FDA 510(k) Applications Received During September, 1990

FDA 510(k) Number Submission Date Device Name Applicant Contact
K904190 09/12/1990 PATIENT EXAMINATION GLOVES 1ST MED, INC. EDWARD J ROHN
K904226 09/13/1990 'TDXFLX ANALYZER ABBOTT LABORATORIES CAROL COOPER
K904126 09/06/1990 VISIRASER ACORN GROUP, INC. JAMES P STOUT
K904446 09/28/1990 CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) ACROMED CORP. WILLIAM CHRISTIANSON
K904383 09/26/1990 ACUFIT TOTAL HIP ACUMED, INC. RANDALL HUEBNER
K904182 09/11/1990 R-800-SF ADVANTECH CHARLES E MORELAND
K904435 09/28/1990 VENTROFIL TENSION RELIEF SUTURE SET AESCULAP, INC. ROBIN BUSH
K904433 09/28/1990 DUAL LUMEN NEEDLES AKCESS MEDICAL PRODUCTS, INC. BALBIR KAPANY
K904139 09/06/1990 SINGLE LUMEN CATHETER KITS AKCESS MEDICAL PRODUCTS, INC. BALBIR B KAPANY
K904140 09/06/1990 SINGLE LUMEN CATHETERS, MODIFICATION AKCESS MEDICAL PRODUCTS, INC. BALBIR B KAPANY
K904523 09/26/1990 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED ALAMAR BIOSCIENCES LABORATORY, INC. MICHAEL V LANCASTER
K904297 09/19/1990 ST-4 COAGULATION INSTRUMENT AMERICAN BIOPRODUCTS CO. LOC B LE
K904128 09/05/1990 PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER AMERICAN ORTHODONTICS WILLIAM C MACHATA
K904381 09/26/1990 DIAZO COLORIMENTRY DIRECT BILIRUBIN AMRESCO, INC. PRAFUL PATEL
K904276 09/19/1990 DISPOSABLE BEARD COVER ANAGO, INC. ANN FAULKER
K904274 09/18/1990 RECEIVING BLANKET ANAGO, INC. ANN FAULKNER
K904244 09/14/1990 SENSIDERM ANSELL INTL. PAUL CACIOLI
K904379 09/25/1990 SURGICAL TROCAR AND CANNULA APPLIED VASCULAR DEVICES, INC. JO STEGWELL
K904437 09/28/1990 ARGENCO 19 ARGEN PRECIOUS METALS, INC. LAL MALHOTRA
K904343 09/24/1990 ARGENCO 22 ARGEN PRECIOUS METALS, INC. LAL MALHOTRA
K904404 09/25/1990 MULTI-LUMEN CENTRAL VENOUS CATHETER SET ARROW INTL., INC. THOMAS NICKEL
K904240 09/13/1990 SINGLE USE LAPARSCOPIC ELECTRODE ASPEN LABS JANE JOHNSON
K904187 09/12/1990 ECONOMY C-ARM TABLE, MODEL # 056-005 ATOMIC PRODUCTS CORP. CLYDE SCHLEIN
K904236 09/17/1990 ENDOSSEOUS IMPLANTS ATTACHMENTS INTL., INC. PETER STAUBLI
K904317 09/20/1990 AVALON GENERAL PURPOSE SCANNER, PREVIEW GP AVALON TECHNOLOGY CORP. WILLIAM D LIPPS
K904133 09/06/1990 DISPOSABLE FLUID COLLECTION BAG AXIOM MEDICAL, INC. MAHENDRA SANGHVI
K904218 09/12/1990 SUCTION SYSTEM AXIOM MEDICAL, INC. MAHENDRA SANGHVI
K904225 09/13/1990 KWIKMIX BAXA CORP., SUB. OF COOK GROUP, INC. MARY STEGGALL
K904036 09/05/1990 BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN BAXTER HEALTHCARE CORP. TOM TROTTER
K904329 09/20/1990 CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY BAXTER HEALTHCARE CORP. TOM TROTTER
K904142 09/07/1990 GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS BAXTER HEALTHCARE CORP. LAJUAN MCGILL
K904173 09/11/1990 INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS BAXTER HEALTHCARE CORP. LAJUAN MCGILL
K904221 09/13/1990 SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS BAXTER HEALTHCARE CORP. DONALD BUCHHLZ
K904223 09/13/1990 SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS BAXTER HEALTHCARE CORP. DONALD BUCHHOLZ
K904143 09/07/1990 V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES BAXTER HEALTHCARE CORP. LAJUAN MCGILL
K904397 09/25/1990 TEC 1410 BAY SHORE MEDICAL EQUIPMENT CORP. JOHN MARCO
K904390 09/25/1990 ANTI-HUMAN LEU-2A (CD8) PE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K904209 09/12/1990 SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K904219 09/12/1990 SYNCHRON CX 7 CLINICAL ANALYZER BECKMAN WILLIAM T RYAN
K904220 09/12/1990 SYNCHRON CX4-CE BECKMAN WILLIAM T RYAN
K904254 09/14/1990 NA ALPHA 1 MICROGLOBULIN KIT BEHRING DIAGNOSTICS, INC. JOHN HUGHES
K904016 09/04/1990 MAXI TEST BHC BIOTECH LTD. DON CROWE
