FDA 510(k) Decisions During July, 1999  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K991874 07/30/1999 EMS SURFACE MOUNT SCALER (EMS SA) ELECTRO MEDICAL SYSTEMS SHEILA HEMEON-HEYER
K991588 07/21/1999 EMS SWISS ORTHOCLAST (EMS SA) ELECTRO MEDICAL SYSTEMS SHEILA HAMEON-HEYER
K991173 07/19/1999 FERTILIZATION MEDIA-HTF INTL., INC. MICHAEL D CECCHI
K991870 07/30/1999 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 A.P. TOTAL CARE, INC. LUIS P LEON
K991469 07/20/1999 AWARE PAD AAC CONSULTING GROUP, INC. EDUARDO MARCH
K991605 07/09/1999 CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION ABBOTT LABORATORIES MICHELLE B ROEDING
K984563 07/14/1999 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. LUANNE TERMEER
K991607 07/26/1999 VANTAGE 2.5 ADAC LABORATORIES DENNIS W HENKELMAN
K983940 07/15/1999 EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR ADAM SPENCE CORP. CAROL ROSENBLOOM
K992054 07/07/1999 ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS ADVENTURES IN COLOR TECHNOLOGY, LTD. MARTIN DALSING
K991285 07/12/1999 LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE AESCULAP-MEDITEC NORTH AMERICA WILLIAM KELLEY
K991546 07/30/1999 AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K991992 07/13/1999 ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K990822 07/15/1999 RAPIDONE - COCAINE TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K990818 07/07/1999 RAPIDONE - MARIJUANA TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K990820 07/15/1999 RAPIDONE - OPIATES TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K990681 07/15/1999 DBSET MULTIDRUG SCREEN TEST KIT AMERITEK, INC. K. C. YEE
K991626 07/02/1999 WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION ANALOGIC CORP. GARET VAN GENNEP
K984392 07/21/1999 ANSELL CONDOMS ANSELL, INC. LON MCLLVAIN
K983518 07/06/1999 LIFESTYLES XTRA PLEASURE ANSELL, INC. LON MCILVAIN
K984482 07/30/1999 AVE GL-1 GUIDING CATHETER ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. NORMA J LEMAY
K984627 07/27/1999 AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER ARTERIAL VASCULAR ENGINEERING, INC. DEBORAH L HERRINGTON
K991512 07/29/1999 ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X ASAHI MEDICAL CO., LTD. DAVID L WEST
K990304 07/15/1999 MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM ASTRA TECH, INC. NIKLAS LIDSKOG
K991937 07/30/1999 ULTRASOUND SCANNER, MODEL TYPE 2101 B & K MEDICAL A/S VILLY BRAENDER
K984060 07/26/1999 LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K991817 07/22/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP. GABRIEL J MURACA JR.
