| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K954575 |
10/02/1995 |
AXSYM TOXO IGG ANTIBODY ASSAY |
ABBOTT LABORATORIES |
JOANNE RUPPRECHT |
| K954576 |
10/02/1995 |
AXSYM TOXO IGM |
ABBOTT LABORATORIES |
JOANNE RUPPRECHT |
| K954691 |
10/11/1995 |
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM |
ACCESS RADIOLOGY CORP. |
CAROLYN S LANGER |
| K954605 |
10/04/1995 |
ACE CYLINDER DENTAL IMPLANT |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K954770 |
10/17/1995 |
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM |
ADVANCED SPINE FIXATION SYSTEMS, INC. |
JAMES A RINNER |
| K954652 |
10/10/1995 |
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
| K954678 |
10/10/1995 |
PRO VISION |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K954987 |
10/31/1995 |
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
ALAN LEWIS |
| K954747 |
10/16/1995 |
NIOMED BARRIER GOWNS |
AMERASIA CORP. |
DAVID SONG |
| K954701 |
10/12/1995 |
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K954876 |
10/24/1995 |
AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K954637 |
10/06/1995 |
AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K954791 |
10/18/1995 |
SEMINAL FLUID COLLECTION KIT II |
APEX MEDICAL TECHNOLOGIES, INC. |
STEFANIE BEDARD |
| K954964 |
10/30/1995 |
AQUACENTER 2000 SYSTEM |
AQUARIUS MEDICAL CORP. |
JEFF CHANDLER |
| K954802 |
10/19/1995 |
RITE-ANGLE DISPOSABLE PROPHY ANGLES |
ASH-USA |
P. JEFFERY LEHN |
| K954864 |
10/23/1995 |
ASLAN MODULAR INSTRUMENT |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
THOMAS J HOOGEBOOM |
| K954875 |
10/24/1995 |
ASPECT ACQUISITION MODULE (AAM) |
ASPECT ELECTRONICS, INC. |
GARY J ALLSEBROOK |
| K954810 |
10/19/1995 |
MYERSON IR DENTURE BASE |
AUSTENAL, INC. |
RONALD DUDEK |
| K954971 |
10/27/1995 |
ACETAL DENTAL/PREFORMED CLASP |
B & H TECHNICAL SERVICES LTD. |
RAYMOND CHINEA |
| K954607 |
10/04/1995 |
RETICULOCYTE METHOD |
BAYER CORP. |
GABRIEL J MURACA |
| K954594 |
10/03/1995 |
RETICULOCYTE METHOD, RBC INDICES |
BAYER CORP. |
GABRIEL J MURACA |
| K954953 |
10/30/1995 |
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
GREGORY W MORGAN |
| K955434 |
10/02/1995 |
ACCESS FOLATE ASSAY (MODIFICATION) |
BECKMAN COULTER, INC. |
KIMNIS WALKER |
| K954930 |
10/26/1995 |
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DENNIS R MERTZ |
| K954923 |
10/26/1995 |
BACTEC FUNGAL MEDIUM |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DAVID R MERTZ |
| K954925 |
10/26/1995 |
BACTEC LYTIC/10 ABAERIBIC/F CULTURE VIALS |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DAVID R MERTZ |
| K954924 |
10/26/1995 |
BACTEC PEDS PLUS CLUTURE VIALS |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DAVID R MERTZ |
| K954927 |
10/26/1995 |
BACTEC PEDS PLUS/F CULTURE VIALS |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DENNIS R MERTZ |
| K954921 |
10/26/1995 |
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DENNIS R MERTZ |
| K954932 |
10/27/1995 |
BBL MGIT PRODUCTS |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
DENNIS R MERTZ |
| K954592 |
10/02/1995 |
VACUTAINER BRAND PST PLASMA SEPARATION TUBE |
BECTON DICKINSON VACUTAINER SYSTEMS |
DENISE DUCHENE |
| K954906 |
10/25/1995 |
FIRST PICC INTRODUCER CATHETER |
BECTON DICKINSON VASCULAR ACCESS, INC. |
C J WELLE |
| K954936 |
10/27/1995 |
BELTONE ULTIMA 80 OTOSONIC POWER PAS |
BELTONE ELECTRONICS CORP. |
ROBERT A KRATOCHVILKK |
| K954928 |
10/26/1995 |
PORTABLE REVERSE OSMOSIS MACHINE |
BETTER WATER, INC. |
MIKE CLINE |
| K954769 |
10/16/1995 |
BIEGLER BW385L BLOOD & INFUSION WARMER |
BIEGLER MEDICAL PRODUCTS, INC. |
MARTIN COSTELLO |
| K954763 |
10/17/1995 |
BIO-INTERFACES, INC,. "BII-PLAST" |
BIO-INTERFACES, INC. |
JOHN F KAY |
| K954954 |
10/30/1995 |
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K954733 |
10/02/1995 |
ACCESS CORTISOL ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
DENNIS GRIFFIN |
| K954825 |
10/20/1995 |
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BIO-RAD LABORATORIES, INC. |
JAN OLSEN |
| K954680 |
10/02/1995 |
ACCESS PROLACTIN ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
DENNIS GRIFFIN |
| K954687 |
10/11/1995 |
ACCESS RUBELLA IGG |
BIO-RAD LABORATORIES, INC. |
CAROLE STAMP |
| K954732 |
10/02/1995 |
ACCESS TOTAL BHCG ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
DENNIS GRIFFIN |
| K955435 |
10/02/1995 |
