FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K970013 |
03/13/1997 |
BIORIGID NAIL TIBIA |
AAP GMBH AND CO. BETRIEBS KG |
DIPL.-ING CHRISTIAN ABEL |
K952558 |
03/19/1997 |
AARON VAC 2 |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
K954301 |
03/24/1997 |
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) |
ABBOTT LABORATORIES |
MARY SPIEWAK |
K970527 |
03/03/1997 |
ABBOTT HCG SERUM CONTROLS |
ABBOTT LABORATORIES |
KAREN L GATES, M.S. |
K965186 |
03/24/1997 |
AXSYM B12 |
ABBOTT LABORATORIES |
LAURA L GRANITZ |
K961661 |
03/04/1997 |
OXIMETRIX 4 COMPUTER SYSTEM |
ABBOTT LABORATORIES |
DAVID GUZEK |
K965190 |
03/19/1997 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
K965239 |
03/28/1997 |
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) |
ACCUTRON, INC. |
JIM MOORE |
K970046 |
03/28/1997 |
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) |
ACCUTRON, INC. |
JAMES R MOORE |
K965046 |
03/14/1997 |
ISOLA TWISTER CONNECTOR |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
K970693 |
03/21/1997 |
ACRYDERM GEL WOUND DRESSING |
ACRYMED, INC. |
BRUCE GIBBINS |
K965028 |
03/17/1997 |
ACUMED SUTURE WASHER |
ACUMED, INC. |
SHARI L JEFFERS |
K961459 |
03/26/1997 |
LEVEL 10 HDI |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRANCE J SWEENEY |
K964128 |
03/17/1997 |
MCL 29 DERMABLATE ERBIUM LASER SYSTEM |
AESCULAP-MEDITEC GMBH |
WILLIAM T KELLEY |
K970541 |
03/28/1997 |
AESCULAP MODULAR MONOPOLAR ELECTRODES |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
K961676 |
03/28/1997 |
AIRCAST VENAFLOW SYSTEM (MODIFICATION) |
AIRCAST, INC. |
STEPHEN L KENNEY |
K951944 |
03/28/1997 |
NASALFLAIR |
AIRWAYS LTD., INC. |
WAYNE W DISANZA |
K965185 |
03/31/1997 |
ACRYPAK FOLDER |
ALCON LABORATORIES |
MARTIN A KAUFMAN |
K970268 |
03/31/1997 |
ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
K970815 |
03/27/1997 |
CONVERTORS IMPERVIOUS SHOE COVERS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
K964474 |
03/11/1997 |
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
INGRID M HOOS |
K964910 |
03/10/1997 |
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS |
ALPHA-OMEGA SERVICES, INC. |
CARY HEDGER |
K961269 |
03/10/1997 |
PULSEMASTER |
AMERICAN DENTAL TECHNOLOGIES, INC. |
MICHAEL YESSIK |
K970279 |
03/18/1997 |
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) |
AMERICAN ELECTROMEDICS CORP. |
NOEL A WREN |
K952910 |
03/19/1997 |
THE SWIRLER NEBULIZER |
AMICI, INC. |
MICHAEL BONO |
K964745 |
03/18/1997 |
AMSINO URINARY DRAINAGE BAG |
AMSINO INTL., INC. |
RICHARD Y LI, PH.D. |
K964890 |
03/06/1997 |
ANATOM 2000 |
ANALOGIC CORP. |
JAMES R LEVANI |
K961892 |
03/07/1997 |
SPECKTIN-LA TEST SET |
ANALYTICAL CONTROL SYSTEMS, INC. |
PAULINE W BONDERMAN |
K964522 |
03/21/1997 |
ELLIPSE 4 |
ANDROMEDA MEDIZINISCHE SYSTEME GMBH |
NORMAN F ESTRIN, PH.D. , RAC |
K964698 |
03/03/1997 |
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT |
ANDWIN SCIENTIFIC |
A. THOMAS DOYLE |
K963887 |
03/31/1997 |
PT-PAC PORTABLE HEATING PAD |
ANTHONY A. CHIURCO |
LAWRENCE E LIBERTI |
K970744 |
03/31/1997 |
STYLE EYES OPTICS |
ANTI-RAY, INC. |
PHILIP KAHN |
K970788 |
03/27/1997 |
PNEUMO-MATIC INSUFFLATION NEEDLE |
APPLE MEDICAL CORP. |
ROBERT W SCHAEFER |
K970762 |
03/28/1997 |
DUAL LUMEN EMBOLECTOMY CATHETER |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
K963318 |
03/03/1997 |
LEGIONELLA IGG/IGM ELISA TEST SYSTEM |
ARMKEL, LLC. |
WILLIAM L BOTELER JR. |
K964609 |
03/06/1997 |
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE |
ARRAY MEDICAL, INC. |
PATRICIA E BONNESS |
K963257 |
03/04/1997 |
PERIPHERALLY INSERTED MEDLINE CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
K932221 |
03/19/1997 |
NEUROLOGICAL OR CRANI TRAYS (PACKS) |
ASSOCIATED MEDICAL PRODUCTS CO. |
SCOTT WEISS |
K963293 |
03/28/1997 |
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
K970064 |
03/17/1997 |
AMICAS WEB/INTRANET IMAGE SERVER |
AUTOCYT GROUP, INC. |
ADRIAN GROPPER, M.D. |
K964359 |
03/25/1997 |
AVANTA ORTHOPAEDICS TENDON SPACER |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
K965146 |
03/10/1997 |
FLAT CLOSED WOUND DRAIN WITH TROCAR |
AXIOM MEDICAL, INC. |
RIDWAN HARDY |
K970359 |
03/18/1997 |
COMBIPROT EMERGENCY ENFUSION DEVICE |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
K955179 |
03/12/1997 |
CONTRAST MEDIA SET |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
K962141 |
03/19/1997 |
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
K964021 |
03/27/1997 |
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) |
BAXTER EDWARDS |
PAULA A TORRIANNI |
K963203 |
03/25/1997 |
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT |
BAXTER HEALTHCARE CORP. |
SCOTT BEGGINS |
K964029 |
03/17/1997 |
EMERGENCY RELIEF KIT SYSTEM |
BAXTER HEALTHCARE CORP. |