K990649 07/09/1999 GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS BAYER CORP. GEORGE M TANCOS
K991702 07/28/1999 MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 BECTON DICKINSON VACUTAINER SYSTEMS ANDREA HRONCICCH
K990656 07/20/1999 CHROMOPHARE D 530 LDR SURGICAL LIGHT BERCHTOLD HOLDING GMBH WOLFRAM K HILL
K991741 07/22/1999 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 BIOCHECK, INC. ROBIN J HELLEN
K992146 07/30/1999 SCARAID SILICONE GEL SHEETING BIODERMIS CORP. JEFF S SCHLEUNING
K984054 07/30/1999 AGC V2 REVISION KNEE SYSTEM BIOMET, INC. PATRICIA BERES
K992058 07/01/1999 BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM BIOMET, INC. MARY L VERSTYNEN
K991763 07/30/1999 LACTOSORB HAND SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K992167 07/28/1999 PERFORMANCE KNEE SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K991807 07/08/1999 TITANIUM LOW PROFILE SCREWS BIOMET, INC. PATRICIA SANDBORN BERES
K991708 07/30/1999 ZIRCONIA 22.22MM CERAMIC MODULAR HEADS BIOMET, INC. DALENE HUFZIGER BINKLEY
K991591 07/29/1999 BIOTHANE PATIENT RESTRAINT BIOPLASTICS CLAIRE BORON
K991446 07/23/1999 BIOSACA SYSTEM, MODEL 800 BIOSYS AB (PUBL) JANE B CAMPBELL
K991650 07/12/1999 CMV BRITE TURBO KIT BIOTEST DIAGNOSTICS CORP. PATRICIA E BONNESS
K991169 07/01/1999 SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 BIOTRONIK, INC. Jon Brumbaugh
K982326 07/12/1999 MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY BOSTON SCIENTIFIC CORP. LAURA MONDANO
K991902 07/26/1999 LC PIT & FISSURE SEALANT BOSWORTH CO. MILDRED M GOLDSTEIN
K983660 07/14/1999 EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) BRAINLAB, INC. ERIC LINDQUIST
K990355 07/08/1999 STAINLESS STEEL SOFT SUTURE WIRE BREGMA INTERNATIONAL TRADING COMPANY LTD. ASSEM HEDAYAT
K992021 07/23/1999 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) BRIGHTSWAY HOLDINGS SDN BHD G. BASKARAN
K992020 07/26/1999 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) BRIGHTSWAY HOLDINGS SDN BHD G. BASKARAN
K991939 07/01/1999 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K991940 07/12/1999 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990597 07/19/1999 SUMMER'S EVE LUBRICATING JELLY C.B. FLEET CO., INC. PETER S REICHERTZ
K991844 07/21/1999 PRO-GLASS CAD CAM VENTURES RON FISHELL
K991073 07/30/1999 ACIER SUTURES CARDIO THORACIC SYSTEMS MICHAEL J BILLIG
K983270 07/28/1999 VOYAGER QUAD CANNULA CARDIOTHORACIC SYSTEMS, INC. MIKE BILLIG
K991065 07/26/1999 CARESIDE PT CARESIDE, INC. NENNETH B ASARCH
K992034 07/23/1999 DOCUMENT THYROID CAL*VER CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) KAREN HICKEY
K984188 07/28/1999 AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) CHROMAVISION MEDICAL SYSTEMS, INC. BERTRAM J HUDSON
K991403 07/16/1999 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K991322 07/26/1999 ENHANCE-S PLUS CONCEPTION TECHNOLOGY, INC. GREG HOLLAND
K991104 07/19/1999 MICROTOOLS CONCEPTION TECHNOLOGY, INC. GREG HOLLAND
K992186 07/30/1999 QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT CONMED CORP. IRA D DUESLER, JR
K992151 07/14/1999 REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE CONSOLIDATED TECHNOLOGIES, INC. E. KAY ROBINSON
K991291 07/14/1999 STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION CONWAY STUART MEDICAL, INC. DAVID A TUCKER