ACCESS TOTAL T3 ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
DENNIS GRIFFIN |
| K955436 |
10/02/1995 |
ACCESS VITAMIN B12 ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
DENNIS GRIFFIN |
| K954838 |
10/20/1995 |
EZ FIX |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODDGEMAN |
| K954768 |
10/17/1995 |
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD |
BIOLOGICALLY ORIENTED PROSTHESES |
VALERIE GARDNER |
| K954901 |
10/25/1995 |
BIONIKE A/Q PREGNANCY TEST |
BIONIKE LABORATORIES, INC. |
JANIS FREESTONE |
| K954636 |
10/06/1995 |
BLINDE OPTICS |
BLINDE EYEWEAR, INC. |
RACHELLE WALKER |
| K954659 |
10/10/1995 |
MOONSHADES SUNGLASSES |
BLUBLOCKER CORP. |
MARY STANKE |
| K954942 |
10/30/1995 |
NATRACAREN APPLICATOR TAMPON |
BODYWISE (UK), LTD. |
S. P. HEWSON |
| K954833 |
10/20/1995 |
ACCU-CHEK ADVANTAGE TEST STRIPS |
BOEHRINGER MANNHEIM CORP. |
MICHAEL FLIS |
| K954608 |
10/04/1995 |
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH |
BOEHRINGER MANNHEIM CORP. |
BETSY SOARES-MADDOX |
| K954807 |
10/19/1995 |
CEDIA T UPTAKE ASSAY |
BOEHRINGER MANNHEIM CORP. |
BETSY SOARES-MADDOX |
| K954622 |
10/05/1995 |
IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK |
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES |
MICHAEL E KLICPERA |
| K954552 |
10/02/1995 |
RAILWIRE |
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES |
MICHAEL E KLICPERA |
| K954651 |
10/10/1995 |
ELECTRODE RECORDING CATHETER |
BOSTON SCIENTIFIC CORP. |
WANDA M CARPINELLA |
| K954861 |
10/23/1995 |
BRAINLAB CT/X-RAY LOCALIZER |
BRAINLAB MED. COMPUTERSYSTEME GMBH |
MICHAEL BERTRAM |
| K954789 |
10/18/1995 |
BRAINLAB HEADPINS |
BRAINLAB, AG |
STEFAN LIP[PSTREU |
| K954974 |
10/25/1995 |
PACE SAVER LITTLE JUNIOR (MODIFICATION) |
BURKE MOBILITY PRODUCTS |
DUWAYNE KRAMER |
| K954577 |
10/02/1995 |
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS |
C.A.I. INDUSTRIES CORP. |
LU RAO |
| K954850 |
10/23/1995 |
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR |
C.R. BARD, INC. |
DOUGLAS E FERGUSON |
| K954872 |
10/24/1995 |
CANDELA CRYO-PROBE HOLDER |
CANDELA LASER CORP. |
BURTON SALKIN |
| K954934 |
10/27/1995 |
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE |
CANDELA LASER CORP. |
JONATHAN S KAHAN |
| K954913 |
10/03/1995 |
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) |
CARDIOMETRICS, INC. |
SUSAN E OSBORNE-NORIEGA |
| K954631 |
10/06/1995 |
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE |
CERAMED CORP. |
MARK BOWERMAN |
| K954834 |
10/20/1995 |
CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K954548 |
10/02/1995 |
THE CHEN MEDIUM |
CHEN OPHTHALMIC LABORATORIES |
CHUNG-HO CHEN |
| K954565 |
10/02/1995 |
EXPLOR-X (AZTEH) HF |
CHICAGO X-RAY SYSTEMS, INC. |
AL SOSA |
| K954697 |
10/12/1995 |
CIBA CORNING ACS ESTRADIOL-6 ASSAY |
CIBA CORNING DIAGNOSTICS CORP. |
STEVEN R RAKITIN |
| K954589 |
10/03/1995 |
CLARK TUT IMAGE PROCESSING SYSTEM |
CLARK RESEARCH AND DEVELOPMENT, INC. |
MICHAEL S PEARL |
| K954670 |
10/10/1995 |
PRESSORE MONITOR |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
| K954955 |
10/27/1995 |
STORC INTRAUTERINE PRESSURE CATHETER |
CLINICAL INNOVATIONS, INC. |
WM. DEAN WALLACE |
| K954914 |
10/26/1995 |
BREATHE RIGHT NASAL STRIP |
CNS, INC. |
M.W. (ANDY) ANDERSON |
| K954857 |
10/23/1995 |
COMFEEL:ALGINATE FILLER |
COLOPLAST CORP. |
RICHARD A HAMER |
| K954988 |
10/31/1995 |
CRYSTALLESSENCE |
CONFI-DENTAL PRODUCTS CO. |
SHARON A LUTTON |
| K954633 |
10/06/1995 |
CONMED ELECTROSURGICAL GROUNDING PAD |
CONMED CORP. |
IRA D DUESLER |
| K954599 |
10/03/1995 |
CONMED TROGARD ELECTRONIC TROCAR SYSTEM |
CONMED CORP. |
IRA D DUESLER |
| K954871 |
10/24/1995 |
LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM |
CONMED CORP. |
IRA D DUESLER, JR. |
| K954728 |
10/13/1995 |
PROD NO. 01-1694 - 4X4 FOAM DRESSING |
CONTINENTAL MEDICAL LABORATORIES, INC. |
JOSEPH DUNN |
| K954581 |
10/02/1995 |
ARC SERIES |
CONTINENTAL X-RAY CORP. |
OSCAR KHUTORYANSKY |
| K954905 |
10/25/1995 |
CB DIODE/532 LASER SYSTEM |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K954918 |
10/26/1995 |
COMBIDERM ACD |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
MCFORD ZAMORE |
| K954903 |
10/25/1995 |
PEDI VAGINAL ASPIRATOR |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K954595 |
10/03/1995 |
CORDIS BRITE TIP SHEATH INTRODUCER |
CORDIS CORP. |
TAMARA YOUNT |
| K954949 |
