| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K980824 |
03/19/1998 |
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K974778 |
03/17/1998 |
ABBOTT GEMSTAR IV INFUSION PUMP |
ABBOTT LABORATORIES |
DAVID T GUZEK |
| K971522 |
03/03/1998 |
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II |
ABBOTT LABORATORIES |
GRACE LEMIEUX |
| K974757 |
03/05/1998 |
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS |
ACROMED CORP. |
GREG CANNEDY |
| K980103 |
03/16/1998 |
ACUMED SUTURE ANCHOR |
ACUMED, INC. |
SHARI JEFFERS |
| K974863 |
03/17/1998 |
IMIX DIGITAL THORAX SYSTEM |
ADVANCED INSTRUMENT DEVELOPMENT, INC. |
JAMES M TAYLOR |
| K974706 |
03/13/1998 |
AESCULAP ABC CERVICAL PLATING SYSTEM |
AESCULAP, INC. |
LIA SPASARO |
| K980806 |
03/25/1998 |
AFFINITY MEDICAL PATIENT CABLE SYSTEM |
AFFINITY MEDICAL TECHNOLOGIES, LLC. |
MARY F PHILLIPP |
| K972213 |
03/13/1998 |
MS-700 |
ALAN S. LEE |
ALAN S LEE |
| K974624 |
03/04/1998 |
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 |
ALCON LABORATORIES |
RALPH H LARSEN |
| K974625 |
03/04/1998 |
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER |
ALCON LABORATORIES |
RALPH H LARSEN |
| K973548 |
03/23/1998 |
MERCURY DENTAL |
ALEACIONES DENTALES ZEYCO, S.A. DE C.V. |
JORGE ZEPEDA GALVEZ |
| K980574 |
03/24/1998 |
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 |
ALFA BIOTECH (UK) LTD. |
M J TAYLOR |
| K974544 |
03/18/1998 |
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER |
ALOKA CO., LTD. |
PAUL D SMOLENSKI |
| K980872 |
03/20/1998 |
RAPID DRUG SCREEN' 8 PANEL |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K980075 |
03/04/1998 |
CYBERSONIC |
AMERICAN DENTRONICS, INC. |
RONALD K MURAYAMA |
| K971740 |
03/16/1998 |
AMPLAID MK12 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K971314 |
03/17/1998 |
DCAT EMBOLECTOMY CATHETER SYSTEM |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K980564 |
03/25/1998 |
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES |
ANSELL PERRY |
JAMES R CHATTERTON |
| K970093 |
03/19/1998 |
TYROSINE 50-HOUR REAGENT KIT |
ASTORIA-PACIFIC,INC. |
RAYMOND L PAVITT |
| K974737 |
03/24/1998 |
ASTRA TECH IMPLANT DENTAL SYSTEM |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
| K980698 |
03/19/1998 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
| K974670 |
03/13/1998 |
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE |
ATHENA TECHNOLOGY, INC. |
WLLIAM T ANDERSON |
| K974671 |
03/11/1998 |
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR |
ATHENA TECHNOLOGY, INC. |
WILLIAM T ANDERSON |
| K974603 |
03/10/1998 |
PLAQUAGRAFE, AGRAFE P4V |
ATLAS TECHNOLOGY |
HILLARD W WELCH |
| K974911 |
03/16/1998 |
EXTERNAL FIXATOR |
AVANTA ORTHOPAEDICS, INC. |
LOUISE FOCHT |
| K974630 |
03/11/1998 |
72 HOUR USE TRACH CARE WITH MICROBAN |
BALLARD MEDICAL PRODUCTS |
E. MARTIN CHAMBERLAIN JR. |
| K974723 |
03/10/1998 |
RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K974780 |
03/11/1998 |
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
MICHAEL A SANTALUCIA |
| K970662 |
03/11/1998 |
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K970653 |
03/11/1998 |
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K974721 |
03/03/1998 |
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA JR. |
| K974597 |
03/09/1998 |
ADC COMPACT (AGFA DIAGNOSTIC CENTER) |
BAYER CORP., AGFA DIV. |
MICHAEL SULLIVAN |
| K980714 |
03/25/1998 |
BCI 3401 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K974697 |
03/11/1998 |
REUSABLE FINGER SENSOR 3444 |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K980414 |
03/03/1998 |
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
JOHN SCHALAGO |
| K980173 |
03/18/1998 |
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 |
BECKMAN INSTRUMENTS, INC. |
SANDRA F SCHWARTZ |
| K974360 |
03/11/1998 |
