| 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 |