K904159 09/11/1990 DEFIBRILLATOR ANALYZER MODEL QED-5 BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K904181 09/11/1990 ANTI-GBM ANTIBODIES QUANTITATIVE KIT BIOCHEMICAL DIAGNOSTIC, INC. PATRIK SWANLJUNG
K904405 09/25/1990 BIOCLONES ELEGANCE FSH ELISA KIT BIOCLONE AUSTRALIA PTY LTD. BRUCE MACKLER
K904387 09/25/1990 BIOCLONES ELEGANCE LH ELISA KIT BIOCLONE AUSTRALIA PTY LTD. BRUCE F MACKLER
K904311 09/19/1990 RHEUMAGEN ASO T-CONTROL BIOKIT USA, INC. ODRIOZOLA
K904312 09/19/1990 RHEUMAGEN CRP T-CONTROL BIOKIT USA, INC. ODRIOZOLA
K904310 09/19/1990 RHEUMAGEN RF T-CONTROL BIOKIT USA, INC. ODRIOZOLA
K904376 09/25/1990 ANEROID BLOOD PRESSURE GAUGE BIOMEDICAL DYNAMICS, INC. MATTHEW BELLIN
K904335 09/20/1990 SECONDARY CALIBRATORS BIONOSTICS, INC. BRUCE R WILLIAMS
K904207 09/12/1990 BIOPRO TRINITY ACETABULAR CUP BIOPRO, INC. LOUIS A SERAFIN
K904448 09/28/1990 TOWNLEY TOTAL KNEE (TTK) BIOPRO, INC. LOUIS A SERAFIN
K904130 09/05/1990 CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL) BIOSAFETY SYSTEMS, INC. COUTURE JR
K904211 09/12/1990 BIOSELF 2000 FERTILITY INDICATOR BIOSELF, INC. JAMES PULCRANO
K904416 09/27/1990 CROATEST (R) RHEUMATOID DIAGNOSTIC BIOTRAX, INC. SANTO L GRILLO
K904184 09/12/1990 BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT BIOTRON U.S.A., INC. ALLAN C MURPHY
K904164 09/11/1990 AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED BOEHRINGER LABORATORIES JOHN KARPOWICZ
K904168 09/11/1990 ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM BOEHRINGER MANNHEIM CORP. CYNTHIA A SPAIN
K904292 09/19/1990 ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM BOEHRINGER MANNHEIM CORP. PAUL FREIBERG
K904102 09/06/1990 REFLOTRON CREATINE KINASE TEST TABS BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K904232 09/12/1990 BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC BOSTON MEDICAL CORP. TIMOTHY F HAND
K904394 09/25/1990 INFLATION/DEFLATION DEVICE BOSTON SCIENTIFIC CORP. JEANNE LESNIAK
K904195 09/12/1990 DISPOSABLE FACE MASK BP LTD. KATHLEEN BORDONI
K904196 09/12/1990 MICRO-MIST NEBULIZER BP LTD. KATHLEEN BORDONI
K904069 09/04/1990 BRODA NURSING CARE CHAIR BRODA ENT., INC. JOHN ALLDREDGE
K904160 09/11/1990 CYTOSMEAR BRUSH BROOKE INTL. TODD M GATES
K904250 09/17/1990 MODEL 4222 AMBULATORY ECG MONITOR BYRNCREST GLOBAL, INC. LISA JONES
K904403 09/25/1990 BARD AMBULATORY PCA DRUG DELIVERY SYSTEM C.R. BARD, INC. ERIC ANKERUD
K904079 09/05/1990 BARD UTERINE MANIPULATOR C.R. BARD, INC. ERNEST MANFREDO
K904040 09/04/1990 SOFTSHELL VENOUS RESERVOIR C.R. BARD, INC. CHRISTINE MORGIDA
K904095 09/06/1990 HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING CALIFORNIA INTEGRATED DIAGNOSTICS, INC. SUSAN C FULLER
K904325 09/20/1990 COAG-1 PT-NC TEST CARD CARDIOVASCULAR DIAGNOSTIC SERVICES SHARON C DERMOTT
K904273 09/17/1990 MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. CARTER PRODUCTS STEPHEN KOLAKOWSKY
K904106 09/06/1990 SPA SHELL CENTURY MANUFACTURING CO. KATHY KUHLENENGEL
K904266 09/18/1990 AUTODERM SCANNER CONTROL CONSOLE CHARLES I. ROSE & CO., INC. CHARLES I ROSE
K904248 09/17/1990 MODEL GLASE 210 HOLMIUM LASER SYSTEM CHARLES L. ROSE AND CO., INC. CHARLES L ROSE
K904242 09/17/1990 QI-GONG MACHINE THERAPEUTIC MASSAGER CHINA HEALTHWAYS INSTITUTE RICHARD LEE
K904082 09/05/1990 CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST CHOLESTECH CORP. SUSAN WILLSON
K904123 09/06/1990 CIBA CORNING ACS HCG IMMUNOASSAY CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K904189 09/12/1990 CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K904188 09/12/1990 CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K904432 09/28/1990 SLEEP I/T-5 AND SLEEP I/T-8 CNS, INC. JOHN STOLTE
K904336 09/20/1990 NEW COBE SATURATION/HEMATOCRIT MONITOR COBE LABORATORIES, INC. MARY L ARMSTRONG
K904120 09/06/1990 ACCU-FLO* UNITIZED SHUNT CODMAN & SHURTLEFF, INC. JEANNETTE CLOUTIER
