YAKOV ALTSHULER |
| K982119 |
02/04/1999 |
DIODE LASER |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K984247 |
02/25/1999 |
ELIPAR TRILIGHT |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K993566 |
12/06/1999 |
PROMPTFLOW |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K983925 |
02/03/1999 |
ENDOPATH ULTRA VERESS NEEDLE |
ETHICON ENDO-SURGERY, INC. |
EDWIN O BILLIPS |
| K993054 |
12/09/1999 |
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
| K984220 |
02/23/1999 |
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH |
ETHICON, INC. |
GREGORY R JONES |
| K991439 |
12/20/1999 |
POLLER CALIBRANTS |
EUROPEAN CONCERTED ACTION ON ANTICOAGULATION |
L. POLLER |
| K984263 |
02/02/1999 |
EWC: ECG II CABLE LEADWIRE SYSTEM |
EWC |
TIM DAVIS |
| K990197 |
02/04/1999 |
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM |
EXACTECH, INC. |
GARY J MILLER |
| K993820 |
12/02/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS |
FELDA RUBBER CORP. |
YUNUS LATIF |
| K984199 |
02/17/1999 |
EXONIX |
FIBRA SONICS, INC. |
ROBERT BROHM |
| K984143 |
02/16/1999 |
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM |
FIBRA SONICS, INC. |
ROBERT BROHM |
| K984413 |
02/10/1999 |
BIONECT HYDROGEL |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
| K984264 |
02/10/1999 |
MODIFICATION OF BIONECT CLEAR HYDROGEL |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
| K984267 |
02/10/1999 |
MODIFICATION OF BIONECT HYDROGEL FOAM |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
| K984262 |
02/10/1999 |
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
| K984266 |
02/10/1999 |
MODIFICATION OF BIONECT HYDROGEL SPRAY |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
| K993450 |
12/29/1999 |
LATEX SURGICAL GLOVES, PRE-POWDERED |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH PEREIRA |
| K984233 |
02/01/1999 |
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE |
FRESENIUS HEMOTECHNOLOGY, INC. |
VIRGINIA R SINGER |
| K993095 |
12/09/1999 |
FRIALIT-2 SELECT COMPONENTS |
FRIADENT GMBH |
CAROL PATTERSON |
| K980689 |
02/18/1999 |
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM |
FRIDDLE'S ORTHOPEDIC APPLIANCES, INC. |
FRANK E FRIDDLE, JR. |
| K982559 |
02/01/1999 |
GUIDEWIRE |
GALT MEDICAL CORP. |
JIM EDINGS |
| K980386 |
02/24/1999 |
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
| K984365 |
02/25/1999 |
GC UNIFAST TRAD |
GC AMERICA, INC. |
TERRY L JORITZ |
| K984505 |
02/04/1999 |
MIRACLE MIX POWDER/LIQUID |
GC AMERICA, INC. |
TERRY L JORITZ |
| K993687 |
12/21/1999 |
UROVIEW 2800 |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K983139 |
02/19/1999 |
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K993645 |
12/21/1999 |
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K990226 |
02/09/1999 |
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K994075 |
12/27/1999 |
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K993202 |
12/17/1999 |
EIM-107 PREP-CHECK |
GENERAL DEVICES |
MICHAEL SMITH |
| K973910 |
02/17/1999 |
GLIADIN ANTIBODIES ELISA |
GENESIS DIAGNOSTICS LTD. |
MICHAEL WALKER |
| K982472 |
02/04/1999 |
GENICON TROCAR |
GENICON, LC |
GARY W HABERLAND |
| K983449 |
02/08/1999 |
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR |
GEREONICS, INC. |
GERALD A ROST |
| K993752 |
12/03/1999 |
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K993127 |
12/02/1999 |
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) |
GLOVESWORLD INDUSTRIES SDN. BHD. |
BIEN LONG NIEN |
| K992456 |
12/21/1999 |
GRADILEIDEN V TEST |
GRADIPORE LTD. |
RHONDA PILGRIM |
| K993386 |
12/20/1999 |
LATEX EXAMINATION POWDERED GLOVES |
GREAT GLOVE SDN BHD |
K.M. LEE |
| K990079 |
12/23/1999 |
FASTSEAL CHEST WOUND DRESSING |
GREENFIELD MEDICAL TECHNOLOGIES, INC. |
DONALD R GORSUCH |
| K991964 |
12/20/1999 |
EIS THREADED SCREW FRACTURE FIXATION |
GROUPE LEPINE |
DOUGLAS W STUART |
| K983541 |
02/26/1999 |
HSV 1+2 IGG ELISA TEST |
GULL LABORATORIES, INC. |
FRED W RACHFORD |
| K990228 |
02/19/1999 |
GUTHRIE PRIME POWDER-FREE |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K990213 |
02/02/1999 |
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET |
GYRUS ENT L.L.C. |
JEFF COBB |
| K994166 |
12/27/1999 |
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K993749 |
12/03/1999 |
GYRUS HYSTEROSCOPIC RESECTOSCOPE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K984442 |
02/12/1999 |
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 |
HAND BIOMECHANICS LAB, INC. |
TIMOTHY STALLINGS |
| K993812 |
12/21/1999 |
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K |
HARDY DIAGNOSTICS |
MELISSA M TAYLOR |
| K993993 |
12/27/1999 |
HARDYDISK AMIKACIN 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
| K993994 |
12/21/1999 |
HARDYDISK AZITHROMYCIN 15MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K991492 |
12/02/1999 |
LC COMPOSITE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K993716 |
12/21/1999 |
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K981862 |
02/09/1999 |
RESIN 4 |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K983204 |
02/26/1999 |
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP |
HARWILL MEDICAL (PTY) LTD. |
E.J. Smith |
| K990807 |
12/03/1999 |
HL148 & HL168 |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K993766 |
12/08/1999 |
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
HELAX AB |