K990350 07/26/1999 WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 COOPERSURGICAL, INC. DEBRA A PEKAR
K990349 07/26/1999 WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST COOPERSURGICAL, INC. DEBRA A PARKER
K990348 07/26/1999 WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N COOPERSURGICAL, INC. DEBRA A PEKAR
K984512 07/12/1999 NITRILON CORRECT-TOUCH CT INTL. MIKE KYLE
K992084 07/12/1999 CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER CYNOSURE, INC. GEORGE CHO
K984501 07/28/1999 DADE BEHRING BFTII DADE BEHRING, INC. CAROLYN K GEORGE
K991787 07/07/1999 N LATEX IGE MONO REAGENT DADE BEHRING, INC. REBECCA S AYASH
K991705 07/15/1999 N PROTEIN STANDARD UY DADE BEHRING, INC. REBECCA S AYASH
K991177 07/01/1999 OPUS TROPONIN I (CTN) TEST MODULES DADE BEHRING, INC. REBECCA S AYASH
K991176 07/01/1999 OPUS TROPONIN I CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K992037 07/30/1999 MAMEX DEL MEDICAL IMAGING CORP. JEFFREY N MOELLER
K991449 07/22/1999 SNORE-AID PLUS DENTAL IMAGINEERS, LLC. WILLIAM BELFER
K990680 07/30/1999 DENTEC LD 15 DIODE LASER DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. DI WOLFGANG NINAUS
K992065 07/12/1999 GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD DEPUY ORTHOPAEDICS, INC. JANET JOHNSON
K991649 07/14/1999 DEPUY ROCKWOOD CLAVICLE PIN DEPUY, INC. SALLY FOUST
K991608 07/20/1999 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K991933 07/30/1999 DERMAPHYLYX FOAM ISLAND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K991609 07/20/1999 DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING DERMAPHYLYX, INC. ANDREW M REED
K991525 07/20/1999 DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF DEROYAL INDUSTRIES, INC. LOIS MARSH
K991300 07/12/1999 BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE DHD HEALTHCARE CORP. LARRY WEINSTEIN
K983203 07/12/1999 IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K992105 07/06/1999 IMMULITE TURBO INTACT PTH, MODEL LSKPTZ DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K980380 07/14/1999 NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS DIAMETRICS MEDICAL, LTD. JAN WALTERS
K992191 07/12/1999 ETI-EA-G ASSAY DIASORIN, INC. JUDITH J SMITH
K991694 07/15/1999 DYNAREX DRAIN SPONGE DYNAREX CORP. JOHN G MOULDEN
K991695 07/15/1999 DYNAREX NON-WOVEN SPONGE DYNAREX CORP. JOHN G MOULDEN
K991170 07/02/1999 RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 EDWARDS LIFESCIENCES RESEARCH MEDICAL JOHN W SMITH
K991789 07/09/1999 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOCKING
K992251 07/27/1999 SWISS LITHOCLAST MULTIPURPOSE PROBE ELECTRO MEDICAL SYSTEMS SA SHEILA HEMEON-HEYER
K991636 07/20/1999 ELEKTA STEREOTACTIC GUIDE ELEKTA INSTRUMENT AB CAROL PATTERSON
K991953 07/01/1999 MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION ENGINEERED MEDICAL SYSTEMS BONNIE HOLLY
K991955 07/06/1999 MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION ENGINEERED MEDICAL SYSTEMS BONNIE HOLLY
K991001 07/15/1999 MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER EP MEDSYSTEMS JOSEPH C GRIFFIN, III
K991913 07/26/1999 PENTAMIX 2 ESPE DENTAL AG A. PETERMANN
K984640 07/01/1999 THERMAL ANGEL ESTILL MEDICAL TECHNOLOGIES, INC. THOMAS KISTNER
K991900 07/12/1999 XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 EXCEL TECH. LTD. MARK T ZAJAC
K991238 07/08/1999 FCI CRAWFORD PROBE INTUBATION SETS FCI OPHTHALMICS, INC. ANNE BOHSACK