MULTITEST CD3/CD8/CD45/CD4 |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
| K980280 |
03/13/1998 |
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K980285 |
03/13/1998 |
POWDERFREE BLUE NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K980275 |
03/13/1998 |
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K980167 |
03/13/1998 |
POWDERFREE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K980194 |
03/13/1998 |
POWDERFREE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K973238 |
03/11/1998 |
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER |
BILL OLSON CORP. |
SCOTT RYAN |
| K973883 |
03/05/1998 |
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K980218 |
03/23/1998 |
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
BIOCOMPATIBLES EYEWEAR, INC. |
LISA HAHN |
| K974475 |
03/02/1998 |
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 |
BIOCONTROL TECHNOLOGY, INC. |
PATRICK J COOPER |
| K974756 |
03/12/1998 |
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODGEMAN |
| K980374 |
03/04/1998 |
IMPLANT SITE DILATORS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K973819 |
03/10/1998 |
VIDAS D-DIMER (DD) ASSAY |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K974558 |
03/04/1998 |
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K972919 |
03/27/1998 |
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW |
BIONX IMPLANTS, INC. |
JONATHAN S KAHAN |
| K974876 |
03/20/1998 |
BIONX DISTAL RADIUS SCREW |
BIONX IMPLANTS, INC. |
JONATHAN S KAHAN |
| K974192 |
03/04/1998 |
BIOSENSOR HOLTER MONITOR SYSTEM |
BIOSENSOR CORP. |
STEVE SPRINGROSE |
| K974546 |
03/04/1998 |
BIOSENSOR HOLTER MONITOR SYSTEM |
BIOSENSOR CORP. |
STEVE SPRINGROSE |
| K974881 |
03/20/1998 |
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K972500 |
03/04/1998 |
TIR/TIJ AND POLYROX |
BIOTRONIK, INC. |
LAUREN L FOOTE CHRISTENSEN |
| K973523 |
03/03/1998 |
ACCUSTAT H. PYLORI ONE STEP TEST |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K972162 |
03/18/1998 |
ELECSYS CA 125 II |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS |
| K980240 |
03/25/1998 |
ELECSYS CA 125II ON THE ELECSYS 1010 |
BOEHRINGER MANNHEIM CORP. |
JODY J SAVAGE |
| K974640 |
03/13/1998 |
COAXIAL DILATOR SET |
BOSTON SCIENTIFIC CORP. |
WANDA CARPINELLA |
| K974788 |
03/20/1998 |
CRE(TM) BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLION |
| K980163 |
03/13/1998 |
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING |
BOSTON SCIENTIFIC SCIMED, INC. |
RONALD W BENNETT |
| K974160 |
03/11/1998 |
BRUXTRAK MATERIAL |
BRUXCARE, L.L.C. |
JUSTUS N BAIRD |
| K980392 |
03/05/1998 |
PSI-TEC ASPIRATOR |
BYRON MEDICAL |
STEVE BOLLINGER |
| K972749 |
03/13/1998 |
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) |
C.M. CHANCE LTD. |
DAVID PAO |
| K974725 |
03/18/1998 |
BIOZ.COM SYSTEM |
CARDIODYNAMICS INTERNATIONAL CORP. |
DENNIS G HEPP |
| K963965 |
03/17/1998 |
CTS MIDCAB STITCHER |
CARDIOTHORACIC SYSTEMS, INC. |
MICHAEL J BILLIG |
| K980381 |
03/03/1998 |
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO |
CARMEL PHARMA AB. |
BRITT NOVEN |
| K980127 |
03/11/1998 |
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K973839 |
03/19/1998 |
DISPOSABLE ESOPHAGEAL STETHOSCOPE |
CATHETER RESEARCH, INC. |
JOHN A STEEN, PH.D. |
| K972992 |
03/30/1998 |
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS |
CERAMATEC, INC. |
GORDON ROTH |
| K973282 |
03/04/1998 |
HANDI OXYGEN ANALYZER |
CERAMATEC, INC. |
GORDON ROTH |
| K972993 |
03/31/1998 |
CHASE FEMORAL ACCESS CANNULATION SET |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K980718 |
03/27/1998 |
PARA-CARE |
CHATTANOOGA GROUP, INC. |
JOE ELROD |
| K973002 |
03/23/1998 |
HURRISEAL DENTIN DESENSITIZER |
CHENG & ASSOC., INC. |
AN-SHIH CHENG |
| K980190 |
03/06/1998 |
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) |