E.S. MARTELL |
| K993330 |
12/30/1999 |
THERMOCHEM-HT SYSTEM |
HEMOCLEANSE, INC. |
STEPHEN R ASH |
| K990143 |
02/25/1999 |
GLUMA ONE BOND |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K993602 |
12/15/1999 |
PRE-VISION FILL |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K993932 |
12/22/1999 |
SOLITAIRE 2 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K992977 |
12/01/1999 |
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A |
HEWLETT-PACKARD CO. |
WARREN R WALTERS |
| K990400 |
02/24/1999 |
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM |
HEWLETT-PACKARD CO. |
STEPHEN B SINGLAR |
| K993169 |
12/20/1999 |
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A |
HEWLETT-PACKARD CO. |
SHEILA W PICKERING, PHD. |
| K990339 |
02/18/1999 |
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O |
HEWLETT-PACKARD CO. |
ANN FAY MICHAELS |
| K992595 |
12/08/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K984280 |
02/08/1999 |
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K984432 |
02/24/1999 |
DALL-MILES CABLE GRIP (A-GRIP) |
HOWMEDICA OSTEONICS CORP. |
FRANK MAAS |
| K993692 |
12/02/1999 |
DURACON INSET PATELLA, 25MM |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K990849 |
12/20/1999 |
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K993402 |
12/20/1999 |
OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K984202 |
02/05/1999 |
HOWMEDICA HUMERAL INTERCALARY SYSTEM |
HOWMEDICA, INC. |
FRANK MAAS |
| K984251 |
02/24/1999 |
XIA SPINE SYSTEM |
HOWMEDICA, INC. |
VIVIAN KELLY |
| K984305 |
02/01/1999 |
ZETA MULTIZONE LOCKING NAIL SYSTEM |
HOWMEDICA, INC. |
JOSEPH VOLPE |
| K983637 |
12/10/1999 |
ACTIFRESH 400 LENS |
HYDRON LTD. |
JULIAN B HOLLOWAY |
| K983160 |
02/18/1999 |
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR |
HYDRON LTD. |
JULIAN B HOLLOWAY |
| K984441 |
02/22/1999 |
KVO CHECK VALVE ACCESSORY, MODEL EV-0001 |
I-FLOW CORP. |
SHANE P NOEHRE |
| K984063 |
02/09/1999 |
PARAGON BASAL/BOLUS ADMINISTRATION SET |
I-FLOW CORP. |
ROBERT J BARD |
| K984638 |
02/09/1999 |
PARAGON BOLUS ACCESSORY SET |
I-FLOW CORP. |
ROBERT J BARD |
| K984146 |
02/09/1999 |
PARAGON INFUSION |
I-FLOW CORP. |
ROBERT J BARD |
| K993673 |
12/21/1999 |
SNN FLUORO NAVIGATION SYSTEM |
I.S.G. TECHNOLOGIES, INC. |
DOLORES MCGIRR |
| K993338 |
12/29/1999 |
INTEGRATED DIGITAL MEDICAL RECORD (IDMR) |
IBM ISRAEL LTD. |
ELI M ORBACH |
| K984523 |
02/16/1999 |
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS |
IGEL VISION CARE PTE LTD. |
JOHN M SZABOCSIK |
| K983539 |
02/12/1999 |
TRAJECTORY GUIDE, MODEL # TGX-XXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
MICHAEL J RENNER |
| K993936 |
12/27/1999 |
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE |
IMAGYN SURGICAL |
JULIE POWELL |
| K992759 |
12/06/1999 |
COLON ALERT TEST |
IMMUNOSTICS, INC. |
VINCENT P LASTELLA |
| K993532 |
12/15/1999 |
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) |
IMPAX TECHNOLOGY, INC. |
PAULA PFEIFLE |
| K984291 |
02/01/1999 |
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT |
IMPLEX CORP. |
JOHN SCHALAGO |
| K982751 |
02/01/1999 |
IMPLEX SCREW AND WASHER SYSTEM |
IMPLEX CORP. |
ROBERT POGGIE |
| K993693 |
12/29/1999 |
INVIGRA |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K990160 |
02/16/1999 |
MICROTAC-BONE ANCHOR SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K990095 |
02/01/1999 |
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
INFLUENCE, INC. |
PETER BICK |
| K984117 |
02/10/1999 |
INNOVA TELESCOPIC DISTRACTOR |
INNOVA CORP. |
HOWARD M HOLSTEIN |
| K994010 |
12/17/1999 |
INNOVAQUARTZ GENERAL SHAPE LASER FIBER |
INNOVAQUARTZ |
RANDY MCLELLAN |
| K993975 |
12/20/1999 |
ABSOLUTE ABSORBABLE INTERFERENCE SCREW |
INNOVASIVE DEVICES, INC. |
KATHLEEN MORAHAN |
| K990052 |
02/19/1999 |
TEL-ECHO SYSTEM |
INNOVATIVE MEDICAL SOLUTIONS, INC. |
LAWRENCE E SIEB,JR |
| K984336 |
02/08/1999 |
QUANTA LITE GBM ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K984437 |
02/02/1999 |
QUANTEX ASO-CRP-RP CONTROL II |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K984030 |
02/10/1999 |
VIPERSOFT |
INTEGRA MEDICAL |
W. EDWARD JOHANSEN |
| K993808 |
12/06/1999 |
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K984294 |
02/22/1999 |
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES |
INTERVASCULAR, INC. |
JAMES S MILLER |
| K991074 |
12/21/1999 |
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST |
INTRACEL CORP. |
SHERYL RUPPEL |
| K984405 |
02/08/1999 |
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 |
INTRACOM CORP. |
JAMES A NATIONS |
| K993153 |
12/17/1999 |
INTRALASE 600C LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K990157 |
02/03/1999 |
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K993413 |
12/15/1999 |
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL |
INVACARE CORP. |
EDWAED A KROLL |
| K992298 |
12/09/1999 |
IRIDERM, MODEL APEX 800 |
IRIDEX CORP. |
BRAD RENTON |
| K991878 |
12/10/1999 |
LUMA-CATH STEERABLE EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K983580 |
02/18/1999 |
BLASTOCYST MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K983586 |
02/18/1999 |
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K983584 |
02/08/1999 |
HUMAN SERUM ALBUMIN (HSA) |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K983589 |
02/18/1999 |
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K991339 |
