FDA 510(k) Decisions During July, 1992  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K921933 07/08/1992 "O" BUTMENT HB "O" CO., INC. BRIAN L GERSTAD
K921051 07/16/1992 3M PRECISE BRAND INTERNAL SURGICAL STAPLES 3M HEALTH CARE, LTD. WILLARD D LARSON
K915183 07/08/1992 SARNS 8000 MODULAR PERFUSION SYSTEM 3M HEALTH CARE, SARNS JAMES BALUN
K923177 07/27/1992 OPTICAL FRAMES A TO Z IMPORTING CO. ZORIK PIRVEYSIAN
K920836 07/27/1992 SUNGLASSES A TOZ IMPORTING CO. ZORIK PIRVEYSIAN
K922392 07/10/1992 ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID A-1 HEARING AID LAB CARL R SCHULZ
K922490 07/22/1992 ABBOTT STREP A CONTROLS ABBOTT LABORATORIES JEAN FRYDMAN
K922345 07/16/1992 TESTPACK PLUS STREP A ABBOTT LABORATORIES JEAN FRYDMAN
K920738 07/27/1992 ACE 100 DEGREES TUBULAR PLATE ACE ORTHOPEDIC MANUFACTURING CO. JANICE L FILIPPELLI
K922080 07/17/1992 GENESYS II ADAC LABORATORIES PAUL VICHA
K921877 07/01/1992 AD/V SPOOLER ADAPTIVE VIDEO, INC. LISA S JONES
K922657 07/02/1992 AGA TRACH TIES AGA MEDICAL PRODUCTS, INC. MICHAEL SCHUSTER
K922150 07/21/1992 EXAMINATION LAMP AIR-SHIELDS, INC. FRANCIS X CASEY
K920222 07/27/1992 HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS AKERS RESEARCH CORP. AKERS JR.
K922168 07/28/1992 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL ALAMAR BIOSCIENCES LABORATORY, INC. MICHAEL V LANCASTER
K921622 07/02/1992 ALPHATEC COMPRESSION HIP SCREW SYSTEM ALPHATEC MFG., INC. THOMAS A HOGHAUG
K921711 07/13/1992 FLEXION DISTRATION SUPPORT ALTOONA MEDICAL SUPPLY DONALD A MACKENZIE
K920943 07/13/1992 FDP PLASMA TEST KIT AMERICAN BIOPRODUCTS CO. LOC B LE
K922493 07/27/1992 AMERICAN MEDICAL MFG. LUMBAR CPM AMERICAN MEDICAL CORP. MICHELLE J ALSUP
K922290 07/09/1992 SINGLE-STEP PREGNANCY, HCG TEST AMERICAN MEDICAL PRODUCTS, INC. MARTIN R GOULD
K922296 07/14/1992 IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST AMPCOR, INC. MARTIN R GOULD
K922297 07/14/1992 INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST AMPCOR, INC. MARTIN R GOULD
K920827 07/14/1992 AMRAD HEL-PTEST AMRAD BRUCE MACKLER
K921118 07/28/1992 ACS APCT REAGENT ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K915219 07/23/1992 URETHRAL ELECTRODE SHEATH APPLIED UROLOGY, INC. JO STEGWELL
K915636 07/13/1992 GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. ASSOCIATED ENT., INC. EDDI LEACH
K915715 07/02/1992 CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER AUSONICS PTY LTD. RICHARD S MOREY
K921326 07/27/1992 DADE RECOMBOPLASTIN S BAXTER DIAGNOSTICS, INC. ALODIA M RUIZ
K920636 07/07/1992 DADE URINE CHEMISTRY CONTROL LEVELS I AND II BAXTER DIAGNOSTICS, INC. ALODIA M RUIZ
K922387 07/15/1992 DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL BAXTER DIAGNOSTICS, INC. ALODIA M RUIZ
K922125 07/21/1992 STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY BAXTER DIAGNOSTICS, INC. NANCY A HORNBAKER
K922475 07/01/1992 BACTEC 9120 SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K912437 07/13/1992 IRRIGATING SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K921520 07/10/1992 VACUTAINER BRAND LUER ADAPTER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K922827 07/01/1992 OTOSONIC ACS K BELTONE ELECTRONICS CORP. ROBERT A KRATOCHVIL
K915201 07/28/1992 CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO BENNETT X-RAY CORP. SCHNEIDER
K915608 07/23/1992 BICUT BERCHTOLD HOLDING GMBH WOLFRAM K HILL
K921958 07/02/1992 ELISA TUBE TSH TEST BIO CLINIC CO. BRUCE G WATKINS