K904352 09/24/1990 CODMAN COLLINS RADIOPARENT STERNAL BLADES CODMAN & SHURTLEFF, INC. JEANETTE CLOUTIER
K904086 09/05/1990 DISCRENE SELF-SUPPORTING BREAST FORM COLOPLAST A/S RICHARD A HAMER
K904085 09/05/1990 ELLA BREAST FORM COLOPLAST A/S RICHARD A HAMER
K904316 09/21/1990 NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT COLOPLAST CORP. TRACY L SADOWSKI
K904198 09/12/1990 SAFETY NEEDLE SHEATH CONCORD/PORTEX ROBERT WHEELER
K904114 09/06/1990 ANATECH X-RAY GENERATOR CONTINENTAL X-RAY CORP. ROBERT D WALKER
K904233 09/05/1990 CONVATEC ABSORBENT BANDAGE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS MARILYN DREYLING
K904421 09/27/1990 CMS ONCOPROBE (TM) CRYOMEDICAL SCIENCES, INC. FINKELSTIEN
K904349 09/24/1990 CUI CURVILINEAR SILICONE CHIN CUI CORP. MORRIS SHERWOOD
K904350 09/24/1990 CUI DORSAL COLUMELLA PROSTHESIS CUI CORP. MORRIS SHERWOOD
K904348 09/24/1990 CUI FEATHERED SILICONE MALAR CUI CORP. MORRIS SHERWOOD
K904380 09/26/1990 SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM CUSTOM MEDICAL CONCEPTS, INC. EDWARD MCNAMARA
K904243 09/14/1990 TSRH VARIABLE ANGLE SACRAL SCREW DANEK MEDICAL, INC. FRANK LEWIS
K904389 09/26/1990 SI-PRO DAVID F. TRUNGALE DAVID F TRUNAGLE
K904117 09/06/1990 SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. DAWN MEDICAL BRUCE FITZGERALD
K904118 09/06/1990 SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. DAWN MEDICAL BRUCE FITZGERALD
K904251 09/13/1990 NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL DENTIFAX INTERN, INC. JEFFERY LEHN
K904205 09/12/1990 AMK MODULAR TIBIAL WEDGE SYSTEM DEPUY, INC. DAVID A KOTKOVETZ
K904351 09/24/1990 FOCUS COBALT CHROMIUM TOTAL HIP DEPUY, INC. DAVID KOTKOVETZ
K904119 09/06/1990 PROFILE COLLARED HIP PROSTHESIS DEPUY, INC. DAVID A KOTKOVETZ
K904122 09/06/1990 INSYTE-A ARTERIAL CATHETERIZATION UNIT DESERET MEDICAL, INC. CHARLES J WELLE
K904121 09/06/1990 VIALON OBTURATOR DESERET MEDICAL, INC. CHARLES J WELLE
K904417 09/27/1990 CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM DEVICE LABS, INC. ELTON M TUCKER
K904344 09/24/1990 SLEEPER MASK SYSTEM DEVILBISS HEALTH CARE, INC. DAVID GAST
K904451 09/28/1990 MILENIA (TM) METHAMPHETAMINE DIAGNOSTIC PRODUCTS CORP. KENNETH ASARCH
K904167 09/11/1990 PATHODX HERPES TYPING DIAGNOSTIC PRODUCTS CORP. KENNETH B ASARCH
K904100 09/06/1990 DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHNNY R WILLIS
K904172 09/11/1990 ACCUPLACE (TM) DLP, INC. ROGER BRINK
K904149 09/07/1990 FLEXISYS DORNIER MEDTECH AMERICA, INC. ROBERT E YOCHER
K904155 09/07/1990 MEDILAS 4060N FIBERTOM(R) SURGICAL LASER DORNIER MEDTECH AMERICA, INC. ROBERT E YOCHER
K904366 09/24/1990 CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES DOUGLAS DONALDSON
K904261 09/14/1990 LITTER, NONRIDGID, POLELESS, NYLON STRETCHER DOW COVER CO., INC. MARK STEINHARDT
K904326 09/20/1990 DE-TOX TUBES A AND DE-TOX TUBES B DYNA-TEK INDUSTRIES PAUL SOOD
K904299 09/19/1990 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF E-Z-EM, INC. GEORGANNE BROWN
K904301 09/19/1990 DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904308 09/19/1990 DUPONT ALCOHOL CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904302 09/19/1990 DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904305 09/19/1990 DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904304 09/19/1990 DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904306 09/19/1990 DUPONT DRUG CALIBRATOR-A E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904303 09/19/1990 DUPONT DRUG CLIBRATOR-B E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904307 09/19/1990 DUPONT SALICYLATE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC. RICHARD M VAUGHT
K904238 09/14/1990 KODAK X-MAT 270 RA PROCESSOR EASTMAN KODAK COMPANY NORMAN GEIL
K904406 09/24/1990 EER ERECTION ENHANCED RESPONDER EER, INC. RUDOLPH YANUCK