CHIRON CORP. |
NANCY A HORNBAKER |
| K980528 |
03/03/1998 |
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K973061 |
03/13/1998 |
CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) |
CITIZEN WATCH CO., LTD. |
JOSEPH D EDMONDSON |
| K973123 |
03/26/1998 |
EA-D IGG ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
WILLIAM L BOTELER |
| K974563 |
03/02/1998 |
COLPO CUP CVC-2000 |
CLINICAL INNOVATIONS, INC. |
WM. DEAN WALLACE |
| K974897 |
03/31/1998 |
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K974906 |
03/24/1998 |
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K974465 |
03/09/1998 |
SYNERGY |
COLTENE/WHALEDENT INC. |
H.J. VOLGELSTEIN |
| K980382 |
03/09/1998 |
NON-WOVEN COMPRESS |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K980298 |
03/09/1998 |
FLOWABLE HYBRID |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K980900 |
03/26/1998 |
N-ASSAY CPK-L |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
| K980902 |
03/26/1998 |
N-ASSAY L AST/GOT |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
| K973836 |
03/05/1998 |
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM |
CROSS MEDICAL PRODUCTS, INC. |
PHIL MELLINGER |
| K974749 |
03/13/1998 |
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS |
CROSS MEDICAL PRODUCTS, INC. |
PHIL MELLINGER |
| K980442 |
03/16/1998 |
CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM |
CRYSTAL MEDICAL TECHNOLOGY |
CLINT FOLSOM |
| K970599 |
03/20/1998 |
TOWNLEY PEDICLE SCREW PLATING SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE, PH.D. |
| K973527 |
03/31/1998 |
CARDIO-PAGER SYSTEM |
DATA CRITICAL CORP. |
TED SCHMUHL |
| K974903 |
03/13/1998 |
GAS MODULE II, MODEL 0998-00-0143 |
DATASCOPE CORP. |
RUSSELL OLSEN |
| K974575 |
03/06/1998 |
DAUM ASPIRATIONBIOPSY NEEDLE |
DAUM CORP. |
E.J. Smith |
| K974576 |
03/06/1998 |
DAUM BIOPSYGUN |
DAUM CORP. |
E.J. Smith |
| K974631 |
03/09/1998 |
DAUM NEUROBIOPSY NEEDLE |
DAUM CORP. |
E.J. Smith |
| K974574 |
03/06/1998 |
DAUM NEUROPUNCTURE NEEDLE |
DAUM CORP. |
E.J. Smith |
| K971591 |
03/13/1998 |
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) |
DAVID C. BISHOP, PH.D. |
DAVID C BISHOP |
| K980062 |
03/20/1998 |
MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE |
DAVIS & GECK, INC. |
STEPHEN J TARNSETT |
| K973129 |
03/17/1998 |
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS |
DENVER BIOMATERIALS, INC. |
BONNIE VIVIAN |
| K974781 |
03/10/1998 |
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL |
DEPUY, INC. |
KATHLEEN A DRAGOVICH |
| K974740 |
03/18/1998 |
DEPUY TRI-LOCK HIP STEM |
DEPUY, INC. |
ARLENE C SAULL |
| K973532 |
03/19/1998 |
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR |
DHD DIEMOLDING HEALTHCARE DIV. |
JEAN WALLACE |
| K980031 |
03/03/1998 |
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973999 |
03/11/1998 |
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K980032 |
03/02/1998 |
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973108 |
03/02/1998 |
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974889 |
03/06/1998 |
DIAMEDIX IS-RF TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K974694 |
03/03/1998 |
IS-DSDNA TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K980523 |
03/19/1998 |
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
STEVE BOEH |
| K974817 |
03/13/1998 |
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K972603 |
03/11/1998 |
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B |
DR. LEE CO., LTD. |
GREG HOLLAND |
| K980118 |
03/17/1998 |
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER |
EASTMAN KODAK COMPANY |
NANCY BUTCHER |
| K974726 |
03/18/1998 |
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER |
ELEKTA IMPLANTS, SA |
BARBRA RAMSEYER |
| K972324 |
03/02/1998 |
LEKSELL STEREOTACTIC SYSTEM |
