| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K970796 |
03/04/1997 |
3M RED DOT 2560 & 2570 MONITORING ELECTRODES |
3M HEALTH CARE |
LINDA JOHNSEN |
| K971143 |
03/28/1997 |
NEURO PULSE II,III |
AARON MEDICAL INDUSTRIES |
J. R SARON |
| K970820 |
03/06/1997 |
ETEST SPARFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K971152 |
03/28/1997 |
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) |
ABBOTT LABORATORIES |
SHERRY HAIFLICH |
| K970955 |
03/17/1997 |
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM |
ACROMED CORP. |
SALLY LEVINE |
| K970950 |
03/14/1997 |
EASY ROD |
ACROMED CORP. |
MARY LEWIS |
| K970851 |
03/07/1997 |
LYOPLANT DURA SUBSTITUTE(VARIOUS) |
AESCULAP, INC. |
VICTORIA MACKINNON |
| K971099 |
03/26/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971108 |
03/26/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971107 |
03/26/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K970799 |
03/04/1997 |
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970787 |
03/04/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970784 |
03/04/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970786 |
03/04/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970921 |
03/12/1997 |
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) |
ALKO DIAGNOSTIC CORP. |
JANET A MCGRATH |
| K970827 |
03/06/1997 |
PRECISE |
ALLAN SCHULMAN,D.D.S., M.S. |
ALLAN SCHULMAN |
| K970815 |
03/06/1997 |
CONVERTORS IMPERVIOUS SHOE COVERS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K971183 |
03/31/1997 |
GOLD FINGERS |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K971015 |
03/20/1997 |
AHCS HEMOPERFUSION SYSTEM |
AMERICAN HEALTH CARE SYSTEMS, INC. |
EARL G SCHMIT |
| K970882 |
03/10/1997 |
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970875 |
03/10/1997 |
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970878 |
03/10/1997 |
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970873 |
03/10/1997 |
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970814 |
03/06/1997 |
NON-STERILE ISOLATION GOWN |
AMERICAN SEAL CO. |
JOSEPH TUNG |
| K970788 |
03/04/1997 |
PNEUMO-MATIC INSUFFLATION NEEDLE |
APPLE MEDICAL CORP. |
ROBERT W SCHAEFER |
| K970762 |
03/03/1997 |
DUAL LUMEN EMBOLECTOMY CATHETER |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
| K971129 |
03/27/1997 |
OXYPURE PORTABLE OXYGEN GENERATOR |
ARBOR RESEARCH CORP. |
BLAKE M PATERSON |
| K971457 |
03/28/1997 |
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED |
ARCAN ORTHOPAEDIC CORP. |
DONALD W BRYAN |
| K970977 |
03/14/1997 |
LATEX EXAMINATION GLOVES, POWDER FREE |
ARISTA MEDI PRIMA |
HADY SUYANTHO |
| K970769 |
03/03/1997 |
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR |
ARISTO MEDICAL |
LARRY LEPLEY |
| K970847 |
03/07/1997 |
IMPULSE HVG |
ARMSTRONG INDUSTRIES, INC. |
JOHN P LANDINO |
| K970864 |
03/10/1997 |
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K971049 |
03/21/1997 |
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
ASPECT VISION CARE, LTD. |
MARTIN S KNOPF |
| K971164 |
03/31/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS |
ASPECT VISION CARE, LTD. |
ANTHONY GALLEY |
| K970951 |
03/14/1997 |
GRASS BRAINWAVE SOFTWARE |
ASTRO-MED, INC. |
STEPHEN E JOHNSON |
| K971100 |
03/26/1997 |
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARKE |
| K971105 |
03/26/1997 |
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM |
AVECOR CARDIOVASCULAR, INC. |
DENNIS E STEGER |
| K970943 |
03/14/1997 |
GUIDELINE SYSTEM |
AXON INSTRUMENTS, INC. |
ANDREW L BLATZ |
| K970926 |
03/13/1997 |
DOUBLE LUMEN PICC |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971086 |
03/25/1997 |
RADIAL AND FEMORAL ARTERY CATHETER |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971085 |
03/25/1997 |
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971168 |
03/31/1997 |
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE |
BAXTER HEALTHCARE CORP. |
PATRICIA S BARSANTI |
| K970801 |
03/04/1997 |
BCI MODEL 6004 NIBP MONITOR (6004) |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K970905 |
03/12/1997 |
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
| K970919 |
03/12/1997 |
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
| K971110 |
03/26/1997 |
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
| K971158 |
03/28/1997 |
DUALINE 400 CIC |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K971080 |
03/25/1997 |
MAICO MA52 |
BERNAFON-MAICO, INC. |
SCOTT SAVRE |
| K971048 |
03/21/1997 |