K904255 09/17/1990 FOCUS T41,T41F,T43, T43F,T44F ELAMEDICAL PAUL KOHL
K904103 09/06/1990 SEP 90 ELEMA-SCHONANDER, INC. ELLEN FARNEY
K904359 09/24/1990 ESI-3000 ULTRASOUND SYSTEM ELSCINT, INC. ROCHELLE SOBEL
K904289 09/17/1990 PERTAC UNIVERSAL BOND ESPE GMBH (US) HAROLD A OPOTOW
K904096 09/06/1990 PHOTAC-BOND ESPE GMBH (US) HAROLD A OPOTOW
K904097 09/06/1990 PHOTAC-BOND APLICAP ESPE GMBH (US) HAROLD OPOTOW
K904104 09/06/1990 ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR ETHICON, INC. JAMES P O'DONNELL
K904125 09/06/1990 UC IMU A EUCARDIO LABORATORY, INC. WANG
K904137 09/06/1990 UC IMU B EUCARDIO LABORATORY, INC. WANG
K904152 09/07/1990 S.P.F. PREMIER 2 WHEELCHAIR EVEREST & JENNINGS, INC. JACKIE WILKINS
K904407 09/26/1990 DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG FIBER DELIVERY CONCEPTS, INC. JAMES P WALKER
K904420 09/27/1990 DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FIBER DELIVERY CONCEPTS, INC. JAMES P WALKER
K904378 09/24/1990 F.T.I. MEDICAL LIGHT GUIDE FIBEROPTICS TECHNOLOGY, INC. ALLEN GUILLOTTE
K904193 09/12/1990 FLOCARE FLOCARE MEDICAL AL W KRAUS
K904246 09/14/1990 SYSTEM 70 AND 100 FOLIO PRODUCTS, INC. W. F KIDWELL
K904200 09/12/1990 SPIROSIFT 500A FUKUDA DENSHI USA, INC. ROBERT J STEURER
K904177 09/11/1990 GALIX MA-6C HOLTER CASSETTE RECORDER GALIX INSTRUMENTACION BIOMEDICA JORDAN GAVRIELIDES
K904176 09/11/1990 GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER GALIX INSTRUMENTACION BIOMEDICA JORDAN GAVREILIDES
K904324 09/14/1990 LATEX EXAMINATION GLOVE GALLIMORE ENT., INC. WAYNE DRISCOLL
K904358 09/24/1990 MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES BRIAN BARRY
K904047 09/04/1990 ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. GEN-PROBE, INC. CONNIE KIRBY
K904268 09/18/1990 ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. GEN-PROBE, INC. CONNIE KIRBY
K904174 09/10/1990 STARCAM 4000 GENERAL ELECTRIC CO. LARRY KROGER
K904346 09/24/1990 BAUMAN CPR/RESUSCITATOR GENERAL MEDICAL PRODUCTS, INC. JACK BAUMAN
K904418 09/27/1990 ULTRASOUND COUPLING GEL GENO LABORATORIES JEFFREY W GENO
K904084 09/05/1990 RUBELLA IGM ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K904083 09/05/1990 RUBEOLA IGM ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K904041 09/04/1990 HAEMONETICS CELL SAVER 4 PLUS HAEMONETICS CORP. MICHAEL MATHEWS
K904204 09/12/1990 THROMBELASTOGRAPH HAEMOSCOPE CORP. LEON ZUCKERMAN
K904247 09/14/1990 FREE PROTEIN S REAGENT CAT. NO. 5363 HELENA LABORATORIES PAT FRANKS
K904377 09/24/1990 ELECTROCONDUCTIVE MEDIA HENLEY INTL. ERNEST HENLEY
K904081 09/05/1990 GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM HERAEUS KULZER, INC. ROSANNE M SAVOL
K904423 09/27/1990 CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM HERAEUS LASERSONICS, INC. BOB MILDER
K904444 09/28/1990 MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 HERAEUS LASERSONICS, INC. ROBERT MILDER
K904342 09/21/1990 SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A HGM MEDICAL LASER SYSTEMS, INC. DENNIS REIGLE
K904293 09/19/1990 HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) HICHEM DIAGNOSTICS RALPH BOLSTAD
K904099 09/06/1990 URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS HICHEM DIAGNOSTICS BENTLEY TAM
K904199 09/12/1990 HORIZON REGULAR ETCHING GEL HORIZON CHEMICAL CO. JEFF I WILLIAMS
K904208 09/12/1990 KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM HOWMEDICA CORP. ROBERT E SMITH
K904170 09/11/1990 PCA (R) TIBIAL BONE WEDGES HOWMEDICA CORP. MARY C SPICER
K904115 09/06/1990 HYCOR ACCUPINCH METHAMPHETAMINE TEST HYCOR BIOMEDICAL, INC. RON HOOVER
K904048 09/04/1990 MULTI DRUG INFUSION SYSTEM I-FLOW CORP. ROBERT BARD
K904398 09/25/1990 WATER COLUMN RELIEF VALVE ICN PHARMACEUTICALS, INC. ALICE WEI
K904338 09/20/1990 ICOR HCH 4, ICOR HCH 7 ICOR AB ANDRAS GEDEON