MARYALICE SMITH |
K964853 |
03/31/1997 |
INTRAVIA CONTAINER, EMPTY |
BAXTER HEALTHCARE CORP. |
MARY E SNYDER |
K970737 |
03/28/1997 |
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
PETER ZURLO |
K963974 |
03/06/1997 |
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
K964257 |
03/24/1997 |
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
K964843 |
03/06/1997 |
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
K963976 |
03/19/1997 |
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
K965240 |
03/10/1997 |
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
K965108 |
03/06/1997 |
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT |
BECKMAN INSTRUMENTS, INC. |
KATHLEEN M JAKER |
K970212 |
03/06/1997 |
LEVOFLOXACIN, 5MCG, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
K970385 |
03/10/1997 |
SPARFLOZACIN, 5 MCG, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
K964860 |
03/03/1997 |
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER |
BELL INTL., INC. |
DEWEY BELL |
K970340 |
03/26/1997 |
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER |
BELLAB |
MARTIN ERIKSSON |
K964528 |
03/07/1997 |
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT |
BENZ RESEARCH AND DEVELOPMENT CORP. |
WALLY STIRLING |
K970313 |
03/11/1997 |
PREPOWDERED LATEX EXAMINATION GLOVE |
BESGLOVE HEALTHCARE SDN. BHD. |
LIM HO PENG |
K970666 |
03/10/1997 |
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL |
BIO-RAD |
ELIZABETH PLATT |
K960072 |
03/06/1997 |
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX |
BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
RICHARD KEEN |
K964047 |
03/19/1997 |
CRYOSIL SILICONE GEL SHEETING |
BIODERMIS CORP. |
DENNIS A REPELLA |
K960373 |
03/05/1997 |
BIOJECTOR 2000 MODEL 1B02000 |
BIOJECT, INC. |
MARK K NORTON |
K970615 |
03/19/1997 |
PROMED 55-G SOFT DAILY WEAR CONTACT LENS |
BIOMED DEVICES CORP. |
MARTIN J DALSING |
K961021 |
03/17/1997 |
KIRSCHNER KNEE MODIFIED |
BIOMET, INC. |
JOHN WAGGONER |
K961782 |
03/28/1997 |
BIO-BINKI |
BIOMNI MEDICAL SYSTEMS, INC. |
LAVON L BENNETT |
K970565 |
03/28/1997 |
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) |
BIOPSYS MEDICAL, INC. |
MARK A COLE, PH.D. |
K964871 |
03/03/1997 |
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS |
BIOSEARCH MEDICAL PRODUCTS, INC. |
ROLAN SOUBRA |
K963936 |
03/31/1997 |
ACCESSPOINT, MED E-MAIL, DICOM READER |
BIOSOUND, INC. |
WAYNE NETHERCUTT |
K963262 |
03/28/1997 |
ARTOSCAN M |
BIOSOUND, INC. |
WAYNE NETHERCUTT |
K964604 |
03/10/1997 |
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION |
BIOTRONIK, INC. |
JOSEPH J SCHWOEBEL, RAC |
K970452 |
03/06/1997 |
ELECSYS CALCHECK CEA |
BOEHRINGER MANNHEIM CORP. |
Patricia M Klimley |
K970459 |
03/06/1997 |
ELECSYS CALCHECK CEA |
BOEHRINGER MANNHEIM CORP. |
Patricia M Klimley |
K970458 |
03/06/1997 |
ELECSYS CALCHECK PSA |
BOEHRINGER MANNHEIM CORP. |
Patricia M Klimley |
K964841 |
03/24/1997 |
ELECSYS PROGESTERONE ASSAY |
BOEHRINGER MANNHEIM CORP. |
MARY KENING |
K964889 |
03/18/1997 |
ELECSYS TESTOSTERONE ASSAY |
BOEHRINGER MANNHEIM CORP. |
YVETTE LLODY |
K965085 |
03/19/1997 |
ENZYMUN-TEST PSA |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS, RAC |
K970052 |
03/25/1997 |
EXTRACTORRX |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
K965229 |
03/04/1997 |
IMAGER TORQUE CATHETER |
BOSTON SCIENTIFIC CORP. |
CAROL J HOLLOWAY |
K964538 |
03/10/1997 |
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM |
BOSTON SCIENTIFIC CORP. |
WANDA M CARPINELLA |
K970053 |
03/28/1997 |
ULTRATOMERX |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
K960840 |
03/28/1997 |
C.E. VASCULAR MACHINE |
C.E. DIAGNOSIS, INC. |
CARLOS A SELMONOSKY |
K964066 |
03/06/1997 |
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) |
C.R. BARD, INC. |
PEGGY KEIFFER |
K965125 |
03/19/1997 |
DAKOTA SMITH, NICOLE MILLER SUNGLASSES |
CALIFORNIA DESIGN STUDIO, INC. |
BRIAN SEIGEL |
K963079 |
03/03/1997 |
CANON TX-10 TONOMETER |
CANON U.S.A., INC. |
GLENN IMPAL |
K960849 |
03/26/1997 |
MAGNO ALARM |
CARDIAC ASSIST DEVICES, INC. |
RASSOLL RASHIDI |
K963688 |
03/28/1997 |
FOCUS PV BALLOON DILATATION CATHETER |
CARDIOVASCULAR DYNAMICS, INC. |
MICHAEL CROCKER |
K961380 |
03/17/1997 |
CPC PROBE |
CARL ZEISS, INC. |
KENNETH M NICOLL |
K964852 |
03/03/1997 |
RADIACARE ORAL WOUND RINSE |
CARRINGTON LABORATORIES, INC. |
DENNIS R SPARKMAN, PH.D. |
K962370 |
03/31/1997 |
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE |
CHALLENGE PRODUCTS, INC. |
RICHARD O WOOD |
K964198 |
03/19/1997 |
CAHSE AORTIC ROOT CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
K964199 |
03/19/1997 |
CHASE CORONARY SINUS PERFUSION CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
K964195 |
03/19/1997 |