10/30/1995 |
TRANSIT INFUSION CATHETER WITH SIDEHOLES |
CORDIS NEUROVASCULAR, INC. |
MARLENE W VALENTI |
| K954688 |
10/11/1995 |
FLOW-COUNT COULTER FLUOROSPHERES |
COULTER CORP. |
MARION S GAIDE |
| K954692 |
10/11/1995 |
CPR PROMPT |
COUNTY LINE LTD. |
TERRY G MAHN |
| K954716 |
10/13/1995 |
DEROYAL INDUSTRIES INFANT HEEL WARMER |
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
DEBRA F MANNING |
| K954820 |
10/20/1995 |
SCALEX 800 |
DENTAMERICA |
JERRY HUANG |
| K954761 |
10/17/1995 |
FINESSE LOW-FUSING PORCELAIN SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K954811 |
10/19/1995 |
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT |
DEPUY, INC. |
SALLY FOUST |
| K954684 |
10/11/1995 |
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT |
DEPUY, INC. |
DAVID A KOTKOVETZ |
| K954630 |
10/06/1995 |
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM |
DEPUY, INC. |
STEVE WENTWORTH |
| K954664 |
10/10/1995 |
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING |
DERMA SCIENCES, INC. |
ROBERT DIGIOVINE |
| K954739 |
10/16/1995 |
DERMAGRAN HYDROPHILIC OINTMENT |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954738 |
10/16/1995 |
DERMAGRAN HYDROPHILIC WOUND DRESSING |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954741 |
10/16/1995 |
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954742 |
10/16/1995 |
DERMAGRAN WET DRESSING (ZINC-SALINE) |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954740 |
10/16/1995 |
DERMAGRAN WOUND DRESSING |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954743 |
10/16/1995 |
DERMAGRAN WOUND DRESSING CLEANER W/ZINC |
DERMA SCIENCES, INC. |
HOWARD ENFIEJIAN |
| K954755 |
10/16/1995 |
COAT-A-COUNT DIRECT ANDROSTENEDIONE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K955440 |
10/23/1995 |
IMMULITE SHBG (MODIFICATION) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K954569 |
10/02/1995 |
IMMULITE THEOPHYLLINE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K954566 |
10/02/1995 |
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K954784 |
10/17/1995 |
DRYSIDE NEISSERIA |
DIFCO LABORATORIES, INC. |
DAVID W GATES |
| K954783 |
10/17/1995 |
DRYSLIDE CARTARRHALIS |
DIFCO LABORATORIES, INC. |
DAVID W GATES |
| K954826 |
10/20/1995 |
DISETRONIC MULTIFUSE PUMP SYSTEM |
DISETRONIC MEDICAL SYSTEMS |
ROBERT CERZA |
| K954983 |
10/31/1995 |
EXTENSION SET WITH CHECK VALVE |
DISTRONIC STERILE PRODUCTS, INC. |
JOYCE MCDOUGALL |
| K954984 |
10/31/1995 |
MINIBORE STOPCOCK SET |
DISTRONIC STERILE PRODUCTS, INC. |
JOYCE MCDOUGALL |
| K954611 |
10/04/1995 |
DRAGER PT4000 PHOTOTHERAPY SYSTEM |
DRAGER, INC. |
HARALD KNEUER |
| K954842 |
10/23/1995 |
D.O.R.C. VFI/VFE SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K954926 |
10/26/1995 |
HM-CAP CONTROL PANEL |
E-Z-EM, INC. |
GARY LEHNUS |
| K954718 |
10/13/1995 |
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE |
ELLMAN INTL., INC. |
RICHARD C LANZILLOTTO |
| K954703 |
10/12/1995 |
MEDI-FRIG |
ELLMAN INTL., INC. |
RICHARD C LANZILLOTTO |
| K954788 |
10/18/1995 |
EUREDUC PNEUMATIC DRAINAGE SYSTEM |
EUREDUC |
PHILIPPE JOUBERT |
| K954945 |
10/30/1995 |
HANEL MAVIG MONITOR SUSPENSION SYSTEM |
F. WALTER HANEL GMBH |
MARY M MCNAMARA |
| K954757 |
10/16/1995 |
FIXANO D.D.S. (DOUBLE SLIDING SCREW) |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K954756 |
10/16/1995 |
FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K954773 |
10/13/1995 |
QUICKELS QS 100 SYSTEM |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K954772 |
10/13/1995 |
QUICKELS QS 200 SYSTEM |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K954867 |
10/24/1995 |
IONOSIT SEAL |
FOREMOST DENTAL MFG., INC. |
D. T. WOLF |
| K954707 |
10/12/1995 |
BRONCHOSCOPE |
FUJINON, INC. |
GARY A ADLER |
| K954774 |
10/17/1995 |
SHIELDED TROCAR (OBTURATOR) |
GABRIS SURGICAL CORP. |
BARBARA E KENNY |
| K954623 |
10/05/1995 |
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) |
GAMBRO HEALTHCARE |
MATHEW M HULL |
| K954564 |
10/02/1995 |
PID-1 PRECISION INTELLIGENT DOSIMETER |
GAMMEX, INC. |
THOMAS A DEMKE |
| K954666 |
10/10/1995 |
MPH50, MPH65, AND MPH80 |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K954874 |
10/24/1995 |
SPECTEF PROTOCOL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K954828 |
10/20/1995 |
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT |
GIBECK, INC. |
BRIAN GRIGSBY |