ELEKTA INSTRUMENT AB |
CAROL PATTERSON |
| K973684 |
03/31/1998 |
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND |
ELEKTA INSTRUMENT AB |
CAROL L PATTERSON |
| K974793 |
03/19/1998 |
ELMED ESU 120 M/M DIGITAL |
ELMED, INC. |
WERNER HAUSNER |
| K974614 |
03/04/1998 |
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 |
ELSCINT, INC. |
STEVEN M KAY |
| K974798 |
03/20/1998 |
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
BRUCE G PIEKARSKI |
| K980023 |
03/18/1998 |
ENDOPATH AND PROXIMATE LINEAR CUTTERS |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
| K980022 |
03/09/1998 |
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
| K980533 |
03/23/1998 |
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) |
ETYMOTIC RESEARCH |
KRISTA M BUCKLES, M.A. |
| K980597 |
03/09/1998 |
CARRARA PDF, CARRARA H, CARRARA R |
EUROPEAN DENTAL IMPORTS, INC. |
MICHAEL H EVERNGAM |
| K971565 |
03/12/1998 |
BICOAG COAGULATING FORCEPS |
EVEREST MEDICAL CORP. |
DAVID J PARINS |
| K973664 |
03/13/1998 |
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING |
EVERGRADE HEALTHCARE PRODUCTS SDN BHD |
JANNA P TUCKER |
| K980056 |
03/06/1998 |
CARESIDE ANALYZER |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K980043 |
03/30/1998 |
CARESIDE CREATININE |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K963794 |
03/19/1998 |
PUNCTURENEEDLE |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K962615 |
03/19/1998 |
TUMORLOCALIZER MRI |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K974493 |
03/31/1998 |
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES |
FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH |
|
| K980919 |
03/31/1998 |
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER |
FORTUNE MEDICAL INSTRUMENT CORP. |
KAREN U SALINAS |
| K980560 |
03/27/1998 |
FOTONA SKINPLUS LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K964878 |
03/05/1998 |
ESOP S/C FEMORAL STEM |
FOURNITURES HOSPITALIERES |
BEN VAN DER KOOIJ |
| K974628 |
03/11/1998 |
FRIALIT-2 PROTECT ABUTMENT |
FRIATEC AG |
ROBERT J SLOMOFF |
| K980377 |
03/18/1998 |
FONIX FP35 HEARING AID ANALYZER |
FRYE ELECTRONICS, INC. |
GEORGE J FRYE |
| K974636 |
03/30/1998 |
FLOSI RIGID GAS PERMEABLE CONTACT LENS |
FUTURISTIC DESIGN ASSOC. |
WILLIAM PLATT |
| K980114 |
03/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K974751 |
03/06/1998 |
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC |
GENERAL HEARING INSTRUMENTS, INC. |
ROGER P JUNEAU |
| K980565 |
03/19/1998 |
LD2000 SERIES |
GENERAL SCANNING, INC. |
STEVEN P ZIS |
| K980531 |
03/06/1998 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
| K974084 |
03/03/1998 |
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT |
GETINGE/CASTLE, INC. |
TREVOR WILLIAMSON |
| K974587 |
03/09/1998 |
H2O |
GRASS-TELEFACTOR PRODUCT GROUP |
JAMES S BRYAN |
| K971759 |
03/02/1998 |
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER |
GREEN FIELD MEDICAL SOURCING, INC. |
DONALD R GORSUCH |
| K980119 |
03/20/1998 |
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE |
GUIDANT CORP. |
SUSAN SILAVIN |
| K974773 |
03/13/1998 |
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC |
GUIDANT CORP. |
MARGARET ANDERSON |
| K980247 |
03/17/1998 |
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM |
GYNEX CORP. |
DAVID W SCHLERF |
| K974311 |
03/04/1998 |
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K980318 |
03/11/1998 |
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K980572 |
03/13/1998 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K974746 |
03/18/1998 |
M1765A ECG MANAGER |
HEWLETT-PACKARD CO. |
JAMES R VEALE |
| K971910 |
03/23/1998 |
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K974720 |
03/13/1998 |
HOWMEDICA(R) FULLY THREADED SCREWS |
HOWMEDICA, INC. |
VIVIAN KELLY |
| K974313 |
03/02/1998 |