CHASE TWO STAGE VENOUS RETURN CATHETER |
CHASE MEDICAL, INC. |
BERT DAVIS |
K970087 |
03/06/1997 |
CR PERFECT |
CHIMERA RESEARCH & CHEMICAL, INC. |
CHARLES A HAY, PH.D. |
K970539 |
03/24/1997 |
CHIRON DIAGNOSTICS ACS:180TU P |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
K962109 |
03/13/1997 |
SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL |
CLASSY LADY BY MEHL OF PUERTO RICO, INC. |
THOMAS BLAKE |
K964690 |
03/21/1997 |
LIBERTY VALVE |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
K965214 |
03/28/1997 |
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) |
COEUR LABORATORIES, INC. |
James M Clinton |
K952567 |
03/04/1997 |
AUTOSTATTMII ANTI-DSDNA |
COGENT DIAGNOTICS LTD. |
JIM WESTON |
K971057 |
03/28/1997 |
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM |
COGENT LIGHT TECHNOLOGIES, INC. |
RICHARD B DAVIES |
K970489 |
03/19/1997 |
COMEG ENDOSCOPY GRASPING FORCEPS |
COMEG ENDOSCOPY |
PETER DUFFY |
K955841 |
03/11/1997 |
SLEEP SYSTEM FOR CLINICS & RESEARCH |
COMPUMEDICS PTD LTD. |
STEVE REITZLER |
K963507 |
03/19/1997 |
EXTRA TENS (RI-2500) NEO TENS (RI-2000E) |
COMTEK INTL., CORP. |
PING TSUNG HUAN |
K964844 |
03/24/1997 |
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS |
CONMED CORP. |
IRA D DUESLER, JR. |
K963787 |
03/11/1997 |
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM |
CONMED CORP. |
IRA D DUESLER, JR. |
K965082 |
03/11/1997 |
SOOTHING WATER-FILLED TEETHER |
CONSOLIDATED STORES CORP. |
JOHANN COZART |
K970125 |
03/04/1997 |
NOAH MONITORING ELECTRODE SYSTEM |
CONTOUR MEDICAL TECHNOLOGY, INC. |
JOSH TRANTUM |
K970391 |
03/06/1997 |
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES |
CONTOUR MEDICAL TECHNOLOGY, INC. |
R. KEITH FERRARI |
K970041 |
03/19/1997 |
ASCEND BALLOON DAILATION CATHETER |
COOK UROLOGICAL, INC. |
TAMMY BACON |
K965211 |
03/11/1997 |
VISTA BRITE TIP CATHETERS |
CORDIS CORP. |
KATHERINE TREVISOL |
K965181 |
03/21/1997 |
CES INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
JODI LYNN FRASIER |
K965174 |
03/21/1997 |
TRUFILL PVA PARTICLES |
CORDIS NEUROVASCULAR, INC. |
JODI LYNN FRASIER |
K965019 |
03/25/1997 |
THE C-FIT FEMORAL HIP SYSTEM |
CORIN U.S.A. |
JACK THOMAS |
K964988 |
03/06/1997 |
COULTER AC.T SERIES ANALYZER |
COULTER CORP. |
THOMAS J ENGLISH |
K964939 |
03/06/1997 |
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS |
CREATIVE BIOMEDICS, INC. |
DANIEL BROWN |
K960842 |
03/19/1997 |
LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) |
CROCKER INDUSTRIAL RESOURCES SDN. BHD. |
TIMOTHY F HAND |
K964971 |
03/28/1997 |
CRYOGEN CRYOSURGICAL SYSTEM |
CRYOGEN, INC. |
JOHN DOBAK |
K964336 |
03/20/1997 |
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
K964737 |
03/19/1997 |
HYDROPREP GEL |
D.O. WEAVER CO. |
DAVID O WEAVER |
K970101 |
03/04/1997 |
JAMES ALEX SUNGLASSES |
D&K STORES, INC. |
ROBERT DWECK |
K970387 |
03/10/1997 |
HUMAN CHORIONIC GONADOTROPIN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
K970336 |
03/03/1997 |
MMB CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
CATHY P CRAFT |
K970393 |
03/03/1997 |
THYROID STIMULATING HORMONE METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
K964346 |
03/28/1997 |
PARAMAX TRIGLYCERID REAGENT |
DADE INTL., INC. |
MARIAN HARDING COCHRAN, ESQ. |
K964987 |
03/17/1997 |
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 |
DATASCOPE CORP. |
KEVIN CROSSEN |
K970037 |
03/12/1997 |
TARGOGRID |
DAUM GMBH |
E.J. Smith |
K964879 |
03/04/1997 |
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM |
DAVOL, INC., SUB. C.R. BARD, INC. |
ROBIN DRAGO |
K963174 |
03/13/1997 |
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) |
DEL MAR AVIONICS |
RAPHAEL HENKIN, PH.D. |
K970433 |
03/27/1997 |
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFREY LEHN |
K964046 |
03/04/1997 |
DENTSPLY PRECISION TORQUE SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K970202 |
03/21/1997 |
DEPUY ACE AIM TITANIUM TIBIAL NAIL |
DEPUY ACE MEDICAL CO. |
PAUL DONER |
K965145 |
03/13/1997 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
CHERYL HASTINGS |
K964024 |
03/26/1997 |
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
CHERYL HASTINGS |
K962628 |
03/18/1997 |
MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
CHERYL HASTINGS |
K964915 |
03/26/1997 |
MAGNESIUM |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN, PH.D. |
K965127 |
03/17/1997 |
DGH MODEL 9000 |
DGH TECHNOLOGY, INC. |
EARL W HENDERSON |
K962323 |
03/10/1997 |
IMMULITE OPIATES SCREEN/CONTROL MODULE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K970402 |
03/26/1997 |
DOCTORS REVIEW SYSTEM |
DIGISONICS, INC. |
DIANA MC SHERRY, PH.D |
K965120 |
03/21/1997 |
ALLCLENZ WOUND CLEANSER |
DPT LABORATORIES, LTD. |
RICHARD A HAMER |
K963994 |
03/19/1997 |