K904038 09/04/1990 MYOGLOBIN RIA TEST KIT IMMUNO DIAGNOSTIC CENTER, INC. AMAL MUKHERJEE
K904265 09/18/1990 INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER INAMED DEVELOPMENT CO. ELLEN DUKE
K904237 09/17/1990 RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM INNOVATIVE MEDICAL TECHNOLOGIES, INC. RICHARD VOLLO
K904224 09/13/1990 NOVA LITE TM THYROID INOVA DIAGNOSTICS, INC. BRYS C MYERS
K904355 09/24/1990 CARDIOCAP II TM CH-RESP MONITORS INSTRUMENTARIUM CORP. HANNU AHJOPALO
K904363 09/24/1990 MULTI FORMAT VIDEO IMAGER 600 PLUS INTERNATIONAL IMAGING ELECTRONICS JOHN MIERS
K904454 09/17/1990 HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION INTERNATIONAL TECHNIDYNE CORP. LES HEIMANN
K904087 09/04/1990 MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON INVACARE CORP. JAMES THALER
K904197 09/12/1990 CHILDRENS SUNGLASSES JASCO PRODUCTS CO., INC. HAROLD PLUNK
K904281 09/17/1990 NONPRESCRIPTION SUNGLASSES JENNIE G. SALES CO., INC. SEYMOUR GOLDSTEIN
K904525 09/27/1990 PATIENT EXAMINATION GLOVES JIAN WIN LATEX PRODUCT FACTORY MISS MARGARET
K904161 09/11/1990 JMB TRADING COMPANY SUNGLASSES JMB TRADING CO. RICHARD BUTLER
K904300 09/19/1990 INSET PATELLAR COMPONENT JOHNSON & JOHNSON ORTHOPAEDICS, INC. MARSHA J STONE
K904101 09/06/1990 COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH JOHN J VOZELLA
K904361 09/24/1990 KLEARTEX LATEX SURGEONS GLOVES KLEARTEX SDN BHD KENNEDY PH.D.
K904070 09/04/1990 COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A KRETZTECHNIK AG JAY C CONE
K904450 09/28/1990 BIOCERAM DENTAL IMPLANT, SERIES II KYOCERA AMERICA, INC. KAZ HAYASHI
K904093 09/06/1990 BUCCAL TUBE, BUCCAL ATTACHMENT LANCER ORTHODONTICS, INC. MIKE EKINAKA
K904094 09/06/1990 C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE LANCER ORTHODONTICS, INC. MIKE EKINAKA
K904092 09/06/1990 LANCER ORIGINAL, SIERRA, GENERAL PURPOSE LANCER ORTHODONTICS, INC. MIKE AKINAKA
K904090 09/06/1990 ORTHODONTIC BONDING ADHESIVE CONTROL LANCER ORTHODONTICS, INC. MIKE EKINAKA
K904089 09/06/1990 PERMA MESH LANCER ORTHODONTICS, INC. MIKE EKINAKA
K904091 09/06/1990 TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO LANCER ORTHODONTICS, INC. MIKE EKINAKA
K904331 09/21/1990 L.P.I. LASER DELIVERY SYSTEM LASER PHOTONICS, INC. ROBERT J ANSELMO
K904354 09/24/1990 LPI MULILASE YAG/532 SURGICAL LASER SYSTEM LASER PHOTONICS, INC. ROBERT ANSELMO
K904227 09/13/1990 MULTILASE 45 LASER PHOTONICS, INC. ROBERT ANSELMO
K904229 09/13/1990 MULTILASE 60 LASER PHOTONICS, INC. ROBERT ANSELMO
K904269 09/18/1990 NEUROSEARCH-24 OR NRS-24 LEXICOR MEDICAL TECHNOLOGY, INC. MICHAEL HICKEY
K904385 09/24/1990 JANUS ATAC ENG ANALYSIS SYSTEM LIFE-TECH INTL., INC. ALFRED COATS
K904386 09/24/1990 UROLAB JANUS LIFE-TECH INTL., INC. ALFRED COATS
K904185 09/12/1990 SENSATRACE LUDLOW CORP., TECHNICAL PAPERS DIVISION JAY RUEHLEN
K904147 09/07/1990 HUGH YOUNG II UROLOGICAL X-RAY SYSTEM MALLINCKRODT GROUP, INC. THOMAS F DONOHUE
K904145 09/07/1990 HYDRA VISION UROLOGICAL X-RAY SYSTEM MALLINCKRODT GROUP, INC. THOMAS F DONOHUE
K904146 09/07/1990 NEURO VISION RADIOGRAPHIC X-RAY SYSTEM MALLINCKRODT GROUP, INC. THOMAS F DONOHUE
K904144 09/07/1990 PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM MALLINCKRODT GROUP, INC. THOMAS F DONOHUE
K904212 09/12/1990 HIGH-PRESSURE CONNECTOR TUBE MALLINCKRODT MEDICAL DAVID E BROWN
K904278 09/17/1990 HOLDER, DENTAL BUR, ALUMINUM MAVERICK SURGICAL, INC. KEN KEHOE
K904360 09/24/1990 CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR MAXIMUM PERFORMANCE TECHNOLOGIES, MPTS, INC. HOWARD M HOLSTEIN
K904375 09/25/1990 KIMONO PLUS MAYER LABORATORIES DAVID MAYER
K904453 09/27/1990 LABELLING MODIFICATION TO MAXX PLUS MAYER LABORATORIES DAVID P MAYER
K904410 09/26/1990 MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. PATRICIA G CHRISTIA