| K954549 |
10/02/1995 |
SURGICAL APPAREL |
GLOBAL HEALTHCARE, INC. |
ALAM AHMED |
| K954665 |
10/10/1995 |
GLYCAR STAPLE STRIPS |
GLYCAR, INC. |
DIRK A FRATER |
| K954995 |
10/31/1995 |
QUIX RAPID CHOLERA STRIP TEST |
GUARDIAN SCIENTIFIC, CORP. |
KATHRYN B POWERS |
| K954993 |
10/31/1995 |
QUIX RAPID PREGNANCY STRIP TEST |
GUARDIAN SCIENTIFIC, CORP. |
KATHRYN B POWERS |
| K954994 |
10/31/1995 |
TRUST |
GUARDIAN SCIENTIFIC, CORP. |
KATHRYN B POWERS |
| K954967 |
10/30/1995 |
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
KATHY SALFINGERE |
| K954911 |
10/25/1995 |
OMEGA ULTRASCAN |
GYNE-TECH INSTRUMENT CORP. |
J. KERMIT FLOYD |
| K954648 |
10/10/1995 |
FEMRX OPERASTAR SYSTEM |
GYNECARE INNOVATION CENTER |
MICHAEL A DANIEL |
| K954775 |
10/17/1995 |
FLO-STAT FLUID MONITORING SYSTEM |
GYNECARE INNOVATION CENTER |
MICHAEL A DANIEL |
| K954562 |
10/02/1995 |
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT |
GYNETECH, INC. |
WILLIAM J DUNN |
| K954976 |
10/27/1995 |
POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) |
HEALEX PRODUCTS, INC. |
MILTON HODOSH |
| K954604 |
10/04/1995 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY |
HEART TECHNOLOGY MFG., INC. |
DIANE JOHNSON |
| K954860 |
10/23/1995 |
ECHONET |
HEARTLAB, INC. |
RICHARD PETROCELLI |
| K954723 |
10/13/1995 |
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT |
HELIX DIAGNOSTICS, INC. |
VIRGINIA L CAPPEL |
| K954700 |
10/12/1995 |
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT |
HELIX DIAGNOSTICS, INC. |
VIRGINIA L CAPPEL |
| K954929 |
10/25/1995 |
CHARISMA SINGLE DOSE |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K954957 |
10/27/1995 |
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION |
HEWLETT-PACKARD CO. |
NANCY WINN |
| K954668 |
10/10/1995 |
HP ECHO IMAGE MANAGEMENT SYSTEM |
HEWLETT-PACKARD CO. |
ROB BUTLER |
| K954980 |
10/31/1995 |
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO |
HEWLETT-PACKARD CO. |
NANCY WINN |
| K954835 |
10/20/1995 |
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET |
HOLGRATH MEDICAL TECHNOLOGIES, INC. |
ROBERT P HENDERSHOT |
| K954621 |
10/05/1995 |
RECLOSABLE WOUND COVER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K954787 |
10/18/1995 |
ILLUMINATOR |
HOSPITAK, INC. |
WILLIAM LACCY |
| K954554 |
10/02/1995 |
ALTA TIBIAL/HUMERAL ROD |
HOWMEDICA CORP. |
JOHN DICHIARA |
| K954559 |
10/02/1995 |
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K954667 |
10/10/1995 |
MONOTUBE TUBE-TO-TUBE CLAMP |
HOWMEDICA CORP. |
JOHN DICHIARA |
| K954895 |
10/25/1995 |
HYTEC AUTOIMMUNE KIT (JO-1) |
HYCOR BIOMEDICAL, INC. |
THOMAS M LI |
| K954893 |
10/25/1995 |
HYTEC AUTOMIMMUNE KIT (DS-DNA) |
HYCOR BIOMEDICAL, INC. |
THOMAS M LI |
| K954892 |
10/25/1995 |
HYTEC AUTOMIMMUNE KIT (RF) |
HYCOR BIOMEDICAL, INC. |
THOMAS M LI |
| K954890 |
10/25/1995 |
HYTEC AUTOMMUNE KIT (ENA) |
HYCOR BIOMEDICAL, INC. |
THOMAS M LI |
| K954813 |
10/19/1995 |
ICU EXTENSION KIT |
ICU MEDICAL, INC. |
RICHARD WATERS |
| K954713 |
10/10/1995 |
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) |
IDEAS FOR MEDICINE, INC. |
ELIZABETH M PAUL |
| K954854 |
10/23/1995 |
INTERMOORE FRACTURE HIP STEM |
INTERMEDICS ORTHOPEDICS |
JACQUELYN HUGHES |
| K954719 |
10/13/1995 |
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
LORI KLEINSCHRODT HOLDER |
| K954610 |
10/04/1995 |
MODEL 430-07 ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
ALAN D TOTAH |
| K954837 |
10/20/1995 |
DW260 19 |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSCO |
| K954647 |
10/10/1995 |
INCLINOMETER |
J-TECH, INC. |
J. TRACY LIVINGSTON |
| K954737 |
10/16/1995 |
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE |
J-TECH, INC. |
TRACY LIVINGSTON |
| K954933 |
10/27/1995 |
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
YVONNE E MIDDLEFELL |
| K954851 |
10/23/1995 |
BIOPOLAR FORCEPS LINE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
SIGALIT CARON |
| K954699 |
10/12/1995 |
BRAY RONGEUR |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
SIGI CARON |
| K954935 |
10/27/1995 |
S-ROM FEMORAL HIP STEM - SIZE 14 X 8 |
JOINT MEDICAL PRODUCTS CORP. |
AMY WALTERS |
| K954981 |
10/31/1995 |
KARL STORZ HEMPFLING DILATION SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K954910 |
10/25/1995 |
KARL STORZ OPTICAL MEDIASTINOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K954797 |
10/18/1995 |
