| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K972823 |
10/10/1997 |
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER |
A & A MEDICAL, INC. |
ADIB KHOURY |
| K973579 |
10/28/1997 |
AM SERIES HEARING AID |
A & M HEARING, LTD. |
MARIA E BONILLA |
| K972607 |
10/10/1997 |
PLATALLOY |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K973265 |
10/16/1997 |
VERABOND 2V |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K973811 |
10/21/1997 |
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) |
ABSOLUTE QUALITY LEADERSHIP, INC. |
DONNA DI GANGI |
| K972718 |
10/01/1997 |
M-2 ANTERIOR PLATE SYSTEM |
ACROMED CORP. |
GREG CANNEDY |
| K971980 |
10/23/1997 |
MCD-AC |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K972763 |
10/20/1997 |
HEMAPROMPT |
AERSCHER DIAGNOSTICS |
ROBERT SCHREIBER |
| K972789 |
10/17/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972780 |
10/20/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972786 |
10/17/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972746 |
10/21/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972787 |
10/17/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972779 |
10/20/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972801 |
10/21/1997 |
ALLIANCE RUBBER, EC-GRIP |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K971015 |
10/22/1997 |
AHCS HEMOPERFUSION SYSTEM |
AMERICAN HEALTH CARE SYSTEMS, INC. |
EARL G SCHMIT |
| K972561 |
10/06/1997 |
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY |
AMERICAN LASER MEDICAL |
DANIEL HOEFER |
| K972765 |
10/21/1997 |
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER |
AMERICAN LASER MEDICAL |
DANIEL HOEFER |
| K971576 |
10/16/1997 |
REJOYN PENILE SUPPORT SYSTEM |
AMERICAN MEDTECH |
DONALD R STONE |
| K973142 |
10/20/1997 |
DBEST REAGENT STRIP FOR URINALYSIS |
AMERITEK, INC. |
K.C. YEE |
| K972862 |
10/31/1997 |
AMPLAID 171S |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K973107 |
10/02/1997 |
AMSINO I.V. ADMINISTRATION SET |
AMSINO INTL., INC. |
RICHARD Y LI |
| K972918 |
10/27/1997 |
RAPID FIRE HAIR IMPLANTER CAROUSEL |
APEX MEDICAL PRODUCTS, LLC. |
NORMAN R ESTRIN |
| K973352 |
10/27/1997 |
BRAND NAME *1-STEP PREGNANCY |
ARMKEL, LLC. |
THERESA SINES |
| K973310 |
10/27/1997 |
TBD* ONE-STEP OVULATION PREDICTOR TEST |
ARMKEL, LLC. |
THERESA SINES |
| K970864 |
10/17/1997 |
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K973418 |
10/09/1997 |
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) |
ASSEMBLY REQUIRED DIST., INC. |
ROBERT J MURPHY |
| K972964 |
10/10/1997 |
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARK |
| K973260 |
10/21/1997 |
HYDRASORB STERILE DRESSING |
AVITAR, INC. |
PAUL H PATRONE |
| K971935 |
10/01/1997 |
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) |
B & D CORP. |
LADISLAU BIRO |
| K971259 |
10/27/1997 |
COMBIPORT FLUID LAVAGE DEVICE |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K972703 |
10/01/1997 |
REDYROB-CLOSED WOUND DRAINAGE SYSTEM |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971233 |
10/17/1997 |
SOFT TIP EPIDURAL CATHETER KIT |
B. BRAUN MEDICAL, INC. |
MARK S ALBERGE |
| K973846 |
10/29/1997 |
AIR CONDUCTION HEARING AID |
BARON TRADING, INC. |
PHILLIP RECHISTER |
| K961008 |
10/10/1997 |
AUTOMIX 3+3/AS COMPOUNDER SYSTEM |
BAXTER HEALTHCARE CORP. |
MARCIA MARCONI |
| K972579 |
10/01/1997 |
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE |
BAXTER HEALTHCARE CORP. |
DAVID C ROSS |
| K973654 |
10/24/1997 |
VIAL-MATE RECONSTITUTION DEVICE (2B8071) |
BAXTER HEALTHCARE CORP. |
TAMIMA ITANI |
| K964098 |
10/31/1997 |
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K971989 |
10/22/1997 |
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA |
| K973743 |
10/31/1997 |
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
MICHELE Z BURTNESS |
| K973966 |
10/31/1997 |
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
SHELLIE GUST |
| K970742 |
10/22/1997 |
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
ANNA LONGWELL, ESQ. |
| K972929 |
10/20/1997 |
N ANTISERUM TO HUMAN ALBUMIN |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K972840 |
10/17/1997 |
N ANTISERUM TO HUMAN TRANSFERRIN |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K973832 |
10/27/1997 |
OPUS HLH CONTROLS |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K972807 |