K904077 09/05/1990 VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM MED INSTITUTE, INC. NEAL E FEARNOT
K904252 09/17/1990 HEATWAVE MEDADVANCES, INC. PATRICK GRIFFIN
K904298 09/19/1990 EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR MEDI-SWISS CORP. DAVID HAYDEN
K904073 09/05/1990 COAGULATION REFERENCE PLASMA, ABNORMAL MEDI-TECH, INC. MICHAEL BICK
K904141 09/06/1990 TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III MEDICAL ANALYSIS SYSTEMS, INC. DONNA L ANDERSON
K904264 09/18/1990 MODEL SW-103 SOLITANS STIMULATOR MEDICAL CONSULTANTS INTL. LTD. SAUL LISS
K904113 09/06/1990 OPERATIVE RECORDING CAMERA MEDICAL DYNAMICS, INC. JO BREHM
K904337 09/20/1990 OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN. MEDICAL FITTINGS, INC. JOHN R SELADY
K904045 09/04/1990 #504 MINI COMPRESSOR MEDICAL INDUSTRIES AMERICA, INC. RUSSELL BIRD
K904271 09/17/1990 OXLIFE MEDICAL REPAIR SERVICE, INC. STUART BASSINE
K904353 09/24/1990 CARDIOMATIC MODEL MSC-2001 MEDICAL SYSTEMS CORP. MARDIN VARELA
K904409 09/26/1990 MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER MEDTRONIC VASCULAR LINDA S ALEXANDER
K904524 09/27/1990 CAPTIA(R) SYPHILIS M, MODIFICATION MERCIA DIAGNOSTICS LTD. D. H LEWIS
K904400 09/21/1990 MERIFLUOR TM PNEUMOCYSTIS MODIFICATION MERIDIAN DIAGNOSTICS, INC. ALLEN NICKOL
K904393 09/25/1990 PREMIER-CRYPTOCOCCAL ANTIGEN MERIDIAN DIAGNOSTICS, INC. ALLEN NICKOL
K904270 09/18/1990 BIOLINK AUDIOMETER SOFTWARE ACCESSORY MICRO AUDIOMETRICS CORP. AARON MARGOSIS
K904239 09/13/1990 SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES MICROBIO-MEDICS, INC. GREGORY SMALLWOOD
K904098 09/06/1990 CEDIA TOTAL T3 ASSAY MICROGENICS CORP. PATRICIA M KLIMLEY
K904413 09/26/1990 CEDIA(TM) PHENOBARBITAL ASSAY MICROGENICS CORP. PATRICIA M KLIMLEY
K904210 09/12/1990 RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 MINNTECH CORP. LEROY FISCHBACH
K904436 09/28/1990 QUICKANCHOR (TM) MITEK SURGICAL PRODUCTS, INC. ROBERT P ZOLETTI
K904430 09/05/1990 MENS FREEDOM MICRO MONAD CORP. MARK HANKINS
K904288 09/19/1990 MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS MONAD CORP. MARK HANKINS
K904235 09/05/1990 MENS-O-MATIC 2000 MONAD CORP. MARK HANKINS
K904260 09/14/1990 MENS-O-MATIC 3000 MONAD CORP. MARK HANKINS
K904234 09/07/1990 MENS-O-MATIC I MONAD CORP. MARK HANKINS
K904258 09/14/1990 MICRO DERM MONAD CORP. MARK HANKINS
K904428 09/27/1990 PANOSOL II UAB-228 NATIONAL BIOLOGICAL CORP. ARTHUR GODDARD
K904426 09/27/1990 PANOSOL II UVA-218 NATIONAL BIOLOGICAL CORP. ARTHUR GODDARD
K904427 09/27/1990 PANOSOL II UVB-206 NATIONAL BIOLOGICAL CORP. ARTHUR GODDARD
K904107 09/06/1990 CAP-AID NDA SYSTEMS STEVEN B ARAGON
K904039 09/04/1990 REFLECTANCE SENSOR (RS-10) NELLCOR, INC. KENNETH MICHAEL
K904340 09/20/1990 FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM NEOLIGAMENTS, LTD. KENNETH E CARRIER
K904402 09/25/1990 NIDEK INC. MODEL AC-2000 DERM NIDEK, INC. JANET MCCOMB
K904162 09/11/1990 CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES NORCO, INC. LYLE FEELY
K904163 09/11/1990 CLINICAL BLOOD GAS MIXTURES NORCO, INC. LYLE FEELY
K904275 09/18/1990 MORSE BALLOON INFLATION DEVICE NORTH AMERICAN INSTRUMENT CORP. ROBERT FRANKLIN
K904135 09/06/1990 FOUNDATION HYBRID COMPOSITE NULITE SYSTEMS RESEARCH CHRISTOPHER P DOUBE
K904165 09/11/1990 SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT OCCUPATIONAL PREVENTIVE DIAGNOSTICS, INC. CLIFTON, JR
K904138 09/06/1990 SMART SCALE X-RAY PLATFORM OLYMPIC MEDICAL CORP. KEN THOMAS
K904445 09/28/1990 OMIBAND OMIKRON SCIENTIFIC, LTD. MARC COLES
K904332 09/21/1990 MSTIM-2000 EMS OMS MEDICAL SUPPLIES, INC. THOMAS RIIHIMAKI
K904388 09/25/1990 POINTER F-3 TENS OMS MEDICAL SUPPLIES, INC. THOMAS RIIHIMAKI
K904156 09/07/1990 ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS ORIGIN MEDSYSTEMS, INC. CHIN, M.D.