HYDROFERA SURGICAL SPEAR |
HYDROFERA, LLC. |
HEATHER S BOND |
| K974759 |
03/09/1998 |
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE |
HYDROX LABORATORIES |
KAPPANA RAMANANDAN |
| K974758 |
03/09/1998 |
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE |
HYDROX LABORATORIES |
KAPPANA RAMANANDAN |
| K980003 |
03/13/1998 |
M500-100 SHARPS CONTAINER |
IMAGINATION MEDICAL, INC. |
TIM WEIST |
| K980291 |
03/11/1998 |
IMPOWER EXTERNAL VACUUM SYSTEM |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
RONALD H BERGESON |
| K980722 |
03/23/1998 |
TRIMAX RADIOGRAPHIC CASSETTE |
IMATION CORP. |
STEPHEN G SLAVENS |
| K974755 |
03/04/1998 |
DYNA VUE 3-D IMAGING PRODUCT |
IMD SYSTEMS, INC. |
KENNETH M NICOLL |
| K972873 |
03/17/1998 |
IMMUSTRIP HAMA IGG |
IMMUNOMEDICS, INC. |
JOSEPH E PRESSLITZ |
| K974752 |
03/03/1998 |
IMTEC/BIOBARRIER MEMBRANE |
IMTEC CORP. |
M. K. PATTERSON |
| K980482 |
03/27/1998 |
TRIANGLE SLING |
INFLUENCE, INC. |
MARK D KRAMER |
| K980511 |
03/13/1998 |
NITRILE EXAMINATION GLOVES - POWDER FREE |
INFLUX PACIFIC SDN. BHD. |
GAN SOONG TEE |
| K980097 |
03/04/1998 |
FLEXIGEL-G HYDROGEL WOUND DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD COX |
| K980230 |
03/24/1998 |
QUANTA LITE B2 GPI SCREEN |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K980242 |
03/19/1998 |
IL TEST HEPARIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K974009 |
03/13/1998 |
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
| K971840 |
03/04/1998 |
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM |
INVIVO RESEARCH, INC. |
FRANCIS X CASEY |
| K974855 |
03/27/1998 |
PHORESOR II, MODEL PM900 |
IOMED, INC. |
W. TIM MILLER |
| K980001 |
03/19/1998 |
JENASCAN |
JENOPTIK LASER, OPTIK, SYSTEME GMBH |
WILLIAM T KELLEY |
| K974902 |
03/30/1998 |
JMS APHERESIS NEEDLE |
JMS CO., LTD. |
TETSUHARN HIROSE |
| K973797 |
03/12/1998 |
BREATHING CIRCUIT BACTERIAL FILTER |
KING SYSTEMS CORP. |
BRUCE E GREEN |
| K974143 |
03/27/1998 |
KMC NEWSKIN |
KMC INTL. CO. |
CINDIE SHIMM |
| K974896 |
03/27/1998 |
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES |
LASERSCOPE |
LISA MCGRATH |
| K974724 |
03/02/1998 |
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT |
LENS COMFORT, INC. |
JAMES C DEMESTICHAS |
| K974538 |
03/03/1998 |
MENISCAL REPAIR DEVICE |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K980123 |
03/09/1998 |
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET |
LOUISVILLE LABORATORIES, INC. |
MARK STERRETT |
| K980618 |
03/13/1998 |
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES |
LOVYTEX SDN BHD |
M.G. DESAI |
| K974789 |
03/09/1998 |
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L |
LUMENIS, INC. |
MICHELE DEETON |
| K980213 |
03/17/1998 |
DI-2000 |
LUMISYS, INC. |
TRINDY LEFORGE |
| K980090 |
03/24/1998 |
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) |
LUTHER MEDICAL PRODUCTS, INC. |
BARBARA C LUTHER |
| K980454 |
03/18/1998 |
LYSONIX ASPIRATION PUMP |
LYSONIX, INC. |
RONALD F LAGERQUIST |
| K973364 |
03/17/1998 |
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG |
MAERSK MEDICAL A/S |
JOERGEN M NIELSEN |
| K973403 |
03/12/1998 |
CARDIOSMART ST |
MARQUETTE MEDICAL SYSTEMS, INC. |
DIANNE SCHMITZ |
| K980582 |
03/16/1998 |
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS |
MARQUETTE MEDICAL SYSTEMS, INC. |
MICHAEL LAUGHRAN |
| K974878 |
03/27/1998 |
E3 MICROPROBE |
MARTIN URAM, MD |
MARTIN URAM |
| K974679 |
03/23/1998 |
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM |
MEDCON LTD. |
ELI M ORBACH |
| K971914 |
03/26/1998 |
TECA NCS ELECTRODE SYSTEM 2000 |
MEDELEC, INC. D.B.A. TECA CORP. |
JAMES P HURLMAN |
| K980514 |
03/04/1998 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOTT D KINGHORN |
| K974034 |
03/02/1998 |
PORTABLE INTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K980086 |
