| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K001114 |
06/09/2000 |
3M QUIK TEMP TEMPORIZATION MATERIAL |
3M COMPANY |
CHERI SMOKOVICH |
| K993154 |
06/29/2000 |
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM |
A.R.C. LASER CORP. |
DANIEL HOEFER |
| K001382 |
06/27/2000 |
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
AARON MEDICAL INDUSTRIES |
RICK KOZLOFF |
| K001223 |
06/23/2000 |
ACULUX, MODEL AX3001, AX3002 |
ACULUX |
KIM MARSH |
| K000792 |
06/08/2000 |
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX |
ADVANCED RENAL TECHNOLOGIES, INC. |
ROBIN CALLAN |
| K993066 |
06/07/2000 |
WINDOW CERVICAL DYNAMIC PLATE SYSTEM |
ADVANCED SPINE TECHNOLOGY, INC. |
GORDON TAO |
| K991999 |
06/15/2000 |
STERRAD 100S STERILIZER |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K993775 |
06/01/2000 |
STERRAD BI TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K001567 |
06/19/2000 |
ADVANTAGE THC TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K994116 |
06/01/2000 |
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) |
AESCULAP-MEDITEC NORTH AMERICA |
WILLIAM KELLEY |
| K001080 |
06/29/2000 |
SPINE SYSTEM EVOLUTION |
AESCULAP, INC. |
LIA S JONES |
| K001722 |
06/30/2000 |
AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE |
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
EGON PFEIL |
| K001436 |
06/07/2000 |
AGILENT M2636A TELEMON MONITOR |
AGILENT TECHNOLOGIES, INC. |
DENISE HALEY |
| K001664 |
06/30/2000 |
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K001711 |
06/20/2000 |
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 |
AGILENT TECHNOLOGIES, INC. |
STEVE SINGLAR |
| K001776 |
06/30/2000 |
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDSON |
| K001313 |
06/08/2000 |
AIRDENT II CS |
AIR TECHNOLOGIES, INC. |
JOSEPH CAREY |
| K001157 |
06/27/2000 |
MONARCH II IOL DELIVERY SYSTEM |
ALCON RESEARCH, LTD. |
SHERRI J LAKOTA |
| K994410 |
06/21/2000 |
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994405 |
06/02/2000 |
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K001484 |
06/19/2000 |
CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 |
ALKO DIAGNOSTIC CORP. |
PATRICK CHIU |
| K000813 |
06/08/2000 |
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM |
ALLEGIANCE HEALTHCARE COPORATION |
ERICA SETHI |
| K001667 |
06/23/2000 |
RESOLVE SURGICAL O.R. TOWELS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K993623 |
06/23/2000 |
GEMINI E |
ALLEN MEDICAL INSTRUMENTS CORP. |
JUDITH ALLEN |
| K000164 |
06/02/2000 |
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K001215 |
06/22/2000 |
DBEST HCG 2 IU/ML TEST KIT |
AMERITEK, INC. |
K.C. YEE |
| K001341 |
06/02/2000 |
DR5000 DEDICATED CHEST X-RAY SYSTEM |
ANALOGIC CORP. |
ROBERT H FRENCH |
| K001336 |
06/02/2000 |
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM |
ANALOGIC CORP. |
ROBERT H FRENCH |
| K990435 |
06/05/2000 |
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 |
APEX MEDICAL CORP. |
DANIEL LEE |
| K001142 |
06/23/2000 |
AUDIO TECHNOLOGIES S:R.1 |
AUDIO TECHNOLOGIES S.R.L. |
FRANCO BEONI |
| K001480 |
06/21/2000 |
AURECAST 40 B |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001478 |
06/20/2000 |
AURECAST SUPER INLAY |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001477 |
06/20/2000 |
AURELUX Y 84 PREMIUM |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001482 |
06/23/2000 |
AURENORM 75 KF |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001481 |
06/23/2000 |
PALCERAM 49 |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001479 |
06/21/2000 |
PALCERAM 53 |
AUREX SA (PTY) LTD. |
J. D DAVIS |
| K001632 |
06/19/2000 |
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K000947 |