K991560 07/13/1999 NASO-LARYNGO-PHARYNGOSCOPE FIBER IMAGING TECHNOLOGIES, INC. JOSEPH RESS
K991464 07/20/1999 DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 FISMA, INC. TRACY S BEST
K991520 07/30/1999 FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K991517 07/27/1999 CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 GALIL MEDICAL LTD. JONATHAN S KAHAN
K991272 07/12/1999 CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E GALIL MEDICAL LTD. HOWARD M HOLSTEIN
K991774 07/09/1999 ACRON MC MODIFICATION GC AMERICA, INC. TERRY L JORITZ
K992208 07/12/1999 GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K991514 07/16/1999 GEBAUER'S CHLORIDE FINE NOZZE GEBAUER CO. DENISE E SPELLMAN
K990068 07/14/1999 SOLAR 9500 INFORMATION MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K991382 07/15/1999 SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 GENICON, LC GARY HABERLAND
K991416 07/20/1999 ENDOSCOPIC CAMERA GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) MARY MCNAMARA CULLINANE
K991554 07/09/1999 GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K992244 07/26/1999 GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K991489 07/15/1999 ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K991490 07/15/1999 ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K991631 07/26/1999 FASTRAY LC HARRY J. BOSWORTH CO. MILDRED J BOSWORTH
K991616 07/14/1999 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) HARTALEGA SDN BHD KUAN KAM HON
K990476 07/22/1999 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION HEWLETT-PACKARD GMBH EGON PFEIL
K991535 07/30/1999 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS HITACHI MEDICAL CORP. OF AMERICA GARY W ENOS
K992344 07/30/1999 OSTEONICS ACCP SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP. KATE SUTTON
K990712 07/20/1999 OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K990847 07/14/1999 INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M HUMAGEN FERTILITY DIAGNOSTICS, INC. CINDY SHOWALTER
K990941 07/14/1999 NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L HUMAGEN FERTILITY DIAGNOSTICS, INC. CINDY SHOWALTER
K991497 07/28/1999 ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM ICS MEDICAL CORP. DELMAR F BLOEM
K990640 07/09/1999 VELOGENE RAPID MRSA IDENTIFICATION ASSAY ID BIOMEDICAL CORP. ROBERT N BRYAN
K991723 07/22/1999 TRANSFX MULTI PIN CLAMP IMMEDICA, INC. ROY BOGERT
K992041 07/23/1999 RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 IMMUNO CONCEPTS, INC. ERIC S HOY
K991869 07/14/1999 COBREX HIP STEM, MODEL 01-128-XXXXX IMPLEX CORP. ROBERT POGGIE
K983837 07/01/1999 HEDROCEL ACETABULAR CAGE SYSTEM IMPLEX CORP. ROBERT POGGIE
K992227 07/30/1999 CRIT-LINE MONITOR III (CLM III) IN-LINE DIAGNOSTICS CORP. MATTHEW L HAYNIE
K991122 07/01/1999 CRYO-MONO CRYOGRNIC SYSTEM INFLUENCE, INC. PETER M BICK
K992277 07/30/1999 STAPLETAC BONE ANCHOR SYSTEM INFLUENCE, INC. JONATHAN S KAHAN
K990454 07/01/1999 BIO-INTERFERENCE SCREW INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K990496 07/01/1999 ANESFLOW-DUAL DRIP IV INFUSION SET INNOVATIVE DESIGN ASSOC. JERRY D VLOKA
K991725 07/30/1999 SIDESTREAM NEBULIZER INSPIRED MEDICAL PRODUCTS LTD. PAUL E DRYDEN
K983631 07/01/1999 AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P INSTRUMENTATION INDUSTRIES, INC. EDWARD C HOREY, JR.