K922046 07/10/1992 LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 BIO-RAD TEVA C ROTHWELL
K922284 07/10/1992 ELEGANCE FT4 ELISA BIOCLONE AUSTRALIA PTY LTD. BRUCE F MACKLER
K923350 07/23/1992 CLOSED CHAIN ATTACHMENT, MODEL #820-520 BIODAN MEDICAL SYSTEMS, LTD. CLYDE SCHLEIN
K922772 07/13/1992 TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR BIODAN MEDICAL SYSTEMS, LTD. CLYDE SCHLEIN
K921139 07/01/1992 HEALEY REVISION COMPONENT SYSTEM BIOMET, INC. DUTCH HARRISON
K915860 07/02/1992 LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE BIOSOUND, INC. WILLIAM E MCKAY
K920177 07/13/1992 VERSA-VIAL BIOTEQUE AMERICA, INC. DENIS DORSEY
K915756 07/23/1992 BIOTRACK CARBAMAZEPINE TEST CARTRIDGE BIOTRACK, INC. JILL FINDLAY
K915755 07/23/1992 BIOTRACK PHENYTOIN TEST CARTRIDGE BIOTRACK, INC. JILL FINDLAY
K920604 07/27/1992 BIVONA TRACHEAL T-TUBE STENT BIVONA MEDICAL TECHNOLOGIES HARRY M KAUFMAN
K922302 07/24/1992 JAGWIRE(TM) RECANALIZATION GUIDEWIRE BOSTON SCIENTIFIC CORP. WANDA M CARPINELLA
K920946 07/01/1992 UROLOGICAL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. PAMELA L CADORETTE
K915321 07/17/1992 BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR BT MEDICAL CO., INC. JOHN J MALLOY
K921563 07/01/1992 CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM CARDIOMETRICS, INC. MICHAEL BILLIG
K921879 07/16/1992 CBIS CATHETER PULL-BACK DEVICE CARDIOVASCULAR IMAGING SYSTEMS, INC. STAN E TILLMAN
K921750 07/13/1992 CVIS INSIGHT III SYSTEM CARDIOVASCULAR IMAGING SYSTEMS, INC. STAN E TILLMAN
K921631 07/02/1992 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL CARDIOVASCULAR IMAGING SYSTEMS, INC. STAN TILLMAN
K920967 07/08/1992 ZEISS MULTI YAG LASER CARL ZEISS, INC. CHISTOPHER TALBOT
K922735 07/09/1992 ZIESS ENDOPROBE CARL ZEISS, INC. CHRISTOPHER TALBOT
K913302 07/23/1992 DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED CARWILD CORP. JOEL S WILDSTEIN
K922499 07/30/1992 REFLECTIONS - CERAMIC DENTAL BRACKET CDB CORP. SYLVIA C JOYE
K913244 07/28/1992 KTP/532 & KTP/YAG SURGICAL LASERS CHARLES L. ROSE AND CO., INC. DONNA PAGE
K922996 07/27/1992 MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS CHIRON VISION CORP. BRUNT MILLER
K921403 07/30/1992 MODEL 654 ANALYZER CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K921692 07/01/1992 INTEGRATED VIDEO SYSTEM CITATION MEDICAL CORP. EDWARD F WADDELL
K921298 07/02/1992 MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER CJ LASER CORP. CEM GOKAY
K914136 07/21/1992 COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE COHERENT MEDICAL GROUP VIRGINIA SINGER
K921799 07/08/1992 PATIENT EXAMINATION GLOVES CONSOLEX CORP. SDN. BHD. 2A,
K914692 07/02/1992 URINARY DIVERSION EVACUATING CATHETER COOK UROLOGICAL, INC. MICHELLE YOUNG
K921654 07/02/1992 MCLEAN-STOCK PERCUTANEOUS T-TUBE SET COOK, INC. APRIL LAVENDER
K921390 07/27/1992 XENON LIGHT SOURCE AND ACCESSORIES COOPERVISION SURGICAL CLIFFORD F POTOCKY
K922655 07/14/1992 SUCTION/IRRIGATION "Y" TUBING SET CORE DYNAMICS, INC. TIM REIS
K915791 07/10/1992 CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION CORITECHS, INC. ERIK G MILLER
K922704 07/27/1992 COULTER MAXM W/ AUTOLOADER COULTER ELECTRONICS, INC. RICHARDSON-JONES
K921567 07/06/1992 COULTER MH017 COULTER ELECTRONICS, INC. RICHARDSON-JONES
K922624 07/13/1992 ULTRAGATER WHEELCHAIR LIFT CROW RIVER INDUSTRIES, INC. KENNETH B HERLAND
K921842 07/08/1992 CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER CYNOSURE, INC. GEORGE CHO
K921840 07/16/1992 CYNOSURE PHOTOTRIPTER LASER CYNOSURE, INC. GEORGE CHO