06/16/2000 |
ULTRASTIM ELECTRODE, MODEL US4040 |
AXELGAARD MFG. CO., LTD. |
DAN JEFFERY |
| K001574 |
06/09/2000 |
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 |
AXIS-SHIELD |
EILEEN A MCCAFFERTY |
| K001422 |
06/02/2000 |
PSN HEMODIALYZER, MODELS PSN 170, PSN 210 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K992532 |
06/13/2000 |
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING |
BAXTER HEALTHCARE CORP. |
JASON SMITH |
| K001344 |
06/26/2000 |
ADVIA IMS |
BAYER CORP. |
FREDRICK CLERIE |
| K001364 |
06/28/2000 |
BD DIRECTIGEN FLU A+B |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
Monica Giguere |
| K000687 |
06/12/2000 |
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST |
BEACON BIOLOGICALS, INC. |
KANTI DAYA |
| K001458 |
06/02/2000 |
SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K994384 |
06/22/2000 |
CLICKER |
BIOJECT, INC. |
NANCY GERTLAR |
| K001219 |
06/21/2000 |
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K001660 |
06/14/2000 |
MALLORY HEAD MODULAR CALCAR |
BIOMET ORTHOPEDICS, INC. |
MICHELLE L MCKINLEY |
| K000978 |
06/22/2000 |
ANATOMIC TOTAL KNEE PROSTHESIS |
BIOMET, INC. |
LONNIE WITHAM |
| K000683 |
06/27/2000 |
MODIFIED SINGLE AXLE TOTAL ELBOW |
BIOMET, INC. |
FRED MCCLURE |
| K000836 |
06/08/2000 |
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K001046 |
06/08/2000 |
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS |
BIOPRO, INC. |
CHERYL WARSINSKE |
| K001640 |
06/23/2000 |
BIOSOFT RESIN |
BIOSOFT INTERNATIONAL CORP. |
ROY SHU |
| K000931 |
06/08/2000 |
AU5 ULTRASOUND IMAGING SYSTEM |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K001413 |
06/02/2000 |
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K991206 |
06/06/2000 |
BONASSE CONTACT LENS CASE |
BONASSE ENT. CO., LTD. |
MILTON N BENEKE |
| K000798 |
06/08/2000 |
TALON BALLOON DILATION CATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
| K000001 |
06/05/2000 |
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
RON BENNETT |
| K991038 |
06/22/2000 |
VASO PRESS DVT SYSTEM, MODELS VP500, VP501 |
BRITT CORP., INC. |
J. JAMES BRITTON |
| K000904 |
06/08/2000 |
PENADAPT 10 |
BUFFALO FILTER CO., INC. |
KATHLEEN H SELOVER |
| K000981 |
06/13/2000 |
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX |
C-MIX |
ART WARD |
| K001034 |
06/09/2000 |
MODEL APS ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K992606 |
06/21/2000 |
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 |
CANON U.S.A., INC. |
KEN SHADOFF |
| K000959 |
06/22/2000 |
CRITERION 60 OR PM 60 |
CARADYNE, LTD. |
PAUL DRYDEN |
| K001081 |
06/30/2000 |
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRIAN PARK |
| K000890 |
06/16/2000 |
CHAD THERAPEUTICS OXYMATIC MODEL 401 |
CHAD THERAPEUTICS, INC. |
OSCAR J SANCHEZ |
| K001593 |
06/14/2000 |
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL |
CHESTER LABS, INC. |
HOLLY SHERWOOD |
| K001705 |
06/29/2000 |
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF |
CHESTER LABS, INC. |
HOLLY SHERWOOD |
| K994209 |
06/14/2000 |
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K001597 |
06/05/2000 |
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX |
CONMED CORP. |
IRA D DUESLER, JR. |
| K001159 |
06/07/2000 |
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL |
CONMEDCORP |
CHARLES M (MIKE) HART |
| K001161 |
06/07/2000 |
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), |
CONMEDCORP |
CHARLES M (MIKE) HART |
| K000543 |
06/16/2000 |
CONTEMPRO-MIST |
CONTEMPORARY PRODUCTS, INC. |
BARRY A SCHWARTZ |
| K992935 |
06/20/2000 |
OCD2001 |
CONTEMPORARY PRODUCTS, INC. |
BARRY A SCHWARTZ |
| K001258 |
06/27/2000 |