K992216 07/26/1999 BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K982180 07/06/1999 DURAGEN DURAL GRAFT MATRIX INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K984295 07/09/1999 INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) INVACARE CORP. EDWARD A KROLL
K991338 07/14/1999 BOVINE SERUM ALBUMIN (BSA) IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991421 07/02/1999 FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991341 07/08/1999 ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991420 07/02/1999 MODIFIED HAM'S F-10 WITH ALBUMIN IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991342 07/08/1999 PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991343 07/14/1999 PVP (POLYVINYLPYRROLIDONE) IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991337 07/08/1999 SPERM MAINTENANCE MEDIUM WITH GLYCEROL IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K991572 07/08/1999 ISOLUX SURGICAL HEADLIGHT ISOLUX AMERICA STUART L MCGHEE
K991222 07/09/1999 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT JOHNSON & JOHNSON PROFESSIONALS, INC. JAMES M FLAHERTY
K992218 07/30/1999 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K991625 07/30/1999 KOMET XK-95 PERFORATOR MOTOR (MI-102) KOMET MEDICAL COURTNEY S PARADICE
K991479 07/07/1999 VISER PENILE TUMESCENCE MONITOR LABORIE MEDICAL TECH CORP. DALE COLEMAN
K992018 07/30/1999 LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) LAGLOVE (M) SDN. BHD. G. BASKARAN
K992083 07/12/1999 SCATTERFREE LATERAL EMITTING FIBER LASER PERIPHERALS LLC. NANCY L ARNOLD
K992061 07/30/1999 PULSTAR LASERMED, INC. CALVIN D OSTLER
K991114 07/14/1999 REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM LIFECORE BIOMEDICAL, INC. CAROLYN ANDERSON
K990770 07/30/1999 BIORC ANCHOR LINVATEC CORP. LAURA SENEFF
K990524 07/15/1999 E9000 SYSTEM LINVATEC CORP. LAURA SENEFF
K983802 07/30/1999 LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB LUCAS MEDICAL, INC. DANIEL LUCAS
K991235 07/08/1999 SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) LUDLOW TECHNICAL PRODUCTS KATHLEEN M MURPHY
K991615 07/30/1999 POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE MAXXIM MEDICAL JOYCE MOODY
K992122 07/15/1999 TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE MAXXIM MEDICAL JOYCE MOODY
K991275 07/01/1999 WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS MCKINLEY, INC. JOHN MCINROY
K991659 07/29/1999 UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES MEDART CORP. MARILYN M CHOU
K991297 07/12/1999 UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES MEDART CORP. MARILYN M CHOU
K991434 07/06/1999 QUADRATURE WRIST COIL, MODEL 445PH-64 MEDICAL ADVANCES, INC. THOMAS E TYNES
K991336 07/12/1999 BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) TYRONE L HARDY
K991424 07/22/1999 INSULSCAN INSULATION TESTING SYSTEM MEDICOR CORP. SCOTT B KERRIGAN
K983504 07/09/1999 PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST MEDISENSE, INC. MICHAEL HALPIN
K984639 07/12/1999 THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER MEDISON AMERICA, INC. BOB LEIKER
K992155 07/08/1999 VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 MEDISON AMERICA, INC. MICHAELA MAHL
K992328 07/21/1999 FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 MEDITEC CO., LTD. D. H. CHANG
K991367 07/19/1999 MEDITRON STETHOSCOPE SYSTEM MEDITRON AS CHARLES H KYPER
K991557 07/21/1999 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC. JAN E DOBSCHA