K914005 07/30/1992 FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000 DAILY MEDICAL PRODUCTS, INC. ALAN SEACORD
K922366 07/13/1992 SPINE LINE DAMBRECINE, INC. MICHAEL DAMBRO
K921772 07/13/1992 BIOLOR DEGUSSA AG HOLGER MEINICKE
K921619 07/02/1992 DENTAL PORCELAIN DENTSPLY INTL. JEFFERY LEHN
K922721 07/23/1992 VLC DYCAL II DENTSPLY INTL. JEFFERY LEHN
K913344 07/14/1992 DERMAGRAN WET DRESSING (ZINC-SALINE) DERMA SCIENCES, INC. MARY G CLARK
K920796 07/23/1992 DEROYAL TRANSPARENT FILM DRESSIGN DEROYAL INDUSTRIES, INC. DEBRA MANNING
K913392 07/17/1992 OXYGEN SENSING DEVICE, MODIFICATION DEVILBISS HEALTH CARE, INC. DAVID L GAST
K921709 07/14/1992 ENDOBAG, MODIFICATION DEXIDE, INC. KEITH JUNG
K922032 07/30/1992 ENZIP URINARY MICROALBUMIN TEST DIAGNOSTIC SPECIALTIES PAGNUCCO
K921205 07/10/1992 DSL ACTIVE ALDOSTERONE (DSL 8600) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHNNY R WILLIS
K922793 07/28/1992 CEFZIL DIFCO LABORATORIES, INC. DAVID W GATES
K922794 07/28/1992 ENOXACIN DIFCO LABORATORIES, INC. DAVID W GATES
K921637 07/14/1992 ESP BLOOD CULTURE SYSTEM DIFCO LABORATORIES, INC. JERRY W SMITH
K922791 07/28/1992 LORACARBEF 30MCG DISK DIFCO LABORATORIES, INC. DAVID W GATES
K922792 07/30/1992 ZITHROMAX DIFCO LABORATORIES, INC. DAVID W GATES
K915268 07/27/1992 CATHETER TWO STAGE VENOUS RETURN DLP, INC. ROGER W.BRINK
K920198 07/21/1992 GLYCOMAT HAEMOGLOBIN ANALYSER DREW SCIENTIFIC LTD. DREW
K921651 07/08/1992 MICROLINE SCREEN FOR PHENCYCLIDINE DRUG SCREENING SYSTEMS, INC. KENNETH S CARPENTER
K922736 07/10/1992 KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA EASTMAN KODAK COMPANY YVONNE ADAIR
K922072 07/10/1992 KODAK EKTACHEM 250 ANALYER EASTMAN KODAK COMPANY YVONNE ADAIR
K921844 07/21/1992 KODAK EKTACHEM DT SLIDES (NBIL) EASTMAN KODAK COMPANY NORMAN H GEIL
K921743 07/01/1992 KODAK EKTASCAN 2180 LASER PRINTER EASTMAN KODAK COMPANY NORMAN H GEIL
K913749 07/02/1992 EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 EDENTEC CORP. GARY SYRING
K920765 07/07/1992 EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 ELECTRONIC MONITORING DEVICES, INC. STEPHEN ESPOSITO
K921787 07/28/1992 SYNELISA TPO ANTIBODIES ELIAS USA, INC. GOTTFRIED KELLERMANN
K915738 07/21/1992 EXCEL CT TWIN ELSCINT, INC. ROCHELLE M SOBEL
K921913 07/24/1992 HYPO-GARD EPI MEDICAL PRODUCTS, INC. LEE TAYLOR
K920437 07/30/1992 SYNTHETIC ABSORBABLE SUTURE, UNDYED ETHICON, INC. JOHN D.PAULSON
K923226 07/30/1992 EURION LOTOS PP HEARING AID EURION HEARING INSTRUMENTS ROBERT A CUNNINGHAM
K922375 07/08/1992 EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG EXCEL TECH. LTD. RAMA RAO
K920575 07/23/1992 MERKUR 4000 F.M. WIEST USA, INC. GEORGE BATHELOR
K914272 07/02/1992 KOKO SPIROMETER FERRARIS RESPIRATORY, INC. ARLIN LEHMAN
K921444 07/13/1992 DIGI SPORTLENS SYSTEM FITNESS QUEST, INC. DREW H SEVERS
K914267 07/16/1992 GE 4096 PLUS & GE 2048 GE MEDICAL SYSTEMS LARRY A KROGER
K922085 07/28/1992 MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM GEN TRAK, INC. DEBORAH L LINDEMUTH
K922084 07/28/1992 MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM GEN TRAK, INC. DEBORAH L LINDEMUTH
K921435 07/23/1992 ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE GEN-PROBE, INC. RUBEN CHAIREZ
K922165 07/27/1992 ATC725, ATC525, AND AP300 GENDEX CORP. GERALD V LEVY
K921951 07/21/1992 MPG 65-80-100 X-RAY GENERATOR AND CONTROL GENERAL ELECTRIC CO. LARRY A KROGER
K915845 07/29/1992 HAIR TRONICS MODEL HT8000 GLOBAL TRONICS INTL., INC. MANTELL, JR.