10/15/1997 |
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI |
BENZ RESEARCH AND DEVELOPMENT CORP. |
PATRICK H BENZ |
| K973948 |
10/28/1997 |
DUALINE 100 BTE |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K973043 |
10/27/1997 |
MODEL C-1 HEARING AID |
BETTER HEARING, INC. |
LOUIS T GNECCO |
| K971501 |
10/14/1997 |
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K971273 |
10/08/1997 |
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF |
BIO-TEK INSTRUMENTS, INC. |
MICHAEL N SEVIGNY |
| K962783 |
10/23/1997 |
EDEMA SYSTEM |
BIOANALOGICS, INC. |
CAROL L PATTERSON |
| K972860 |
10/31/1997 |
CURVTEK TSR SYSTEM |
BIOLECTRON, INC. |
RICHARD S DUGOT |
| K972895 |
10/03/1997 |
VIDAS ROTAVIRUS (RTV) ASSAY |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K972691 |
10/15/1997 |
ABC TOTAL ELBOW PROTHESIS |
BIOMET, INC. |
KARL SCHWARTZ |
| K965141 |
10/31/1997 |
TRUQUANT BR RIA |
BIOMIRA USA, INC. |
JILLIAN CASTRUCCI |
| K973126 |
10/06/1997 |
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K973112 |
10/10/1997 |
ELECSYS DIGOXIN |
BOEHRINGER MANNHEIM CORP. |
YVETTE R LLOYD |
| K972876 |
10/09/1997 |
GLUCOTREND BASIC SYSTEM |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K973358 |
10/06/1997 |
MYOGLOBIN CONTROL SET |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K973629 |
10/07/1997 |
PRECINORM RF, PRECIPATH RF |
BOEHRINGER MANNHEIM CORP. |
YVETTE R LLOYD |
| K973015 |
10/09/1997 |
MULTITAK SS SUTURE SYSTEM |
BONUTTI RESEARCH |
LYNNETTE WHITAKER |
| K972986 |
10/08/1997 |
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K971320 |
10/09/1997 |
CRE BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K971367 |
10/27/1997 |
BRAINSCAN CONFORMAL RT MODULE |
BRAINLAB, AG |
STEFAN VILSMEIER |
| K973125 |
10/08/1997 |
MAMMOLOADER BY C.M.A. SRL |
C.M.A. |
CARL ALLETTO |
| K973500 |
10/16/1997 |
BARD ENDOSCOPIC OVERTUBE (#000307) |
C.R. BARD, INC. |
MARION GORDON |
| K971137 |
10/16/1997 |
BARD RAPIDFIRE MULTIPLE BAND LIGATOR |
C.R. BARD, INC. |
BETH A ROCHETTE |
| K971265 |
10/23/1997 |
VIKING DIAGNOSTIC ELECTRODE CATHETER |
C.R. BARD, INC. |
ANNE KULIS |
| K970741 |
10/16/1997 |
POWERHEART AECD |
CARDIAC SCIENCE, INC. |
RAYMOND COHEN |
| K972762 |
10/14/1997 |
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES |
CARDIOMETRICS, INC. |
Claire Andrews |
| K970638 |
10/30/1997 |
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT |
CARDIOTHORACIC SYSTEMS, INC. |
MICHAEL J BILLIG |
| K973431 |
10/28/1997 |
LASETTE |
CELL ROBOTICS, INC. |
CONNIE WHITE |
| K971013 |
10/28/1997 |
CHASE TEMPERATURE PROBE |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K972495 |
10/10/1997 |
ACCUMETER THEOPHYLLINE TEST |
CHEMTRAK, INC. |
SUBBARAO GUNUPUDI |
| K972968 |
10/08/1997 |
ROTOGRAPH PLUS |
CHICAGO X-RAY SYSTEMS, INC. |
AL SOSA |
| K972808 |
10/24/1997 |
HANSATOME MICROKERATOME |
CHIRON VISION CORP. |
JUDY F GORDON |
| K970595 |
10/24/1997 |
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP |
CIRCON VIDEO |
TODD J POLK |
| K970143 |
10/29/1997 |
C4 |
CLINICON CORP. |
ALAN BUNTING |
| K971712 |
10/08/1997 |
COEUR 130 ML ANGIOGRAPHIC SYRINGE |
COEUR LABORATORIES, INC. |
CHRISTINE L PANZL |
| K972530 |
10/01/1997 |
CONVATEC ODOR CONTROL WOUND DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K972977 |
10/10/1997 |
INSULATOR WIRE GUIDE |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K972825 |
10/07/1997 |
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB |
CORDIS CORP. |
MIRJAM BARBOZA |
| K972978 |
10/21/1997 |
VISTA BRITE TIP GUIDING CATHETERS |
CORDIS CORP. |
KATHERINE TREVISOL |
| K970264 |
10/28/1997 |
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM |
CORDIS WEBSTER, INC. |
MARY ADAMS |
| K973634 |
10/29/1997 |
COULTER AC.T DIFF ANALYZER |
COULTER CORP. |
THOMAS J ENGLISH |
| K972257 |
10/20/1997 |
N-ASSAY TIA ANTITHROMBIN III TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
| K971985 |
10/20/1997 |
N-ASSAY TIA PLASMINOGEN TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
| K972662 |
10/01/1997 |
CRYOGEN CRYOSURGICAL SYSTEM |
CRYOGEN, INC. |
CHERYL L SHEA |
| K970570 |
10/03/1997 |
NIVP3 (WINDOWS VERSION OF NIVP |
D. E. HOKANSON, INC. |
D. E HOKANSON |
| K973650 |
10/20/1997 |
TROPONIN (TROP) METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