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K954982 |
10/31/1995 |
KSEA SCALP BLOOD COLLECTION SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIKA ANDERSON |
| K954561 |
10/02/1995 |
XENON NOPPVA |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
BETTY M JOHNSON |
| K954674 |
10/10/1995 |
P1OP2B OR P1O92T |
KAY BORCH A/S |
MICHAEL MOSEGAARD |
| K954798 |
10/18/1995 |
7100 SWALLOWING WORKSTATION |
KAY ELEMETRICS CORP. |
WILLIAM D HARBESON |
| K954706 |
10/12/1995 |
KENDALL BLUNT TUOHY EPIDURAL NEEDLE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K954781 |
10/17/1995 |
KOWA GENESIS HAND-HELD FUNDUS CAMERA |
KOWA OPTIMED, INC. |
SAMIA N RODRIGUEZ |
| K954782 |
10/17/1995 |
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B |
KOWA OPTIMED, INC. |
SAMIA N RODRIGUEZ |
| K954780 |
10/17/1995 |
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C |
KOWA OPTIMED, INC. |
SAMIA N RODRIGUEZ |
| K954609 |
10/04/1995 |
HEARTSTART 911 |
LAERDAL MEDICAL CORP. |
KENNETH B HERLAND |
| K954771 |
10/17/1995 |
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) |
LAERDAL MEDICAL CORP. |
KEN HERLAND |
| K954865 |
10/23/1995 |
RESTORE HA DENTAL IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
LYNN CUPERUS |
| K954819 |
10/20/1995 |
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
LYNN CUPERUS |
| K954682 |
10/11/1995 |
WASHER, BOLT, NUT, ORTHOPEDIC |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K954887 |
10/16/1995 |
STERILE WATER O.9% STERILE SALINE |
LOCKETT MEDICAL CORP. |
DENISE TREACY |
| K954760 |
10/17/1995 |
LMI ARTERIAL EMBOLECTOMY CATHETER |
LUCAS MEDICAL, INC. |
DANIEL LUCAS |
| K954792 |
10/18/1995 |
LUMISCOPE MODEL 2018 THERMOMETER |
LUMISCOPE CO., INC. |
THOMAS C PARNELL |
| K954749 |
10/16/1995 |
MALLINCKRODT SHILEY 15MM CAP |
MALLINCKRODT MEDICAL |
MICHAEL B SCHOECK |
| K954593 |
10/03/1995 |
THE AIRCEL SYSTEM |
MARCON GROUP, INC. |
DANIEL J MANELLI |
| K954852 |
10/23/1995 |
SOLAR 9000 ANESTHESIA INFORMATION MONITOR |
MARQUETTE ELECTRONICS, INC. |
DIANNE SCHMITZ |
| K954736 |
10/16/1995 |
ACCESS (POWERCLAVE) |
MDT BIOLOGIC CO. |
CHARLES O HANCOCK |
| K954940 |
10/30/1995 |
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE |
MDT BIOLOGIC CO. |
CHARLES O HANCOCK |
| K954848 |
10/23/1995 |
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
CAROLYN TAUBER |
| K954869 |
10/24/1995 |
MEDCARE YANKAUER SUCTION DEVICE |
MEDCARE CUSTOM PACKAGING, INC. |
CRAIG J BELL |
| K954970 |
10/30/1995 |
STOPCOCK & LUER LOCK PLUG |
MEDEX, INC. |
JOHN C TOOMEY |
| K954584 |
10/02/1995 |
RACZ EPIDURAL CATHETER |
MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. |
DONALD R HENDERSON |
| K954824 |
10/20/1995 |
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE |
MEDICAL CREATIVE TECHNOLOGIES, INC. |
PERK CROOK |
| K954952 |
10/30/1995 |
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL |
MEDRAD, INC. |
RODNEY J RYLANDS |
| K954705 |
10/12/1995 |
ACRYSTEEL BLOCKING TRAY |
MEDTEC, INC. |
DONALD F RIIBE |
| K954969 |
10/30/1995 |
POLYFIN QR SUBCUTANEOUS INFUSION SET |
MEDTRONIC MINIMED |
TERRANCE H GREGG |
| K954809 |
10/19/1995 |
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 |
MEDTRONIC VASCULAR |
VALERIE K STUHR |
| K954866 |
10/24/1995 |
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR |
MERCURY MEDICAL |
KATHY L HANN |
| K954919 |
10/26/1995 |
MEROCEL SOFT WOUND DRESSING |
MEROCEL CORP. |
DAVID TIMLIN |
| K954702 |
10/12/1995 |
IMPLANTALOY |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K954812 |
10/19/1995 |
LYFO(TM) DIFFERIENTAL DISK-PYR |
MICRO BIO LOGICS, INC. |
GERI HOTZ |
| K954626 |
10/03/1995 |
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION) |
MICROGENICS CORP. |
PATRICIA KLIMLEY |
| K954904 |
10/25/1995 |
MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER |
MICROQUARTZ MEDICAL, INC. |
JOE D BROWN |
| K954641 |
10/10/1995 |
ENDO-LEADER |
MICROSURGE, INC. |
MARY M MCNAMARA |
| K954642 |
10/10/1995 |
HYDRO-SELECT GUIDEWIRE |
MICROVENA CORP. |
JODI LOCHER |
| K954883 |
10/20/1995 |
FREE FLOW SAFETY DEVICE |
MIGADA, INC. |
ZVI LEVINHAR |
| K954745 |
10/16/1995 |
MILL-ROSE RIGID SCOPE CLEANING BRUSHES |
MILL-ROSE LABORATORY |
ALAN C POJE |
| K954900 |
10/25/1995 |
3M RED DOT ECG LEAD WIRES A |
MINNESOTA MINING AND MFG. CO. |
LINDA JOHNSON |
| K954941 |
10/30/1995 |
MIRACLE EAR AND AUDIOTONE |
MIRACLE-EAR, INC. |