12/06/1999 |
TYRODE'S SOLUTION-ACIDIFIED |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K990077 |
02/12/1999 |
D-SIGN III (R&D PROJECT DW264#7) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990078 |
02/12/1999 |
D-SIGN IV (R&D PROJECT DW265#37) |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K993783 |
12/13/1999 |
TETRIC FLOW |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K993482 |
12/06/1999 |
K-ASSAY FIBRINOGEN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993853 |
12/27/1999 |
K-ASSAY MULTI-ANALYTE CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993539 |
12/15/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K983901 |
02/01/1999 |
KSEA HF-SNARE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K990155 |
02/25/1999 |
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 |
KAY SEE DENTAL MFG. CO. |
CLARK SMITH |
| K992954 |
12/21/1999 |
KEELER CRYO MASTER & PROBES |
KEELER INSTRUMENTS, INC. |
EUGENE R VAN ARSDALE |
| K984125 |
02/09/1999 |
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE |
KILANG BARANGAN GETAH DIOH |
NORLI MANAFF |
| K990094 |
02/18/1999 |
KMI WRIST FUSION SYSTEM |
KINETIKOS MEDICAL, INC. |
MICHAEL COLLINS |
| K980760 |
12/21/1999 |
KLS-MARTIN MMF SCREW |
KLS-MARTIN L.P. |
PATRICK J LAMB |
| K990040 |
02/04/1999 |
CLEARFIL SE BOND |
KURARAY CO. |
KOJI FUJITA |
| K993668 |
12/20/1999 |
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
LAERDAL MEDICAL A/S |
MAGNE STEINSET |
| K990270 |
02/18/1999 |
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K990285 |
02/18/1999 |
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K990268 |
02/24/1999 |
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K990043 |
02/11/1999 |
SMOOTHLASE ALEXANDRITE LASER SYSTEM |
LEISEGANG MEDICAL, INC. |
LORNA K LINVILLE |
| K993096 |
12/20/1999 |
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR |
LIFESTREAM TECHNOLOGIES, INC. |
JACKSON B CONNOLLY |
| K993339 |
12/10/1999 |
ENDOPEARL WITH THREADER |
LINVATEC CORP. |
LAURA SENEFF |
| K984609 |
02/09/1999 |
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III |
LITE SPECIALTY METAL WORKS, INC. |
DAVID R COLE |
| K990044 |
02/11/1999 |
LOBOB UNIVERSAL CONTACT LENS CLEANER |
LOBOB LABORATORIES, INC. |
DANIEL J MANELLI |
| K990067 |
02/19/1999 |
SHEER GLYDE DAMS |
LOUISE C. MYERS |
LOUISE C MYERS |
| K993883 |
12/21/1999 |
M-PACT CORNEAL LIGHT SHIELD |
M-PACT CORP. |
AL BOEDEKER |
| K990110 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990112 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990113 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990111 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K990115 |
12/06/1999 |
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 |
MAERSK MEDICAL A/S |
RICHARD A HAMER |
| K983250 |
12/12/1999 |
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR |
MAGNETIC RESONANCE EQUIPMENT CORP. |
G.RONALD MORRIS |
| K984088 |
12/06/1999 |
OPTISTAR MR INJECTOR SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
BRIDGET DRAKE |
| K993008 |
12/06/1999 |
QUANTITATIVE SENTINEL SYSTEM |
MARQUETTE MEDICAL SYSTEMS, INC. |
MARIA VITUG FOUTS |
| K993572 |
12/13/1999 |
CERADIUM V NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
| K993530 |
12/15/1999 |
SYSTEM 2100 |
MATH SOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K990173 |
12/21/1999 |
PATHFINDER II ANGIOGRAPHIC CATHETER |
MAXXIM MEDICAL |
EDDIE MONROE |
| K991441 |
12/28/1999 |
CADENCE DOPPLER ULTRASOUND SYSTEM |
MEDASONICS, INC. |
WILLIAM E MCKAY |
| K982371 |
02/12/1999 |
MEDCO ASPIRATOR IV |
MEDCO MFG. |
ELAINE MARTIN |
| K973865 |
02/26/1999 |
BIRTCHER UV LAMP |
MEDFAXX, INC. |
BOB JOHNSON |
| K981125 |
02/26/1999 |
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K983634 |
02/24/1999 |
PREPARE HOME INFUSION PUMP |
MEDICAL INFUSION TECHNOLOGIES, INC. |
THOMAS L PARKER |
| K992943 |
12/10/1999 |
VIT ENHANCER |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
LINDA M UPTON |
| K972719 |
02/04/1999 |
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS |
MEDICEL, S.A. DE C.V. |
T. WHIT ATHEY |
| K983430 |
02/09/1999 |
LITE-TOUCH SYRINGE |
MEDICORE, INC. |
BONNIE J KAPLAN |
| K993764 |
12/16/1999 |
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH |
MEDIPACK MEDICAL PACKAGING MFG. CO. |
NORMAN F ESTRIN |
| K993761 |
12/28/1999 |
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K983887 |
02/12/1999 |
UP-GRADE AND UP-GRADE PRO |
MEDISIM LTD. |
JONATHAN S KAHAN |
| K990380 |
02/22/1999 |
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 |
MEDITEC CO., LTD. |
|
| K992111 |
12/16/1999 |
VERDICT -II OPIATES 2000 |
MEDTOX DIAGNOSTICS, INC. |
|
| K981733 |
02/04/1999 |
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
ANN-CHRISTINE JONSSON |
| K984053 |
02/04/1999 |
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM |
MEDTRONIC PS MEDICAL |
JEFFREY HENDERSON |
| K990104 |
02/09/1999 |
MEDTRONIC MODEL 7495 EXTENSION KIT |
MEDTRONIC VASCULAR |
LISA L PRITCHARD |
| K993226 |
12/10/1999 |
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 |
MEMCATH TECHNOLOGIES LLC. |
MARC JAKER |
| K993308 |
12/13/1999 |
MENTOR EVACARE VAGINAL PESSARIES |
MENTOR CORP. |
DONNA A CRAWFORD |
| K993914 |
12/10/1999 |
PREMIER TOXINS A&B, MODEL 616096 |
MERIDIAN DIAGNOSTICS, INC. |
DAVID H WILLIS |
| K993475 |
12/09/1999 |