K904180 09/11/1990 PROSTHETIC CEMENT REMOVER ORIGIN MEDSYSTEMS, INC. RICHARD RUSH
K904253 09/14/1990 ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY ORTHO DIAGNOSTIC SYSTEMS, INC. PATRICK ROCHE
K904150 09/07/1990 CATH-FINDER(TM) CATHETER TRACKING SYSTEM PHARMACIA DELTEC, INC. W NUMAINVILLE
K904334 09/21/1990 PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT PHARMACIA DELTEC, INC. EDWARD NUMAINVILLE
K904050 09/04/1990 MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. EDWARD KROLL
K904124 09/06/1990 PHILIPS MULTILEAF COLLIMATOR (MLC) PHILIPS MEDICAL SYSTEMS, INC. WILLIAM G MCMAHON
K904434 09/28/1990 SEXTON CYSTOTOMY URINE PUMP (SCUP2) PHOENIX BIOENGINEERING, INC. WILMER
K904075 09/04/1990 CLINICAL CHEMISTRY CONTROL PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K904443 09/28/1990 PATIENT EXAMINATION GLOVES PISAK ENTERPRISE CO., LTD. VARUN SONI
K904633 09/25/1990 SPIROLOOP, MODIFICATION PNEUMEDICS, INC. RICHARD P IMBRUCE
K904440 09/28/1990 LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS PREFERRED MEDICAL PRODUCTS JANE PATRICK
K904148 09/07/1990 PREVEN-A-STIK PREVEN-A-STIK, INC. MARVIN E CHERNOSKY
K904296 09/19/1990 LYSTA HYGIENIST III SCALER PRODENT INTL., INC. RICHARD O WOOD
K904283 09/17/1990 PS MEDICAL CRANIAL HAND DRILL PUDENZ-SCHULTE MEDICAL RESEARCH CORP. STEPHEN LAGUETTE
K904037 09/04/1990 PUMUCKL AND/OR DIETERLE PUMUCKL SCHIEFERLE
K904294 09/19/1990 QSI 9500 QUANTIFIED SIGNAL IMAGING, INC. HOWARD GALIN
K904320 09/20/1990 STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX) R.K.F. LABORATORIES, INC. ANGEL TORRES
K904175 09/11/1990 RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT REAGENTS APPLICATIONS, INC. NORBERT NEUMANN
K904051 09/04/1990 RICH-MAR MODEL V ULTRASOUND RICH-MAR CORP. DAVID RICHARDS
K904049 09/04/1990 ROCHE COBAS READY RENAL PROFILE REAGENT STRIP ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL KRIEGER
K904279 09/17/1990 PAROJECT ANESTHETIC SYRINGE RONVIG INSTRUMENTS, LTD. DANIEL PARRILLI
K904262 09/14/1990 MINNOW PENILE IMPLANT PROTECTOR RUJA-MED MEDICAL MARKETING PAUL K BERMAN
K904295 09/19/1990 PROGUARD(TM) BLOOD COLLECTION NEEDLE SAFETY-JECT, INC. ROBERT J BARD
K904171 09/11/1990 SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM SCIMED SWANSON LANO
K904088 09/05/1990 ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC SENTINEL WM. R FLETCHER
K904263 09/17/1990 DACRON R SURGICAL SUTURES SHARPPOINT, INC. BOB BAREFOOT
K904341 09/20/1990 APTT REAGENT SIGMA CHEMICAL CO. DANIEL E LAWSON,PHD
K904396 09/25/1990 SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM SIMPLEX MEDICAL SYSTEMS, INC. JAMES WEIGL
K904151 09/07/1990 SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE SITE MICROSURGICAL SYSTEMS, INC. JAMES K MCCRACKEN
K904186 09/12/1990 SITE DIAPHRAGM CASSETTE SITE MICROSURGICAL SYSTEMS, INC. JAMES K MCCRACKEN
K904183 09/12/1990 SITE PHACOEMULSIFICATION HANDPIECE SITE MICROSURGICAL SYSTEMS, INC. JAMES K MCCRACKEN
K904284 09/17/1990 ARTHROSCOPIC SURGICAL BLADE SMITH & NEPHEW DYONICS, INC. ERIC BANNON
K904412 09/26/1990 ALLEVYN DRESSING CLAIMS CHANGE SMITH & NEPHEW UNITED, INC. JIM IRVIN
K904411 09/26/1990 INTRASITE GEL (LABELING REVISION) SMITH & NEPHEW UNITED, INC. JIM IRVINE