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM |
CORDIS CORP. |
DEAN A KNIGHT |
| K001322 |
06/30/2000 |
PERFORMER 30 HPS |
CORNELIA DAMSKY, INC. |
CORNELIA DAMSKY |
| K001173 |
06/23/2000 |
NYLON, NONABSORBABLE SURGICAL SUTURES USP |
CP MEDICAL |
PATRICK FERGUSON |
| K001299 |
06/23/2000 |
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP |
CP MEDICAL |
PATRICK FERGUSON |
| K001172 |
06/23/2000 |
POLYESTER NONABSORBABLE SURGICAL SUTURES URP |
CP MEDICAL |
PATRICK FERGUSON |
| K001185 |
06/23/2000 |
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP |
CP MEDICAL |
PATRICK FERGUSON |
| K001184 |
06/23/2000 |
SILK, NONABSORBABLE, SURGICAL SUTURES, USP |
CP MEDICAL |
PATRICK FERGUSON |
| K992835 |
06/06/2000 |
C.S.O. TONOMETER |
CSO |
R. BRENT MINER |
| K994199 |
06/09/2000 |
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR |
CUSTOM MEDICAL PRODUCTS, INC. |
STEVE WOODY |
| K000237 |
06/13/2000 |
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION |
CYBERCARE, INC. |
RICHARD HALBACH |
| K992757 |
06/29/2000 |
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K001064 |
06/21/2000 |
BEHRING COAGULATION TIMER ANALYZER (BCT) |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K001067 |
06/20/2000 |
DADE BEHRING COAGULATION ANALYZER (BCT) |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K001888 |
06/30/2000 |
UNICORN MODEL SYS0630 |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NEERGAARDSVEJ 5F |
| K000815 |
06/08/2000 |
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) |
DATEX-OHMEDA |
JOEL C KENT |
| K000882 |
06/05/2000 |
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM |
DATEX-OHMEDA |
JOEL KENT |
| K000892 |
06/16/2000 |
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES |
DATEX-OHMEDA, INC. |
JOEL KENT |
| K001688 |
06/30/2000 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
DALE THANIG |
| K001463 |
06/16/2000 |
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLARK SMITH |
| K001269 |
06/21/2000 |
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC |
DENTALMATIC TECHNOLOGIES, INC. |
NAOUM ARAJ |
| K000996 |
06/16/2000 |
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K001534 |
06/12/2000 |
PINNACLE ACETABULAR SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K001277 |
06/23/2000 |
TRIFLANGE ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K001285 |
06/02/2000 |
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K001286 |
06/20/2000 |
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K000463 |
06/01/2000 |
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K001602 |
06/08/2000 |
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) |
DIDECO S.P.A. |
BARRY SALL |
| K001629 |
06/21/2000 |
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM |
DISETRONIC MEDICAL SYSTEMS AG |
Lee Leichter |
| K992932 |
06/07/2000 |
CIPA (ADULTS) CIPI (INFANTS) |
DMC MEDICAL LTD. |
CHARMAINE HENDERSON |
| K000072 |
06/12/2000 |
DORNIER MEDILAS D SKINPULSE |
DORNIER SURGICAL PRODUCTS, INC. |
SUSANNE COURTNEY |
| K001488 |
06/09/2000 |
NARKOMED MRI , NM-MRI |
DRAEGER MEDICAL, INC. |
J TERESA DORREITY, JD |
| K000766 |
06/01/2000 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K001627 |
06/03/2000 |
TRIFIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K001437 |
06/07/2000 |
ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
ERIC KOEHLER |
| K000820 |
06/05/2000 |
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 |
ENDOSONICS CORP. |
CHRISTINA KICHULA |
| K000831 |
06/05/2000 |
STAT-SHELL DISPOSABLE SP02 SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K001103 |
06/30/2000 |
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K001101 |