03/10/1998 |
HEAT STACK |
MEDICAL SOLUTIONS, INC. |
E J SMITH |
| K974672 |
03/13/1998 |
MSI SURGICAL DRAPES |
MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
CAROLANN KOTULA |
| K974796 |
03/12/1998 |
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER |
MEDISPEC, LTD. |
AVNER SPECTOR |
| K974174 |
03/10/1998 |
ULTRABUR |
MEDNET LOCATOR, INC. |
JUDY CHANDLEER |
| K974703 |
03/10/1998 |
CARBON FIBER BREAST BOARD |
MEDTEC, INC. |
DONALD F RIBE |
| K974700 |
03/04/1998 |
MATRIX MT-MX3 |
MEDTEC, INC. |
DONALD F RIBE |
| K980613 |
03/09/1998 |
PROGOLD ELECTROCOPING SYSTEM |
MICRO DENTAL LABORATORIES |
NICOLAS E AZAR |
| K973508 |
03/10/1998 |
PYLORI DETECT IGG |
MICRO DETECT, INC. |
MEHDI ALEM PH.D. |
| K974611 |
03/20/1998 |
MICRO-STRIP FOR AMPHETAMINE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K980758 |
03/27/1998 |
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
| K972511 |
03/06/1998 |
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER |
MICROVENA CORP. |
JANELL COLLEY |
| K973800 |
03/11/1998 |
23:1 REDUCTION ANGLE |
MIDWEST DENTAL PRODUCTS CORP. |
ROBERT E BOOTH |
| K974291 |
03/05/1998 |
MITEK BTB ABSORBABLE (PLA) CROSS PIN |
MITEK PRODUCTS |
EDWARD F KENT |
| K972591 |
03/04/1998 |
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT |
MORAX |
BOREK JANIK |
| K980331 |
03/16/1998 |
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K973916 |
03/09/1998 |
NP MEDICAL CAPLESS LUER ACTIVATED VALVE |
N.P. MEDICAL, INC. |
PAUL A CARACCIOLO |
| K974172 |
03/30/1998 |
SILGEL TOPICAL GEL SHEET |
NAGOR LTD. |
J A EVANS |
| K980082 |
03/04/1998 |
J-TIP NEEDLESS INJECTOR |
NATIONAL MEDICAL PRODUCTS, INC. |
ROHIT PATEL |
| K974805 |
03/11/1998 |
CO-STAT(TM) END TIDAL BREATH ANALYZER |
NATUS MEDICAL, INC. |
ESTHER KADASH |
| K973419 |
03/25/1998 |
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR |
NELLCOR PURITAN BENNETT, INC. |
SHERYLL A MATHEWS |
| K980241 |
03/17/1998 |
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE |
NETCO COMMUNICATIONS CORP. |
TOM QUINTAVALLE |
| K973740 |
03/23/1998 |
ROUND WINDOW E-CATH |
NEURO-BIOMETRIX, INC. |
MICHAEL H ARENBERG |
| K974708 |
03/10/1998 |
GEMINI STANDARD AND MINI VALVES |
NEUROCARE GROUP |
LORI L HAYS |
| K980201 |
03/16/1998 |
DIO-LIGHT LASER SYSTEM |
NIDEK, INC. |
KEN KATO |
| K974732 |
03/18/1998 |
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 |
NIDEK, INC. |
WILLIAM STERLING |
| K980677 |
03/16/1998 |
NITRILE EXAM GLOVE, POWDER FREE |
NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. |
JANNA P TUCKER |
| K974828 |
03/24/1998 |
BRANEMARK SYSTEM(R) EBON(TM) FIXTURE |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
| K980419 |
03/13/1998 |
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE |
OMNIGRACE (THAILAND) LTD. |
WILLIAM E PATTON |
| K980421 |
03/13/1998 |
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED |
OMNIGRACE (THAILAND) LTD. |
WILLIAM E PATTON |
| K974599 |
03/02/1998 |
ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) |
OPTI-CENTRE LABORATORIES |
MARTIN DALSING |
| K974464 |
03/19/1998 |
ORATEC SPINECATH INTRADISCAL CATHETER |
ORATEC INTERVENTIONS, INC. |
MICHAEL KWAN |
| K974877 |
03/27/1998 |
CRANEX TOME CEPH, OR CRANEX TOME |
ORION CORPORATION SOREDEX |
KAI LANER |
| K980195 |
03/11/1998 |
FACEBOW |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
| K974186 |
03/18/1998 |
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING |
ORTHOFIX SRL |
ROBERT L SHERIDAN |
| K974785 |
03/18/1998 |
AUTO-DRIVE BONE SCREW |
OSTEOMED CORP. |
BRUCE HOROWITZ |
| K974807 |
03/16/1998 |
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM |
OSTEONICS CORP. |
TERRY SHERIDAN |
| K980518 |
03/06/1998 |
OSTEOMARK |
OSTEX INTL., INC. |
NANCY JS MALLINAK |
| K980215 |
03/13/1998 |
LATEX EXAMINATION GLOVES |
P.T. WANTONG INDUSTRY |
C.S. HUNG |