NARKOMED GS ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
K970440 |
03/27/1997 |
EKONIC DENTAL/MEDICAL MASK (MD 610) |
EKONIC COMPANY, LTD. |
WILLIE YUNG |
K965203 |
03/17/1997 |
RADX SYSTEM |
ELECTRO MEDICAL SYSTEMS, INC. |
STEVEN A CLARKE |
K964385 |
03/06/1997 |
ELIAS ANA-HEP-2 |
ELIAS USA, INC. |
GOTTFRIED KELLERMANN, PH.D. |
K970005 |
03/28/1997 |
GYREX 2T-PRESTIGE |
ELSCINT, INC. |
THOMAS J SPACKMAN |
K961360 |
03/13/1997 |
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM |
ENCORE ORTHOPEDICS, INC. |
ASHLEY BOCK |
K970357 |
03/10/1997 |
EPISCREEN |
EPITOPE, INC. |
CAROLINE R SAYRE, RAC |
K965015 |
03/14/1997 |
TOPAZ 30 SURGICAL LASER SYSTEM |
ESC MEDICAL SYSTEMS, INC. |
HILLEL BACHRACH |
K970079 |
03/11/1997 |
PROXIMATE DISPOSABLE SKIN STAPLER |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
K970424 |
03/06/1997 |
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
K970467 |
03/18/1997 |
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
K970425 |
03/06/1997 |
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
K963894 |
03/11/1997 |
SMARTGUIDE |
FERGUSON MEDICAL |
FRANK FERGUSON |
K964806 |
03/04/1997 |
MD-1835 |
FISCHER IMAGING CORP. |
WILLIAM J ENGEL |
K970240 |
03/11/1997 |
DIFFUSER PANEL |
FOCUSED VIEWER, INC. |
WILLIAM BRAUER, M.D. |
K970293 |
03/21/1997 |
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
ROBERT A UZENOFF |
K970349 |
03/31/1997 |
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
ROBERT A UZENOFF |
K963057 |
03/21/1997 |
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
K970063 |
03/11/1997 |
SERIES 7600 MOBILE DIGITAL C-ARM |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
K962781 |
03/06/1997 |
COROMETRICS MODEL 510 AND 511 MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MARIA V FOUTS |
K964973 |
03/10/1997 |
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR |
GISH BIOMEDICAL, INC. |
JEFF DUMONTELLE |
K964387 |
03/27/1997 |
POINT OF USE II SHARPS-A-GATOR |
GRAPHIC CONTROLS CORP. |
GEORGE AUSTRIA |
K962343 |
03/24/1997 |
TOXO IGG ELISA TEST |
GULL LABORATORIES, INC. |
FRED W RACHFORD, PH.D. |
K964441 |
03/28/1997 |
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU |
GYNECARE INNOVATION CENTER |
MICHAEL A DANIEL |
K961151 |
03/19/1997 |
SPINAL NEEDLES |
HAKKO SHOJI CO., LTD. |
JOHN ROGERS |
K961152 |
03/19/1997 |
TUOHY EPIDURAL NEEDLES |
HAKKO SHOJI CO., LTD. |
JOHN ROGERS |
K964966 |
03/05/1997 |
V-CATH |
HDC CORP. |
GRETCHEN MARCHESANI |
K965051 |
03/12/1997 |
HEARTPORT NEEDLE TROCAR |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
K970161 |
03/25/1997 |
HEDGES CORNEAL WETTING PAK |
HEDGES CWP, INC. |
DAVID JASPAN |
K965163 |
03/19/1997 |
CUTTERSIL COMFORT |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K965165 |
03/19/1997 |
CUTTERSIL COMFORT HARDENER |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K963706 |
03/19/1997 |
PHILIPS SONO DIAGNOST 800 |
HEWLETT-PACKARD CO. |
PAUL SCHRADER |
K970034 |
03/17/1997 |
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM |
HEWLETT-PACKARD CO. |
PAUL SCHRADER |
K965175 |
03/13/1997 |
HOWMEDICA MAINSTAY ANCHOR |
HOWMEDICA CORP. |
JOHN DICHIARA |
K965164 |
03/13/1997 |
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR |
HOWMEDICA CORP. |
MARGARET F CROWE |
K962730 |
03/07/1997 |
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962728 |
03/07/1997 |
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962731 |
03/07/1997 |
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962729 |
03/07/1997 |
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962727 |
03/07/1997 |
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962720 |
03/07/1997 |
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962722 |
03/07/1997 |
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962719 |
03/07/1997 |
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K962578 |
03/07/1997 |
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM, PH.D. |
K965055 |
03/06/1997 |
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES |
IMAGYN MEDICAL, INC. |
DEBRA A RINDERER |
K965077 |
03/17/1997 |
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
K964882 |
03/13/1997 |
IMPLEX REPLACEMENT ACETABULAR CUP INSERT |
IMPLEX CORP. |
JAMES E MALAYTER |
K964877 |
03/20/1997 |
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
K963495 |
03/03/1997 |
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM |
IMZ, GMBH |
ROBEERT J SLOMOFF |
K963522 |
03/03/1997 |
IMZ 2000 INTERLOCK 12/3 - SCREW |
IMZ, GMBH |
ROBERT J SLOMOFF |
K970089 |
03/25/1997 |
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
K963347 |
03/19/1997 |
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
K963698 |
03/20/1997 |
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 |