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT |
BIO-VASCULAR, INC. |
BARBARA ATZENHOEFER |
| K971114 |
03/26/1997 |
BIOACCESS MARROW HARVEST SYSTEM |
BIOACCESS, INC. |
PETER J CARNES |
| K970938 |
03/13/1997 |
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING |
BIOCOMPATIBLES CARDIOVASCULAR, INC. |
NANCY F TEAGUE |
| K970897 |
03/11/1997 |
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODGEMAN |
| K970817 |
03/06/1997 |
MICROMARK CLIP |
BIOPSYS MEDICAL, INC. |
MARK A COLE |
| K970918 |
03/12/1997 |
BROWNE STEAM INDICATOR |
BOARD OF DIRECTORS, ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K970881 |
03/10/1997 |
CEDIA DIGOXIN |
BOEHRINGER MANNHEIM CORP. |
YVETTE LLOYD |
| K970883 |
03/10/1997 |
CEDIA DIGOXIN II |
BOEHRINGER MANNHEIM CORP. |
YVETTE LLOYD |
| K971060 |
03/24/1997 |
PRECINORM TDM CONTROLS |
BOEHRINGER MANNHEIM CORP. |
YVETTE LLOYD |
| K970984 |
03/17/1997 |
THE ELECSYS CALCHECK PROGESTERONE |
BOEHRINGER MANNHEIM CORP. |
YVETTE LLOYD |
| K971144 |
03/28/1997 |
MULTITAK SS SUTURE SYSTEM |
BONUTTI RESEARCH |
LYNNETTE WHITAKER |
| K971139 |
03/28/1997 |
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT |
BOSTON SCIENTIFIC CORP. |
CAROL J HOLLOWAY |
| K971165 |
03/31/1997 |
INTRODUCER SHEATH AND DILATOR |
BOSTON SCIENTIFIC CORP. |
WANDA M CARPINELLA |
| K970927 |
03/13/1997 |
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM |
BRUNO INDEPENDENT LIVING AIDS, INC. |
WILLIAM W BELSON III |
| K971180 |
03/31/1997 |
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT |
C.R. BARD, INC. |
SANDRA L PERREAND |
| K971137 |
03/28/1997 |
BARD RAPIDFIRE MULTIPLE BAND LIGATOR |
C.R. BARD, INC. |
BETH A ROCHETTE |
| K971034 |
03/21/1997 |
USCI MAINSTAY GUIDING CATHETER |
C.R. BARD, INC. |
ANNE KULIS |
| K971025 |
03/20/1997 |
AYURVEDIC TONGUE CLEANER |
CALELLO MARTINEZ P.C. |
ANTONIO C MARTINEZ, II |
| K971169 |
03/28/1997 |
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) |
CAMBRIDGE BIOTECH CORP. |
REBECCA LEAPER |
| K971170 |
03/28/1997 |
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) |
CAMBRIDGE BIOTECH CORP. |
REBECCA LEAPER |
| K970768 |
03/03/1997 |
HUMAN LYME IGM WESTERN BLOT KIT |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
SILE MACMAHON |
| K970761 |
03/03/1997 |
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
SILE MACMAHON |
| K970853 |
03/07/1997 |
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) |
CARDIMA, INC. |
JACK P DOUGLAS, PH.D. |
| K971148 |
03/28/1997 |
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES |
CARDIOTRONICS SYSTEMS, INC. |
TIM J WAY |
| K971130 |
03/27/1997 |
DEFEND FLUID RESISTANT PLEATED MASK |
CARL PARKER ASSOCIATES, INC. |
NEAL DUNNING |
| K971133 |
03/27/1997 |
URIC, UA, OR URIC ACID |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971121 |
03/27/1997 |
ENCORE BOND |
CENTRIX, INC. |
JOHN DISCKO |
| K970914 |
03/12/1997 |
CHASE AORTIC PERFUSION CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971041 |
03/21/1997 |
CHASE CORONARY OSTIAL PERFUSION CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971021 |
03/20/1997 |
CHASE PHRENIC NERVE PAD |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971022 |
03/20/1997 |
CHASE SUCKER |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971013 |
03/20/1997 |
CHASE TEMPERATURE PROBE |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971023 |
03/20/1997 |
CHASE THORACIC CATHETER |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971019 |
03/20/1997 |
CHASE VESSEL CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K970956 |
03/17/1997 |
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K970979 |
03/17/1997 |
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 |
CHIRON DIAGNOSTICS CORP. |
RONALD D SCHAEFER |
| K971071 |
03/24/1997 |
LIQUID LIGAND 1,2,3 |
CHIRON DIAGNOSTICS CORP. |
RONALD D SCHAEFER |
| K971026 |
03/20/1997 |
THE CIRCULATOR BOOT |
CIRCULATOR BOOT CORP. |
RICHARD S DILLON |
| K970930 |
03/13/1997 |
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE |
CLEFT PALATE APPLIANCES, INC. |
ELIZABETH ANN LATHAM |
| K971057 |
03/24/1997 |
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM |
COGENT LIGHT TECHNOLOGIES, INC. |
RICHARD B DAVIES |
| K970764 |
03/03/1997 |
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES |
COMEG ENDOSCOPY |
KAELYN HADLEY |
| K970934 |
03/13/1997 |
CB ERBIUM/2.94(TM) ER:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
ROBERT S ANDERSON |
| K970808 |
03/05/1997 |
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K971040 |