K991389 07/15/1999 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S ANN-CHRISTINE JONSSON
K992300 07/29/1999 QUICK-SERTER, MODEL 395 MEDTRONIC MINIMED DON SELVEY
K992231 07/23/1999 MODIFICATION TO FOUNTAIN INFUSION SYSTEM MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K991917 07/12/1999 OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET METRIKA, INC. YA-CHEN HSU
K991225 07/08/1999 MTI 1 ML SYRINGE MICRO THERAPEUTICS, INC. MARIA D OCHOA
K991212 07/01/1999 MODIFICATION TO TRUZONE PEAK FLOW METER MONAGHAN MEDICAL CORP. JAMES A COCHIE
K991539 07/01/1999 EXCELL 22 MWI, INC. GREGORY A WITHERSPOON
K991072 07/13/1999 AHMED GLAUCOMA VALVE IMPLANT NEW WORLD MEDICAL, INC. A.M. AHMED
K991477 07/14/1999 SPIN SNAP-OFF SCREW NEWDEAL S.A. NORMAN F ESTRIN
K991821 07/01/1999 NITRILE EXAMINATION GLOVE, POWDERED, BLUE NING BO YUJIANG RUBBER & PLASTIC CO. JANNA P TUCKER
K990341 07/14/1999 ELECTRO MECHANICAL LITHOTRIPTOR NORTHGATE TECHNOLOGIES, INC. CASSY KUREK
K991727 07/16/1999 STAT PROFILE M7 ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K991668 07/26/1999 COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) NOVARTIS NUTRITION CORP. ROBERT J LANG
K991267 07/12/1999 SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A OHIO MEDICAL INSTRUMENT CO., INC. KENNETH B MILLER
K990237 07/12/1999 TROCAR SYSTEM ACCORDING TO HASSON OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K991377 07/12/1999 OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER OMNISONICS MEDICAL TECHNOLOGIES DEEBIE IAMPIETRO
K990872 07/13/1999 SCLERAL PLUGS, 19 AND 20 GAUGE OPHTHALMIC CONSULTANTS, INC. JOHN E LINCOLN
K983120 07/29/1999 BICORTICAL SCREW ORALTRONICS MARKETING-UND VERTRIEBS GMBH FLOYD G LARSON
K992408 07/30/1999 ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES ORATEC INTERVENTIONS, INC. SHEILA RAMERMAN
K992353 07/30/1999 BLUNT TIP TROCAR PORT ORIGIN MEDSYSTEMS, INC. LORI E ADELS
K990843 07/09/1999 SERUM CROSSLAPS ONE STEP ELISA OSTEOMETER BIOTECH A/S PER QVIST
K980070 07/23/1999 OSTEONICS HA-COATED DEVICES OSTEONICS CORP. TERRY SHERIDAN
K991586 07/23/1999 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) OSTEOTECH, INC. CHRISTOPHER TALBOT
K991590 07/08/1999 C-LEG (3C100) OTTO BOCK ORTHOPEDIC INDUSTRY, INC. JOHN HENDRICKSON
K984528 07/15/1999 PARKER FLEX-TIP TRACHEAL TUBE PARKER MEDICAL ASSOC. JEFFREY D PARKER
K992163 07/13/1999 ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS PDZ-EUROPA LTD. ROBERT F MARTIN
K991533 07/29/1999 MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION PERIPHERAL AVE SUSAN WALTON
K992217 07/13/1999 AT HOME DRUG TEST, MODEL 9175 PHAMATECH CARL A MONGIOVI
K991945 07/28/1999 PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 PHARMACIA & UPJOHN CO. KAREN E MATIS
K991568 07/19/1999 MR SPECTROSCOPY PACKAGE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K983764 07/08/1999 VIEWPOINT TOOLS- STERRAD PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. HELEN K KEELER
K982859 07/30/1999 UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM PLUS ORTHOPEDICS HARTMUT LOCH
K990579 07/23/1999 CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) PRECISION BIOLOGIC SANDY MORRISON
K990580 07/28/1999 CRYOCHECK LA SURE, MODEL SUR25-10 PRECISION BIOLOGIC SANDY MORRISON
K990823 07/23/1999 PVS 1400 GUIDEWIRE PRECISION VASCULAR SYSTEMS, INC. JOHN RAGAZZO
K992068 07/06/1999 STATUS STIK, ACCUSIGN STIK PRINCETON BIOMEDITECH CORP. JEMO KANG