K920701 07/13/1992 INDUSTRIAL STRENGTH EYEWEAR GRAFIX MARKETING GROUP TIM O'BRIEN
K921810 07/23/1992 CURASOL(TM) WOUND DRESSING HEALTHSOUTH MEDICAL CENTER RICHARD A HAMER
K921676 07/10/1992 COLUMNMATE II HELENA LABORATORIES PAT FRANKS
K922024 07/23/1992 REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 HELENA LABORATORIES PAT FRANKS
K921939 07/16/1992 SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) HERAEUS KULZER, INC. ROSANNE M SAVOL
K912405 07/21/1992 LATEX PROPHYLACTIC (CONDOM) HEVEALACTICS INTL. SDN BHD YONG W KOO
K922184 07/30/1992 HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM HEWLETT-PACKARD CO. PAMELA J WEAGRAFF
K915757 07/30/1992 MODELS M1722A, M1723A, M1724A DEFIBRILLATORS HEWLETT-PACKARD CO. MONICA FERRANTE
K920441 07/30/1992 3D TOF ANGIOGRAPHY MEASURING FUNCTION HITACHI MEDICAL SYSTEMS AMERICA, INC. JOCHEN ROGERS
K910483 07/14/1992 MONOTUBE EXTERNAL FIXATION SYSTEM HOWMEDICA CORP. ROBERT E SMITH
K922008 07/30/1992 CDH HIP SYSTEM HOWMEDICA, PFIZER MEDICAL TECHNOLOGY GROUP ROBERT E SMITH
K921745 07/30/1992 HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO HYBRITECH, INC. JOANNE MARTINIS
K921252 07/17/1992 TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL HYBRITECH, INC. JOANNE MARTINIS
K920556 07/17/1992 TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET HYBRITECH, INC. JOANNE MARTINIS
K922538 07/27/1992 VENTREX ALLERGEN DISC HYCOR BIOMEDICAL, INC. ANNE JEPSON
K921922 07/08/1992 GRICE LAPAROSCOPIC SUTURING NEEDLE IDEAL MEDICAL, INC. LORNA K LINVILLE
K921431 07/21/1992 POTTY PAGER IDEAS FOR LIVING SMITH
K922158 07/21/1992 PROTECTOR SYRINGE SAFETY CAP SYSTEM INJECTIMED, INC. THOMAS C KURACINA
K920614 07/27/1992 HEMO-BAND INNOVATIONS IN ACCESS, INC. TOM TRIBOU
K914538 07/14/1992 UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER INNOVATIVE MEDICAL PRODUCTS, INC. CHARLES D MAYEUX
K920005 07/29/1992 IL TEST ALPHA-1-ANTITRYPSIN (AAT) INSTRUMENTATION LABORATORY CO. GABRIEL J MURACA
K920653 07/23/1992 IL TEST BILIRUBIN TOTAL/DIRECT INSTRUMENTATION LABORATORY CO. MURACA, JR.