| K980160 |
03/10/1998 |
EPILASER I UPGRADE KIT |
PALOMAR MEDICAL PRODUCTS, INC. |
ANTHONY FIORILLO |
| K973679 |
03/10/1998 |
AEROETCHER |
PARKELL, INC. |
NELSON J GENDUSA |
| K974865 |
03/16/1998 |
CSR |
PARKELL, INC. |
NELSON J GENDUSA |
| K972777 |
03/11/1998 |
TEMPORARY OCCLUSION BALLOON SYSTEM |
PERCUSURGE, INC. |
EDWARD J SINCLAIR |
| K980027 |
03/31/1998 |
PEREGRINE SHIELDED DIFFUSION PROBE |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K980025 |
03/31/1998 |
PEREGRINE TAPERED DIFFUSION PROBE |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K974718 |
03/09/1998 |
PERSYST PRISM |
PERSYST DEVELOPMENT CORP. |
SCOTT B WILSON |
| K980532 |
03/11/1998 |
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 |
PHAMATECH |
CARL A MONGIOVI |
| K974844 |
03/10/1998 |
OUTLOOK SYSTEM ENHANCEMENT PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE C PRASCHAN |
| K974642 |
03/13/1998 |
COMBICATH CATHETER |
PLASTIMED LABORATOIRE PHARMACEUTIQUE |
MIKE MCCORMICK |
| K980133 |
03/11/1998 |
BAUSCH & LOMB WETTING AND SOAKING SOLUTION |
POLYMER TECHNOLOGY CORP. |
DEBRA L.B. KETCHUM |
| K980561 |
03/19/1998 |
DERMIUM |
PREMIER LASER SYSTEMS, INC. |
LISA MOJICA |
| K962903 |
03/03/1998 |
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE |
PRESTIGE MEDICAL CORP. |
MARK A HELLER |
| K980249 |
03/13/1998 |
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K973236 |
03/11/1998 |
CREST TOOTHBRUSH WITH MICROSHIELD |
PROCTER & GAMBLE CO. |
MARLENE B FEDER |
| K971612 |
03/16/1998 |
OSMO/PCA PILLOW WOUND DRESSING |
PROCYTE CORP. |
PAUL KETTERIDGE |
| K974202 |
03/19/1998 |
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS |
PULPDENT CORP. |
KENNETH J BERK |
| K974210 |
03/30/1998 |
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 |
RAD-SOURCE, INC. |
RANDOL E KIRK |
| K980430 |
03/16/1998 |
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) |
RADIONICS, INC. |
JEFF MANNION |
| K973993 |
03/06/1998 |
RANDOX CREATININE |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K973405 |
03/13/1998 |
YEUNG ENDOSCOPIC SPINE SYSTEM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K980061 |
03/02/1998 |
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER |
ROCKET MEDICAL PLC |
R KEEN |
| K974354 |
03/05/1998 |
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE |
SCA MOLNLYCKE |
MIGUEL A NEGRON |
| K980313 |
03/19/1998 |
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
| K973652 |
03/27/1998 |
DUOCLIPPER TITANIUM CLIPS |
SCION INTERNATIONAL, INC. |
STEPHEN CHAKOFF |
| K973698 |
03/31/1998 |
SCION BALLOON ELEVATOR |
SCION INTERNATIONAL, INC. |
STEPHEN CHAKOFF |
| K974819 |
03/23/1998 |
SELECTCELLS(TM) MINI |
SELECT MEDICAL SYSTEMS, INC. |
MONIQUE GIRARD |
| K980301 |
03/24/1998 |
IP-16 |
SERVIZI MEDICO ESTETICI ITALINAI SRL. |
JAMES E LENICK |
| K972981 |
03/17/1998 |
SHIELD HELICO-G2 ELISA KIT |
SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K973802 |
03/04/1998 |
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM |
SHIMADZU MEDICAL SYSTEMS |
YASUHARU ISHII |
| K980666 |
03/20/1998 |
INFINITY AST REAGENT (PROCEDURE NO. 51) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K974585 |
03/06/1998 |
IF-727 INTERFERENTIAL STIMULATOR |
SKYLARK DEVICE CO., LTD. |
GEORGE K.C. CHEN |
| K974870 |
03/13/1998 |
LATEX EXAMINATION GLOVE POWDER FREE |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K974907 |
03/13/1998 |
NITRILE PRE-POWDERED EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO K PU |
| K974557 |
03/13/1998 |
SMARTTEX |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K973748 |
03/10/1998 |
TEMPO AND TEMP H20 |
SMITH |
DURWARD FARIES, JR. |
| K980092 |
03/09/1998 |
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS |
SMITH & NEPHEW, INC. |
DEBORAH J CONNOR |
| K963642 |
03/18/1998 |