AUROFLUID M, ALLOY NO. 5315 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993474 |
12/02/1999 |
DELTAPAL, ALLOY NO. 5161 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993506 |
12/08/1999 |
PAGALINOR 4 , ALLOY NO. 5440 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993505 |
12/08/1999 |
V-DELTA SPECIAL, ALLOY NO. 5154 |
METALOR DENTAL USA CORP. |
KENNITH A PUTNEY |
| K993508 |
12/06/1999 |
V-SUPRA PLUS, ALLOY NO. 5025 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993507 |
12/06/1999 |
V-SUPRAGOLD, ALLOY NO. 5024 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K993821 |
12/09/1999 |
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT |
METRON MEDICAL AUSTRALIA PTY LTD |
R.H. HOPKINS |
| K984142 |
02/09/1999 |
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K984114 |
02/09/1999 |
SYS STIM 294, MODEL ME 294 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K984467 |
02/24/1999 |
FUSICRYL |
MICRO DENTAL LABORATORIES |
NICOLAS E AZAR |
| K990168 |
02/25/1999 |
MICROLIFE IT2CA1 |
MICROLIFE SYSTEMS AG |
SCOT J DUBE |
| K990266 |
02/02/1999 |
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE |
MICROMEDICAL INDUSTRIES, LTD. |
DEAN E SYNDER |
| K982276 |
02/18/1999 |
BAHO AUTOCLAVABLE LAPAROSCOPE |
MICROPTIX INT'L, LLC. |
GEORGE N HALLACK |
| K993575 |
12/29/1999 |
RESOLVE QUICKANCHOR |
MITEK PRODUCTS |
PAULA E BULGER |
| K993261 |
12/02/1999 |
TALON ANCHOR SNAP-PAK |
MITEK PRODUCTS |
PAULA A BULGER |
| K993327 |
12/16/1999 |
TALON ANCHOR SNAP-PAK |
MITEK PRODUCTS |
PAULA E BULGER |
| K984368 |
02/22/1999 |
NORMLGEL 0.9% ISOTONIC SALINE GEL |
MOLNLYCKE HEALTH CARE, INC. |
MIGUEL A NEGRON |
| K992148 |
12/29/1999 |
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT |
MORAX |
BOREK JANIK |
| K984310 |
02/24/1999 |
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE |
MOSS TUBES, INC. |
HARRY A SCHLAKMAN |
| K992074 |
12/23/1999 |
MPM REGENECARE WOUND GEL |
MPM MEDICAL, INC. |
RICHARD A HAMER |
| K993776 |
12/03/1999 |
OBC-300 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993819 |
12/03/1999 |
QWH-300 WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K984561 |
02/04/1999 |
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B |
MSR, INC. |
MARY MCNAMARA |
| K991656 |
12/02/1999 |
AED ARTHROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993689 |
12/15/1999 |
AED CYSTOSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K993688 |
12/06/1999 |
AED LAPAROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K984258 |
02/11/1999 |
NEUROVASX SUB-MICROINFUSION CATHETER |
NEURO VASX, INC. |
JEFFREY A LEE |
| K993130 |
12/17/1999 |
ULTRA-GARMENT ELECTRODE |
NEWWAVE MEDICAL LLC. |
ROBERT ARMSTRONG |
| K993643 |
12/28/1999 |
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 |
NEXAN TELEMED LTD. |
KENNETH PALMER |
| K991882 |
12/08/1999 |
NEXFLEX TOTAL KNEE SYSTEM |
NEXMED, INC. |
JASON BLAIN |
| K984520 |
02/05/1999 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIM WONG |
| K984186 |
02/02/1999 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K992188 |
12/06/1999 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 |
NICHOLS INSTITUTE DIAGNOSTICS |
JAMES A RYBSKI |
| K993890 |
12/01/1999 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K984409 |
02/12/1999 |
ELK LASER FILM DIGITIZER |
NISHIMOTO SANGYO CO., LTD. |
GARY J ALLSEBROOK |
| K993359 |
12/21/1999 |
RAPTOR TREATMENT PLANNING SYSTEM |
NOMOS CORP. |
WILLIAM O CHISHKO |
| K983104 |
02/12/1999 |
NORIAN PERIODONTAL/DENTAL CEMENT (PDC) |
NORIAN CORP. |
KIM TOMPKINS |
| K983326 |
02/05/1999 |
OMNIFLATOR 7640 MODEL 7-640-00 |
NORTHGATE TECHNOLOGIES, INC. |
CASSEY KUREK |
| K981679 |
02/09/1999 |
TCM 3000 AND TCM ENDO |
NOUVAG AG |
MARGIT ESCHBAUMER |
| K993104 |
12/02/1999 |
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR |
NOVA BIOMEDICAL CORP. |
PAUL W MAC DONALD |
| K981949 |
02/03/1999 |
NUMOBAG |
NUMOTECH, INC. |
W. PATRICK NOONAN |
| K983314 |
02/19/1999 |
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM |
NYCOMED AMERSHAM IMAGING |
ROSINA ROBINSON |
| K993062 |
12/10/1999 |
CHEST DRAINAGE TUBING |
OLSON MEDICAL SALES, INC. |
GARRY A COURTNEY |
| K984417 |
02/24/1999 |
BIPOLAR GRASPING FORCEPS BIQ+ |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K990055 |
02/02/1999 |
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 |
OMEGA MEDICAL IMAGING, INC. |
DOUGLAS M COON |
| K990416 |
12/23/1999 |
OMNICORDER BIOSCAN SYSTEM |
OMNICORDER TECHNOLOGIES, INC. |
MARK FAUCI |
| K993445 |
12/06/1999 |
OMNISONIC ENDOSCOPIC DEFLECTOR |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
| K993628 |
12/15/1999 |
OMNISONICS ULTRASONIC PROBES |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
| K982599 |
02/16/1999 |
THE FREMSTAD RING |
OPHTHALMIC SOLUTIONS, LLC. |
DARIA A FREMSTAD |
| K982750 |
02/01/1999 |
CORSAIRE |
OPTIWAY, INC. |
FRANK W LAVALLEY |
| K983999 |
02/03/1999 |
PANORAMIC200 OPTHALMOSCOPE |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K981725 |
02/02/1999 |
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 |
OPTOVENT, INC. |
CLAES RYMOND |
| K993854 |
12/06/1999 |
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES |
ORATEC INTERVENTIONS, INC. |
SHIELA RAMERMAN |
| K993967 |
12/17/1999 |
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 |
ORATEC INTERVENTIONS, INC. |
JENNIFER BRENNAN |
| K993576 |
12/14/1999 |