03/21/1997 |
CABLE HOLDER, SUCTION TUBE HOLDER |
CONTOUR FABRICATORS, INC. |
MICHEAL CZOP |
| K970900 |
03/11/1997 |
INSTRUMENT HOLDER |
CONTOUR FABRICATORS, INC. |
MICHAEL CZOP |
| K970854 |
03/10/1997 |
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER |
CORDIS CORP. |
ELENA S JUGO |
| K970842 |
03/07/1997 |
CORDIS ENDEAVOR |
CORDIS CORP. |
TAMARA YOUNT |
| K971010 |
03/20/1997 |
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS |
CORDIS CORP. |
JODI LYNN GREENIZEN |
| K970995 |
03/19/1997 |
CMS CRYOLITE |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
| K970895 |
03/11/1997 |
CUSTOM OPTICAL SUNGLASS FRAMES |
CUSTOM OPTICAL FRAMES, INC. |
MARC H AST |
| K970767 |
03/03/1997 |
CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH |
CUSTOM SERVICES INTL., INC. |
LILLIE C THOMAS |
| K970791 |
03/04/1997 |
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY |
CUSTOM SERVICES INTL., INC. |
LILLIE C THOMAS |
| K970989 |
03/18/1997 |
CYBERREN |
CYBERNIUS MEDICAL LTD. |
ULRICH SIMONSMEIER |
| K971141 |
03/28/1997 |
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM |
DADE CHEMISTRY SYSTEMS, INC. |
CATHY P CRAFT |
| K971044 |
03/21/1997 |
"DASH", "SULLIVAN", "VITAL GARD" |
DASH MEDICAL GLOVES, INC. |
ROBERT J SULLIVAN JR. |
| K971113 |
03/27/1997 |
DMA TRIGLYCERIDES PROCEDURES |
DATA MEDICAL ASSOCIATES, INC. |
C.H. MORRIS |
| K970857 |
03/10/1997 |
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K971104 |
03/26/1997 |
CLASSIC MATCH |
DELAGAR DIVISION BELCAM, INC. |
CALLY LUNETTA |
| K970813 |
03/05/1997 |
DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 |
DENVU, INC. |
ROBERT S MCQUATE |
| K970929 |
03/13/1997 |
DEPUY LOW PROFILE BONE SCREW |
DEPUY, INC. |
SALLY FOUST |
| K971072 |
03/24/1997 |
CHOLESTEROL REAGENT |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN |
| K971005 |
03/19/1997 |
TRIGLYCERIDES |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN |
| K970867 |
03/10/1997 |
URIC ACID REAGENT |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN |
| K970993 |
03/19/1997 |
DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE |
DEROYAL INDUSTRIES, INC. |
MARIA EBIO |
| K970877 |
03/10/1997 |
IMMULITE CEA |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K971051 |
03/24/1997 |
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K971177 |
03/31/1997 |
IMMULITE VITAMIN B12 (LKVB1,LKVB5) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K970915 |
03/12/1997 |
DSL ESTRONE-SULFATE RIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K970906 |
03/12/1997 |
PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR |
DIAMETRICS MEDICAL, LTD. |
JAN WALTERS |
| K971120 |
03/27/1997 |
DISPENS-O-DISC (TM) LEVOFLOXACIN |
DIFCO LABORATORIES, INC. |
DAVID W GATES |
| K971211 |
03/27/1997 |
DISPENS-O-DISC SPARFLOXACIN |
DIFCO LABORATORIES, INC. |
DAVID W GATES |
| K971198 |
03/31/1997 |
BABYTHERM 8004 BABYTHERM 8010 |
DRAGER, INC. |
HERALD KNEUER |
| K971109 |
03/26/1997 |
QUIKPAC II ONE STEP AMPHETAMINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K971083 |
03/25/1997 |
ARTHROSCOPE |
ELECTRO-BIOLOGY, INC. |
JON CAPAROTTA |
| K971176 |
03/31/1997 |
VIEW ARCHIVING STATION |
ELECTROMED INTL., LTD. |
JAMES REIDL |
| K970990 |
03/18/1997 |
GYREX PRIMA 1TG 1.0T MRI SYSTEM |
ELSCINT MR, INC. |
ELIZABETH F LOWDER |
| K970980 |
03/18/1997 |
CARDIAC SCORING FOR CT SCANNERS |
ELSCINT, INC. |
THOMAS J SPACKMAN |
| K971125 |
03/27/1997 |
ENDO SMARTCAP (100501) |
ENDO SMART CAP CO. |
DON BYRNE |
| K970816 |
03/06/1997 |
GLARE WARE |
ERGOVISION, INC. |
MARK H LEVIN |
| K970896 |
03/11/1997 |
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM |
ETHICON, INC. |
GREGORY JONES |
| K970988 |
03/18/1997 |
FAR-EAST BOUFFANT CAPS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
PING JIANG |
| K971191 |
03/31/1997 |
FAR-EAST SHOE COVERS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
DAVID SONG |
| K970909 |
03/12/1997 |
SAFE-CONNECT I.V. SET |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K970789 |
03/04/1997 |
SAFE-CONNECT VIAL DISPENSING SPIKE |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K970819 |
03/05/1997 |
TARGOBEAM |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K970892 |
03/11/1997 |
FIEGERT ENDOTECH CYSTOSCOPE |
FIEGERT, INC. |
ERNESTO HERNANDEZ |
| K970970 |
03/17/1997 |
CARDIOMATCH |
FOCUS MEDICAL SA |
JEAN-LUC BOULNOIS |
| K970775 |
03/04/1997 |
TEMPO CEM (MULTIPLE) |
FOREMOST DENTAL MFG., INC. |
D.T. WOLF |
| K970774 |
03/04/1997 |
TEMPOCEM NE (MULTIPLE) |
FOREMOST DENTAL MFG., INC. |