MELANIEK RASKA |
| K954803 |
10/19/1995 |
BLOOD GAS MIXTURES |
MITTLER SUPPLY, INC. |
DAVID FINNEY |
| K954804 |
10/19/1995 |
LUNG DIFFUSION MIXTURES |
MITTLER SUPPLY, INC. |
DAVID FINNEY |
| K954920 |
10/26/1995 |
MUREX RUB-EX |
MUREX DIAGNOSTICS, INC. |
ROBERT K SHOCKLEY |
| K954959 |
10/27/1995 |
CAP-AID |
NEBL, INC. |
JEFFREY A DANN |
| K954931 |
10/25/1995 |
NEO-MED DLS-1100 |
NEO-LABORATORIES, LLC. |
CHERYL M COSTER |
| K954938 |
10/30/1995 |
DISPOSABLE NEUROVIEW OPERATING SHEATH |
NEURO NAVIGATIONAL CORP. |
KAREN U SALINAS |
| K954899 |
10/25/1995 |
RIGID NEUROVIEW ENDOSCOPE |
NEURO NAVIGATIONAL CORP. |
KAREN U SALINAS |
| K954676 |
10/10/1995 |
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS |
NISSHO CORP. |
KAELYN HADLEY |
| K954943 |
10/30/1995 |
NEVOSCOPE |
NIZAR A. MULLANI |
NIZAR A MULLANI |
| K954614 |
10/05/1995 |
EOS BRAND DISPOSABLE PROCTOSCOPE |
NORTH EOS INDUSTRIES, INC. |
SARA CHEN |
| K954710 |
10/12/1995 |
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K954722 |
10/13/1995 |
MICRO-DISPENSER 7000 & MICRODISPENSER 8000 |
NOUVAG AG |
HOWARD M HOLSTEIN |
| K954847 |
10/23/1995 |
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES |
OCG SYSTEMS, INC. |
FREDRIC I ORKIN |
| K954846 |
10/23/1995 |
OLYMPIC SMART SCALE |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K955357 |
10/23/1995 |
OLYMPIC SMART SCALE MODEL 50/50RA |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K954877 |
10/24/1995 |
OMNI COLD GEL PACKS |
OMNI THERM, INC. |
MATT WALTERS |
| K954829 |
10/20/1995 |
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954831 |
10/20/1995 |
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954814 |
10/19/1995 |
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954830 |
10/20/1995 |
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954815 |
10/19/1995 |
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954832 |
10/20/1995 |
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY |
ORGENTEC |
RICHARD CONLEY |
| K954570 |
10/02/1995 |
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
JOANNE HARRIS |
| K954598 |
10/03/1995 |
OSTEONICS OFFSET HIP STEMS |
OSTEONICS CORP. |
TERRY JAROSZ |
| K954794 |
10/18/1995 |
OTICON |
OTICON, INC. |
PREBEN BRUNVED |
| K954730 |
10/16/1995 |
BENCHMARK TRANSFER TEST |
P.K. MORGAN LTD. |
R. H JKERNAGHAN |
| K954731 |
10/16/1995 |
OXYLOG 2 |
P.K. MORGAN LTD. |
R. H KERNAGHAN |
| K954714 |
10/02/1995 |
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) |
PACESETTER, INC. |
PAUL MASON |
| K954551 |
10/02/1995 |
DF-1 TERMINAL CAP |
PACESETTER, INC. |
JACQUELINE J JACKSON |
| K954841 |
10/23/1995 |
MODEL D-285N ADMINISTRATION SET |
PATIENT SOLUTIONS, INC. |
TOM KANE |
| K954991 |
10/31/1995 |
PHASE CHANGE DENTAL LUBRICANT |
PHASE CHANGE |
J. A GURNEY |
| K954646 |
10/10/1995 |
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K954939 |
10/30/1995 |
MEDPOR OCULAR SCREW & ACCESSORIES |
POREX SURGICAL, INC. |
HOWARD A MERCER |
| K955946 |
10/27/1995 |
ACETAL DENTAL/PREFORMED CLASP |
PRESSING DI MONTICELLI RAG. STEFANO |
STEFANO MONTICELLI |
| K954571 |
10/02/1995 |
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K954671 |
10/10/1995 |
THE FREEDOM BED |
PROBED MEDICAL TECHNOLOGIES, INC. |
STEVE PLUMMER |
| K954596 |
10/03/1995 |
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM |
PROMEDICAL LTD. |
HENRY V SIERAKOWSKI |
| K954669 |
10/10/1995 |
FEMOSTOP, FEMOSTOP PUMP |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K954612 |
10/05/1995 |
ABL SYSTEM 625, 615, 605 |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K954752 |
10/16/1995 |
PEDIATRIC EUROPHYLIC FOLEY CATHETER |
REGULATORY & MARKETING SERVICES, INC. |
PATRICK J LAMB |
| K954568 |
10/02/1995 |
THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS |
REIF WHEELCHAIRS AND ACCESSORIES, INC. |
RICHARD E REIFF |
| K954986 |
10/31/1995 |
GC BASE W/ 1% GCHI |
REMEL, L.P. |
MARY ANN SILVIUS |
| K954572 |
10/02/1995 |
MAESTRO CLINICAL REMOTE CONTROL |
RESPIRONICS, INC. |
RICHARD G CONFER |
| K954922 |
10/26/1995 |
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS |
REXTON, INC. |
DAN ANDERSON |
| K954799 |
10/18/1995 |
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K954992 |
10/31/1995 |
ROCHE COBAS INTEGRA REAGENT CASSETTES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K954655 |
10/10/1995 |
ROCHE CONTROL SERUM N |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K954656 |