INCL II ENDOSCOPE |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K973854 |
03/16/1998 |
ORION ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K974653 |
03/13/1998 |
SILICONE ELASTOMER SHEETING |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K980461 |
03/04/1998 |
SPECTRUM DESIGNS CLEFT CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980140 |
03/03/1998 |
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980139 |
03/03/1998 |
SPECTRUM DESIGNS PROFILE MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K980141 |
03/03/1998 |
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K973687 |
03/18/1998 |
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
TEENA M AUGOSTINO |
| K980818 |
03/30/1998 |
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) |
STEPHEN A. DUNN, INC. |
MARTIN S KNOPF |
| K980439 |
03/16/1998 |
REPLACE CYLINDRICAL IMPLANTS |
STERI-OSS, INC. |
PAUL GASSER |
| K972185 |
03/05/1998 |
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE |
STERIPAK, LTD. |
JOHN HOLLOWAY |
| K972300 |
03/25/1998 |
CROSS-CHECKS P |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
| K980488 |
03/23/1998 |
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM |
STORZ INSTRUMENT CO. |
GARY M RAUVOLA |
| K980071 |
03/13/1998 |
SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES |
SUPERMAX LATEX PRODUCTS SDN. BHD. |
STANLEY THAI |
| K974555 |
03/03/1998 |
SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K974206 |
03/16/1998 |
SYNTHES CRANIAL SPRING CLIP (CSC) |
SYNTHES (USA) |
SHERI MUSGNUNG |
| K974908 |
03/18/1998 |
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES |
SYNTHES (USA) |
KEVIN J O'CONNELL |
| K974525 |
03/02/1998 |
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM |
SYNTHES SPINE |
BARRY E SANDS |
| K980349 |
03/03/1998 |
QUICKPAC II ONE STEP BARBITURATE TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
| K980153 |
03/27/1998 |
DRUG CHECK |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
| K980026 |
03/10/1998 |
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
David Johnston |
| K973640 |
03/12/1998 |
TS2000 MEDICAL DEVICE MONITOR |
TRINCORE SYSTEMS, INC. |
VINCENT OCCHIPINTI |
| K973377 |
03/10/1998 |
SIBELMED AC50D |
TRUTONE |
ZIAD SHWIYAT |
| K980802 |
03/25/1998 |
NITRILE EXAM GLOVE, POWDER-FREE, BLUE |
TUCKER & ASSOCIATES |
JANNA P TUCKER |
| K974786 |
03/03/1998 |
PREPQUICK |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K974734 |
03/10/1998 |
AURORA TITANIUM SPINAL ROD SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K980124 |
03/27/1998 |
SOFSILK SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHRISTOPHER A GRAHAM |
| K972225 |
03/18/1998 |
UFR FIBEROPTIC CABLE |
UNIVERSAL FIBEROPTIC REPAIR, INC. |
DEREK N MAY |
| K980093 |
03/02/1998 |
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE |
UNIVERSAL GLOVES CORP. |
JOHN CHEN |
| K974600 |
03/31/1998 |
UROMED PATCH |
UROMED CORP. |
FREDERICK TOBIA |
| K980089 |
03/24/1998 |
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 |
VALLEY WEST, INC. |
C. KENNETH FRENCH |
| K973628 |
03/13/1998 |
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA |
VITAL SCIENTIFIC N.V. |
ISRAEL M STEIN |
| K980539 |
03/23/1998 |
SOLOBOND M |
VOCO GMBH |
EVAN DICK, PH.D. |
| K974806 |
03/23/1998 |
VYGON NEO-SUMP |
VYGON CORP. |
ANNE MARIE CESARIO |
| K980769 |
03/27/1998 |
WINDMERE MODEL DS-2 FOOT BATH |
WINDMERE CORP. |
RICHARD C LANZILLOTTO |
| K973474 |
03/13/1998 |
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS |
WITT BIOMEDICAL CORPORATION |
LORRAINE R FREDES |
| K971028 |
03/02/1998 |
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED |
WORLDS-BEST GUMMIVAREFABRIK A/S |
CHRISTIAN HJORTH |
| K973357 |
03/02/1998 |
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K972241 |
03/16/1998 |
ZOLL REVIVER |
ZOLL MEDICAL CORP. |
MAURA MCGUIRE |