D.T. WOLF |
| K971131 |
03/27/1997 |
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
| K970987 |
03/18/1997 |
ELECTROSURGICAL ELECTRODE |
FUSION MEDICAL TECHNOLOGIES, INC. |
DEBERA BROWN |
| K971132 |
03/27/1997 |
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS |
G. PREMJEE (USA), INC. |
SUSAN D GOLDSTEIN-FALK |
| K970872 |
03/10/1997 |
PAN (CHIBA ASPIRATING NEEDLE) |
GALLINI INTL., INC. |
PAUL L HAWTHORNE |
| K970871 |
03/10/1997 |
TR NEEDLE |
GALLINI INTL., INC. |
PAUL L HAWTHORNE |
| K971145 |
03/28/1997 |
GLUCOSITE TEST SYSTEM |
GDS TECHNOLOGY, LLC. |
JOHN W SWATOSH |
| K970901 |
03/11/1997 |
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS |
DAVID DUERSTELER |
| K970782 |
03/04/1997 |
IMAGING JET SYSTEM |
GENERAL ROBOTIC DEVICES, INC. |
YANSONG SHAN |
| K971122 |
03/27/1997 |
ACCULINE PREGNANCY TEST |
GENIX BIOTEK, INC. |
RICHARD WANG |
| K971162 |
03/31/1997 |
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR |
GENZYME CORP. |
NANCY E ISAAC |
| K971190 |
03/31/1997 |
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR |
GENZYME CORP. |
NANCY E ISAAC |
| K970866 |
03/10/1997 |
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER |
GEORGIA BIOMEDICAL, INC. |
CYNTHIA J. M NOLTE, PHD. |
| K970907 |
03/11/1997 |
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) |
GETINGE/CASTLE, INC. |
MICHAEL J PALLADINO |
| K970916 |
03/12/1997 |
H.V. PULSE LAVAGE (L31 SERIES) |
GLOBAL MEDICAL PRODUCTS, INC. |
TONYA BALABAN |
| K971031 |
03/21/1997 |
AUDALLION III HEARING SYSTEM |
GN DANAVOX, INC. |
WAYNE E MORRIS |
| K971032 |
03/21/1997 |
DANAVOX MODELS 163/162 BTE |
GN DANAVOX, INC. |
WAYNE MORRIS |
| K971043 |
03/21/1997 |
GOLDEN EAGLE |
GOLDEN TECHNOLOGIES, INC. |
CHRIS MCCONNELL |
| K971050 |
03/21/1997 |
GOLDEN HAWK |
GOLDEN TECHNOLOGIES, INC. |
CHRIS MCCONNELL |
| K970968 |
03/17/1997 |
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
DAVID W SCHLERF |
| K971046 |
03/21/1997 |
HANDIFLEX |
HANDIFLEX CORP. |
JOSE BRUNO ROMAN |
| K971039 |
03/21/1997 |
HEMAGEN ANTI CARDIOLIPIN SCREEN |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K971155 |
03/28/1997 |
MEMOREG |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K970848 |
03/07/1997 |
SILOC SYSTEM |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K971116 |
03/26/1997 |
SONOS 5500 IMAGING SYSTEM |
HEWLETT-PACKARD CO. |
PAUL SCHRADER |
| K971016 |
03/20/1997 |
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES J ROGERS |
| K970758 |
03/03/1997 |
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K971206 |
03/12/1997 |
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING |
HOWMEDICA CORP. |
MARGARET CROWE |
| K970911 |
03/12/1997 |
LEE PLATE |
HOWMEDICA LEIBINGER, INC. |
KRISTYN WASKI |
| K970912 |
03/12/1997 |
LEIBINGER SELF-DRILLING SCREW |
HOWMEDICA LEIBINGER, INC. |
KRISTYN WASKI |
| K970908 |
03/11/1997 |
HOWTEK 960 |
HOWTEK, INC. |
M. RUSSELL LEONARD |
| K970865 |
03/10/1997 |
ISG FAMILY OF VIEWING WANDS |
I.S.G. TECHNOLOGIES, INC. |
CHARLES HALL |
| K970855 |
03/10/1997 |
CLAVE CONNECTOR |
ICU MEDICAL, INC. |
ARLENE DUTCHIK |
| K970750 |
03/03/1997 |
MICROSPAN INSEMINATION SYSTEM |
IMAGYN MEDICAL, INC. |
DEBRA A RINDERER |
| K971192 |
03/31/1997 |
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K970841 |
03/07/1997 |
IMTEC/TITANIUM MESH |
IMTEC CORP. |
M.K. PATTERSON |
| K970754 |
03/03/1997 |
INNERDYNE STEP TROCAR EXPANABLE PORT, "OPEN STEP" |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K971196 |
03/31/1997 |
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA CORP. |
HOWARD M HOLSTEIN |
| K971126 |
03/27/1997 |
HYDROCOLLOID WOUND DRESSINGS |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD |
| K970959 |
03/17/1997 |
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
| K970780 |
03/04/1997 |
ONE-WAY VALVE (WITH CONNECTOR) |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
| K970983 |
03/18/1997 |
PERITONEAL/CARDIAC CATHETER |
INTEGRA NEUROCARE LLC. |
LORI L HAYS |
| K971079 |
03/25/1997 |
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE |
INTERLOGICS, INC. |
DONALD R MCINTYRE |
| K970964 |
03/17/1997 |
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM |
INTERNATIONAL IMAGING ELECTRONICS |
ROGER C CLAAR |
| K971053 |
03/24/1997 |
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
JEFFREY R SHIDEMAN |
| K971159 |
03/31/1997 |
SURGICAL DRAPES |
INTERNATIONAL MEDSURG CONNECTION |
LARA N SIMMONS |
| K971036 |
03/20/1997 |
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE |
INTERPORE INTL. |
MARIO GERSBERG |
| K970843 |
03/07/1997 |
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES |
INTERVASCULAR, INC. |
MELISSA L BILLMAN |
| K971000 |
03/19/1997 |
EPISTAXIS NASAL PACK |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K970888 |
03/11/1997 |
IOTEC TROCAR AND FLEXIBLE CANNULA |
IOTEC INDUSTRIES |
ROGER COOPER |
| K970963 |
03/17/1997 |
TARGIS ALLOY #7 |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K971128 |
03/27/1997 |
CAP-35B III/CINE 275 |
JAMIESON FILM CO. |
GARY W FULLER |
| K970941 |
03/13/1997 |
SLIPPERY GLASS |
JENERIC/PENTRON, INC. |
MURRAY G GAMBERG |
| K970962 |
03/17/1997 |
JMS AV FISTULA NEEDLE |
JMS CO., LTD. |
T HIROSE |
| K970922 |
03/12/1997 |
JOBST ATHROMBIC PUMP/SLEEVE |
JOBST A BEIERSDORF CO. |
ANGELO R PEREIRA |
| K971134 |
03/28/1997 |
VISTA EYESHOWER |
JOHN BRANCH |
GRACE HOLLAND |
| K970894 |
03/11/1997 |
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
| K971156 |
03/28/1997 |
KASHA VISUAL FIELD SYSTEM |
KASHA SOFTWARE, INC. |
|
| K971063 |
03/24/1997 |
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR |
KING DENTAL CORP. |
JAIME F BRIGGS |
| K970997 |
03/19/1997 |
NEO-CARE LUMBER PUNCTURE KIT |
KLEIN-BAKER MEDICAL, INC. |
CLYDE N BAKER |
| K971038 |
03/20/1997 |
KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE |
KONTRON INSTRUMENTS LTD. |
FRANK BRITTO |
| K970994 |
03/19/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
KIM AVES |
| K970846 |
03/07/1997 |
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD |
LANDOS, INC. |
KATH LAFFAN |
| K971068 |
03/24/1997 |
34MM SCARF THREAD-HEAD(TM) SCREW |
LANDOS, INC. |
KATH LAFFAN |
| K971070 |
03/24/1997 |
SCARF THREAD-HEAD (TM) HEAD SCREW |
LANDOS, INC. |
KATH LAFFAN |
| K971069 |
03/24/1997 |
TWIST-OFF (TM) SCREW |
LANDOS, INC. |
KATH LAFFAN |
| K970948 |
03/14/1997 |
800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES |
LASERSCOPE |
LISA MCGRATH |
| K970776 |
03/04/1997 |
LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT |
LIFECORE BIOMEDICAL, INC. |
DONNA BAHLS |
| K971014 |
03/20/1997 |
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS |
LIFESCAN, INC. |
JUDY MARTIN |
| K971059 |
03/24/1997 |
UNIVERSAL DRIVE SYSTEM |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K971002 |
03/19/1997 |
SMILE WITH CONFIDENCE |
LLOYD V. ZIEMENDORF |
LLOYD V ZIEMENDORF |
| K971140 |
03/28/1997 |
VITAL-PORT INFUSION PAL |
MED INSTITUTE, INC. |
NEAL E FEARNOT |
| K971173 |
03/31/1997 |
ML DISPOSABLE ALK TUBING |
MED-LOGICS, INC. |
ROD ROSS |
| K971181 |
03/31/1997 |
THE MIDVIEW-MEDCON'S DICOM VIEWER |
MEDCON LTD. |
ELI M ORBACH |
| K971004 |
03/19/1997 |
MEDCORP FLOW I.V. REGULATOR EXTENSION SET |
MEDCORP INTL. |
DAVE BERBERIAN |
| K970976 |
03/17/1997 |
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
| K970856 |
03/10/1997 |
CARDIOISOZYME, CK/LD ISOENZYME CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
| K971058 |
03/24/1997 |
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
| K971030 |
03/20/1997 |
MIE FALCON, DATEX ENGSTROM FLEXIMA II |
MEDICAL AND INDUSTRIAL EQUIPMENT |
HENRY MARSHALL |
| K970844 |
03/07/1997 |
ATOMISOR |
MEDICAL CONSULTING SERVICE, INC. |
CHERYL WARD |
| K970763 |
03/03/1997 |
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
| K970849 |
03/07/1997 |
ENTERAL NUTRITION 1000 ML/500ML |
MEDICAL INFUSION TECHNOLOGIES, INC. |
JOHN MCNEIRNEY |
| K971067 |
03/24/1997 |
DIGI-INJECTOR |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
JULIAN CORTELLA |
| K970757 |
03/03/1997 |
FOTONA SKINSCAN |
MEDICAL LASER SOLUTIONS |
IAIN D MILLER |
| K971077 |
03/24/1997 |
COVERTIP SAFETY SYRINGE |
MEDISYS TECHNOLOGIES, INC. |
JOEL S FADEN |
| K971001 |
03/19/1997 |
AUTIMO |
MEDIZINTECHNIK, GMBH |
T. WHIT ATHEY |
| K971078 |
03/24/1997 |
HYDROBRUSH (TM) KERATOME |
MEDJET, INC. |
EUGENE GORDON |
| K970946 |
03/14/1997 |
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET |
MEDLINE INDUSTRIES, INC. |
CHRISTINE GALEA |
| K970756 |
03/03/1997 |
MERCURY MEDICAL REUSABLE CPR BAG |
MERCURY MEDICAL |
ARTHUR J WARD |
| K971154 |
03/28/1997 |
MULTIPICS(ME-977) |
MERLIN ENGINEERING WORKS, INC. |
GERALD ENGBRETSON |
| K971153 |
03/28/1997 |
SPLITSCREEN (ME-975) |
MERLIN ENGINEERING WORKS, INC. |
GERALD ENGBRETSON |
| K970880 |
03/10/1997 |
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN |
MICRO-EAR TECHNOLOGY, INC. |
DAVID A PREVES, PH.D. |
| K970826 |
03/06/1997 |
"SELECTA-TIP" LAPAROSCOPIC SCISSORS |
MICROLINE PENTAX, INC. |
HUGHES DE LAFORCADE |
| K970965 |
03/17/1997 |