BACT/ALERT MP PROCESS BOTTLE |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K993423 |
12/15/1999 |
BACT/ALERT SA |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K993421 |
12/14/1999 |
BACT/ALERT SN |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K983690 |
02/02/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K984166 |
02/05/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K994145 |
12/22/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K993926 |
12/17/1999 |
OMNIAXIAL CONNECTOR |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K990899 |
12/21/1999 |
HEMOCHEK-A1C SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K984230 |
02/04/1999 |
OSTEO-MESH TM-300 |
OSTEOGENICS BIOMEDICAL, INC. |
RICHARD A HAMER |
| K990003 |
02/24/1999 |
J-SERIES OMEGA TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K984585 |
02/24/1999 |
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K990158 |
02/01/1999 |
OSTEONICS COMBINATION SCREW RING/BLOCKER |
OSTEONICS CORP. |
KATE SUTTON |
| K990203 |
02/18/1999 |
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| K983457 |
02/02/1999 |
OSTEOMARK NTX SERUM EIA |
OSTEX INTL., INC. |
NANCY J.S. MALLINAK |
| K990046 |
02/17/1999 |
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K973289 |
02/09/1999 |
RE NU |
PACIFIC RIM DENTAL, INC. |
KATHY L EPPEN |
| K993379 |
12/16/1999 |
PALL SUPOR AEF FILTER |
PALL CORP. |
LEONARD S BERMAN |
| K993621 |
12/29/1999 |
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K993486 |
12/22/1999 |
PARAGON LENS CARRIER |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K993487 |
12/22/1999 |
PARAGON LENS VIAL |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K991562 |
12/28/1999 |
PASCAL MEDICAL AB MENIETT 20 |
PASCAL MEDICAL AB |
JEFFREY R SIDEMAN |
| K983648 |
02/24/1999 |
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM |
PERRY BAROMEDICAL SERVICES |
WAYNE C MCCULLOGH |
| K994237 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9063 |
PHAMATECH |
CARL A MONGIOVI |
| K994233 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9068 |
PHAMATECH |
CARL A MONGIOVI |
| K994219 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9073 |
PHAMATECH |
CARL A MONGIOVI |
| K994220 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9078 |
PHAMATECH |
CARL A MONGIOVI |
| K994234 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9083 |
PHAMATECH |
CARL A MONGIOVI |
| K994236 |
12/30/1999 |
AT HOME DRUG TEST, MODEL 9133 |
PHAMATECH |
CARL A MONGIOVI |
| K994093 |
12/16/1999 |
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C |
PHAMATECH |
CARL A MONGIOVI |
| K982938 |
02/05/1999 |
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 |
PHAMATECH |
TUAN PHAM |
| K993388 |
12/01/1999 |
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K990329 |
12/07/1999 |
PHILIPS EASYVISION WORKSTATION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K993227 |
12/21/1999 |
PHILIPS INTURIS DICOM RECORDER |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K984545 |
02/25/1999 |
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
P. ALTMAN |
| K984588 |
02/08/1999 |
PHASED ARRAY FLEXIBLE CARDIAC COIL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K982380 |
02/26/1999 |
SURE |
PLEASURE LATEX PRODUCTS SDN. BHD. |
CHANG AH KAU |
| K993590 |
12/21/1999 |
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS JR. |
| K983836 |
02/11/1999 |
RIGID GAS PERMEABLE CONTACT LENS SOLUTION |
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
DEBRA L.B. KETCHUM |
| K981865 |
02/26/1999 |
MTM BIOSCANNER K TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K983860 |
12/27/1999 |
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K982385 |
02/01/1999 |
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER |
POROUS MEDIA CORP. |
ROCHELLE M MICKSCHL |
| K984183 |
02/01/1999 |
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 |
POSSIS MEDICAL, INC. |
TIMOTHY J KAPPERS |
| K984182 |
02/01/1999 |
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 |
POSSIS MEDICAL, INC. |
TIMOTHY J KAPPERS |
| K994045 |
12/21/1999 |
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 |
PRIMUS CORP. |
JIM NOFFSINGER |
| K991575 |
12/03/1999 |
PRIMUS STEAM STERILIZERS |
PRIMUS STERILIZER CO., INC. |
JEFF REED |
| K993435 |
12/06/1999 |
MANUAL BONE MARROW BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K993683 |
12/13/1999 |
PULPDENT UNO-DUO |
PULPDENT CORP. |
KENNETH J BERK |
| K993271 |
12/02/1999 |
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS |
QUALITY LATEX CORP. SDN BHD |
SHARENE WAN |
| K984463 |
02/16/1999 |
QUANTASE PHE/GAL SCREENING ASSAY |
QUANTASE LTD. |
R. STEWART CAMPBELL |
| K990258 |
12/21/1999 |
QUANTECH TOTAL B-HCG ASSAY |
QUANTECH LTD. |
ROBIN HELLEN |
| K983032 |
02/17/1999 |
CBC-5D HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
SUE GALLO |
| K983471 |
02/23/1999 |
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K983506 |
02/03/1999 |
PRESSUREWIRE SENSOR, MODEL #12001 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K992482 |
12/27/1999 |
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) |
RADIANCY, LTD. |
JONATHAN S KAHAN |
| K993594 |
12/15/1999 |
CONFORMAX MMLC VR1 |
RADIONICS, INC. |
NANCY MACDONALD |
| K990071 |
02/08/1999 |
IMAGEFUSION 2.0 |
RADIONICS, INC. |
NANCY C MACDONALD |
| K990216 |
02/16/1999 |
MAGNETIC TIBC KIT |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K993443 |