10/10/1995 |
ROCHE CONTROL SERUM P |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K954585 |
10/02/1995 |
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE |
RUSCH INTL. |
NEIL R ARMSTRONG |
| K954729 |
10/13/1995 |
PEN-INJECT 2.25 |
SCANDINAVIAN HEALTH LTD. |
THOMAS SCARLETT |
| K955085 |
10/26/1995 |
HM-CAP EIA TEST (MODIFICATION) |
SCHIFF & CO. |
GARY LEHNUS |
| K954845 |
10/23/1995 |
EXPANDACELL INJECTO-PAK NASAL PACK |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH M LAKE |
| K954880 |
10/17/1995 |
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) |
SIAM SEMPERMED CORP. LTD. |
DON MORRIS |
| K954632 |
10/06/1995 |
SIEMENS SC 9000 ETCO2 MODULE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
THOMAS CONNELLY |
| K954840 |
10/20/1995 |
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K954839 |
10/20/1995 |
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K954870 |
10/24/1995 |
SIMS DELTEC ANTI-SIPHON VALVE |
SIMS DELTEC, INC. |
DAVID SHORT |
| K954989 |
10/31/1995 |
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
SMITH & NEPHEW DYONICS, INC. |
DEBORAH J CONNORS |
| K954627 |
10/06/1995 |
ECTRA II LIGAMENT RELEASE SYSTEM |
SMITH & NEPHEW DYONICS, INC. |
ELIZABETH A RYAN |
| K954909 |
10/25/1995 |
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L CRAIG |
| K954696 |
10/12/1995 |
ROGOZINSKI THORACOLUMBAR SPINAL ROD |
SMITH & NEPHEW RICHARDS, INC. |
JEFF COBB |
| K954717 |
10/13/1995 |
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY |
SODEM DIFFUSION SA |
ROSINA ROBINSON |
| K955471 |
10/10/1995 |
INCL ENDOSCOPE |
SOFAMOR DANEK USA,INC. |
RICHARD W THREHARNE |
| K954645 |
10/10/1995 |
TITANIUM GDLH POSTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K954962 |
10/30/1995 |
SPACELABS MEDICAL MULTIGAS ANALYZER |
SPACELABS, INC. |
RUSS GARRISON |
| K954766 |
10/17/1995 |
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
WANDA J TOTTON |
| K954759 |
10/17/1995 |
FLOWMATE LTE |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
TERRY BADGER |
| K954816 |
10/20/1995 |
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX |
STORZ INSTRUMENT CO. |
MICHAEL H SOUTHWORTH |
| K954720 |
10/13/1995 |
STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS |
STRATO/INFUSAID, INC. |
CRAIG M AUDET |
| K954690 |
10/11/1995 |
STRYKER ORAL MAX SYSTEM |
STRYKER CORP. |
TAMMY LOUNDS |
| K954758 |
10/16/1995 |
ROOTFORM DENTAL IMPLANT SYSTEM |
SWISS DENTAL CENTER |
LES PHILLIPS |
| K954689 |
10/11/1995 |
CONNECT |
SYBRON DENTAL SPECIALTIES, INC. |
JEFFREY A ANDERSON |
| K954762 |
10/17/1995 |
NEXUS |
SYBRON DENTAL SPECIALTIES, INC. |
JEFFREY A ANDERSON |
| K954827 |
10/20/1995 |
SEALITE FL |
SYBRON DENTAL SPECIALTIES, INC. |
JEFFREY A ANDERSON |
| K954708 |
10/12/1995 |
SILANE PRIMER |
SYBRON DENTAL SPECIALTIES, INC. |
JEFFERY A ANDERSON |
| K954643 |
10/10/1995 |
TRY-IN GEL |
SYBRON DENTAL SPECIALTIES, INC. |
JEFFERY A ANDERSON |
| K954856 |
10/23/1995 |
CANNULATED FEMORAL NAIL |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K954963 |
10/30/1995 |
SCHUHLI IMPLANT SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K954662 |
10/10/1995 |
THERMALASTIC/TRIPOLYVINALENE |
TAK SYSTEMS |
MICHAEL DIESOO |
| K954951 |
10/30/1995 |
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE |
TAYLOR INDUSTRIES, INC. |
MICHAEL BALLARD |
| K954968 |
10/27/1995 |
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST |
TCPI, INC. |
FRAN WHITE |
| K954685 |
10/11/1995 |
URITEST - NITRITE IN URINE TEST |
TCPI, INC. |
FRAN WHITE |
| K954801 |
10/19/1995 |
TECHFIL |
TECHNIMECA MEDIC, INC. |
JACQUES ROBERGE |
| K954977 |
10/16/1995 |
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) |
TECO DIAGNOSTICS |
K.C. CHEN |
| K954579 |
10/02/1995 |
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION |
TELEX COMMUNICATIONS, INC. |
TOM SCHELLER |
| K954556 |
10/02/1995 |
SURGICAL CAP |
THAI DISPOSABLE PRODUCTS CO., LTD. |
THAWATCHAI MATURAPORN |
| K955084 |
10/19/1995 |
ASPACH 65,000 (MODIFICATION) |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH |
| K954990 |
10/31/1995 |
DENTAL DAM |
THE HYGENIC CORP. |
HANK JUSKE |
| K954634 |
10/06/1995 |
RADIOSURGERY VERIFICATION PHANTOM |
THE PHANTOM LABORATORY, INC. |
JOSHUA R LEVY |
| K954734 |
10/03/1995 |
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) |
THE TULIP MFG. CO. |