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) |
MIDAS REX PNEUMATIC TOOLS, INC. |
MICHAEL FOWLER |
| K970937 |
03/13/1997 |
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) |
MIST, INC. |
CAROLANN KOTULA |
| K971150 |
03/28/1997 |
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE |
MIST, INC. |
CAROLANN KOTULA |
| K970778 |
03/04/1997 |
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K970759 |
03/03/1997 |
SOLAR SPECS |
MORRIS ROSENBLOOM & CO., INC. |
GERALD N MURPHY |
| K970868 |
03/10/1997 |
MODEL HNC NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K971006 |
03/19/1997 |
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K971007 |
03/19/1997 |
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K971167 |
03/31/1997 |
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES |
NEOPROBE CORP. |
SUSAN D TIEDY-STEVENSON |
| K971047 |
03/21/1997 |
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
JAMAL D RUSHDY |
| K970870 |
03/10/1997 |
DIGIT-GRIP WITH LCD (DGR002) |
NK BIOTECHNICAL CORP. |
KAREN GOTFREDSON |
| K970953 |
03/17/1997 |
E-TYPE SPEED REDUCER CONTRA ANGLE |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K971117 |
03/27/1997 |
WARMETTE |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K970797 |
03/04/1997 |
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
| K970947 |
03/14/1997 |
B-350 CEILING MOUNTED C-POSITIONER |
OMEGA MEDICAL IMAGING, INC. |
DOUGLAS COON |
| K970770 |
03/03/1997 |
LATEX EXAMINATION GLOVES |
OON CORP. RESOURCES |
CLEMENT K K.OON |
| K971090 |
03/24/1997 |
OPPORTUNITY DRESSING CHANGE TRAY |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971093 |
03/24/1997 |
OPPORTUNITY I.V. START KIT |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971061 |
03/24/1997 |
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971062 |
03/24/1997 |
OPPORTUNITY INC. GENERAL PURPOSE TRAY |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971088 |
03/24/1997 |
OPPORTUNITY INCISION AND DRAINAGE TRAY |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971095 |
03/24/1997 |
OPPORTUNITY SUTURE REMOVAL KIT |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971089 |
03/24/1997 |
OPPORTUNITY, INC. LACERATION TRAY |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971091 |
03/24/1997 |
OPPURTUNITY TRACHEOSTOMY CARE KIT |
OPPORTUNITY, INC. |
JAMES S SANDERS |
| K971020 |
03/20/1997 |
LSF TRIAD TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K970957 |
03/17/1997 |
OSTEONICS RESTORATION ACETABULAR RING |
OSTEONICS CORP. |
KATE SUTTON |
| K970779 |
03/04/1997 |
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS |
OSTEONICS CORP. |
KATE SUTTON |
| K970902 |
03/11/1997 |
MEDILOG FD4 |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
CHARLES HOLZ |
| K971084 |
03/25/1997 |
MODEL 02 OXYGEN ANALYZER |
OXIGRAF, INC. |
BRUCE MCCAUL |
| K971074 |
03/24/1997 |
THERAPAX SXT 150 |
PANTAK, INC. |
GREG MOREAU |
| K970887 |
03/11/1997 |
BLOOD FLOW ANALYZER |
PARADIGM MEDICAL INDUSTRIES, INC. |
RICHARD DIRKSON |
| K970954 |
03/17/1997 |
O.B. APPLICATOR TAMPONS |
PERSONAL PRODUCTS CO. |
RALPH A PETRONE |
| K971123 |
03/27/1997 |
STONE EXTRACTOR |
PHX TECHNOLOGIES CORP. |
JAMES F CHAPEL |
| K970942 |
03/14/1997 |
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K970812 |
03/05/1997 |
PM 2002 CC PROLINE |
PLANMECA OY |
LARS MORING |
| K970975 |
03/17/1997 |
PROSTYLE INTRA |
PLANMECA OY |
LARS MORING |
| K971174 |
03/31/1997 |
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS |
PLAYTEX, INC. |
IRWIN BUTENSKY |
| K970811 |
03/05/1997 |
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN |
PNEUMOCARE, INC. |
JOSEPH H BALES |
| K970933 |
03/13/1997 |
AUTO HDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR. |
| K970781 |
03/04/1997 |
LIQUID GLUCOSE (OXIDASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K971045 |
03/21/1997 |
BASIS FLEXIBLE TIP DIGITAL THERMOMETER |
POLYMEDICA INDUSTRIES, INC. |
SUSAN COLLINS |
| K970992 |
03/19/1997 |
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS |
PREMIER DENTAL PRODUCTS CO. |
WILLIAM J FREZEL |
| K971118 |
03/21/1997 |
ARAGO |
PREMIER LASER SYSTEMS, INC. |
LISA MOJICA |
| K971075 |
03/24/1997 |
PRIMED "PRIME-PLUS" COTTON GAUZE SPONGES |
PRIMELINE MEDICAL PRODUCTS, INC. |
GUY PLAMONDON |
| K971076 |
03/24/1997 |
PRIMED SHOE COVERS, PRIMED HEAD COVERS |
PRIMELINE MEDICAL PRODUCTS, INC. |
GUY PLAMONDON |
| K970991 |
03/19/1997 |
DATEX ENGSTOM MANUAL RESUSCITATOR |
PROMEDIC, INC. |
PAUL E DRYDEN |
| K970891 |
03/11/1997 |