12/17/1999 |
RTD ARM ASSISTIVE ROBOTIC DEVICE |
REHABILITATION TECHNOLOGIES DIVISION |
RICHARD M MAHONEY |
| K981720 |
02/08/1999 |
IQ SYSTEM |
RENAISSANCE TECHNOLOGY, INC. |
PHILIP E HAMSKI |
| K974426 |
02/10/1999 |
POTENCY TEST STRIPS, INDICATOR TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
WALTER B JANSEN |
| K983897 |
02/01/1999 |
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G |
RI MOS. S.R.L. |
ADENA S RIEMER |
| K993103 |
12/10/1999 |
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARA |
| K993944 |
12/02/1999 |
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE |
RITA MEDICAL SYSTEMS |
ERIN DIGNAN-MAZZONE |
| K990390 |
12/10/1999 |
HEPARIN IV FLUSH SYRINGE, 10 U/ML \ |
ROCAP DIV. OF SABRATEK CORP. |
AVIA TONEY |
| K990308 |
12/10/1999 |
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML |
ROCAP DIV. OF SABRATEK CORP. |
AVIA TONEY |
| K983702 |
02/11/1999 |
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983704 |
02/10/1999 |
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K993829 |
12/09/1999 |
ACCU-CHEK SIMPLICITY SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K990377 |
02/26/1999 |
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K990337 |
02/23/1999 |
ONTRAK TESTCUP-5 M2K |
ROCHE DIAGNOSTICS CORP. |
JENNIFER L TRIBBETT |
| K993048 |
12/20/1999 |
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
| K974503 |
12/01/1999 |
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K993542 |
12/29/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K993432 |
12/20/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K984037 |
02/04/1999 |
CORE-IDE |
ROYDENT DENTAL PRODUCTS, INC. |
DONALD A LEROY |
| K993063 |
12/09/1999 |
RUSCH BRILLANT SILICONE FOLEY |
RUSCH INTL. |
JULIE A BEAUMONT |
| K983010 |
02/12/1999 |
SELF CATH SET/SAFETY CATH |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K984483 |
02/18/1999 |
A-SOFT RELINER |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K984097 |
02/09/1999 |
DC-CORE |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K980751 |
02/24/1999 |
SABRATEK 4040 INFUSION PUMP |
SABRATEK CORP. |
CHARLES P GILL |
| K993651 |
12/23/1999 |
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
SC HENNIG ENTERPRISES EUROPE SRL |
GEORGE O'NEIL |
| K984115 |
02/12/1999 |
SCAREASE & SCAREASE ADHESIVE GEL |
SCAREASE, INC. |
TED HARTLEY |
| K981629 |
02/04/1999 |
NUTRISAFE ENTERAL FEEDING TUBE |
SCHIFF & CO. |
ANNE M CESARIO |
| K984556 |
02/09/1999 |
SCICAN CLASSIC |
SCHOLLY FIBEROPTIC GMBH |
CARSTEN SCHLENKER |
| K982915 |
02/12/1999 |
SCI-PHARM DFV VARNISH |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K984254 |
02/24/1999 |
INFANT FLOW NCPAP MASKS |
SENSORMEDICS CORP. |
PAUL L KITTINGER |
| K992939 |
12/09/1999 |
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K993631 |
12/09/1999 |
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K994036 |
12/20/1999 |
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K984460 |
02/09/1999 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI HUAMAO GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K984461 |
02/09/1999 |
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI HUAMAO GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K990117 |
02/19/1999 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K990081 |
02/19/1999 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K984610 |
02/09/1999 |
POWDER FREE NITRILE EXAMINATION GLOVES |
SHIVA MEDICARE LTD. |
JAMES F LOGAN |
| K984615 |
02/17/1999 |
POWDERED NITRILE EXAMINATION GLOVES |
SHIVA MEDICARE LTD. |
JAMES F LOGAN |
| K984221 |
02/12/1999 |
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR |
SIEMENS CORP. |
KATHLEEN RUTHERFORD |
| K993947 |
12/21/1999 |
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY |
SIEMENS CORP. |
ALICIA JUERGENSEN |
| K984224 |
02/02/1999 |
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS |
SIEMENS CORP. |
KATHLEEN RUTHERFORD |
| K993731 |
12/23/1999 |
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K984574 |
02/11/1999 |
INFINITY GLUCOSE REAGENT |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K992711 |
12/06/1999 |
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K992712 |
12/06/1999 |
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K990083 |
02/12/1999 |
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K983834 |
02/24/1999 |
ECHELON HIP STEM |
SMITH & NEPHEW, INC. |
JOANN KUHNE |
| K993106 |
12/09/1999 |
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) |
SMITH & NEPHEW, INC. |
JANET JOJNSON GREEN |
| K993289 |
12/20/1999 |
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K994175 |
12/21/1999 |
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE |
SODEM SYSTEMS |
DANIEL BACCINO |
| K993851 |
12/27/1999 |
SODEM PERFORATOR DRIVE |
SODEMSYSTEMS |
DANIEL BACCINO |
| K993142 |
12/27/1999 |
ELITE CUSTOM |
SOMA BLUE, INC. |
JOHN M MITCHELL |
| K993143 |
12/27/1999 |
VITALITY SYSTEM |
SOMA BLUE, INC. |
JOHN M MITCHELL |
| K994096 |
12/20/1999 |
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K983985 |
02/25/1999 |
HYBRISONIC SHEATH |
SONOTECH, INC. |
MARGARET J LARSON |
| K993868 |
12/21/1999 |
THE SOUNDVASER DISSECTION SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K981655 |
12/03/1999 |
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR |
SPACELABS MEDICAL, INC. |
NANCY GERTLAR |