| K973668 |
10/20/1997 |
CARDIAC TROPONIN-I (TROP) CALIBRATOR |
DADE INTL., INC. |
REBECCA S AYASH |
| K972799 |
10/10/1997 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K972910 |
10/14/1997 |
PORS ON LITE |
DEGUSSA CORP. |
HOLGER MEINICKE |
| K973422 |
10/28/1997 |
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) |
DEJARNETTE RESEARCH SYSTEMS |
ERIC J FINEGAN |
| K973492 |
10/21/1997 |
DENTALVIEW PERIOVIEW SYSTEM |
DENTALVIEW, INC. |
WENDELL EBLING |
| K972629 |
10/09/1997 |
DEPUY AE TK2 HIP SCREW SYSTEM |
DEPUY, INC. |
KATHLEEN A DRAGOVICH |
| K972494 |
10/01/1997 |
DEPUY DUPONT ABSORBABLE SET SCREW |
DEPUY, INC. |
SALLY FOUST |
| K972832 |
10/21/1997 |
PROVISION SURGICAL HELMET SYSTEM |
DEPUY, INC. |
CHERLLY K HASTINGS |
| K972778 |
10/08/1997 |
DEY VIAL SODIUM CHLORIDE 3% |
DEY LABORATORIES, INC. |
ALLAN S KAPLAN |
| K972021 |
10/31/1997 |
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K973514 |
10/31/1997 |
ACTIVE INTACT PTH |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K973177 |
10/09/1997 |
MAGO AUTOMATED EIA PROCESSOR |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K971877 |
10/08/1997 |
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K972659 |
10/17/1997 |
DONG BANG ACUPUNCTURE NEEDLES |
DONG BANG, U.S.A. |
SUE KIM |
| K972658 |
10/17/1997 |
MAGI ACUPUNCTURE NEEDLES |
DONG BANG, U.S.A. |
SUE KIM |
| K973051 |
10/30/1997 |
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K972848 |
10/30/1997 |
NARKOMED MRI ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K971198 |
10/03/1997 |
BABYTHERM 8004 BABYTHERM 8010 |
DRAGER, INC. |
HERALD KNEUER |
| K973047 |
10/02/1997 |
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K972847 |
10/07/1997 |
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) |
EASTMAN KODAK COMPANY |
ROBERT L HILLER |
| K972745 |
10/21/1997 |
TITANIUM HEMOSTATIC CLIP |
EISNER USA, INC. |
ELLEN HENVE-UNEPP |
| K971588 |
10/24/1997 |
EVI SUTURED-CLIP APPLIER |
ELECTIVE VASCULAR INTERVENTION INC. (EVI) |
MICHAEL A DANIEL |
| K972514 |
10/03/1997 |
LASEREX LP1532 PHOTOCOAGULATOR |
Ellex Medical Pty. Ltd. |
KEITH R DEGENHARDT |
| K972826 |
10/15/1997 |
ESTEEM 1.5T MRI SYSTEM |
ELSCINT MR, INC. |
ELIZABETH F LOWDER |
| K973054 |
10/01/1997 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
| K972558 |
10/07/1997 |
BIPOLAR SCISSORS |
ENABLE MEDICAL CORP. |
MICHAEL D HOOVEN |
| K972353 |
10/28/1997 |
ERCO-RIBBON |
ERCONS, INC. |
YAKOV ALTSHULER |
| K972872 |
10/28/1997 |
DERMA K LASER SYSTEM |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K972028 |
10/24/1997 |
DERMASCAN SURGICAL LASER SCANNER |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K972892 |
10/02/1997 |
CAVIT-LC |
ESPE GMBH & CO. KG. |
BARBARA WAGNER-SCHUH |
| K972578 |
10/01/1997 |
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE |
ETHICON ENDO-SURGERY, INC. |
IVAN S PLACKO |
| K973173 |
10/29/1997 |
POWERSTAR BIPOLAR SCISSORS |
ETHICON, INC. |
GREGORY R JONES |
| K971464 |
10/29/1997 |
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT |
EURO-DIAGNOSTICA AB |
KARL A POSSELT |
| K971689 |
10/29/1997 |
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT |
EURO-DIAGNOSTICA AB |
KARL A POSSELT |
| K971690 |
10/29/1997 |
IMMUNOSCAN PR3-ANCA |
EURO-DIAGNOSTICA AB |
KARL A POSSELT |
| K972130 |
10/09/1997 |
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR |
FAIRMONT MEDICAL |
JOANN MCBAIN |
| K972885 |
10/30/1997 |
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K971131 |
10/03/1997 |
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
| K972836 |
10/22/1997 |
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS |
G. PREMJEE (USA), INC. |
SUSAN D GOLDSTEIN-FALK |
| K970233 |
10/08/1997 |
GELBFISH ENDO-VAC SYSTEM |
GARY A. GELBFISH |
ROBERT L SHERIDAN |
| K973343 |
10/21/1997 |
HYDROFLEX |
GC AMERICA, INC. |
TERRY L JORITZ |
| K964617 |
10/03/1997 |
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS |
DAVID DUERSTELER |
| K973039 |
10/16/1997 |
LEGACY/LEGACY-D TABLE |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K973368 |
10/17/1997 |
STRAIT'MAP OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K973179 |
10/30/1997 |
FEMINIQUE SONIC HAIR REMOVER |
GLOBAL TV CONCEPTS, LTD. |
SAMIA N RODRIGUEZ |
| K973174 |
10/30/1997 |
SONIQUE HAIR REMOVER |
GLOBAL TV CONCEPTS, LTD. |