DRAPE, SURGICAL-LATEX |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K971115 |
03/27/1997 |
GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970885 |
03/11/1997 |
ULTRASOUND SYSTEMS DRAPE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970889 |
03/11/1997 |
ULTRASOUND TRANSDUCER DRAPE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970893 |
03/11/1997 |
ULTRASOUND TRANSDUCER DRAPE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970773 |
03/04/1997 |
POWDER-FREE EXAM GLOVES |
PT. SARANA INDOPROTEX |
MD YUSOF BIN IBRAHIM |
| K970862 |
03/07/1997 |
SPINALSCOPICS |
QUANTIMETRIX CORP. |
EVY JOHNSON |
| K971146 |
03/28/1997 |
LAPARETTE |
RD CHUS, INC. |
ROSINA ROBINSON |
| K970924 |
03/07/1997 |
REGENT BIOGEL SURGICAL GLOVE, BIOGEL "M" GLOVE |
REGENT MEDICAL |
NEIL ANDERSON |
| K970834 |
03/07/1997 |
GRAM SWAB |
REMEL, INC. |
MARY A SILVIUS |
| K970833 |
03/07/1997 |
INDOLE SWAB |
REMEL, INC. |
MARY A SILVIUS |
| K970832 |
03/07/1997 |
PYR SWAB |
REMEL, INC. |
MARY A SILVIUS |
| K970830 |
03/07/1997 |
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK |
REMEL, INC. |
MARY A SILVIUS |
| K970831 |
03/07/1997 |
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK |
REMEL, INC. |
MARY A SILVIUS |
| K970771 |
03/03/1997 |
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM |
RESMED LTD. |
MICHAEL HALLETT |
| K970803 |
03/04/1997 |
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE |
RETRACTABLE TECHNOLOGIES, INC. |
TERANCE GRISSO |
| K971166 |
03/31/1997 |
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K970961 |
03/17/1997 |
VAPORIZATION ELECTRODES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K970825 |
03/06/1997 |
BLUE CHIP GERMICIDAL CLEANER & DEODORANT |
S.C. JOHNSON PROFESSIONAL |
ROBERT B O'BRIEN |
| K970899 |
03/11/1997 |
SAFESKIN POWDERED EXAMINATION GLOVE |
SAFESKIN CORP. |
MICHELLE MOLLOY |
| K971024 |
03/20/1997 |
SOFTSCAN |
SAHAR TECHNOLOGIES, INC. |
SHLOMO ASSA |
| K970850 |
03/07/1997 |
SCANRITE DFS |
SCANRITE SYSTEMS |
BARRY J WALTER |
| K970879 |
03/10/1997 |
CARDIOVIT CS-200 |
SCHILLER AMERICA, INC. |
MARKUS MARITZ |
| K970823 |
03/06/1997 |
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER |
SCIMED LIFE SYSTEMS, INC. |
ANGELA RUAN |
| K970944 |
03/13/1997 |
"BARAKKA", "INFERNO", "STERLING", AND/OR "ONE" |
SENTINAL IMPORTING CORP. |
BRENT MARTIN |
| K970795 |
03/04/1997 |
SHANG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
CHENG KO LIN |
| K970824 |
03/06/1997 |
MDX 2000, DIGITAL ANALYZER |
SHOTWELL & CARR, INC. |
BERT HUDSON |
| K970794 |
03/04/1997 |
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) |
SIAM SEMPERMED CORP. LTD. |
POONSUK CHERDKIATGUMCHAI |
| K970839 |
03/07/1997 |
SERVO VENTILATOR 300A |
SIEMENS ELEMA AB |
ANN-CHRISTINE JONSSON |
| K971055 |
03/24/1997 |
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K970852 |
03/07/1997 |
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K971054 |
03/24/1997 |
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JING ZHANG |
| K970920 |
03/12/1997 |
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JACQUELINE EMERY |
| K970931 |
03/07/1997 |
COPALIS TORC TOTAL ANTIBODY ASSAY |
SIENNA BIOTECH, INC. |
JUDITH J SMITH |
| K970966 |
03/17/1997 |
COMFORT CATH CHOICE MALE EXTERNAL CATHETER |
SIERRA LABORATORIES, INC. |
ANNA PEREZ |
| K971018 |
03/20/1997 |
SMC ACETABULAR COMPONENT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K970785 |
03/04/1997 |
SIMS HYPERINFLATION BAG SYSTEM |
SIMS |
AVIA TONEY |
| K970840 |
03/07/1997 |
INTELLIFLOW RESPIRATORY ANALYZER |
SIMTEC, INC. |
JOHN SIMPSON |
| K971092 |
03/26/1997 |
QA-ES |
SMITH |
E.J. SMITH |
| K970949 |
03/14/1997 |
SMITH & NEPHEW MIS INSTRUMENTS |
SMITH & NEPHEW ENDOSCOPY, INC. |
AMY L WALTERS |
| K971188 |
03/31/1997 |
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS |
SMITH & NEPHEW, INC. |
ELIZABETH A RYAN |
| K970751 |
03/03/1997 |
HEIDELBERG EXTERNAL FIXATOR |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JOANNE KHUNE |
| K970748 |
03/03/1997 |
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JOANNE KUHNE |
| K970806 |
03/05/1997 |
ACPII ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K970800 |
03/04/1997 |
MAXCESS NEEDLEFREE - Y- SITE (100713) |
SOLOPAK MEDICAL PRODUCTS, INC. |
ELIZABETH LOYA |
| K970809 |
03/05/1997 |
BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
| K970838 |
03/07/1997 |
SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE A CONNER |
| K970837 |
03/07/1997 |
SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