INTERNATIONAL BIOPHYSICS CORP. |
H. DAVID SHOCKLEY, JR. |
K961835 |
03/12/1997 |
PROTIME MICROCOAGULATION SYSTEM |
INTERNATIONAL TECHNIDYNE CORP. |
ROBERT N BORGHESE |
K963813 |
03/20/1997 |
SURE CORE BIOPSY KIT |
INTERVENTIONAL CONCEPTS, INC. |
WILLIAM E MCPHERSON |
K964524 |
03/18/1997 |
ILT ARGON HP |
ION LASER TECHNOLOGY |
J. RAYMOND KEMPLE |
K970068 |
03/24/1997 |
JELENKO NO.1 (CODE NAME RD-0601) |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
K970643 |
03/18/1997 |
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
K965142 |
03/18/1997 |
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
K970721 |
03/21/1997 |
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM |
JOHNSON & JOHNSON MEDICAL, INC. |
WILLIAM P ROBB |
K965040 |
03/10/1997 |
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL |
JOHNSON & JOHNSON MEDICAL, INC. |
RALPH H LARSEN |
K970427 |
03/11/1997 |
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
K970055 |
03/05/1997 |
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN, PH.D. |
K964117 |
03/14/1997 |
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE |
KAWASUMI LABORATORIES CO., LTD. |
DONALD R STONE |
K963446 |
03/18/1997 |
KENDALL DUAL LUMEN CATHETER |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
K964014 |
03/03/1997 |
KENLOR H. PYLORI CONTROL SERUM |
KENLOR INDUSTRIES, INC. |
KAMALES SOM |
K962376 |
03/21/1997 |
KREATIV KURING LIGHT SYSTEM |
KREATIV, INC. |
CHARLES W WHUTCHINS |
K965091 |
03/27/1997 |
TEETHMATE F-1 |
KURARAY COMPANY, LTD. |
KOJI FUJITA |
K964932 |
03/17/1997 |
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR |
L & M RESOURCE INFORMATION SERVICE, INC. |
MANUEL J AGUIRRE |
K970018 |
03/28/1997 |
FAST TRACT TRANSTRACHEAL PROCEDURE KIT |
L.W. WARD AND ASSOC., INC. |
LEWIS W WARD |
K970518 |
03/21/1997 |
ALGOPLAQUE HYDROCOLLOID DRESSING |
LABORATOIRES URGO S.A. |
EVAN DICK, PH.D. |
K970994 |
03/25/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
KIM AVES |
K970633 |
03/21/1997 |
TUSTEX FLAVORED CONDOMS |
LINE ONE LABORATORIES |
ROBERT GRUBER |
K970696 |
03/18/1997 |
S.P. 100 |
LSI INTL., INC. |
JAMES C LANE |
K955721 |
03/28/1997 |
CUFFED OROPHARYNGEAL AIRWAY (COPA) |
MALLINCKRODT MEDICAL |
ROBERT A BIRAG |
K965132 |
03/20/1997 |
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES |
MALLINCKRODT MEDICAL |
MICHAEL B SCHOECK |
K961986 |
03/13/1997 |
MANAN D BAG |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
K962547 |
03/06/1997 |
CARDIOSERV P |
MARQUETTE ELECTRONICS, INC. |
KRISTIN PABST |
K964962 |
03/06/1997 |
SENTURA SURGICAL GLOVES |
MAXXIM MEDICAL |
JOYCE MOODY |
K964980 |
03/06/1997 |
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM |
MAXXIM MEDICAL |
JOYCE MOODY |
K963388 |
03/11/1997 |
VESSEL DILATOR |
MAXXIM MEDICAL |
RICHARD A HAMER |
K962433 |
03/17/1997 |
MEADOX EXXCEL EPTFE VASCULAR GRAFT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
STEPHEN B ANDERSON |
K960766 |
03/19/1997 |
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
STEPHEN B ANDERSON |
K965070 |
03/06/1997 |
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. |
MECTA CORP. |
ROBIN H NICOL |
K970152 |
03/05/1997 |
BIOPSY TRAY |
MEDCARE MEDICAL GROUP, INC. |
CRAIG J BELL |
K953902 |
03/19/1997 |
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM |
MEDICAL MARKETING INTL., INC. |
EDWARD C CHEEK |
K970597 |
03/24/1997 |
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) |
MEDICAL PACKAGING CORP. |
PATRICIA V WILLIS |
K963775 |
03/26/1997 |
MODEL 8800 ASPIRATOR |
MEDICAL SPECIFICS, INC. |
HOWARD CHILTON |
K970256 |
03/11/1997 |
INTRAORAL MANDIBULAR DISTRACTION DEVICE |
MEDICON, E.G. |
HOWARD M HOLSTEIN, ESQ. |
K965194 |
03/06/1997 |
MEDICOM, TENS ELECTRODES |
MEDICOTEST A/S |
EMALEE G MURPHY |
K970282 |
03/06/1997 |
MEDLINE CIRCUMCISION TRAY |
MEDLINE |
|
K965107 |
03/11/1997 |
MEDLINE ADMISSION KITS |
MEDLINE INDUSTRIES, INC. |
CHRISTINE GALEA |
K970286 |
03/10/1997 |
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K970130 |
03/28/1997 |
HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING |
MEDTREX, INC. |
WILLIAM F MCKAY |
K970479 |
03/31/1997 |
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 |
MEDTRONIC MINIMED |
DON SELVEY |
K965251 |
03/18/1997 |
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM |
MEDTRONIC VASCULAR |
PATRICK L JOHNSON |
K961343 |
03/13/1997 |
MEDVISION PERSONAL MONITOR |
MEDVISION, INC. |
MIKLOS S RUSCHAK |
K944180 |
03/07/1997 |
MODEL 700 |
MEMTEC CORP. |
HAROLD A SANFORD |
K970019 |
03/25/1997 |
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS |
MENICON U.S.A., INC. |
S. WES SIEGNER, JR. |
K965101 |
03/17/1997 |
CARDIOBEEPER CB-12L |
MERIDIAN MEDICAL TECHNOLOGIES, INC. |
SHEILA HEMEON-HEYER |
K964003 |
03/21/1997 |
METAGEN ALL POLY ACETABULAR CUP SYSTEM |
