FDA 510(k) Decisions During February, 1999  

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
K984525 02/26/1999 "RAPID DRUG SCREEN" 5-PANEL WITH METHAMPHETAMINE TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
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
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
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K984258 02/11/1999 NEUROVASX SUB-MICROINFUSION CATHETER NEURO VASX, INC. JEFFREY A LEE
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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
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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
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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
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K993227 12/21/1999 PHILIPS INTURIS DICOM RECORDER PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
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K993048 12/20/1999 ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST ROCHE DIAGNOSTICS CORP. LUANN OCHS
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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
K992676 12/16/1999 PATIENT LATEX EXAMINATION "POWDER-FREE" POLYMER COATED GLOVES WEAR SAFE MALAYSIA SDN. BHD. CLAUDE COTTET
K992681 12/16/1999 PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE 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


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