K915829 07/29/1992 IL TEST(TM) HAPTOGLOBIN (HPT) INSTRUMENTATION LABORATORY CO. GABRIEL J MURACA
K921992 07/10/1992 MP3000 SERIES III VIDEO IMAGER INTERNATIONAL IMAGING ELECTRONICS JOHN R MIERS
K920324 07/29/1992 ITC BUNJI COIL (MODIFICATION) INTERVENTIONAL THERAPEUTICS CORP. JULIE D BELL
K922569 07/15/1992 TETRIC LIGHT-CURING COMPOSITE IVOCLAR NORTH AMERICA, INC. LLOYD V ZIEMENDORF
K921260 07/13/1992 LAPAROSCOPIC SURGICAL INSTRUMETNS JANA MEDICAL
K923095 07/21/1992 KAYE MODEL KIAO PELVIC/THIGH STABILIZER KAYE PRODUCTS, INC. H, BAGSHAWE
K922108 07/15/1992 KING DIAGNOSTICS AST (GOT) REAGENT KING DIAGNOSTICS, INC. FRANCES LOH
K921006 07/28/1992 LAPAROSCOPIC RETRACTOR SYSTEM LAPAROMED CORP. PAUL LUBOCK
K921096 07/28/1992 LASER-6 LASER ENDO TECHNIC PHILIPPE C LEVY
K914918 07/24/1992 LASERSCOPE'S MICROSPOT DERMASTAT LASERSCOPE DONNA PAGE
K920217 07/23/1992 MAX-E-VAC LEISEGANG MEDICAL, INC. DOUGLAS KWART
K920807 07/01/1992 SUNGLASSES LIBBYLEE TOYS, INC. SUSAN L MILLER
K920844 07/21/1992 PIM 1.0 LASER DOPPLER PERFUSION IMAGER LISCA DEVELOPMENT AB GERT NILSSON
K922619 07/01/1992 DIGITIZER, MODEL # 3-000A-1518 LORAD MEDICAL SYSTEMS, INC. EDWARD MCDERMOTT
K921997 07/23/1992 CUFF-M LORIN MEDICAL, INC. NORBET J SCHMITT
K922006 07/29/1992 QQUADRATURE LUMBAR CONTOUR COIL MAGNETIC RESEARCH, INC. SANFORD LARSEN
K922412 07/06/1992 ECG MODULATOR MAGUIRE ENT., INC. WILLIAM R HACKETT
K921320 07/02/1992 ELIOS DIODE OPHTHALMIC LASER MARCO OPHTHALMIC, INC. SCOTT E LEWIS
K911577 07/08/1992 HYPOTRANS MODEL 750 MARTIN MCLANE MEDICAL DEBRA MCQUILLEN
K920645 07/28/1992 ORTHODONTIC ELASTICS BANDS MASEL INDUSTRIES, INC. ROBERT BRIGHT
K922468 07/10/1992 ANGEL WING SETS -- MODIFIED MBO LABORATORIES, INC. J. B BLECHER
K921860 07/30/1992 MODIFICATION TO IV SPIKE MCGAW, INC. DIANE GERST
K920959 07/13/1992 INSUFFLATOR, LAPAROSCOPIC MECTRA LABS, INC. ELIZABETH FELDMAN
K922354 07/30/1992 BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET MED INSTITUTE, INC. NEAL E FEARNOT
K921201 07/21/1992 VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. MED INSTITUTE, INC. NEAL E FEARNOT
K915075 07/16/1992 NEBULIZER (DIRECT PATIENT INTERFACE) MEDI NUCLEAR CORP., INC. RUSSELL W.KING
K921961 07/01/1992 SDMO APPLICATOR CODE: ASN.8236 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING KATHRYN B PATTERSON
K920071 07/21/1992 MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 MEDICAL DEVICES, INC. SAMUEL DICKSTEIN
K921062 07/30/1992 GAELTEC MPR SERIES MEDICAL MEASUREMENTS, INC. WILLIAM SONES
K914733 07/01/1992 TTL MEDICATED DRESSING MEDIMIX PRODUCTS, INC. BRIAN DAVIES
K914772 07/24/1992 MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001 MEDIX CORP. PHILIP STIMPSON
K913624 07/30/1992 MEDRAD MCT-PLUS INJECTOR MEDRAD, INC. FRANCIS X DOBSCHA
K920135 07/24/1992 MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE MEDROYAL, INC. DEBRA F MANNING
K922031 07/21/1992 HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL MEDTRONIC HEMOTEC, INC. DESSIE FAFOUTIS
K921558 07/07/1992 MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS MEDTRONIC VASCULAR DARYLE PETERSEN
K915700 07/30/1992 PERMIER HISTOPLASMA MERIDIAN DIAGNOSTICS, INC. ALLEN D NICKOL
K915493 07/10/1992 PREMIER COCCIDIOIDES MERIDIAN DIAGNOSTICS, INC. ALLEN NICKOL
K915678 07/30/1992 MERIT ADMINISTRATION SET MERIT MEDICAL SYSTEMS, INC. DENNIS REIGLE
K921794 07/02/1992 CERADELTA 2 METALOR DENTAL USA CORP. BRIAN F SCHILLER
K921167 07/30/1992 ULTRABLADE MICRON TECHNOLOGY, INC. RICHARD ROSENTHAL
K923268 07/30/1992 AFFIRM PROCESSOR MICROPROBE CORP. RUSSEL K ENNS
K920536 07/30/1992 AFFIRM VP SAMPLE COLLECTION SET MICROPROBE CORP. MONICA A KRIEGER
K922659 07/21/1992 GENERAL SURGERY CLAMP AND NEEDLE HOLDER MILTEX INSTRUMENT CO. ROBERT B PUGLIESI
K921935 07/07/1992 THYROXINE (T4) COATED TUBE RIA MONOBIND FREDERICK R JEROME