| K984106 |
02/12/1999 |
MAMMARY SIZER, MAMMARY PROTHESIS SIZER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T.JAN VARNER |
| K983015 |
02/05/1999 |
VIRILIS PENILE PROSTHESIS |
SPECIALTY SURGICAL PRODUCTS, INC. |
T.JAN VARNER |
| K990005 |
02/12/1999 |
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
PEPPER A CHASTAIN |
| K990959 |
12/27/1999 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
PAMELA SNYDER |
| K993454 |
12/03/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K993457 |
12/02/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K992587 |
12/22/1999 |
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM |
STELLAR BIO SYSTEMS, INC. |
JOHN BREWER |
| K992384 |
12/01/1999 |
CPAP/PRO CPAP INTERFACE |
STEVENSON INDUSTRIES, INC. |
DAVID W SCHLERF |
| K991835 |
12/20/1999 |
HANG UPS POWER II |
STL INTL., INC. |
ROGER C TEETER |
| K992635 |
12/20/1999 |
INTERFACE MODULE IDDD |
STOECKERT INSTRUMENTE |
MARY MCNAMARA-CULLINANE |
| K991706 |
12/07/1999 |
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE |
STRYKER CORP. |
NICOLE PETTY |
| K990038 |
02/19/1999 |
HUMMER TRAK SYSTEM |
Stryker Endoscopy |
DAVID HIMES |
| K994053 |
12/20/1999 |
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE |
STRYKER INSTRUMENTS |
SUSANNE VELAQUEZ |
| K993288 |
12/29/1999 |
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM |
SULZER CARBOMEDICS, INC. |
EDWARD E NEWTON |
| K993569 |
12/01/1999 |
APR METASUL ACETABULAR INSERT |
SULZER MEDICA |
MITCHELL A DHORITY |
| K990137 |
02/18/1999 |
ANATOMICA HUMERAL STEM/HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K983509 |
02/03/1999 |
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT |
SULZER ORTHOPEDICS, INC. |
SHAVAWN E PARDUHN |
| K993043 |
12/02/1999 |
MS-30 FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K990503 |
12/09/1999 |
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS |
SULZERMEDICA |
EDWARD E NEWTON |
| K984309 |
02/12/1999 |
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED |
SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. |
HIDEAKI OCHIAL |
| K984311 |
02/09/1999 |
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE |
SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. |
HIDEAKI OCHIAI |
| K993485 |
12/27/1999 |
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K983372 |
02/05/1999 |
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP |
SUNSCOPE INTL., INC. |
PHIL TRIOLO |
| K992626 |
12/16/1999 |
SURE-WAY REUSABLE SHARPS CONTAINER |
SURE-WAY SYSTEMS, INC. |
GARY CHILCOTT |
| K992927 |
12/29/1999 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ANGELIQUE DESTRUEL |
| K993072 |
12/10/1999 |
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) |
SURVIVALINK CORP. |
Sew-Wah Tay |
| K990225 |
02/25/1999 |
ENDO ANALYZER, MODEL 8005, MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990252 |
02/25/1999 |
SOLO PLUS ORTHO |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K992008 |
12/23/1999 |
PHARMASEED, MODEL BT-125-1 |
SYNCOR PHARMACEUTICALS, INC. |
GARY GILMORE |
| K984498 |
02/18/1999 |
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K994187 |
12/21/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K993314 |
12/06/1999 |
SYNTHES LIGHT GUIDE |
SYNTHES (USA) |
JONATHAN GILBERT |
| K993755 |
12/21/1999 |
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 |
SYVA CO. |
PAUL L ROGERS |
| K994101 |
12/21/1999 |
E. HISTOLYTICA II |
TECHLAB, INC. |
DAVID M LYERLY |
| K992402 |
12/22/1999 |
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH |
TELEMED SYSTEMS, INC. |
JOHN A CHAVES |
| K992390 |
12/22/1999 |
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD |
TELEMED SYSTEMS, INC. |
JOHN A CHAVES |
| K990288 |
02/24/1999 |
FREE FLOW SAFETY DEVICE, MODEL MG 245052 |
TEVA MEDICAL, LTD. |
MARYANN MELUS |
| K991465 |
12/10/1999 |
DRUG STOP |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
| K993562 |
12/29/1999 |
POWDER FREE LATEX STERILE SURGICAL GLOVES |
TG MEDICAL SDN BHD |
T.S. PUON |
| K984165 |
02/02/1999 |
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K984163 |
02/02/1999 |
ANTI-TPO EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K983696 |
02/05/1999 |
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K983692 |
02/05/1999 |
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K983695 |
02/05/1999 |
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K983694 |
02/05/1999 |
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993727 |
12/21/1999 |
BINDAZYME ANTI-DSDNA EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993612 |
12/21/1999 |
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K984619 |
02/23/1999 |
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981783 |
12/20/1999 |
C3 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981785 |
12/20/1999 |
C4 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K982100 |
12/20/1999 |
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981784 |
12/21/1999 |
IGM MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981915 |
12/20/1999 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993862 |
12/29/1999 |
MODUS SAGITTAL SPLIT PLATE |
THE STRAUMANN CO. |
LINDA JALBERT |
| K993209 |
12/23/1999 |
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY |
THERMOLASE CORP. |
GERALD FELDMAN, MPH, MBA |
| K990358 |
02/26/1999 |
CROSS SPORT, RIGID WHEELCHAIR |
TISPORT |