METAGEN, L.L.C. |
WESLEY JOHNSON |
K970044 |
03/05/1997 |
AUROFLUID 22 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K970045 |
03/05/1997 |
SOLARO 33 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K964902 |
03/11/1997 |
CONTACT LENSES METRO-G 3X (HIOXIFILCON B) |
METRO OPTICS OF AUSTIN, INC. |
WALLY STIRLING |
K963198 |
03/05/1997 |
PS-41 6M PATIENT SIMULATOR |
METRON U.S., INC. |
JIM QUINN |
K965170 |
03/11/1997 |
ROCCOBAROCCO & PRO-DYNAMIX |
MICHELANGELO, INC. |
FIDENZIO BIZZOTTO |
K963843 |
03/31/1997 |
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT |
MICRO MOTORS, INC. |
DONNA L FREE |
K970002 |
03/05/1997 |
STERILE WATER PUMP |
MICRO MOTORS, INC. |
CHARLES E STRAIT |
K970826 |
03/28/1997 |
SELECTA-TIP LAPAROSCOPIC SCISSORS |
MICROLINE PENTAX, INC. |
HUGHES DE LAFORCADE |
K970430 |
03/11/1997 |
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI |
MIDWEST CITY HEARING AID CENTER |
FRANKLIN D CARTER |
K965043 |
03/10/1997 |
3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE |
MINNESOTA MINING AND MFG. CO. |
KAREN C MAASS |
K964967 |
03/06/1997 |
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR |
MINNTECH CORP. |
RICHARD GOLDHABER |
K951728 |
03/19/1997 |
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE |
MIRA, INC. |
ROGER R O'BRIEN |
K970262 |
03/31/1997 |
MULTI-CHANNEL COMPRESSION BTE (SD) |
MIRACLE-EAR, INC. |
MELANIE RASKA |
K970360 |
03/10/1997 |
MITEK SUTURE RETROGRADER |
MITEK PRODUCTS |
EDWARD F KENT |
K970521 |
03/31/1997 |
TRX POWER TILT AND RECLINE SYSTEM |
MOTION CONCEPTS |
DAVID HARDING |
K964167 |
03/21/1997 |
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) |
MULTIDATA SYSTEMS INTERNATIONAL CORP. |
ARNE ROESTEL |
K965078 |
03/06/1997 |
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS |
NEURO NAVIGATIONAL CORP. |
KAREN U SALINAS |
K965115 |
03/10/1997 |
ROUND WINDOW CATH |
NEURO-BIOMETRIX, INC. |
MICHAEL H ARENBERG |
K962791 |
03/13/1997 |
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM |
NEW STAR LASERS, INC. |
DAVID R HENNINGS |
K962687 |
03/28/1997 |
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
K965058 |
03/11/1997 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
K962408 |
03/18/1997 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
K970017 |
03/18/1997 |
NIDEK CYBERSCAN |
NIDEK, INC. |
KEN KATO |
K953996 |
03/19/1997 |
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS |
NIKKISO CO. LTD. |
JEFFERY R SHIDERMAN |
K970076 |
03/27/1997 |
NIPRO DISPOSABLE SOLUTION INFUSION SET |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
K954676 |
03/04/1997 |
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS |
NISSHO CORP. |
KAELYN HADLEY |
K964231 |
03/10/1997 |
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
CHARLES E MEISCH |
K964589 |
03/04/1997 |
FLEXILOG 3000 |
OAKFIELD INSTRUMENTS, LTD. |
JOHN GIDDINGS |
K954488 |
03/06/1997 |
ROLLER ELECTRODE |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
K965093 |
03/19/1997 |
OMNITECH RESECTOSCOPE ROLLER ELECTRODE |
OMNITECH SYSTEMS, INC. |
GENE S ESTILL |
K964891 |
03/26/1997 |
ORBSHOT KERATOMETER |
ORBTEK, INC. |
PIER CALACINO |
K965076 |
03/18/1997 |
MDA HEPARIN ANTI-X ASSAY |
ORGANON TEKNIKA CORP. |
RON SANYAL |
K964934 |
03/18/1997 |
THROMBONOSTIKA F1.2 |
ORGANON TEKNIKA CORP. |
RON SANYAL |
K965121 |
03/20/1997 |
CANNULA |
ORIGIN MEDSYSTEMS, INC. |
ANTHONY DURSO |
K951632 |
03/06/1997 |
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
JOANNE HARRIS |
K962565 |
03/20/1997 |
POWERED WHEELCHAIR |
ORTHOFAB, INC. |
RICHARD LAPIERRE |
K964342 |
03/11/1997 |
CYTOPLAST GBR |
OSTEOGENICS CO. |
RICHARD A HAMER |
K964924 |
03/07/1997 |
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K963001 |
03/11/1997 |
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
PERMEABLE TECHNOLOGIES, INC. |
MARTIN S KNOPF |
K970640 |
03/21/1997 |
PHILIPS EASY DIAGNOST |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K962010 |
03/21/1997 |
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
K965176 |
03/04/1997 |
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS |
PILLING WECK GROUP |
KARENANN J BROZOWSKI |
K970377 |
03/31/1997 |
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) |
PLANCON INSTRUMENTS |
ALAIN DUPRAT |
K964224 |
03/19/1997 |
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE |
PMT CORP. |
EDWARD F VALDEZ |
K970560 |
03/11/1997 |
URIC ACID (LIQUID) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR. |
K964979 |
03/11/1997 |
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER |
POROUS MEDIA CORP. |
KEITH A ROBERTS |
K965020 |
03/14/1997 |
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER |
POROUS MEDIA CORP. |
KEITH A ROBERTS |
K970372 |
03/11/1997 |