K991276 07/12/1999 PASS/FAIL CHALLENGE PACK PROPPER MFG. CO., INC. JOHN D DYCKMAN
K992177 07/29/1999 NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE PT. BERLIAN GLOVINDO TONY JAP
K990234 07/08/1999 QUALISYS PSA IMMUNOASSAY QUALISYS DIAGNOSTICS, INC. GRACE KWAN
K983768 07/02/1999 MODIFICATION TO GAMMA GUIDANCE SYSTEM RADIATION MONITORING DEVICES, INC. PAUL STOPPEL
K991523 07/30/1999 TLC PEDIATRIC FRAME, MODEL TLC-SYS RADIONICS, INC. NANCY C MACDONALD
K991110 07/26/1999 REDI-TEST COCAINE REDWOOD BIOTECH, INC. JANIS FREESTONE
K991504 07/22/1999 REDI-TEST METHAMPHETAMINE REDWOOD BIOTECH, INC. JANIS FREESTONE
K984428 07/26/1999 SULLIVAN AUTOSET NASAL CPAP SYSTEM RESMED LTD. SCOTT DUDEVOIR
K991211 07/08/1999 EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM REYNOLDS MEDICAL LTD. GEORGE MYERS
K991827 07/19/1999 GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 RI MOS. S.R.L. ADENA NORA S RIEMER
K991598 07/22/1999 COBAS INTEGRA ACETAMINOPHEN ROCHE DIAGNOSTICS CORP. LISA GERARD
K991597 07/22/1999 COBAS INTEGRA AMIKACIN MAB ROCHE DIAGNOSTICS CORP. LISA GERARD
K991863 07/19/1999 CUTE-LITE I LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. STERLING CHENG
K991865 07/20/1999 Q-LITE 75 LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. STERLING CHENG
K982974 07/02/1999 DD URETERAL STENT, INTEGRAL STENT RUSCH INTL. KARENANN J BROZOWSKI
K991951 07/26/1999 SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) SAFESKIN CORP. EUGENE V GOORCHENKO
K991537 07/06/1999 SAMSUNG RAYPAX SYSTEM SAMSUNG SDS CO., LTD HERMAN OOSTERWJICK
K991733 07/13/1999 ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS SCHIAPPARELLI BIOSYSTEMS, INC. STEVEN DALESSIO
K992142 07/21/1999 SCIMED ANGIOGRAPHIC CATHETERS SCIMED MELANIE RASKA
K991849 07/07/1999 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC SEAL POLYMER INDUSTRIES BHD. CHAN CHIN HONG
K992031 07/12/1999 LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) SHANGHAI CHANGZHENG LATEX FACTORY JANNA P TUCKER
K992206 07/29/1999 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. SUSAN D GOLDSTEIN-FALK
K992205 07/23/1999 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. SUSAN D GOLDSTEIN-FALK
K991457 07/01/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. DANNY WANG
K992100 07/29/1999 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. DANNY WANG
K991567 07/14/1999 SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. SHELHIGH, INC. SHLOMO GABBAY
K990719 07/12/1999 EARLOOP FACE MASK SHUENN BAO SHING CORP. CHARLIE CHEN
K990345 07/30/1999 RABEA DEVICE, MODEL PXXXXXX SIGNUS MEDIZINTECHNIK GMBH THOMAS HOGHAUG
K991450 07/09/1999 ETCHING GEL SILICON-UND COMPOSITE SPEZIALITATEN GMBH JURGEN ENGELBRECHT
K984506 07/29/1999 SD-100 SKYEAR THERMOMETER SKYLARK DEVICE CO., LTD. GEORGE K C CHEN
K991624 07/09/1999 POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD FOO KHON PU
K991500 07/14/1999 SMITH & NEPHEW SUTURE LOK SMITH & NEPHEW ENDOSCOPY, INC. SIGI CARON
K991957 07/20/1999 CICACARE MANAGEMENT FOR SCARS SMITH & NEPHEW, INC. JIM IRVIN
K991968 07/30/1999 CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. SMITH & NEPHEW, INC. JIM IRVIN
K991323 07/06/1999 SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR SMITH & NEPHEW, INC. DEBORAH CONNORS
K991485 07/12/1999 SYNERGY POROUS SIZE 8 HIP STEM SMITH & NEPHEW, INC. DAVID HENLEY
K991400 07/12/1999 PARIETENE POLYPROPYLENE MESH SOFRADIM PRODUCTION MARY MCNAMARA CULLINANE