SANDRA GLADSTONE |
| K993452 |
12/20/1999 |
GREEN POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K993605 |
12/20/1999 |
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
| K993680 |
12/13/1999 |
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
| K984178 |
02/18/1999 |
PRONOSCO X-POSURE SYSTEM |
TORSANA OSTEOPOROSIS DIAGNOSTICS A/S |
JONATHAN S KAHAN, ESQ |
| K992992 |
12/03/1999 |
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DIANA THORSON |
| K983110 |
02/25/1999 |
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K984091 |
02/05/1999 |
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 |
TREX MEDICAL CORP. |
WALTER F SCHNEIDER |
| K984092 |
02/05/1999 |
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 |
TREX MEDICAL CORP. |
WALTER F SCHNEIDER |
| K991697 |
12/21/1999 |
UNI-GOLD H. PYLORI |
TRINITY BIOTECH, PLC |
Erika B Ammirati |
| K982373 |
02/11/1999 |
UNI-GOLD STREP A TEST KIT |
TRINITY BIOTECH, PLC |
Erika B Ammirati |
| K984488 |
02/01/1999 |
SHEER THIN |
TWE COMPANIES, INC. |
KEITH F HEINTZ |
| K993333 |
12/16/1999 |
CLEARPLAN EASY II HOME PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K993703 |
12/02/1999 |
CLEARVIEW EASY HCG PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K990223 |
02/24/1999 |
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR |
UNIPATH LTD. |
Louise Roberts |
| K993123 |
12/17/1999 |
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B |
UNITED PACIFIC CO., LTD. |
DANIEL YE HUA |
| K984168 |
12/07/1999 |
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K983400 |
02/10/1999 |
AUTO SUTURE SITE MARKER CLIP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHRISTOPHER A GRAHAM |
| K993381 |
12/21/1999 |
TONGUE STABILIZER DEVICE |
UNIVERSITY OF OTAGO |
CHRISTINA M LAJOIE |
| K983411 |
02/09/1999 |
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 |
VALNET MEDICAL CORP. |
VICTOR M ORTIZ MEDINA |
| K990085 |
02/08/1999 |
MILLENNIUM MLC -120 |
VARIAN ASSOC., INC. |
LINDA S NASH |
| K980723 |
02/12/1999 |
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) |
VASCUTECH, INC. |
GEORGE W LEMAITRE |
| K992368 |
12/09/1999 |
LEMAITRE EMBOLECTOMY CATHETER |
VASCUTECH, INC. |
TRENT G KAMKE |
| K990098 |
02/11/1999 |
VENTLAB VERIFY II |
VENTLAB CORP. |
E J SMITH |
| K993597 |
12/15/1999 |
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 |
VIDAR SYSTEMS CORP. |
MARY "PENNIE" DRINKARD |
| K984198 |
02/18/1999 |
WIDE BODY ABUTMENTS |
VIDENT |
BARBARA J LEWANDOWSKI |
| K983016 |
02/12/1999 |
GAUZE, SPONGES, CAT # 11-003 |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K990443 |
02/26/1999 |
ARTHRO-SURGIMAT-2000 ECU |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
| K993468 |
12/16/1999 |
WAKO L-TYPE GOT TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K982307 |
02/02/1999 |
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 |
WALLAC, INC. |
JANICE K BROWNLEE |
| K984503 |
02/26/1999 |
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 |
WALLACE A. ERICKSON & CO. |
ABNER T DE LA CRUZ |
| K983208 |
02/22/1999 |
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
| K992681 |
12/16/1999 |
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K992676 |
12/16/1999 |
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K993157 |
12/17/1999 |
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 |
WECK CLOSURE SYSTEMS |
BRIAN YOUNG |
| K984215 |
02/11/1999 |
WELCH ALLYN FRONT-LINE DOC |
WELCH ALLYN, INC. |
COLIN WOLFF |
| K993935 |
12/21/1999 |
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K990130 |
02/12/1999 |
WILSON-COOK PANCREATIC WEDGE STENT |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K993969 |
12/30/1999 |
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION |
WINCHESTER LABORATORIES LLC. |
HOWARD ROSE |
| K993342 |
12/23/1999 |
DUCPREP BREAST ASPIRATOR, MODEL PMPO2 |
WINDY HILL TECHNOLOGY, INC. |
ANGELA B SOITO |
| K982967 |
02/23/1999 |
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
| K983907 |
12/09/1999 |
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R |
WOODSIDE BIOMEDICAL, INC. |
CAROL L PATTERSON |
| K990030 |
02/03/1999 |
ADVANCED REVISION PRODUCT LINE EXTENSION |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K993371 |
12/20/1999 |
SADDLE SHAPED PATELLA |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K993214 |
12/02/1999 |
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
OOI SOO KANG |
| K993215 |
12/02/1999 |
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
OOI SOO KANG |
| K993962 |
12/21/1999 |
PENSIL TRAUMA, MODEL WWS6100 |
WUESTEC MEDICAL, INC. |
BRENDA S. D. DAVIS |
| K984406 |
02/02/1999 |
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM |
XITEC, INC. |
SHEILA M HEMEON-HEYER |
| K982731 |
02/02/1999 |
MEROGEL NASAL DRESSING AND SINUS STENT |
XOMED, INC. |
ROY BERENS |
| K993655 |
12/21/1999 |
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
XOMED, INC. |
MARTIN D SARGENT |
| K993112 |
12/09/1999 |
XOMED ENT RF SYSTEM |
XOMED, INC. |
MARTIN D SARGENT |
| K984363 |
02/26/1999 |
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM |
XOMED, INC. |
DAVID TIMLIN |
| K993424 |
12/23/1999 |
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP |
Y-CLIP ASSOCIATES |
GEORGE YU |
| K984089 |
02/16/1999 |
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW |
ZYMED MEDICAL INSTRUMENTATION |
DUDLEY HARRIS |