SAMIA N RODRIGUEZ |
| K963967 |
10/31/1997 |
GLYCAR PERICARDIAL PATCH |
GLYCAR, INC. |
DIRK A FRATER |
| K963368 |
10/31/1997 |
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE |
GLYCAR, INC. |
BERTRAM HUDSON |
| K972815 |
10/08/1997 |
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT |
Grace Medical, Inc. |
ANTHONY D PRESCOTT |
| K972156 |
10/16/1997 |
QUIX RAPID E. COLI O157 STRIP TEST |
GUARDIAN SCIENTIFIC, CORP. |
KATHRYN B POWERS |
| K972661 |
10/03/1997 |
EYE SPHERE, CONFORMERS |
GULDEN OPHTHALMICS |
THOMAS COCKLEY |
| K973574 |
10/24/1997 |
DURALASTIC ANATOMICAL MALAR IMPLANT |
HANSON MEDICAL, INC. |
ERIK HANSON |
| K973572 |
10/21/1997 |
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL |
HANSON MEDICAL, INC. |
ERIK HANSON |
| K962829 |
10/16/1997 |
HARMAC BALLOON ANGIOGRAPHIC CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KNOIECZNY |
| K963335 |
10/16/1997 |
HARMAC BALLOON WEDGE PRESSURE CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH KONIECZNY |
| K962833 |
10/15/1997 |
HARMAC TEMPORARY PACING CATHETER WITH BALLOON |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KONIECZNY |
| K963136 |
10/10/1997 |
PACER MODEL 100 INFUSION CONTROLLER |
HEALTH WATCH, INC. |
JOHN D GREENBAUM |
| K972570 |
10/01/1997 |
HEARTPORT INTRODUCER SHEATH |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K972229 |
10/16/1997 |
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM |
HEARTWARE, INC. |
CYNTHIA A SINCLAIR |
| K972617 |
10/01/1997 |
HELAX-VISIR |
HELAX AB |
JAN TORNQVIST |
| K973316 |
10/01/1997 |
REP SPE VIS-60/40 KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K972274 |
10/27/1997 |
SPIFE |
HELENA LABORATORIES |
PAT FRANKS |
| K971733 |
10/02/1997 |
2 BOND 2 |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K973466 |
10/24/1997 |
HANAULUX BLUE 75 AND HANAULUX BLUE 120 |
HERAEUS MED GMBH |
MARK SCHULZ |
| K970456 |
10/03/1997 |
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM |
HEWLETT-PACKARD GMBH |
MIKE HUDON |
| K972277 |
10/21/1997 |
DIGIFLEX SURGICAL GLOVES |
HMS SERVICES, INC. |
HARSH AGGARWAL |
| K972727 |
10/10/1997 |
CBALK-1000 BLADE |
HOWARD INSTRUMENTS, INC. |
JACK W HOWARD |
| K972551 |
10/29/1997 |
ARTISAN PULSE LAVAGE SYSTEM |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K963502 |
10/28/1997 |
CSCO FOREHEAD FIXATION SYSTEM |
HOWMEDICA CORP. |
KRISTYN R WASKI |
| K972752 |
10/21/1997 |
DURACON CONVERSION METAL BACKED PATELLA |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K972792 |
10/16/1997 |
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS |
HOWMEDICA CORP. |
FRANK MAAS |
| K972864 |
10/29/1997 |
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS |
HOWMEDICA CORP. |
FRANK MAAS |
| K972863 |
10/29/1997 |
DURATION STABILIZED UHMWPE KNEE COMPONENTS |
HOWMEDICA CORP. |
FRANK MAAS |
| K972813 |
10/09/1997 |
GAMMA LOCKING NAIL SYSTEM |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K972811 |
10/06/1997 |
HOWMEDICA FULLY THREADED SCREWS |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K970912 |
10/01/1997 |
LEIBINGER SELF-DRILLING SCREW |
HOWMEDICA LEIBINGER, INC. |
KRISTYN WASKI |
| K973292 |
10/20/1997 |
I-STAT SYSTEM |
I-STAT CORP. |
IMANTS R LAUKS |
| K972712 |
10/01/1997 |
CORE RESISTANT HUBER INFUSION SETS |
ICU MEDICAL, INC. |
ARLENE DUTCHIK |
| K972879 |
10/15/1997 |
ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION |
IMATRON, INC. |
J. A. CODUTO |
| K972506 |
10/01/1997 |
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR |
INFINITECH, INC. |
ALAN T BECKMAN |
| K972622 |
10/09/1997 |
STRAIGHT-IN BONE SCREW FIXATION SYSTEM |
INFLUENCE, INC. |
MARK D KRAMER |
| K972684 |
10/10/1997 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K973294 |
10/03/1997 |
INNOVATOME MICROKERATOME |
INNOVATIVE OPTICS, INC. |
LARRY HICKS |
| K973283 |
10/21/1997 |
ALGINATE/ZINC WOUND DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD COX |
| K973312 |
10/22/1997 |
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
PRESCILLA WHITEHEAD COX |
| K973006 |
10/20/1997 |
QUANTA LITE B2 GPI IGA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K973014 |
10/20/1997 |
QUANTA LITE B2GPI IGM |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K963858 |
10/21/1997 |
FEMASSIST URINARY DEVICE |
INSIGHT MEDICAL CORP. |
ROBERT W SCHAEFER |
| K973464 |
10/22/1997 |