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS |
PRECISION ENDOSCOPY OF AMERICA, INC. |
DANIEL M HONEYWELL |
K965155 |
03/05/1997 |
LATEX EXAM GLOVES |
PT. IRAMA DINAMIKA LATEX |
ABRAHAM KURIAN |
K963608 |
03/11/1997 |
QUANTITATIVE SENTINEL SYSTEM |
QUANTITATIVE MEDICINE, INC. |
MARIA VITUG FOUTS |
K965182 |
03/12/1997 |
RFG-3CF |
RADIONICS, INC. |
AMY J LAFORTE |
K970232 |
03/21/1997 |
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS |
REGU-TECH ASSOC., INC. |
ROBERT J STAAB |
K970215 |
03/31/1997 |
AUDALLION II HEARING SYSTEM |
RESOUND CORP. |
KRISTA M BUCKLES |
K970537 |
03/28/1997 |
REXTON MODEL 48 AND 49PP |
REXTON, INC. |
DANIEL L ANDERSON |
K970170 |
03/28/1997 |
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE |
RICHARD G. LINDSAY |
RICHARD G LINDSAY |
K970105 |
03/04/1997 |
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K970704 |
03/13/1997 |
PERSONAL CATHETER |
ROCHESTER MEDICAL CORP. |
MARY WILEN |
K950017 |
03/14/1997 |
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM |
ROSS PRODUCTS |
MICHAEWL H HANEY |
K970825 |
03/14/1997 |
BLUE CHIP GERMICIDAL CLEANER & DEODORANT |
S.C. JOHNSON PROFESSIONAL |
ROBERT B O'BRIEN |
K964168 |
03/03/1997 |
PROCEDURE SPECIFIC KITS |
SAGE PRODUCTS, INC. |
KAREN PINTO |
K965087 |
03/18/1997 |
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) |
SANDOZ NUTRITION |
ROBERT J LANG |
K965023 |
03/04/1997 |
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE |
SCIMED LIFE SYSTEMS, INC. |
CONNIE J DEL TORO |
K970244 |
03/28/1997 |
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES |
SCIMED LIFE SYSTEMS, INC. |
CONNIE J DEL TORO |
K970477 |
03/10/1997 |
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT |
SEBIA |
BOREK JANIK, PH.D. |
K965161 |
03/12/1997 |
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) |
SECTRA-IMTEC AB |
HERMAN OOSTERWIJK |
K962327 |
03/06/1997 |
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE |
SEKURE SEAT CORP. |
LAURA ANN REID |
K930683 |
03/04/1997 |
EZTEST-GAS |
SGM BIOMEDICAL, INC. |
JOHN R GILLIS |
K970111 |
03/27/1997 |
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES |
SHANGHAI JIAWANG INDUSTRIAL CO. LTD. |
CHRISTINE GALEA |
K962446 |
03/07/1997 |
SHARPLAN RUBY LASER SYSTEM |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
K970625 |
03/27/1997 |
POLY-MED |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
K964855 |
03/04/1997 |
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH MAXWELL LAKE |
K965238 |
03/19/1997 |
T1 CONTROL HIGH SPEED DENTAL HANDPIECE |
SIEMENS AG |
DIANE E MINEAR |
K963983 |
03/31/1997 |
E. CAM PROFILE ATTENUATION CORRECTION |
SIEMENS CORP. |
PAUL G ORIS |
K965004 |
03/11/1997 |
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JING ZHANG |
K970020 |
03/20/1997 |
SIMAR, INC. SURGICAL DRESSING |
SIMAR, INC. |
FANG XI MEI |
K970100 |
03/10/1997 |
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL |
SIMPLICITY DIAGNOSTICS, INC. |
JEFFREY FLEISHMAN |
K970555 |
03/17/1997 |
IL0292 DP ECHOPORT |
SMITH |
E. J SMITH |
K970151 |
03/18/1997 |
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS |
SMITH & NEPHEW, INC. |
SUSAN A FINNERAN |
K970247 |
03/21/1997 |
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
K965017 |
03/14/1997 |
REGIONAL ANESTHESIA TRAYS |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
TIMOTHY J TALCOTT |
K963273 |
03/11/1997 |
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION |
SMV AMERICA |
TOM BOONE |
K965193 |
03/17/1997 |
LIBERTY ANTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE, PH.D. |
K961707 |
03/11/1997 |
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM |
SORENSON CRITICAL CARE |
R. DOUGLAS JACOB |
K962970 |
03/25/1997 |
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION |
SPACELABS MEDICAL, INC. |
RUSS GARRISON |
K963947 |
03/05/1997 |
EPILASER NORMAL MODE RUBY LASER |
SPECTRUM MEDICAL TECHNOLOGIES, INC. |
SANFORD LANE |
K964404 |
03/26/1997 |
BACFIX SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
ERIN MCGURK |
K964997 |
03/05/1997 |
S-SCORT (2500) |
SSCOR |
L S AY |
K970361 |
03/18/1997 |
LASER EYE GOGGLES |
STEFANOVSKY & ASSOC. |
DAVID W STEFANOVSKY |
K964220 |
03/05/1997 |
REPLACE TITANIUM IMPLANT SYSTEM |
STERI-OSS, INC. |
PAUL GASSER |
K964739 |
03/31/1997 |
STERI-OSS TIODIZED SCREW |
STERI-OSS, INC. |
JEFF HAUSHEER, PH.D. |
K962545 |
03/07/1997 |
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE |
STERILIZATION CASSETTE SYSTEMS, INC. |
STEPHEN F SPENCER |
K970155 |
03/17/1997 |
NEURO-TRAIN II (2) |
STERNE EQUIPMENT CO., LTD. |
TOM WALLACE |
K970613 |
03/18/1997 |
PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) |
STI MEDICAL SDN BHD |
SARASCHANDRAN DAS |
K970807 |
03/14/1997 |
MOBILE OPERATING TABLE 1132.01 |
STIERLEN-MAQUET AG |
REINHARD PFEUFFER |