K922000 07/28/1992 MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL MRI DEVICES CORP. THOMAS SCHUBERT
K913681 07/02/1992 MULTISPIRO-BREEZE MULTISPIRO, INC. DANIEL BROWN
K915451 07/02/1992 MULTISPIRO-SX MULTISPIRO, INC. DANIEL BROWN
K920020 07/09/1992 CARDIO-CARD ECG MANAGEMENT SYSTEM NASIFF ASSOC., INC. ROGER NASIFF
K922676 07/10/1992 CORTISOL CHEMILUMINESCENCE ASSAY NICHOLS INSTITUTE RAMAKRISHNAN
K921268 07/14/1992 NK DYNA-GRIP SENSOR, MODEL DG001 NK BIOTECHNICAL ENGINEERING CO. KAREN GOTFREDSON
K921266 07/14/1992 NK MEDICAL MICROMETER, MODEL MC001 NK BIOTECHNICAL ENGINEERING CO. KAREN GOTGREDSON
K920026 07/28/1992 NOBLES-LAI IMAGING SYSTEM NOBLES-LAI ENGINEERING, INC. KAREN U SALINAS
K911636 07/17/1992 GENESIS(TM) INFUSION SYSTEM NORMAN'S NORMAN GORTZ
K922215 07/17/1992 NOVA 14 NA/K/CL/GLU/BUN ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K921937 07/27/1992 NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K920379 07/15/1992 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX NOVAMETRIX MEDICAL SYSTEMS, INC. ROBERT H SCHIFFMAN
K922180 07/02/1992 LEWICKY O.R.S. TUBING O.R. SPECIALTIES, INC. JACK W HOWARD
K922748 07/10/1992 GUEDEL AIRWAY OEM MEDICAL DIV. JERRY W.SCHEIB
K910571 07/28/1992 BILIBLANKET LIGHT METER OHMEDA MEDICAL ALBERTO F PROFUMO
K922884 07/28/1992 OLYMPUS ALANINE AMINOTRANSFERASE REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922369 07/17/1992 OLYMPUS ALBUMIN REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922885 07/28/1992 OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922233 07/10/1992 OLYMPUS CALCIUM REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922459 07/13/1992 OLYMPUS CREATINE KINASE REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922232 07/16/1992 OLYMPUS GLUCOSE REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K921718 07/21/1992 OLYMPUS ISE MODULE OLYMPUS CORP. LAURA STORMS-TYLER
K922361 07/16/1992 OLYMPUS TOTAL PROTEIN REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922229 07/02/1992 OLYMPUS TRIGLYCERIDE REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922597 07/10/1992 OLYMPUS UREA NITROGEN (BUN) REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K922756 07/17/1992 OLYMPUS URIC ACID REAGENT OLYMPUS CORP. LAURA STORMS-TYLER
K920795 07/13/1992 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX OPTICAL RADIATION CORP. ENID ROKAW
K921773 07/13/1992 TX ELECTRIC TOOTHBRUSH OPTIVA CORP. STEVE MEGINNISS
K920599 07/15/1992 HOOK SURGICAL INSTRUMENT ORIGIN MEDSYSTEMS, INC. ALBET K CHIN
K922195 07/23/1992 OSTEO FEMORAL NAIL OSTEO AG BRYSON, JR.
K922193 07/23/1992 OSTEO KIRSCHNER WIRE OSTEO AG BRYSON, JR.
K922194 07/23/1992 OSTEO STEINMANN PIN OSTEO AG BRYSON, JR.
K922196 07/23/1992 OSTEO TIBIA NAIL OSTEO AG BRYSON, JR.
K922001 07/28/1992 SPECTACLE FRAMES OTEGO OPTICAL, INC. MICHAEL WINSLOW
K905555 07/06/1992 A-ZILICONE OTICON CORP. PREBEN BRUNVED
K920543 07/10/1992 MRI OE 1.5 SI OTSUKA ELECTRONICS JEAN MACHELEDT
K911221 07/24/1992 ATRAUMATIC SPECIAL SPROTTE NEEDLE PAJUNK GMBH BRUCE MACKLER
K922121 07/21/1992 SUNGLASSES PAVILION INVESTMENT LTD. MICHAEL HARARI
K921707 07/01/1992 PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 PENTAX PRECISION INSTRUMENT CORP. LORRAINE SCHWARTZ
K914743 07/10/1992 EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF PERTRACH FREDERIC J TOYE
K921011 07/27/1992 PHARMACIA CMV IGM ELISA PHARMACIA DIAGNOSTICS, INC. STEVEN VINSON
K920702 07/08/1992 TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO PHARMACIA DIAGNOSTICS, INC. STEVEN VINSON
K921881 07/17/1992 VISTA HPQ SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K920793 07/17/1992 PHILIPS DSI SYSTEM RELEASE 3.2 PHILIPS MEDICAL SYSTEMS, INC. WILLIAM G MCMAHON
K920285 07/14/1992 BLOOD GAS/ISE LINEARITY CONTROL PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K920449 07/28/1992 POINTE 750 GLYCOMETER POINTE SCIENTIFIC, INC. WALTERS, JR.
K915345 07/16/1992 STAT K SYSTEM PORTABLE DIAGNOSTIC SERVICES, INC. GERARD J PUTZ
K923193 07/17/1992 SUNRUNNER TE-777 PRIDE HEALTH CARE, INC. THOMAS KRETCHIK
K921421 07/28/1992 LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY PRO-LAB, INC. JOACHIM SPARKUHL
K921866 07/08/1992 LUMINOUS 250 FIBEROPTIC ILLUMINATOR PROGRESSIVE DYNAMICS, INC. WILLIAM F LOHNESS
K915312 07/08/1992 MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN PURITAN BENNETT CORP. MARSHALL SMITH
K915170 07/28/1992 PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR PYMAH CORP. THOMAS THACKSTON
K922563 07/28/1992 LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) RACO PRODUCTS CO. GERALD J CAHILL
K920990 07/06/1992 LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) RACO PRODUCTS CO. GERALD J CAHILL
K922904 07/30/1992 RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II REAGENTS APPLICATIONS, INC. PEACOCK, JR.
K920202 07/23/1992 LATEX EXAM/SURGICAL GLOVES REDSUN LATEX LTD. RAMAKUMARI
K921180 07/28/1992 COBAS CORE IMMUNOCHEMISTRY SYSTEM ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K922762 07/09/1992 ROCHE REAGENT FOR URIC ACID--MODIFICATION ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K921856 07/21/1992 TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. SCHNEIDER INTL., LTD. ROBERT L ULLEN
K922410 07/23/1992 SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL SCIMED LIFE SYSTEMS, INC. MERCEDES P BAYANI
K911419 07/01/1992 SENSITITRE ARIS MODULE SENSITITRE LTD. LAURA BASISTA
K920616 07/14/1992 DIASTAT ANTI-HISTONE KIT SHIELD DIAGNOSTICS, LTD. GEORGE ZAJICEK
K915225 07/01/1992 MEGACART SIEMENS BURDICK, INC. FRANCIS I DOMINY
K921199 07/08/1992 EPISTAXIS NASAL BALLOON CATHETER SMITH & NEPHEW RICHARDS, INC. THOMAS CRAIG
K921786 07/17/1992 INTRAMEDULLARY HIP SCREW SMITH & NEPHEW RICHARDS, INC. THOMAS L CRAIG
K920430 07/21/1992 MODULAR ACETABULAR CUP SYSTEM SMITH & NEPHEW RICHARDS, INC. THOMAS L CRAIG
K921195 07/23/1992 NASAL SEPTAL SPLINT SMITH & NEPHEW RICHARDS, INC. THOMAS CRAIG
K921202 07/23/1992 TURBINATE NASAL SPLINT SMITH & NEPHEW RICHARDS, INC. THOMAS CRAIG
K914878 07/30/1992 ZIRCONIUM ALLOY FRMORAL HEAD SMITH & NEPHEW RICHARDS, INC. TOM CRAIG
K922243 07/14/1992 E-Z CLAMP#1 AND#2 SOUTHWEST MEDICAL MFG., INC. MICHAEL C SIBLEY
K915059 07/27/1992 PEAK FLOW MONITOR SPIROMETRICS, INC. ANN M.THERRIAULT
K915733 07/17/1992 STERI-OSS DRILLS AND TAPS STERI-OSS, INC. DON KENNARD
K920532 07/17/1992 ACU-TRAIN V (5) STERNE MEDICAL EQUIPMENT DIV. ONTARIO LTD. BRENT NELSON
K920890 07/02/1992 OPERATING TABLE SYSTEM-BETAMAQUET 1140 STIERLEN-MAQUET AG BASTERT
K921221 07/17/1992 STERILE/SINGLE USE SYMBLEPHARON RING STORZ INSTRUMENT CO. JANET LACAVICH
K921460 07/02/1992 STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS STORZ INSTRUMENT CO. MICHAEL T TAGGART
K921758 07/16/1992 STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM STORZ INSTRUMENT CO. MICHAEL T TAGGART
K920294 07/07/1992 SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM STUART MEDICAL, INC. LYNNE ARONSON
K920248 07/21/1992 MODEL SLASE 210 HOLMIUM LASER SYSTEM SUNRISE TECHNOLOGIES, INC. CHARLES L ROSE
K913844 07/14/1992 ACCUTRACKER DX SUNTECH MEDICAL INSTRUMENTS, INC. CHRIS MCNEELY
K922973 07/30/1992 RESTCUE CC SUPPORT SYSTEMS INTL. THOMAS E MCFADDEN
K922634 07/15/1992 SLT LASER DELIVERY SYSTEM SURGICAL LASER TECHNOLOGIES, INC. THOMAS BECZE
K921461 07/30/1992 TURKEL THORACENTESIS NEEDLE SYMBIOSIS CORP. KEVIN W SMITH
K922614 07/30/1992 TURKEL THORACENTESIS SYSTEM SYMBIOSIS CORP. KEVIN SMITH
K921495 07/21/1992 DIA STRIPS SYSTEM, MODIFIED SYMCON INTL., INC. DAVID MORGAN
K922784 07/21/1992 SYNERMED UIBC REAGENT KIT SYNERMED, INC. MARCIA J ARENTZ
K922139 07/21/1992 VISTA IMMUNOASSAY SYSTEM -- MODIFICATION SYVA CO. ROGERS, JR.