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K973253 |
10/30/1997 |
ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
JEFFREY R SHIDEMAN |
| K972842 |
10/30/1997 |
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE |
INTERPORE INTL. |
DAVID P BALDING |
| K972923 |
10/27/1997 |
SUPER SILIPLUGS EAR PLUGS |
INTERVIEW MEDICAL TECHNOLOGY CORP. |
LOU MATSON |
| K972922 |
10/08/1997 |
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K |
INTERVIEW MEDICAL TECHNOLOGY CORP. |
LOU MATSON |
| K972143 |
10/16/1997 |
MOA BONE / M-SPHERE |
IOP, INC. |
JASON MALECKA |
| K973022 |
10/20/1997 |
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 |
ISLAND BIOSURGICAL, INC. |
HUNTER A MCKAY |
| K973234 |
10/27/1997 |
MIDAS TOUCH ELECTROSURGICAL ELECTRODE |
ITI MEDICAL TECHNOLOGIES, INC. |
ROGER WERNE |
| K972648 |
10/30/1997 |
SONICSYS INLAY |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K972933 |
10/27/1997 |
VOX/BASE FOR WINDOWS |
J-MAC SYSTEM, INC. |
SHEILA W PICKERING |
| K971649 |
10/29/1997 |
KSEA ARTHROPUMP PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K972926 |
10/08/1997 |
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K972844 |
10/03/1997 |
TEMP BOND CLEAR |
KERR DENTAL MATERIALS CENTER |
WILLIAM R PIKE |
| K955243 |
10/23/1997 |
BARIAIR |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
| K963914 |
10/08/1997 |
CM & CM DS-7 |
KONICA MEDICAL CORP. |
RUSSELL D MUNVES |
| K963913 |
10/08/1997 |
MD100 & MM150 |
KONICA MEDICAL CORP. |
RUSSELL D MUNVES |
| K972984 |
10/29/1997 |
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE |
LERNER MEDICAL, INC. |
MICHAEL POLLACK |
| K972760 |
10/22/1997 |
LINK, ACETABULAR REVISION MESH CUP |
LINK AMERICA, INC. |
DOUGLAS W STUART |
| K971514 |
10/29/1997 |
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE |
LONDON INTERNATIONAL GROUP, INC. |
NEIL ANDERSON |
| K973376 |
10/14/1997 |
LORI/LORI, LORI-S (LORI STOCK AID) |
LORI MEDICAL LABORATORIES, INC. |
JIM HAMMARSTEDT |
| K973110 |
10/21/1997 |
LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD |
LUDLOW TECHNICAL PRODUCTS |
PATRICK A MALIA |
| K965226 |
10/03/1997 |
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE |
LUNAR CORP. |
KENNETH D BUROKER |
| K973140 |
10/31/1997 |
DUET GLUCOSE CONTROL MONITORING SYSTEM |
LXN CORP. |
VIVIANNE T NOETZEL |
| K962977 |
10/09/1997 |
MRI COMPATIBLE BIOPSY NEEDLES |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K971683 |
10/22/1997 |
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET |
MARQUETTE ELECTRONICS, INC. |
DIANNE SCHMITZ |
| K972071 |
10/21/1997 |
BOVIE MODEL X40 |
MAXXIM MEDICAL |
MICHAEL A CLARK |
| K972678 |
10/07/1997 |
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS |
MCGAW, INC. |
REBECCA STOLARICK |
| K971257 |
10/03/1997 |
VTU-1 VACUUM ERECTION SYSTEM |
MCKENNA & CUNEO |
DONALD R STONE |
| K971281 |
10/09/1997 |
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE |
MEDCOMP |
JEANNE M CUSH |
| K971004 |
10/02/1997 |
MEDCORP FLOW I.V. REGULATOR EXTENSION SET |
MEDCORP INTL. |
DAVE BERBERIAN |
| K973071 |
10/24/1997 |
TRI TALON RETRIEVAL FORCEPS |
MEDICAL ENGINEERING LABORATORY, INC. |
WILLIAM J YOUNG |
| K972726 |
10/08/1997 |
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM |
MEDICAL PACKAGING CORP. |
PATRICIA V WILLIS |
| K972654 |
10/08/1997 |
MANIFOLD |
MEDICAL SPECIALTIES INTL., INC. |
LARRY G JUNKER |
| K973062 |
10/09/1997 |
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE |
MEDIDENTA INTL., INC. |
ROBERT T POSTAL |
| K965112 |
10/10/1997 |
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K971897 |
10/21/1997 |
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) |
MEDRON, INC. |
RON WORTLEY |
| K972695 |
10/22/1997 |
FINALLY FREE |
MEHL/GROUP MARKETING |
THOMAS BLAKE |
| K970756 |
10/31/1997 |
MERCURY MEDICAL REUSABLE CPR BAG |
MERCURY MEDICAL |
ARTHUR J WARD |
| K972352 |
10/29/1997 |
THE MERETEK UBT BREATH TEST FOR H.PYLORI |
MERETEK DIAGNOSTICS, INC. |
CLAUDIA T HITCHCOCK |
| K972804 |
10/23/1997 |
BANG POLYMER GEL DOSIMETER, BANG 533 |
MGS RESEARCH, INC. |
MAREK MARYANSKI |
| K972525 |
10/02/1997 |
THUMPER |
MICHIGAN INSTRUMENTS, INC. |
JAMES D MAATMAN |
| K972709 |
10/16/1997 |
TBI STAND |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX W MICK |
| K972723 |
10/02/1997 |
BIO TROL |
MINDMEDIA LABS, INC. |