K984090 07/07/1999 SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) SPECIALTY ULTRAVISION, INC. IVALEE I COHEN
K991622 07/14/1999 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER STELKAST COMPANY DONALD A STEVENS
K990342 07/20/1999 SYNOCTA PROSTHETICS STRAUMANN USA LINDA JALBERT
K991509 07/14/1999 PRO-PORTION CLEANER/DISINFECTANT SULTAN CHEMISTS, INC. LES HEIMANN
K990142 07/30/1999 HT, MODEL HT PB SULZER OSCOR, INC. MILA DOSKOCIL
K991852 07/07/1999 OCUSYSTEM ART ADVANTAGE, MODEL 995 SURGICAL DESIGN CORP. WAYNE H MATELSKI
K991468 07/06/1999 IMMERGE IMAGE CORRELATION SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER WHITE
K991700 07/19/1999 SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO SWEMED LAB INTERNATIONAL AB EDWARD C WILSON
K991808 07/09/1999 OPTIBOND SOLO PLUS 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K990965 07/01/1999 SYNTHES CERVIFIX SYSTEM SYNTHES (USA) JONATHAN GILBERT
K992000 07/20/1999 SYNTHES CRANIAL FLAP TUBE CLAMP SYNTHES (USA) SHERI L MUSGNUNG
K991860 07/20/1999 SYNTHES CRANIAL FLAP TWIST CLAMP SYNTHES (USA) SHERI L MUSGNUNG
K992207 07/22/1999 QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K981938 07/06/1999 TAMPA HYPERBARIC MONOPLACE CHAMBER TAMPA HYPERBARIC ENT. MICHAEL CAPRIA
K990602 07/01/1999 RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES TECSA TECHNICAL SERVICES CHRISTINE EMANUEL
K992219 07/30/1999 POWDERED LATEX STERILE SURGICAL GLOVES TG MEDICAL SDN BHD WEE-CHAI LIM
K991408 07/19/1999 FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR THERMOQUEST CORP. RICHARD L MILLER
K991263 07/08/1999 THERMOPLATE TOKAI HIT CO., LTD. HIDEHARU TSUCHIYA
K991711 07/07/1999 BISTITE II SC TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K982943 07/12/1999 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 TRANSTRACHEAL SYSTEMS LEWIS W WARD
K972772 07/13/1999 ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING TREK DIAGNOSTIC SYSTEMS, INC. NADINE SULLIVAN
K992230 07/12/1999 OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP TRIMEDYNE, INC. SUSAN H GAMBLE
K990761 07/09/1999 TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE TUTTNAUER USA CO. LTD. MARK M YACURA
K992288 07/30/1999 AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE TYCO INTL. (US), INC. CHRISTOPHER A GRAHAM
K991503 07/28/1999 SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 UNITED PACIFIC CO., LTD. DANIEL YE HUA
K990618 07/23/1999 VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) VENTANA MEDICAL SYSTEMS, INC. JUDITH FREDERICK
K991303 07/12/1999 VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE VISTA MEDICAL TECHNOLOGIES, INC. VICKI ANASTASI
K991602 07/09/1999 EPTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC TIMOTHY J RYAN
K992189 07/29/1999 GORE-TEX DUALMESH BIOMATERIAL W.L. GORE & ASSOCIATES,INC R, LARRY PRATT
K990732 07/23/1999 LAP-WAVE 3000 (P07) W.O.M. WORLD OF MEDICINE, GMBH MICHAEL MCGRAIL
K984033 07/08/1999 ATLAS MONITOR WELCH ALLYN, INC. ZORAN I PSENICNKI
K990914 07/30/1999 POLARIS DIODE LASER SYSTEM AND ACCESSORIES XINTEC CORPORATION MARILYN M CHOU
K984180 07/20/1999 THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K991581 07/30/1999 NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO ZIMMER, INC. STEPHEN MCKELVEY
K990135 07/12/1999 TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE ZIMMER, INC. KAREN CAIN
K992197 07/28/1999 MODIFICATION TO ZYMED HOLTER 2000 ZYMED MEDICAL INSTRUMENTATION GRETEL LUMLEY


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact