FDA 510(k) Decisions During June, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K964373 06/18/1997 SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT 3M HEALTH CARE JASON SMITH
K964374 06/18/1997 SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT 3M HEALTH CARE JASON SMITH
K971444 06/11/1997 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES 3M MEDICAL PRODUCTS GROUP LINDA JOHNSEN
K971805 06/13/1997 ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE AARON MEDICAL INDUSTRIES J. ROBERT SARON
K971143 06/06/1997 NEURO PULSE II,III AARON MEDICAL INDUSTRIES J. R SARON
K971621 06/20/1997 RESISTICK SOLID LAPAROSCOPIC ELECTRODES AARON MEDICAL INDUSTRIES J. ROBERT SARON
K971674 06/11/1997 VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST AARON MEDICAL INDUSTRIES J. ROBERT SARON
K971694 06/30/1997 ETEST FOR CEFTAZIDIME AB BIODISK ANNE BOLMSTROM
K972232 06/24/1997 ABBOTT AXSYM FOLATE ABBOTT LABORATORIES LAURA L GRANITZ
K971293 06/27/1997 LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE ABBOTT MFG., INC. THOMAS P SAMPOGNA
K970955 06/11/1997 ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM ACROMED CORP. SALLY LEVINE
K970950 06/03/1997 EASY ROD ACROMED CORP. MARY LEWIS
K971248 06/11/1997 KANEDA SR ANTERIOR SPINAL SYSTEM ACROMED CORP. WILLIAM CHRISTIANSON
K954142 06/06/1997 STERRADD STERILIZATION SYSTEM ADVANCED STERILIZATION PRODUCTS KEVIN CORRIGAN
K970285 06/25/1997 AESUCLAP SOCON SPINAL SYSTEM AESCULAP, INC. VICTORIA MACKINNON
K964131 06/27/1997 ENDOSCOPE AKOS BIOMEDICAL, INC. LACYNE Y AVERY
K971235 06/05/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W ALEXANDER MFG. CO. KEN HEIMENDINGER
K971240 06/06/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 ALEXANDER MFG. CO. KEN HEIMENDINGER
K971099 06/05/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 ALEXANDER MFG. CO. KEN HEIMENDINGER
K971107 06/05/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972246 06/26/1997 SPECTACLE FRAMES (NON-PRESCRIPTION) ALIMAR TRADING, INC. AULIO C GIRON
K972004 06/16/1997 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS ALKO DIAGNOSTIC CORP. JANET A MCGRATH
K971186 06/13/1997 AMO DIPLOMAX/OPSYS CONSOLE ALLERGAN, INC. MONIQUE M HEYNINCK-DURAN
K964549 06/03/1997 ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER ALOKA CO., LTD. PAUL D SMOLENSKI
K970446 06/02/1997 DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL THOMAS D KELLY
K964716 06/26/1997 STA LIATEST CONTROL [N]+[P] KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC BE LE
K964728 06/26/1997 STA-LIATEST D-DI TEST KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC B. LE
K965192 06/24/1997 THAIRAPY VEST SYSTEM AMERICAN BIOSYSTEMS, INC. PHILLIP ROSE
K970882 06/24/1997 ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) AMERICAN MEDICAL DEVICES, INC. FRANK J TIGHE
K971483 06/24/1997 SECURE-WRAP (TM) STERILIZATION WRAP AMERICAN THRESHOLD INDUSTRIES, INC. FRANCES MAYHEW
K971424 06/04/1997 DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES ANSELL PERRY JAMES R CHATTERTON
K971129 06/24/1997 OXYPURE PORTABLE OXYGEN GENERATOR ARBOR RESEARCH CORP. BLAKE M PATERSON
K970977 06/27/1997 LATEX EXAMINATION GLOVES, POWDER FREE ARISTA MEDI PRIMA HADY SUYANTHO
K963920 06/17/1997 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, ARROW INTL., INC. THOMAS D NICKEL
K971244 06/06/1997 PROVOX 2 VOICE PROSTHESIS SYSTEM ATOS MEDICAL AB EDDY ABERG
K964673 06/26/1997 BAIR HUGGER MODEL 630 CARDIAC BLANKET AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K971693 06/06/1997 RIONET HB-79P AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K965204 06/03/1997 AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K961779 06/13/1997 MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER AVION MEDICAL PRODUCTS, INC. ROBERT L JAMES
K961711 06/11/1997 ASPISAFE GASTRIC TUBE B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K964929 06/02/1997 PERIPHERALLY INSERTED CENTRAL CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K971085 06/02/1997 SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K965137 06/04/1997 FOGARTY VALVULOTOME MODEL 700091 BAXTER EDWARDS PAULA TORRIANNI
K971701 06/06/1997 CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K971276 06/16/1997 GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER BAYER CORP. ROSANNE M SAVOL
K971713 06/11/1997 N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP. GABRIEL J MURACA, JR.
K971716 06/27/1997 PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP. GABRIEL J MURACA, JR.
K971602 06/27/1997 ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K964842 06/11/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT BECKMAN INSTRUMENTS, INC. MARGIE GEORGE
K970905 06/04/1997 SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT BECKMAN INSTRUMENTS, INC. SHERI HALL
K971506 06/03/1997 SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR BECKMAN INSTRUMENTS, INC. SHERI HALL
K971283 06/03/1997 SYNCHRON SYSTEMS CAL 5 PLUS BECKMAN INSTRUMENTS, INC. SHERI HALL
K971505 06/11/1997 SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT BECKMAN INSTRUMENTS, INC. SHERI HALL
K971788 06/03/1997 SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K971449 06/17/1997 VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) BECTON DICKINSON VACUTAINER SYSTEMS JOHN A SCHALAGO
K971600 06/25/1997 EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) BEHRING DIAGNOSTICS, INC. DAVID KOLEJAIL
K971596 06/25/1997 EMIT II OPIATES 300/2000 ASSAY BEHRING DIAGNOSTICS, INC. DAVID KOLESAR
K971725 06/18/1997 OPUS PROGESTERONE BEHRING DIAGNOSTICS, INC. RUTH FORSTADT
K964595 06/24/1997 OPUS PSA TEST SYSTEM BEHRING DIAGNOSTICS, INC. KATHLEEN DRAY-LYONS
K970506 06/04/1997 HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT BENLIOGLU DENTAL ITHALAT INC. MUSFIK U BENLIOGLU
K971411 06/03/1997 DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K BENTEC MEDICAL, INC. LOU MATSON
K971517 06/02/1997 SILICONE PUTTY EAR PLUGS BENTEC MEDICAL, INC. LOUIS R MATSON
K971158 06/13/1997 DUALINE 400 CIC BERNAFON-MAICO, INC. RAY ENROTH
K971080 06/06/1997 MAICO MA52 BERNAFON-MAICO, INC. SCOTT SAVRE
K963748 06/06/1997 BIO-PLEXUS DROP-IT NEEDLE HOLDER BIO-PLEXUS, INC. CARL R SAHI
K963018 06/04/1997 BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS BIO-RAD JOHN W NELSON
K971954 06/11/1997 LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) BIO-RAD ELIZABETH PLATT
K971952 06/16/1997 LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) BIO-RAD ELIZABETH PLATT
K972174 06/24/1997 LYPHOCHEK REMEDI CONTROL BIO-RAD DONNA CHAPMAN
K971114 06/03/1997 BIOACCESS MARROW HARVEST SYSTEM BIOACCESS, INC. PETER J CARNES
K971361 06/06/1997 AQ OPIATES (MORPHINE) TEST BIONIKE LABORATORIES, INC. JANIS FREESTONE
K971841 06/25/1997 BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST BIONIKE LABORATORIES, INC. JANIS FREESTONE
K970918 06/24/1997 BROWNE STEAM INDICATOR BOARD OF DIRECTORS, ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K964368 06/16/1997 ELECSYS CEA ASSAY BOEHRINGER MANNHEIM CORP. MARY KONING
K971833 06/02/1997 ELECSYS FERRITIN BOEHRINGER MANNHEIM CORP. LEEANN CHAMBERS
K971379 06/17/1997 TINAQUANT RHEUMATOID FACTOR ASSAY BOEHRINGER MANNHEIM CORP. YVETTE LLOYD
K971144 06/25/1997 MULTITAK SS SUTURE SYSTEM BONUTTI RESEARCH LYNNETTE WHITAKER
K972076 06/26/1997 EPI-MAX EPISTAXIS CATHETER BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972077 06/26/1997 EPI-STOP EPISTAXIS CATHETER BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K965147 06/30/1997 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K971139 06/25/1997 BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K970542 06/24/1997 MASTER NEB II BREMED ITALIA, S.R.L. MARK HEBENSTREIT
K970131 06/16/1997 ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE C.L. MCINTOSH & ASSOC., INC. T. WHIT ATHEY, PH.D.
K971577 06/18/1997 FOCUS-PV BALLOON DILATATION CATHETER CARDIOVASCULAR DYNAMICS, INC. PAM MISAJON
K970049 06/20/1997 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ CARDIOVASCULAR IMAGING SYSTEMS, INC. STEVE JWANOUSKOS
K971130 06/27/1997 DEFEND FLUID RESISTANT PLEATED MASK CARL PARKER ASSOCIATES, INC. NEAL DUNNING
K971967 06/17/1997 BUN CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971907 06/24/1997 CALCIUM REAGENT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971908 06/17/1997 CREA OR CREATININE CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971467 06/16/1997 SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K972073 06/24/1997 TOTAL BILIRUBIN REAGENT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971324 06/20/1997 TRIGLYCERIDES, TG, OR TRIG CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971121 06/27/1997 ENCORE BOND CENTRIX, INC. JOHN DISCKO
K970386 06/04/1997 ACS ESTADIOL-6 II CHIRON DIAGNOSTICS CORP. THOMAS F FLYNN
K971405 06/16/1997 SPECIALITY URINE 1,2 CHIRON DIAGNOSTICS CORP. RONALD D SCHAEFER
K970514 06/20/1997 DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO MEDICAL INSTRUMENTS CO., INC. J. WILLIAM JONES
K970515 06/20/1997 GENERAL PURPOSE LATEX TRANSDUCER COVERS CIVCO MEDICAL INSTRUMENTS CO., INC. J. WILLIAM JONES
K970513 06/20/1997 GENERAL PURPOSE TRANDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC. J. WILLIAM JONES
K972080 06/18/1997 QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 CONSOLIDATED TECHNOLOGIES, INC. VIPIN D SHAH
K964757 06/25/1997 CONTIDRAIN CATHETER CONTIMED, INC. CLAUDE TIHON
K970934 06/11/1997 CB ERBIUM/2.94(TM) ER:YAG LASER CONTINUUM BIOMEDICAL, INC. ROBERT S ANDERSON
K964688 06/20/1997 LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT CORDIS CORP. JOAN MARTIN
K971010 06/18/1997 PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS CORDIS CORP. JODI LYNN GREENIZEN
K971469 06/30/1997 COULTER ACT TRON CELL CONTROL COULTER CORP. THOMAS J ENGLISH
K964295 06/16/1997 N-ASSAY TIA TRANSFERRIN TEST KIT CRESTAT DIAGNOSTICS, INC.
K970767 06/02/1997 CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K970791 06/03/1997 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K970243 06/03/1997 CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR CYNOSURE, INC. GEORGE CHO
K964660 06/04/1997 PARAMAX CHOLESTEROL REAGENT DADE INTL., INC. MARIAN HARDING COCHRAN
K964974 06/24/1997 MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE DAKO CORP. GRETCHEN M MURRAY, PH.D., RAC
K971482 06/24/1997 DEGANIA SILICONE SIL-K DEGANIA SILICONE, LTD. BETTE LUBIN
K964942 06/19/1997 INFECTION CONTROL CARTRIDGE DENTALPURE CORP. STEPHEN J POINDEXTER
K972234 06/30/1997 RCT GEL ROOT CANAL THERAPY GEL DENTSPLY INTL. P. JEFFERY LEHN
K971606 06/03/1997 STERILE FLEXOFILE FILES AND INSTRUMENTS DENTSPLY INTL. P. JEFFERY LEHN
K971603 06/04/1997 STERILE SUREFLEX FILES AND INSTRUMENTS DENTSPLY INTL. P. JEFFERY LEHN
K971753 06/27/1997 DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 DENVER BIOMATERIALS, INC. LYNNE LEONARD
K970929 06/09/1997 DEPUY LOW PROFILE BONE SCREW DEPUY, INC. SALLY FOUST
K964650 06/19/1997 TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS DEPUY, INC. VICKIE E ARFORD
K971072 06/20/1997 CHOLESTEROL REAGENT DERMA MEDIA LAB., INC. CHARLES C ALLAIN
K963349 06/13/1997 DEVILBISS 8650D DEVILBISS HEALTH CARE, INC. MATT SMITH
K971976 06/17/1997 DIASCREEN REAGENT STRIPS DIA-SCREEN CORP. VICKI FRAWLEY
K971823 06/16/1997 ACTIVE TESTOSTERONE EIA (DSL-10-4000) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K970395 06/26/1997 QUIKSTRIP ONE STEP METHAMPHETAMINE DRIAL CONSULTANTS, INC. CLEVE LAIRD
K971551 06/04/1997 DUQIAO DUQIAO GLASSES (GROUP) CO. LTD. MERRY CHEN
K970015 06/24/1997 ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES ECI MEDICAL TECHNOLOGIES, INC. MICHAEL FORER
K971083 06/23/1997 ARTHROSCOPE ELECTRO-BIOLOGY, INC. JON CAPAROTTA
K972072 06/19/1997 SURGITRON MODEL FFPF-EMC ELLMAN INTL., INC. FRANK LIN
K970680 06/20/1997 GLORY ELSCINT, INC. BENY SHERER
K965044 06/16/1997 GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 ELSCINT, INC. THOMAS J SPACKMAN
K971527 06/30/1997 INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM EMPI CAROLYN M STEELE-HUSTEN
K965002 06/27/1997 ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND ENCORE ORTHOPEDICS, INC. ASHLEY M BOCK
K970816 06/05/1997 GLARE WARE ERGOVISION, INC. MARK H LEVIN
K970720 06/27/1997 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER ETHICON ENDO-SURGERY, INC. LORRI CHAVEZ
K970896 06/09/1997 MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM ETHICON, INC. GREGORY JONES
K962312 06/17/1997 KEY CHAIN EMERGENCY AIRWAY FFRENCH POCKET EMERGENCY AIRWAY, INC. H. CLAY WILSON, P.E.
K970970 06/13/1997 CARDIOMATCH FOCUS MEDICAL SA JEAN-LUC BOULNOIS
K970775 06/03/1997 TEMPO CEM (MULTIPLE) FOREMOST DENTAL MFG., INC. D.T. WOLF
K970774 06/03/1997 TEMPOCEM NE (MULTIPLE) FOREMOST DENTAL MFG., INC. D.T. WOLF
K971274 06/13/1997 C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET FRESENIUS AG ANNETTE M FAGNANT
K964969 06/26/1997 SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) GE MEDICAL SYSTEMS LARRY A KROGER, PH.D.
K960724 06/11/1997 BIO-GIDE RESORBABLE BILAYER MEMBRANE GEISTLICH-PHARMA PETER S REICHERTZ
K971399 06/13/1997 AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC GENERAL HEARING INSTRUMENTS, INC. ROGER P JUNEAU
K971162 06/16/1997 LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR GENZYME CORP. NANCY E ISAAC
K971190 06/16/1997 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR GENZYME CORP. NANCY E ISAAC
K971573 06/18/1997 N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET GENZYME CORP. NANCY E ISAAC
K970916 06/20/1997 H.V. PULSE LAVAGE (L31 SERIES) GLOBAL MEDICAL PRODUCTS, INC. TONYA BALABAN
K971031 06/17/1997 AUDALLION III HEARING SYSTEM GN DANAVOX, INC. WAYNE E MORRIS
K971032 06/17/1997 DANAVOX MODELS 163/162 BTE GN DANAVOX, INC. WAYNE MORRIS
K970324 06/06/1997 GSI SA60 DPOAE SYSTEM GRASON-STADLER, INC. NORMAN L SCHULTZ
K971220 06/04/1997 GREINER VACUETTE BLOOD COLLECTION TUBE GREINER AMERICA, INC. ED MAIER
K963074 06/25/1997 HARMAC QUADPOLAR MAPPING PACING CATHETER HARMAC MEDICAL PRODUCTS, INC. JOSEPH M KONIECZNY
K971291 06/17/1997 HEARTPORT ENDOARTERIAL RETURN CANNULA HEARTPORT, INC. MARIANNE C DRENNAN
K971039 06/03/1997 HEMAGEN ANTI CARDIOLIPIN SCREEN HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K971909 06/20/1997 VIRGO AMA ELISA KIT HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K952172 06/10/1997 HOTMAN HEMO SAPIENS, INC. B. BO SRAMEK
K971016 06/06/1997 MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES J ROGERS
K961634 06/16/1997 NIL - POWDER-FREE LATEX EXAMINATION GLOVES HL RUBBER PRODUCTS SDN BHD YUNUS LATIF
K971887 06/10/1997 BREATH TAKER HOFA LLC. ZUDHIR NADKARNI
K971541 06/25/1997 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON HOLLISTER, INC. JOSEPH S TOKARZ
K961787 06/13/1997 BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS HOLOGIC, INC. R. MICHAEL CROMPTON
K963612 06/11/1997 DURATION STABILIZED UHMWPE HOWMEDICA CORP. JOHN DICHIARA
K965173 06/11/1997 DURATION STABILIZED UHMWPE KNEE COMPONENTS HOWMEDICA CORP. JOHN DICHIARA
K970865 06/04/1997 ISG FAMILY OF VIEWING WANDS I.S.G. TECHNOLOGIES, INC. CHARLES HALL
K970855 06/24/1997 CLAVE CONNECTOR ICU MEDICAL, INC. ARLENE DUTCHIK
K970177 06/11/1997 ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA IMMCO DIAGNOSTICS, INC. RICHARD E GRECO, R.A.C.
K964509 06/19/1997 IMPLEX A-240 HEP ACETABULAR CUP SYSTEM IMPLEX CORP. GLENN N BYRD
K971230 06/13/1997 SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, "PERCUTANEOUS GASTROSTOMY KIT" INNERDYNE, INC. RICK GAYKOWSKI
K971126 06/24/1997 HYDROCOLLOID WOUND DRESSINGS INNOVATIVE TECHNOLOGIES LTD. PRISCILLA WHITEHEAD
K970551 06/24/1997 QUANTA LITE B2GPI IGG INOVA DIAGNOSTICS, INC. BRYS C MYERS
K964986 06/02/1997 QUANTA LITE IGA GLIADIN ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K971614 06/20/1997 QUANTA LITE RF IGM INOVA DIAGNOSTICS, INC. BRYS C MYERS
K970959 06/13/1997 INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) INSTRUMENTATION INDUSTRIES, INC. LORI ZURAVLEFF
K970983 06/13/1997 PERITONEAL/CARDIAC CATHETER INTEGRA NEUROCARE LLC. LORI L HAYS
K964264 06/16/1997 HIGH RANGE PEROXIDE TEST STRIP INTEGRATED BIOMEDICAL TECHNOLOGY, INC. WEN H WU
K970964 06/13/1997 MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM INTERNATIONAL IMAGING ELECTRONICS ROGER C CLAAR
K971053 06/16/1997 ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS INTERNATIONAL MEDICAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K971159 06/24/1997 SURGICAL DRAPES INTERNATIONAL MEDSURG CONNECTION LARA N SIMMONS
K971036 06/03/1997 ODONTIT AUTOGENOUS BONE COLLECTION DEVICE INTERPORE INTL. MARIO GERSBERG
K970843 06/05/1997 INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES INTERVASCULAR, INC. MELISSA L BILLMAN
K970507 06/13/1997 PEAK FLOW METER INTL. MEDICAL, INC. WARREN V BIGELOW
K963578 06/30/1997 PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) INTL. PRODUCTS, INC. UWE KLOOTZ
K971245 06/20/1997 BLINK EXTERNAL EYELID WEIGHT IPAX, INC. PHIL PENNELL
K971513 06/03/1997 COMPOGLASS F IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K970339 06/04/1997 TRI AUTO ZX J. MORITA USA, INC. TERRY G MAHN
K971575 06/04/1997 BENCHMARK-IV J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K965027 06/24/1997 VENTED I.V. SET JMS CO., LTD. TETSUKARA HIROSE
K972133 06/24/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. ANN M QUINN
K964923 06/25/1997 CODMAN LUMBAR DRAINAGE CATHETER KIT JOHNSON & JOHNSON PROFESSIONALS, INC. DEANA M BOUSHELL
K971682 06/27/1997 J-FX CERCLAGE SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC. JOHN FERROS
K971063 06/03/1997 OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR KING DENTAL CORP. JAIME F BRIGGS
K972047 06/24/1997 KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE KLS-MARTIN L.P. ED RANSOM
K970222 06/24/1997 LOW PROTEIN LATEX EXAMINATION GLOVES KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM KUANG SIA
K964826 06/24/1997 POWDER - FREE "LATEX EXAMINATION GLOVES APPLICATION KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM KUANG SIA
K963064 06/05/1997 ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM LABORIE MEDICAL TECH CORP. THOMAS HIRTE
K970376 06/06/1997 PTCA GUIDEWIRE LAKE REGION MFG., INC. KIM AVES
K970846 06/05/1997 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD LANDOS, INC. KATH LAFFAN
K971250 06/30/1997 LASERSCOPE MICROBEAM IV MICROMANIPULATOR LASERSCOPE LISA MCGRATH
K964818 06/17/1997 ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) LASERSCOPE LISA MCGRATH
K964805 06/09/1997 BIO-ANCHOR LINVATEC CORP. CAROL A WEIDEMAN
K963932 06/20/1997 PRELOADED SOFT TISSUE ANCHOR LINVATEC CORP. CAROL A WEIDEMAN
K971059 06/18/1997 UNIVERSAL DRIVE SYSTEM LINVATEC CORP. CAROL A WEIDEMAN
K964015 06/19/1997 INDICARD TEST LITMUS CONCEPTS, INC. SUZANNE PARISIAN
K962597 06/13/1997 LXN FRUCTOSAMINE TEST SYSTEM LXN CORP. VIVIANNE T NOETZEL
K963732 06/26/1997 PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA MALLINCKRODT MEDICAL MICHAEL B SCHOECK
K972161 06/18/1997 BOVIE MODEL X15 MAXXIM MEDICAL MICHAEL A CLARK
K971911 06/03/1997 LUMAX CYSTOMETRY ADMINISTRATION TUBE SET MEDAMICUS, INC. DENNIS S MADISON
K965065 06/20/1997 TECA. MILLENNIUM MEDELEC LTD. JEFF HALL
K970012 06/26/1997 ESCORT LINK CENTRAL STATION MONITOR MEDICAL DATA ELECTRONICS DAVID TRUEBLOOD
K971995 06/26/1997 MEDIVISION SINOSCOPE MEDIVISION SCOPE SERVICE CENTER, INC. WAYNE B STERNER
K971001 06/13/1997 AUTIMO MEDIZINTECHNIK, GMBH T. WHIT ATHEY
K970946 06/10/1997 MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET MEDLINE INDUSTRIES, INC. CHRISTINE GALEA
K971154 06/25/1997 MULTIPICS(ME-977) MERLIN ENGINEERING WORKS, INC. GERALD ENGBRETSON
K971153 06/25/1997 SPLITSCREEN (ME-975) MERLIN ENGINEERING WORKS, INC. GERALD ENGBRETSON
K965042 06/17/1997 MICRODL DIARYCARD SPIROMETER MICRO DIRECT, INC. DAVID R STASZAK
K970880 06/06/1997 POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN MICRO-EAR TECHNOLOGY, INC. DAVID A PREVES, PH.D.
K971350 06/04/1997 SERIES XE, SERIES SE, SERIES TE MICRO-MEGA SOCIETE ANONYME JM BADOZ
K965222 06/19/1997 MICROJECT MODEL PCA-1 MICROJECT, INC. LARRY RIGBY
K963717 06/10/1997 MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) MILLIPORE CORP. THOMAS G BORROWS
K964634 06/06/1997 ANOKRYO MK CONQUEST INTL., INC. RICHARD A HAMER
K971921 06/24/1997 PROLACTIN (PRL) HORMONE MICROPLATE ELISA MONOBIND DREDERICK R JEROME
K971780 06/24/1997 THYROTROPIN(TSH) ELISA MONOBIND FREDERICK R JEROME
K971709 06/16/1997 TOTAL THROXINE MICROPLATE EIA(225-300) MONOBIND FREDERICK R JEROME
K971779 06/16/1997 TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA MONOBIND FREDERICK R JEROME
K971622 06/20/1997 MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM MPL TECHNOLOGIES, INC. DANIEL J OSTERBY
K970868 06/06/1997 MODEL HNC NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K965180 06/05/1997 STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) MYRIADLASE, INC. RICHARD A HAMER
K971714 06/20/1997 NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO NATIONAL DATA CORP. SANDRA BARNES
K971465 06/04/1997 NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS NATIONAL HEALTHCARE MFG. CORP. CAROLANN KOTULA
K971296 06/20/1997 TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 NATIONAL HEARING AID DIST., INC. PAUL MENEZES
K964019 06/18/1997 MORPHEE PLUS ALPHA NELLCOR PURITAN BENNETT, INC. CHRIS HADLAND
K971167 06/26/1997 NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES NEOPROBE CORP. SUSAN D TIEDY-STEVENSON
K971047 06/20/1997 FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT NEXA ORTHOPEDICS, INC. JAMAL D RUSHDY
K972070 06/26/1997 NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS NICHOLS INSTITUTE DIAGNOSTICS DAVE D SMITH
K971331 06/25/1997 SATELLITE NICOLET BIOMEDICAL, INC. DOUGLAS E PFRANG
K971707 06/13/1997 SUNGLASSES (NON-PRESCRIPTION) NIKO SUNGLASSES CORP. FU-HSING LIU
K970590 06/13/1997 N/A NORTH AMERICAN TECHNICAL SERVICES CORP. RICHARD C LANZILLOTTO
K970592 06/13/1997 N/A NORTH AMERICAN TECHNICAL SERVICES CORP. RICHARD C LANZILLOTTO
K971774 06/20/1997 NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K964206 06/20/1997 NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 NUCLETRON CORP. RANDOLPH HEMINGWAY
K965041 06/17/1997 OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM OHMEDA MEDICAL CHARLES MORREALE
K963160 06/27/1997 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC. BARRY E SANDS
K971817 06/11/1997 OLYMPUS CK-MB REAGENT OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K963575 06/13/1997 HBF-1000 OMRON BODY COMPOSITION ANALYZER OMRON HEALTHCARE, INC. EDWARD SIEMENS
K971679 06/25/1997 I-SCOPE OPHTHALMIC ENDOSCOPE OPHTHALMIC TECHNOLOGIES, INC. RICHARD WEITZ
K971061 06/11/1997 OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY OPPORTUNITY, INC. JAMES S SANDERS
K971062 06/09/1997 OPPORTUNITY INC. GENERAL PURPOSE TRAY OPPORTUNITY, INC. JAMES S SANDERS
K971537 06/27/1997 PYLORISET EIA-G (68926) ORION DIAGNOSTICA, DIV. ORION CORP. ANNIKKA RANTAMA
K971453 06/24/1997 ORTHOTEC K-CAP SYSTEM ORTHOTECH PATRICK BERTRANOU
K971020 06/18/1997 LSF TRIAD TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K971692 06/27/1997 OSTEOPOWER SYSTEM AND ACCESSORIES OSTEOMED CORP. CINDY WALTERS
K971778 06/27/1997 OSTEO SMALL AND MINI BONE SCREWS OSTEONICS CORP. DONNA S WILSON
K970957 06/03/1997 OSTEONICS RESTORATION ACETABULAR RING OSTEONICS CORP. KATE SUTTON
K971289 06/18/1997 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) OSTEOTECH, INC. CHRISTOPHER TALBOT
K971368 06/26/1997 IDS4 IMAGE DISPLAY SYSTEM SERIES OTECH, INC. HERMAN OOSTERWIJK
K971451 06/26/1997 WISE IMAGE MANAGEMENT SYSTEM OTECH, INC. HERMAN OOSTERWIJK
K971428 06/17/1997 COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 PACIFIC HEMOSTASIS LAURA A WORFOLK
K971290 06/20/1997 STRATASYS FDM MEDMODELER SYSTEM PALADIN MEDICAL, INC. ELAINE DUNCAN
K971074 06/13/1997 THERAPAX SXT 150 PANTAK, INC. GREG MOREAU
K970887 06/17/1997 BLOOD FLOW ANALYZER PARADIGM MEDICAL INDUSTRIES, INC. RICHARD DIRKSON
K972136 06/26/1997 TV MONITOR (P12/17) PERKINS MFG. CO. JIM FURSE
K970954 06/10/1997 O.B. APPLICATOR TAMPONS PERSONAL PRODUCTS CO. RALPH A PETRONE
K970420 06/30/1997 MASTERCAP AM 5.0/MASTERCAP RM 5.0 PHARMACIA, INC. KAREN E MATIS
K971804 06/06/1997 PHILIPS S1694, S1695 PHILIPS HEARING INSTRUMENTS CO. TED MIKSIEWICZ
K964947 06/20/1997 PHOTON RADIOSURGERY SYSTEM (PRS) PHOTOELECTRON CORPORATION JAMES R VEALE
K971123 06/27/1997 STONE EXTRACTOR PHX TECHNOLOGIES CORP. JAMES F CHAPEL
K970942 06/02/1997 MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM PHYSIOMETRIX, INC. DAWN E FRAZER
K971334 06/11/1997 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR PILLING WECK GROUP KARENANN J BROZOWSKI
K972033 06/20/1997 PLANMECA INTRACAM PLANMECA OY LARS MORING
K971547 06/19/1997 PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS PLAYTEX PRODUCTS, INC. MARK ROSENGARTEN
K971193 06/24/1997 LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM POLYTEC PI, INC. SUSAN D GOLDSTEIN-FALK
K971583 06/30/1997 MEDPOR OCULAR SCREW AND ACCEOSSORIES POREX TECHNOLOGIES CORP. HOWARD MERCER
K970083 06/17/1997 DYNABITE HOT GI BIOPSY FORCEPS PORTLYN CORP. GEORGE A LYNA
K970992 06/17/1997 PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS PREMIER DENTAL PRODUCTS CO. WILLIAM J FREZEL
K971075 06/22/1997 PRIMED "PRIME-PLUS" COTTON GAUZE SPONGES PRIMELINE MEDICAL PRODUCTS, INC. GUY PLAMONDON
K970153 06/05/1997 LAMIN-2 HYDRATING GEL PROCYTE CORP. PAUL KETTERIDGE
K970991 06/16/1997 DATEX ENGSTOM MANUAL RESUSCITATOR PROMEDIC, INC. PAUL E DRYDEN
K970102 06/24/1997 FILTER PROMEDIC, INC. PAUL E DRYDEN
K971115 06/13/1997 GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE PROTEK MEDICAL PRODUCTS, INC. RICK L PRUTER
K964724 06/16/1997 POWDER-FREE LATEX EXAMINATION GLOVES PWA INDUSTRIES SDN. BHD. AZMAN ISMAIL
K970543 06/26/1997 BOBCAT DX QUEST ENABLING DESIGNS LTD. NAHEED AKHTAR
K964801 06/02/1997 OPTICAL TRACKING SYSTEM (OTS) RADIONICS SOFTWARE APPLICATIONS, INC. AMY J LAFORTE, PH.D.
K970578 06/04/1997 RADIONICS BURR HOLE VALVE RADIONICS, INC. LINDA JALBERT
K970735 06/06/1997 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL RANDOX LABORATORIES, LTD. P. ARMSTONG
K970523 06/03/1997 SOLO RANGER ALL SEASON CORP. RON STEWART
K943535 06/25/1997 MODEL ME 300 MUSCLE TESTER REGULATORY STRATEGIES, INC. GREGORY J MATHISON
K970771 06/20/1997 SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM RESMED LTD. MICHAEL HALLETT
K972194 06/24/1997 RIVIERA SUNGLASS4ES RIVIERA OPTICAL CO., LTD. JAMES LOGAN
K972214 06/24/1997 ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) ROCHE DIAGNOSTIC SYSTEMS, INC. JAMES W HAYNES
K971902 06/16/1997 ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC. JAMES W HAYNES
K964507 06/13/1997 ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST ROCHE MOLECULAR SYSTEMS, INC. ALEX WESOLOWSKI
K964593 06/30/1997 DIASCOPE TRAVELLER PLUS (4053) S & W MEDICO TEKNIK A/S CARSTEN W JENSON
K971024 06/17/1997 SOFTSCAN SAHAR TECHNOLOGIES, INC. SHLOMO ASSA
K971639 06/24/1997 PLUSTRON ION TOOTHBRUSH SYSTEM SAS GROUP, INC. MICHAEL D SOBO
K970879 06/25/1997 CARDIOVIT CS-200 SCHILLER AMERICA, INC. MARKUS MARITZ
K970528 06/10/1997 CLYDE CORONARY GUIDEWIRE SCHNEIDER (EUROPE) GMBH RUDOLF OTT
K971299 06/06/1997 SCIENTIFIC PLASTICS MODEL SP SCIENTIFIC PLASTICS, INC. JEFFREY STEGMAN
K970823 06/03/1997 SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER SCIMED LIFE SYSTEMS, INC. ANGELA RUAN
K970612 06/24/1997 SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY SEALITE SCIENCES, INC. CATHRYN N CAMBRIA
K970707 06/20/1997 ELECT II BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL A ADILETTO, M.S.
K971927 06/30/1997 HI DENSE TC SHOFU DENTAL CORP. HIDEAKI KUMAZAWA
K971055 06/20/1997 DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K970852 06/05/1997 MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K971054 06/13/1997 OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. JING ZHANG
K965062 06/04/1997 SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE EMERY
K970785 06/13/1997 SIMS HYPERINFLATION BAG SYSTEM SIMS AVIA TONEY
K970269 06/26/1997 CLINICATH IR PERIPHERALLY INSERTED CATHETER SIMS DELTEC, INC. LISA STONE
K971665 06/27/1997 SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES SJ MEDICAL PRODUCTS (M) SDN BHD FOO KHON PU
K971676 06/27/1997 LIMITED REUSE ENDOSCOPIC BLADES SMITH & NEPHEW, INC. ELIZABETH A RYAN
K971188 06/27/1997 SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS SMITH & NEPHEW, INC. ELIZABETH A RYAN
K971253 06/13/1997 VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS SMITH & NEPHEW, INC. ELIZABETH A RYAN
K970809 06/18/1997 BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL SOMNUS MEDICAL TECHNOLOGIES, INC. EVE CONNER
K971711 06/24/1997 SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR SOMNUS MEDICAL TECHNOLOGIES, INC. EVE CONNER
K962811 06/24/1997 SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION SPACELABS MEDICAL, INC. RUSS GARRISON
K964042 06/06/1997 EXTRESAFE PHLEBOTOMY SPECIALIZED HEALTH PRODUCTS, INC. WILLIAM E MCKAY
K971468 06/10/1997 SCAR HEAL SPECIALTY SYSTEMS, INC. GLENN R JOYNER
K971307 06/27/1997 AMSCO SURGICAL TABLE STERIS CORPORATION MATTHEW M HULL
K971439 06/17/1997 STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES STORZ INSTRUMENT CO. PATRICK BALSMANN
K971578 06/30/1997 ENDOSSEOUS DENTAL IMPLANT STRAUMANN USA DEBORAH L FULLER
K970127 06/23/1997 EDOSSEOUS DENTAL IMPLANT SULZER CALCITEK, INC. DONNA K HOWARD
K970752 06/23/1997 SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM SULZER CALCITEK, INC. JOSEPH S SHAN
K970497 06/04/1997 PACE 101H SULZER OSCOR, INC. MILA DOSKOCIL
K971247 06/16/1997 SNT DISPOSABLE BIOPSY NEEDLE SURGICAL NAVIGATION TECHNOLOGIES, INC. DAVID A MIRE
K971149 06/23/1997 SVL-9130 DEFIBRILLATION ELECTRODE SURVIVALINK CORP. SEW-WAY TAY
K971644 06/24/1997 CEBE SUUNTO USA HENRI SYVANEN
K964005 06/09/1997 SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE SYNERGETICS, INC. JAMES TAYLOR
K971491 06/26/1997 SYNERMED IR 200 CHEMISTRY ANALYZER SYNERMED, INC. MARCIA J ARENTZ
K963546 06/24/1997 SMF TITANIUM (TI) ALLOY BONE SCREWS SYNTHES (USA) ANGELA J SILVESTRI
K971987 06/24/1997 SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR SYNTHES (USA) SHERI L MUSGNUNG
K971066 06/04/1997 TAMARYN I.V. FLOW REGULATOR EXTENSION SET TAMARYN MEDICAL SYSTEMS, INC. JIM KEANE
K972014 06/24/1997 SUNGLASSES (NON-PRESCRIPTION) TAMFORT, LTD. CAROLYN Z SLOVIS
K971875 06/13/1997 OPTIM-EYES 450 TAYLOR/FOX ENTERPRISES, LLC. ELIZABETH S CROCKETT
K964396 06/06/1997 DOUBLE UP BREAST PUMP THE NATURAL CHOICE CO., INC. NANETTE NETTLES
K940954 06/20/1997 SYNAPTIC 3000 THE SYNAPTIC CORP. MARK K SHANER
K964606 06/26/1997 THERATRON 780E THERATRONICS, INC. E.S. MARTELL
K970804 06/03/1997 TRU-PULSE CO2 SURGICAL LASER TISSUE TECHNOLOGIES, INC. ROBERT FISHER
K970792 06/02/1997 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE TITAN CONDOMS LILLIE C THOMAS
K971685 06/24/1997 IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM TOMEY CORPORATION USA HOWARD M HOLSTEIN
K971103 06/27/1997 AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM TOSOH MEDICS, INC. LORI ROBINSON
K971178 06/27/1997 RAND SURGICAL SPONGE TRANS AIRE DUANE TRACY
K971272 06/05/1997 TRAUMA-FIX EXTERNAL FIXATOR TREND MEDICAL, INC. DAVID W SCHLERF
K971111 06/16/1997 TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER TRI-TECH, INC. WENDIE WALKER
K971899 06/26/1997 ENDO-SEAL ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K971284 06/03/1997 OPALDAM ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K971898 06/24/1997 PERMALUTE, TRY-IN PASTE ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K971303 06/06/1997 INSTEAD, SOFTCUP ULTRAFEM, INC. PETER S REICHERTZ
K971842 06/20/1997 COAXIAL NEEDLE UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN Y COHEN
K971201 06/03/1997 AUTO SUTURE* ILM** KIT UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K971886 06/11/1997 ACCUTEST HCG-URINE UNOTECH DIAGNOSTICS, INC. KEN WU
K971246 06/20/1997 LEO 7000 QUADRATURE KNEE COIL USA INSTRUMENTS, INC. RONY THOMAS
K971382 06/06/1997 PRONE BREAST POSITIONING BOARD, MODEL #37-018 VICTOREEN, INC. LINDA S NASH
K964785 06/13/1997 VERIDOSE DIODES VICTOREEN, INC. LINDA S MORIN
K971064 06/09/1997 BAYERS BIMANUAL I/A HANDPIECES VISION CARE DEVICES, INC. CHET CRACCHIOLO
K970939 06/06/1997 VISTA V-38 CIC VISTA LABS JAMES E PANNETTE
K963571 06/02/1997 VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR VYGON CORP. ANNE MARIE CESARIO
K971087 06/13/1997 SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) W.J. BYRNES & CO. OF LOS ANGELES, INC. CHRISTY PRATT
K964067 06/05/1997 GORE IRRIGATION SET W.L. GORE & ASSOCIATES,INC DAWN LOPEZ
K963653 06/11/1997 WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM WALLACH SURGICAL DEVICES, INC. RAYMOND A WILEY
K971750 06/30/1997 WELCH ALLYN PHACO ILLUMINATOR WELCH ALLYN, INC. COLIN WOLFF
K964679 06/10/1997 WHITE RIVER AUTOMATIC BREAST PUMP WHITE RIVER CONCEPTS E.J. SMITH
K971535 06/06/1997 WIDEX SENSO DIGITAL (MINI CANAL) WIDEX HEARING AID CO., INC. RON MELTSNER
K970917 06/10/1997 SOLOS 10MM OPERATING LAPAROSCOPE WOODBINE OPTICAL CORP. JOHN M AHERN
K971282 06/27/1997 ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. CHRISTIE MANUEL
K971978 06/18/1997 GRAFT HARVESTING SAWBLADES WRIGHT MEDICAL TECHNOLOGY, INC. CRISTIE MANUEL
K971135 06/05/1997 MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. CRISTIE MANUEL
K964025 06/13/1997 MITAYA ALUMINUM INTERSPACED X-RAY GRID X-RAY ACCESSORY CORP. WILLIAM HAGUE
K971539 06/03/1997 NOVATIP FAMILY OF LASER HANDPIECE TIPS XANOVA CORP. MICHAEL LEVY
K971065 06/17/1997 DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES XINTEC CORPORATION MARILYN M CHOU
K970149 06/18/1997 LEGIONELLA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KEPNITSKY
K970150 06/16/1997 MYCOPLASMA IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK KOPNITSKY
K925501 06/13/1997 NYLON COATED SPECULA ZINNANTI SURGICAL INSTRUMENTS, INC. TRISH WILLGING


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