RICHARD S HUNTER |
| K954679 |
10/10/1995 |
THERAPLAN PLUS |
THERATRONICS, INC. |
E. S MARTELL |
| K954855 |
10/23/1995 |
POWDER FREE PLUS PATIENT EXAMINATION GLOVE |
TILLOTSON HEALTHCARE CORP. |
IMOGENE TIBBETTS |
| K954574 |
10/02/1995 |
PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES |
TILLOTSON HEALTHCARE CORP. |
IMOGENE TIBBETTS |
| K954573 |
10/02/1995 |
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES |
TILLOTSON HEALTHCARE CORP. |
IMOGENE TIBBETTS |
| K954590 |
10/02/1995 |
MAX-1000A/R1 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
JAVAD SEUEDZADEH |
| K954591 |
10/02/1995 |
AIA-PACK CORT ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K954795 |
10/18/1995 |
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES |
TREBAY MEDICAL CORP. |
DAN H TREACE |
| K954796 |
10/18/1995 |
MICRO-INGRESSOR HANDIPIECE |
TREBAY MEDICAL CORP. |
DAB H TREACE |
| K954715 |
10/12/1995 |
MICRO-PLANER HANDPIECE |
TREBAY MEDICAL CORP. |
DAN H TREACE |
| K954912 |
10/23/1995 |
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) |
TREBAY MEDICAL CORP. |
DAN H TREACE |
| K954597 |
10/03/1995 |
RIGHT ANGLE LASER FIBERS |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K954790 |
10/19/1995 |
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS |
TULSA DENTAL PRODUCTS, LTD. |
RUSSELL VANDERSLICE |
| K954746 |
10/16/1995 |
PHACO TIP |
U.S. IOL, INC. |
GLEN A DUNKI-JACOBS |
| K954818 |
10/20/1995 |
CONSENSUS POSTERIOR STABILIZED KNEE |
U.S. MEDICAL PRODUCTS, INC. |
WILLIAM N THOMPSON |
| K954693 |
10/11/1995 |
MEHTA BRONCHIAL BIOSPY DRILL |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER |
| K954879 |
10/13/1995 |
PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION) |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER |
| K954776 |
10/06/1995 |
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER |
| K954853 |
10/23/1995 |
AUTO SUTURE SUTURE CLOSURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K954808 |
10/19/1995 |
USSC POLYPROPLENE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JOHNATHAN GILBERT |
| K954753 |
10/16/1995 |
PEDIATRIC SILICONE ENDOTRACHEAL TUBE |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K954750 |
10/16/1995 |
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K954751 |
10/16/1995 |
SILICONE ENDOTRACHEAL TUBE |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K954754 |
10/16/1995 |
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K954619 |
10/05/1995 |
CORDGUARD II |
UTAH MEDICAL PRODUCTS, INC. |
KEVIN L CORNWELL |
| K954972 |
10/27/1995 |
LYELL SOUND |
VENTURE MANAGEMENT CORP. |
GENE ZAMBA |
| K954884 |
10/23/1995 |
PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 |
VINGMED SOUND, INC. |
WALTER E GUNDAKER |
| K954658 |
10/10/1995 |
PERNECZKY CLIP APPLIER/REMOVER |
VON ZEPPELIN GMBH |
DIETER VON ZEPPELIN |
| K954638 |
10/06/1995 |
5 FR PICC-LINE CATHETER |
VYGON CORP. |
ANNE MARIE CESARIO |
| K954657 |
10/10/1995 |
WAKO AUTOKIT APO B |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K954639 |
10/10/1995 |
SUNGLASSES |
WALMART STORES |
SUSAN DUFFY |
| K954704 |
10/12/1995 |
VS-200 VIDEO SIGMOIDOSCOPE |
WELCH ALLYN, INC. |
LAWRENCE E MAROCCO |
| K954603 |
10/04/1995 |
DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT |
WESLEY JESSEN CORP. |
RICK MAIN |
| K954748 |
10/16/1995 |
POCKETALKER PRO |
WILLIAMS SOUND, LLC |
PAUL INGEBRIGTSEN |
| K954649 |
10/10/1995 |
WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP |
WILSON GREATBATCH TECHNOLOGIES, INC. |
COLIN P HART |
| K954823 |
10/20/1995 |
VENIPUNCTURE KIT |
WINFIELD INDUSTRIES |
DAVID OLMSTEAD |
| K954683 |
10/11/1995 |
QUESTLOCK ACL FIXATOR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CLIFF R KLINE |
| K954735 |
10/16/1995 |
ENTERALITE |
ZEVEX INTL., INC. |
DAN REIGLE |
| K954915 |
10/26/1995 |
FLEXIBLE INTRAMEDULLARY REAMER |
ZIMMER, INC. |
LYNNETTE WHITAKER |
| K954698 |
10/12/1995 |
TRILOGY ACETABULAR COMPONENT 7MM OFFSET |
ZIMMER, INC. |
THEODORE M WENDT |
| K954555 |
10/02/1995 |
VERSA-FX FEMORAL FIXATION SYSTEM |
ZIMMER, INC. |
LYNNETTE WHITAKER |
| K954744 |
10/16/1995 |
ZCH ALPHA SYSTEM |
ZIMMER, INC. |
ANGIE IDE |
| K954661 |
10/10/1995 |
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER, |
ZIPPER MEDICAL, INC. |
GREG DOLL |
| K954965 |
10/30/1995 |
ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES |
ZOMED INTL. |
THOMAS C WEHMAN |