TOM ALLEN |
| K960513 |
10/01/1997 |
PERACT 20 LIQUID STERILANT |
MINNTECH CORP. |
LEROY J FISCHBACH |
| K973073 |
10/08/1997 |
DRTS IMAGE INTENSIFIER DRAPE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K973067 |
10/16/1997 |
DRTS REMOTE CONTROL DRAPE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K972271 |
10/28/1997 |
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A |
ML STRATEGIES, INC. |
ALLAN M GREEN |
| K972015 |
10/27/1997 |
HYDRAGEL 7,15,30, CHOL-HDL KIT |
MORAX |
BOREK JANIK |
| K971313 |
10/27/1997 |
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET |
NATIONAL MEDICAL CARE, INC. |
DEBRA L BING |
| K972837 |
10/21/1997 |
NPB-290 PULSE OXIMETER (NPB-290) |
NELLCOR PURITAN BENNETT, INC. |
ROGER D BROWN |
| K972974 |
10/06/1997 |
ACCUWELL T4-EIA |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K971896 |
10/10/1997 |
GALILEO HIGH RESOLUTION MICRO COUPLER |
NETOPTIX CORP. |
KIN WONG |
| K971436 |
10/21/1997 |
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K970499 |
10/16/1997 |
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM |
NOBEL BIOCARE UAS INC |
BESTY A BROWN |
| K972882 |
10/31/1997 |
APOLLO |
NORLAND CORP. |
TERRY SCHWALENGERG |
| K972569 |
10/08/1997 |
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K972924 |
10/30/1997 |
SURGIC II IMPLANT CONTROL UNIT |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K973219 |
10/08/1997 |
AMBER DU |
OLDELFT CORP. OF AMERICA |
L. DON PHILLIPS |
| K964661 |
10/30/1997 |
HX-20/21-1 ENDOSCOPIC LIGATOR |
OLYMPUS AMERICA, INC. |
SUBHASH PATEL |
| K972481 |
10/21/1997 |
AUTO-LYTE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
SAM R NIEDBALA |
| K971392 |
10/21/1997 |
HISTOFREEZER VERRUCA PLANA |
ORASURE TECHNOLOGIES, INC. |
LISA VAIL |
| K972685 |
10/01/1997 |
ORIGIN LIGATOR DEVICE |
ORIGIN MEDSYSTEMS, INC. |
ANTHONY DURSO |
| K973331 |
10/22/1997 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) |
Ortho-Clinical Diagnostics, Inc. |
ANN M QUINN |
| K962774 |
10/10/1997 |
OSTEOMED QUICKFIX |
OSTEOMED CORP. |
JAMES D LAFFERTY |
| K973487 |
10/06/1997 |
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K973488 |
10/10/1997 |
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLIGSWORTH |
| K973489 |
10/10/1997 |
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K972871 |
10/02/1997 |
GENESIS |
PACIFIC RIM DENTAL, INC. |
KATHY L EPPEN |
| K972973 |
10/15/1997 |
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM |
PERCEPTION, INC. |
SUSAN D GOLDSTEIN-FALK |
| K973570 |
10/31/1997 |
QUICK CARD HCG ONE STEP PREGNANCY TEST |
PHAMATECH |
CARL MONGIOVI |
| K972818 |
10/17/1997 |
D72 DIGITAL |
PHILIPS HEARING INSTRUMENTS CO. |
TED MIKSIEWICZ |
| K973098 |
10/27/1997 |
COMPRESSION CERCLAGE GUNDOLF CCG-GF |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K972597 |
10/01/1997 |
PMT NEW BEGINNINGS GELSHAPES & AMEND |
PMT CORP. |
STEPHEN M TRINTER |
| K973588 |
10/22/1997 |
LIQUID ALKALINE PHOSHATASE REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K973157 |
10/10/1997 |
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K973589 |
10/08/1997 |
LIQUID LDH-L REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K964398 |
10/24/1997 |
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED |
POLYMEDICA INDUSTRIES, INC. |
JULIE CHAFFEE |
| K972515 |
10/02/1997 |
SENSOR AMPLIFIER |
PRO-TECH SERVICES, INC. |
ANTHONY ZARAGOZA |
| K973090 |
10/28/1997 |
MEDSTATION |
PROGRAM S.R.L. |
DIANA UPTON |
| K973362 |
10/01/1997 |
NEEDLE GUIDE/GRID |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970889 |
10/20/1997 |
ULTRASOUND TRANSDUCER DRAPE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970893 |
10/20/1997 |
ULTRASOUND TRANSDUCER DRAPE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K972445 |
10/02/1997 |
PULPDENT OX-OUT |
PULPDENT CORP. |
KENNETH J BERK |
| K972169 |
10/03/1997 |
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE |
PWA INDUSTRIES SDN. BHD. |
AZMAN ISMAIL |
| K973526 |
10/16/1997 |
SUNGLASSES |
PYRAMID HANDBAGS, INC. |
JENNIFER EPSTEIN |
| K973557 |
10/10/1997 |
LUBRIGLIDE |
QUALIS, INC. |
MARY A FINN |
| K973894 |
10/29/1997 |
IMMUSURE |
QUANTIMETRIX CORP. |
EVY JOHNSON |
| K971672 |
10/21/1997 |
SERAQUEST TOXOPLASMA IGM |
QUEST INTL., INC. |
ROBERT A CORT |
| K973367 |
10/06/1997 |