| K970999 |
03/19/1997 |
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR |
SONY MEDICAL SYSTEMS |
CYNTHIA A SINCLAIR |
| K970952 |
03/14/1997 |
PRECISE IMPRESSION KIT |
STARKEY LABORATORIES, INC. |
SHARI L SWIDEN |
| K970807 |
03/05/1997 |
MOBILE OPERATING TABLE 1132.01 |
STIERLEN-MAQUET AG |
REINHARD PFEUFFER |
| K971157 |
03/28/1997 |
MACRALP(A) ENZYME IMMUNOASSAY KIT |
STRATEGIC DIAGNOSTICS, INC. |
JOSEPH X DAUTLICK |
| K971138 |
03/28/1997 |
DINABASE (TM) |
SULTAN CHEMISTS, INC. |
LES HEIMANN |
| K970752 |
03/03/1997 |
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM |
SULZER CALCITEK, INC. |
JOSEPH S SHAN |
| K971102 |
03/26/1997 |
AMBIDERM |
SUPERTEX INDUSTRIAL, S.A. DE C.V. |
ENRIQUE SALCEDO PADILLA |
| K971149 |
03/28/1997 |
SVL-9130 DEFIBRILLATION ELECTRODE |
SURVIVALINK CORP. |
SEW-WAY TAY |
| K971142 |
03/28/1997 |
ADVENTURER |
T.E.S., LTD. |
JIM COCKS |
| K971066 |
03/24/1997 |
TAMARYN I.V. FLOW REGULATOR EXTENSION SET |
TAMARYN MEDICAL SYSTEMS, INC. |
JIM KEANE |
| K971009 |
03/20/1997 |
SCAR CARE |
TARGET HEALTH, INC. |
JULES T MITCHEL |
| K971182 |
03/31/1997 |
TOX A/B TEST |
TECHLAB, INC. |
DAVID M LYERLY |
| K970969 |
03/17/1997 |
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET |
THE KENDAL CO. |
DAVID A OLSON |
| K971207 |
03/27/1997 |
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER |
THERMOLASE CORP. |
ROBERT VAN OSDEL |
| K970804 |
03/04/1997 |
TRU-PULSE CO2 SURGICAL LASER |
TISSUE TECHNOLOGIES, INC. |
ROBERT FISHER |
| K970792 |
03/04/1997 |
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE |
TITAN CONDOMS |
LILLIE C THOMAS |
| K970829 |
03/06/1997 |
PHUSIS ABSORBABLE INTERFERENCE SCREW |
TORNIER |
DAVID W SCHLERF |
| K971103 |
03/26/1997 |
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K971178 |
03/31/1997 |
RAND SURGICAL SPONGE |
TRANS AIRE |
DUANE TRACY |
| K970890 |
03/11/1997 |
#ES-32 SUCTION CATHETER 32 FR. |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
| K970982 |
03/18/1997 |
T-RX RETRIEVAL FORCEPS |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
| K971111 |
03/26/1997 |
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER |
TRI-TECH, INC. |
WENDIE WALKER |
| K970828 |
03/06/1997 |
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER |
UNITED HEARING SYSTEMS, INC. |
RALPH CAMPAGNA |
| K970945 |
03/14/1997 |
ANGLED TIP POLYPECTOMY SNARE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER-COHEN |
| K970793 |
03/04/1997 |
IMPLANTABLE CLIP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K970863 |
03/10/1997 |
MODIFIED USSC* POLYSORB SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JONATHAN GILBERT |
| K970971 |
03/17/1997 |
URO MED NERVE STIMULATOR |
UROMED CORP. |
FREDERICK TOBIA |
| K971382 |
03/14/1997 |
PRONE BREAST POSITIONING BOARD, MODEL #37-018 |
VICTOREEN, INC. |
LINDA S NASH |
| K971101 |
03/26/1997 |
HSV-2 ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFFE |
| K971064 |
03/24/1997 |
BAYERS BIMANUAL I/A HANDPIECES |
VISION CARE DEVICES, INC. |
CHET CRACCHIOLO |
| K970939 |
03/13/1997 |
VISTA V-38 CIC |
VISTA LABS |
JAMES E PANNETTE |
| K970755 |
03/03/1997 |
STEALTHSHIELD |
VITAL CONNECTIONS, INC. |
MARK L MEISTER |
| K971087 |
03/25/1997 |
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) |
W.J. BYRNES & CO. OF LOS ANGELES, INC. |
CHRISTY PRATT |
| K970884 |
03/10/1997 |
RESOLUT REGENERATIVE MATERIAL |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
| K970986 |
03/18/1997 |
WAKO DIRECT BILIRUBIN V |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K970985 |
03/18/1997 |
WAKO TOTAL BILIRUBIN V |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K970904 |
03/12/1997 |
WIDEX SENSO DIGITAL (CIC) |
WIDEX HEARING AID CO., INC. |
RON MELTSNER |
| K970974 |
03/17/1997 |
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER |
WILLIAMS SOUND, LLC |
PAUL INGEBRIGTSEN |
| K970917 |
03/12/1997 |
SOLOS 10MM OPERATING LAPAROSCOPE |
WOODBINE OPTICAL CORP. |
JOHN M AHERN |
| K971028 |
03/20/1997 |
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED |
WORLDS-BEST GUMMIVAREFABRIK A/S |
CHRISTIAN HJORTH |
| K971135 |
03/27/1997 |
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISTIE MANUEL |
| K971056 |
03/24/1997 |
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISTIE MANUEL |
| K971065 |
03/24/1997 |
DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |
| K971124 |
03/27/1997 |
TM MICRO-CATHETERS |
XOMED, INC. |
DAVID TIMLIN |
| K970910 |
03/12/1997 |
XOMED SILICONE BLOCK/STRIP |
XOMED, INC. |
DAVID TIMLIN |