K904447 09/28/1990 SONY CINE VIDEO SYSTEM SME-3500 SONY MEDICAL ELECTRONICS CO. LYNNE M BENNETT
K904318 09/20/1990 LOCAL REPORT GENERATOR SPACELABS, INC. RAYMOND W GIFFORD
K904112 09/06/1990 STI DRAPE SHEET STYLE 1908 STERILIZER TECHNOLOGIES CORP. JORGE A VIVONI
K904425 09/27/1990 MODEL 6/01 UV-B FIXTURE STRATO-RAY CO. DONALD GUSTAFSON
K904345 09/24/1990 FASHION FRAMES SUNLAND OPTICAL CO. JOHANNA JOHNSTON
K904216 09/12/1990 STERILE WATER SOLUTION CATALOG # 10000 SUPERIOR HEALTHCARE GROUP, INC. MAUREEN G MCCABE
K904136 09/06/1990 SUTURE TENSION ADJUSTMENT REEL SURGICAL SYSTEMS, INC. COHEN, MD
K904203 09/12/1990 SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM SURGILASE, INC. TIMOTHY J SHEA
K904287 09/14/1990 STEALTH DILATION CATHETER SYSTEM/MODIFICATION TARGET THERAPEUTICS MARIE DANIELS
K904222 09/13/1990 VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER TELEDIAGNOSTIC SYSTEMS, INC. LARRY WOODARD
K904328 09/20/1990 VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM TELEDIAGNOSTIC SYSTEMS, INC. LARRY WOODARD
K904105 09/06/1990 V-TREND TARGET RF TEST TEXAS IMMUNOLOGY, INC. CHARLES W GILL
K904401 09/25/1990 BATTERY-POWERED TOOTHBRUSH THE B & F SYSTEM, INC. DEBORA ZARATE
K904043 09/04/1990 KXO-80C/80D TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TIMOTHY CAPEHART
K904044 09/04/1990 TF-63SA TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TIMOTHY CAPEHART
K904327 09/20/1990 ADVANCED C- SPINE COIL TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K905441 09/25/1990 MRT 35-A" (TM) TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K905442 09/25/1990 MRT35-SP TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K904116 09/06/1990 IRON 5 X CONC REAGENT TRACE SCIENTIFIC LTD. PETER MURPHY
K904392 09/24/1990 MULTILAB 2000 UNETIXS, INC. JOHN HAEFELE
K904588 09/26/1990 AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC STEVE REITZLER
K904111 09/06/1990 HTR POLYMER, HTR-MX UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC DAVID S JOHNSON
K904478 09/28/1990 NONABSORBABLE SILK SURGICAL SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC STEVE REITZLER
K904364 09/24/1990 VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C VARIAN ASSOC., INC. CHARLES WILL
K904169 09/11/1990 VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY VARIAN CANADA, INC. ANTHONY B BAILEY
K904330 09/20/1990 TURBO-RAST SPECIFIC IGE ASSAY VENTREX LABORATORIES, INC. JAMES W CHAMPLIN
K904391 09/25/1990 VIDENT IMPAC IMPLANT ACCESSORIES VIDENT RAY MARROW
K904074 09/04/1990 VITREORETINAL INFUSION CANNULA VISITEC CO. LIAQUAT ALLARAKHIA
K904217 09/12/1990 PRO-LOK (TM) EXTENSION SETS VLV ASSOCIATES, INC. VINCENT VAILLANCOURT
K904282 09/18/1990 BIFURCATED GORE TEX STRETCH VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC JAMES LEWIS
K904158 09/07/1990 ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY WELCON, INC. RICHARD P WELCH
K904290 09/17/1990 NOZOVENT, NASAL DILATOR WPM INTL AB INTL TRADE & MANAGEMET CONSULTING PETRUSON, M.D.
K904382 09/26/1990 SAFE-T-STIK XIKON TECHNOLOGY WALTER ENGLERT
K904109 09/06/1990 BIO-IMPEDANCE ANALYZER XITRON TECHNOLOGIES, INC. JAMES MATTHIE
K904267 09/18/1990 ZOEX ANTISHOCK TROUSERS ZOEX CORP. RALPH PELLIGRA


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