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K972905 |
10/28/1997 |
XPLAN-1 |
RADIONICS SOFTWARE APPLICATIONS, INC. |
LINDA TALBERT |
| K973297 |
10/29/1997 |
COSMAN COAGULATOR (CC-1) SYSTEM |
RADIONICS, INC. |
WILLIAM RITTMAN |
| K972342 |
10/06/1997 |
REAADS PROTEIN C ANTIGEN TEST KIT |
REAADS MEDICAL PRODUCTS, INC. |
NANCI DEXTER |
| K970230 |
10/29/1997 |
SPOROX |
RECKITT BENCKISER, INC. |
EILEEN J MOYER |
| K972093 |
10/21/1997 |
REGENESIS MODEL 42 |
REGENESIS BIOMEDICAL, INC. |
T. WHIT ATHEY |
| K972829 |
10/28/1997 |
CRICKET 2000 RECORDING PULSE OXIMETER |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K973440 |
10/20/1997 |
REXAM FRACTURE RESISTANT POUCH |
REXAM MEDICAL PACKAGING, INC. |
ANDREA HAFERKAMP |
| K971420 |
10/22/1997 |
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K970162 |
10/29/1997 |
NEUROLOGICAL ENDOSCOPE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K972891 |
10/01/1997 |
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K973075 |
10/09/1997 |
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K972867 |
10/24/1997 |
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT |
ROCKET MEDICAL PLC |
L TODD |
| K973539 |
10/30/1997 |
ROEKO CALCIUM HYDROXIDE POINTS |
ROEKO USA, INC. |
JAMES DELANEY |
| K971643 |
10/07/1997 |
RUSCH BRILLANT BALLOON CATHETER |
RUSCH INTL. |
JAMES R WHITNEY |
| K964056 |
10/10/1997 |
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE |
RUSCH INTL. |
NEIL R ARMSTRONG |
| K972878 |
10/30/1997 |
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K973911 |
10/29/1997 |
2 GALLON ALTERNATE CARE SHARPS CONTAINER |
SAGE PRODUCTS, INC. |
KAREN PINTO |
| K972612 |
10/08/1997 |
DISSECTRON PORTABLE UNIT |
SATELEC |
JACKIE MASSE |
| K973791 |
10/14/1997 |
ABC CALIBRATION VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
STEVE CHIAMORI |
| K973790 |
10/14/1997 |
ABC LINEARITY VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
ROY F SCHALL JR. |
| K973535 |
10/20/1997 |
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS |
SCHIAPPARELLI BIOSYSTEMS, INC. |
STEVEN DALESSIO |
| K972886 |
10/01/1997 |
MIRAGE |
SEGAMI CORP., INC. |
PHILIPPE BRIANDET |
| K971760 |
10/01/1997 |
COLORPOINT OR PROFESSIONAL COLORPOINT |
SEIKO INSTRUMENTS USA, INC. |
TOMOHIKO SAKAI |
| K971590 |
10/07/1997 |
TACTYLON CONDOM |
SENSICON CORP. |
JORGE HAIDER |
| K972757 |
10/29/1997 |
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
ONG LAY MAU |
| K973342 |
10/08/1997 |
DAR-3000B |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K973327 |
10/08/1997 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K973329 |
10/08/1997 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K972292 |
10/29/1997 |
SOLIDEX |
SHOFU DENTAL CORP. |
HIDEAKI KUMAZAWA |
| K973247 |
10/16/1997 |
VINTAGE HALO |
SHOFU DENTAL CORP. |
THOMAS D YANKELITIS |
| K970839 |
10/14/1997 |
SERVO VENTILATOR 300A |
SIEMENS ELEMA AB |
ANN-CHRISTINE JONSSON |
| K972714 |
10/17/1997 |
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MARK KOLNSBERG |
| K973274 |
10/31/1997 |
ACCUCOLOR HIGH CALIBRATOR (A3089) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K972260 |
10/20/1997 |
CS-400 COAGULATION ANALYZER SYSTEM (A1208) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K971858 |
10/09/1997 |
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K972796 |
10/10/1997 |
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K971018 |
10/24/1997 |
SMC ACETABULAR COMPONENT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K972521 |
10/01/1997 |
NAVIGATOR (STYLET) 2006 |
SIL-MED CORP. |
KAREN K SYLVIA |
| K971947 |
10/03/1997 |
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) |
SIM ITALIA S.R.L. |
SUSAN D GOLDSTEIN-FALK |
| K964434 |
10/09/1997 |
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR |
SKYLARK DEVICE CO., LTD. |
GEORGE K.C. CHEN |
| K972471 |
10/24/1997 |
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K973843 |
10/29/1997 |
MSI PRESSURE INFUSOR |
SMITH ASSOC. |
E.J. Smith |
| K972686 |
10/14/1997 |
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER |
SMV AMERICA |
WILLIAM BISHOP |
| K971184 |
10/01/1997 |
OXI-SNAP |
SNAP LABORATORIES, L.L.C. |
GIL RAVIV |
| K964159 |
10/16/1997 |
CD SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE, PH.D. |
| K973175 |
10/14/1997 |
TONGUE KLEAN |
SOFTEK ENT. |
PROMILA GUPTA |