K922138 07/21/1992 VISTA ULTRASENSITIVE HTSH ASSAY SYVA CO. JR.
K921934 07/15/1992 INTRADUCER TAUT, INC. KENSETH
K921801 07/15/1992 MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM TECHMEDICA, INC. DAVE SAMSON
K921458 07/17/1992 TMP MICROPLATING SYSTEM TECHMEDICA, INC. DAVE SAMSON
K920045 07/02/1992 DURATECH HOSPITAL TOWEL TECHSTYLES WINFIELD SINGLETARY
K920153 07/01/1992 THERMUFF BAG TECHSTYLES WINFIELD SINGLETARY
K921540 07/21/1992 COOLING/HEATING THERAPY DEVICE TEMPACURE HOME CARE WILSON II
K920928 07/15/1992 PRE-STERILIZED ITI DENTAL IMPLANTS THE STRAUMANN CO. HEIDI RAU
K921446 07/13/1992 HOT OR COLD PACK (THERMIPAQ) THERMIONICS CORP. TERRY L PANCAKE
K921815 07/15/1992 TOMEY PE-300 PORTABLE ERG TOMEY CORPORATION USA LORI A TRUITT
K922535 07/24/1992 THE TERMINATOR TOP END WHEELCHAIR SPORTS, INC. CAROL PETERSON
K922098 07/27/1992 CAG-02A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TIMOTHY W CAPEHART
K920096 07/10/1992 MRT-150 QD KNEE COIL TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K921720 07/16/1992 MRT-50A QD SPINE COIL TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K923021 07/21/1992 AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM TOSOH CORP. PATRICIA B SHRADER
K922980 07/13/1992 745-M (MAGNUM) TRI W-G, INC. KAVID KESLER
K923325 07/21/1992 MODEL 600 MEDICAL TREATMENT TABLE TRI W-G, INC. DAVID KESLER
K922033 07/21/1992 SALINE SOLUTION- STERILE TRINITY LABORATORIES, INC. PARTHA BASUMALLIK
K920272 07/09/1992 ORIEL TRUPHATEK, LTD. EMANUEL A ROSEN
K922965 07/13/1992 TUMBLE FORMS TRISTANDER TUMBLE FORMS CAROLANN KOTULA-COOK
K915593 07/01/1992 TRANSDUCER PROTECTOR UNITED PHARMACEUTICAL AND MEDICAL SUPPLY CO. THOMAS CANE
K921623 07/02/1992 VITADUR ALPHA PORCELAIN VIDENT RAY E MORROW
K922313 07/10/1992 P-LINK VIRTUAL IMAGING MATTHEW LONG
K921302 07/28/1992 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM VITEK SYSTEMS, INC. CHERYL WINTERS-HEARD
K922310 07/30/1992 VORTECH'S PERSONAL DISPLAY SYSTEM VORTECH DATA, INC. KEM MYERS
K920443 07/02/1992 MININEB VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K921249 07/21/1992 WAKO AUTOKIT LIPASE-COLOR WAKO CHEMICALS, USA, INC. ED ZIOR
K920531 07/14/1992 WAKO AUTOKIT MICRO TP WAKO CHEMICALS, USA, INC. ED ZIOR
K922151 07/28/1992 WAKO AUTOKIT RF WAKO CHEMICALS, USA, INC. EDWARD ZIOR
K922095 07/17/1992 LX 150 LIGHT SOURCE WELCH ALLYN, INC. LAWRENCE E MAROCCO
K911356 07/30/1992 LEGIONELLA STAT IGG/IGM TEST KIT WHITTAKER BIOPRODUCTS, INC. LEIF E OLSEN
K920649 07/23/1992 COMPASEP WILDE-USA, INC. ROBERT W BAUER
K920861 07/30/1992 WOODLYN CLASSIC LENSMETER WOODLYN, INC. RONALD NIELSON
K921639 07/02/1992 BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM ZIMMER, INC. CAROL VIERLING


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