K962755 |
03/04/1997 |
STRYKER ENCORE STERILIZER |
STRYKER CORP. |
CHAD COBERLY |
K962605 |
03/11/1997 |
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) |
SURGICOT, INC. |
BEN B BROCK |
K962479 |
03/03/1997 |
SYNERMED ISE REAGENTS |
SYNERMED, INC. |
MARCIA J ARENTZ |
K970097 |
03/13/1997 |
PROXIMAL FEMORAL NAIL (PFN) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K964416 |
03/17/1997 |
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM |
SYNTHES (USA) |
DIANE T BROWN |
K963325 |
03/25/1997 |
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K964946 |
03/18/1997 |
SYSMEX CA-1000/SYSMEX CA-5000 |
SYSMEX CORP. |
MARGARET BARRANCO, MA, MT (ASCP) |
K964375 |
03/13/1997 |
SYSMEX SE/RAM-1 |
SYSMEX CORP. |
CATHERINE M TRESTER, MT(ASCP) |
K965189 |
03/24/1997 |
SPINNAKER |
TARGET THERAPEUTICS |
LLOYD GRIESE |
K963268 |
03/18/1997 |
GENESIS RMP |
TECAN U.S., INC. |
CHRISTY LYCAN |
K970120 |
03/24/1997 |
BILE ACIDS REAGENT SET |
TECO DIAGNOSTICS |
ANDREW REAMS |
K970124 |
03/06/1997 |
LIPASE REAGENT SET (COLIPASE METHOD) |
TECO DIAGNOSTICS |
ANDREW REAMS |
K970594 |
03/31/1997 |
KALGINATE IMPRESSION MATERIAL |
TELEDYNE WATER PIK |
MICHAEL J RYAN |
K970042 |
03/14/1997 |
OOLI-U(TONGUE SCRAPER) |
TELEFAX INTL. |
UPEN SHAH |
K965012 |
03/11/1997 |
LIFESTYLE BREAK THRU (POLYMACON) |
THE LIFESTYLE CO., INC. |
LEONARD SEIDNER, OD |
K965059 |
03/04/1997 |
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) |
THOMAS INDUSTRIES |
DAN PFISTER |
K970047 |
03/04/1997 |
PHASED ARRAY TRANSDUCER - - PSK-20CT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
STEVEN M KAY |
K964865 |
03/10/1997 |
PVK-720ST ENDOCAVITARY TRANSDUCER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
STEVEN M KAY |
K961144 |
03/12/1997 |
MS-2000 |
TOURITU ENGINEERING CO., INC. |
JAMES R GREENWOOD, PH.D. |
K962723 |
03/13/1997 |
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
TRACE AMERICA, INC. |
David Johnston |
K970722 |
03/31/1997 |
EYE TRAY |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
K970134 |
03/21/1997 |
THERMAPREP PLUS OVEN |
TULSA DENTAL PRODUCTS, LTD. |
RUSSELL VANDERSLICE |
K970084 |
03/13/1997 |
LINK CERCLAGE WIRE SYSTEM |
TURNKEY INTERGRATION USA, INC. |
DOUGLAS W STUART |
K970114 |
03/14/1997 |
ULTRACAL XS |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
K963051 |
03/28/1997 |
ERCP CANNULA |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER-COHEN |
K970356 |
03/25/1997 |
IRRIGATION/ASPIRATION POLYPECTOMY |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN R YOUNKER |
K970036 |
03/25/1997 |
FIXATION PIN OR ROD |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MELISSA MAZZONI |
K970598 |
03/12/1997 |
INTEGRATED VISUALIZATION SYSTEM |
UROHEALTH, INC. |
RONALD BERGESON |
K955663 |
03/17/1997 |
ABC IN-LINE BLOOD SAMPLING KIT |
UTAH MEDICAL PRODUCTS, INC. |
JOHN W SMITH |
K970140 |
03/28/1997 |
E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH |
VALLEYLAB, INC. |
JOHN DICARO |
K964636 |
03/11/1997 |
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM |
VALLEYLAB, INC. |
CHARLES M COPPERBERG |
K965030 |
03/04/1997 |
BRANNON ARTERIO-VENOUS PORTSYRINGE |
VASCULAR LOGICS, INC. |
JAMES K BRANNON |
K964959 |
03/10/1997 |
VASCUTEK TWILLWEAVE VASCULAR GRAFT |
VASCUTEK LTD. |
TEENA M AUGOSTINO |
K955461 |
03/19/1997 |
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). |
VBM MEDIZINTECHNIK GMBH |
R. DOUGLAS JACOB |
K970538 |
03/25/1997 |
VICTORY EYEWEAR CO |
VICTORY EYEWEAR CO., LTD. |
MICHAEL CHEN |
K963315 |
03/17/1997 |
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE |
VINGMED SOUND, INC. |
WALTER E GUNDAKER |
K964875 |
03/18/1997 |
CMV ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFFE |
K964870 |
03/18/1997 |
RSV ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFF |
K964872 |
03/18/1997 |
VZV ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFFE |
K964555 |
03/31/1997 |
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) |
VITROTEC, INC. |
JAMES TAYLOR |
K963348 |
03/19/1997 |
WALLACH INTEGRATION UNIT |
WALLACH SURGICAL DEVICES, INC. |
RAYMOND A WILEY |
K965131 |
03/26/1997 |
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
WILLIAM L BOTELER JR. |
K965129 |
03/26/1997 |
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
WILLIAM L BOTELER JR. |
K964954 |
03/20/1997 |
SUPERLIGHT |
WHEELCARE SCOOTERS, INC. |
HAROLD GUTTERMAN |
K965254 |
03/12/1997 |
WIDEX MODEL SENSO DIGITAL (C9) |
WIDEX HEARING AID CO., INC. |
RON MELTSNER |
K970904 |
03/26/1997 |
WIDEX SENSO DIGITAL (CIC) |
WIDEX HEARING AID CO., INC. |
RON MELTSNER |
K963587 |
03/24/1997 |
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROBERT CHURINETZ |
K964909 |
03/10/1997 |
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS |
XOMED, INC. |
DAVID TIMLIN |