| K971628 |
10/10/1997 |
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K973086 |
10/07/1997 |
PLA-96P |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973088 |
10/03/1997 |
PLS-96P |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K970482 |
10/31/1997 |
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 |
SRS INTL. |
MICHAEL G FARROW, PH.D. |
| K973028 |
10/28/1997 |
HELIOS LASER IMAGER 1417 |
STERLING DIAGNOSTIC IMAGING, INC. |
TIMOTHY W CAPEHART |
| K972204 |
10/08/1997 |
ACU-RAY HF SERIES PORTABLE X-RAY UNIT |
STERNE EQUIPMENT CO., LTD. |
BRENT NELSON |
| K972664 |
10/10/1997 |
STORZ MILLENNIUM VISCOUS FLUID SYSTEM |
STORZ INSTRUMENT CO. |
PATRICK G BALSMANN |
| K972584 |
10/01/1997 |
STRYKER HUMMER II MICRODEBRIDER SYSTEM |
Stryker Endoscopy |
CARLOS GONZALEZ |
| K973195 |
10/24/1997 |
TOTAL PERFORMANCE SYSTEM SHAVER |
Stryker Endoscopy |
ERIC FINLEY |
| K972501 |
10/01/1997 |
APOLLO REVISION/CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
LORI KLEINSCHRODT HOLDER |
| K971523 |
10/01/1997 |
DISTALLY FIXED HIP STEM |
SULZER ORTHOPEDICS, INC. |
SAM MIRZA |
| K972637 |
10/01/1997 |
PRECEDENT REVISION HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
LORI KLEINSCHRODT HOLDER |
| K973017 |
10/16/1997 |
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP |
SYNTHES (USA) |
KEVIN J O'CONNELL |
| K971883 |
10/16/1997 |
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
SYNTHES (USA) |
BARRY E SANDS |
| K964210 |
10/31/1997 |
RETRIEVER II |
TARGET THERAPEUTICS |
LARAINE PANGELINA |
| K973208 |
10/20/1997 |
FIRST SIGN |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
| K973245 |
10/07/1997 |
TOKUSO REBASE MR. BOND |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K972697 |
10/03/1997 |
AIA-PACK IGE II ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K973550 |
10/29/1997 |
TUTTNAUER TABLE-TOP AUTOCLAVE |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
| K972635 |
10/01/1997 |
ULTRACELL SUCTION SPONGE |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE O KORTEWEG |
| K973153 |
10/28/1997 |
UBI MAGIWEL AMPHETAMINE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K973156 |
10/28/1997 |
UBI MAGIWEL COCAINE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K973155 |
10/28/1997 |
UBI MAGIWEL OPIATE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K971680 |
10/24/1997 |
AUTO SUTURE BONE WAX |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MELISSA MAZZONI |
| K970971 |
10/27/1997 |
URO MED NERVE STIMULATOR |
UROMED CORP. |
FREDERICK TOBIA |
| K973391 |
10/03/1997 |
CHEMMATE KAPPA |
VENTANA MEDICAL SYSTEMS, INC. |
KATHLEEN WINDALL |
| K973390 |
10/03/1997 |
CHEMMATE L26 (CD20) |
VENTANA MEDICAL SYSTEMS, INC. |
KATHLEEN WINDALL |
| K973392 |
10/03/1997 |
CHEMMATE LAMBDA |
VENTANA MEDICAL SYSTEMS, INC. |
KATHLEEN WINDALL |
| K973389 |
10/03/1997 |
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING |
VENTANA MEDICAL SYSTEMS, INC. |
KATHLEEN WINDALL |
| K940583 |
10/20/1997 |
VENTANA CD45 PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
KURT REINHARDT |
| K973345 |
10/29/1997 |
MATRIX PLUS MULTI-CALIBRATOR KIT |
VERICHEM LABORATORIES, INC. |
ANTHONY J DIMONTE |
| K972880 |
10/22/1997 |
MDP2000 MEDICAL DATA PROCESSOR |
VIDCO, INC. |
BRADLEY COHEN |
| K972200 |
10/20/1997 |
ANEUVYSION |
VYSIS |
RUSSEL K EVANS |
| K964880 |
10/16/1997 |
VARI-ANGLE HIP SCREW (VHS) SYSTEM |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K973074 |
10/06/1997 |
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR |
WATERS CORPORATION |
VIRGINIA L CORBIN |
| K972621 |
10/24/1997 |
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
CHOW YUE WAH |
| K971375 |
10/31/1997 |
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GARY J SFEIR |
| K972770 |
10/21/1997 |
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DAN REGAN |
| K972641 |
10/09/1997 |
DUAL OFFSET PERFECTA IMC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KIM TOMPKINS |
| K973530 |
10/16/1997 |
INFINTY DISTAL FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KIM TOMPKINS |
| K971056 |
10/03/1997 |
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISTIE MANUEL |
| K973196 |
10/29/1997 |
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K972690 |
10/15/1997 |
ZIRCONIA CERAMIC FEMORAL HEAD |
ZIMMER, INC. |
KAREN CAIN |