06/30/2000 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K000702 |
06/07/2000 |
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K001107 |
06/23/2000 |
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K001112 |
06/14/2000 |
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K001305 |
06/27/2000 |
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
J. LAN MCDONALD |
| K993625 |
06/20/2000 |
INSUFFLATION NEEDLE- 120MM, MODEL 900-200 |
GENICON, LC |
GARY HABERLAND |
| K001146 |
06/30/2000 |
GENYX FLEXIBLE INJECTION NEEEDLE |
GENY MEDICAL, INC. |
JUDY F GORDON |
| K001434 |
06/12/2000 |
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
MARY E GRAY |
| K001435 |
06/02/2000 |
VIKING OPTIMA GUIDING CATHETER |
GUIDANT CORP. |
STACEY SIMON |
| K000801 |
06/19/2000 |
PC COATED FLUOROPLASTIC VENT TUBES |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K001686 |
06/23/2000 |
GALILEO VENTILATOR |
HAMILTON MEDICAL, INC. |
J. DAVID THOMPSON |
| K000351 |
06/23/2000 |
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE |
HANWELLA RUBBER PRODUCTS LTD. |
B. DAMITHA P DHARMASENA |
| K001490 |
06/01/2000 |
HARDYDISK CEFONICID, 30 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K001489 |
06/01/2000 |
HARDYDISK CEFOPERAZONE, 75 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K001487 |
06/07/2000 |
HARDYDISK CINOXACIN, 100 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000456 |
06/01/2000 |
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 |
HARVEST TECHNOLOGIES, LLC. |
ANNETTE M FAGNANT |
| K990209 |
06/22/2000 |
NOVAC7 |
HITESYS S.P.A. |
WALTER E GUNDAKER |
| K001559 |
06/20/2000 |
CALCIUM SULFATE PELLETS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K001548 |
06/07/2000 |
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K001312 |
06/20/2000 |
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL |
IGC-MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K001192 |
06/07/2000 |
SELF ADHERING NAVIGUS GUIDE |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K992955 |
06/02/2000 |
XPLORER 1000 |
IMAGING DYNAMICS CORP. |
ROBIN WINSOR |
| K001084 |
06/15/2000 |
TRANS FX ADJUSTABLE PIN TO BAR CLAMP |
IMMEDICA, INC. |
ROY BOGERT |
| K001039 |
06/15/2000 |
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP |
IMPLEX CORP. |
JOHN SCHALAGO |
| K000535 |
06/07/2000 |
QUANTA LITE LKM-1 ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
| K001439 |
06/22/2000 |
ORTHOCEPH OC100 D |
INSTRUMENTARIUM CORP. |
TOMMI JOKINIEMI |
| K000976 |
06/01/2000 |
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) |
INSTRUMENTARIUM IMAGING, INC. |
MAX LINDERT |
| K994238 |
06/23/2000 |
IL TEST LIQUID ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K001113 |
06/13/2000 |
IVC THREE BLASTOCYST MEDIUM, CAT # 2007 |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K000989 |
06/08/2000 |
SPERM WASH MEDIUM, CAT# 2003/2005 |
INVITROCARE, INC. |
RPBERT E LOVINS |
| K001360 |
06/20/2000 |
SIGNUM |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K001787 |
06/30/2000 |
QUART ARTERIAL FILTER, MODEL HBF 140 |
JOSTRA MEDIZINTECHNIK AG |
KATHY JOHNSON |
| K000769 |
06/01/2000 |
KSEA MANHES PNEUMOTROCAR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K001309 |
06/13/2000 |
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 |
KAY SEE DENTAL MFG. CO. |
CLARK SMITH |
| K001058 |
06/02/2000 |
AUDIOSCREENER OAE + ABR |
KEDLY, INC. |
RANDALL J KROHN |
| K001557 |
06/09/2000 |
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
LIM KWAN HWA |
| K990060 |
06/15/2000 |
MACH 7 |
KREATIV, INC. |
JOSEPH FOREHAND |
| K001737 |
06/19/2000 |
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM |
LACRIMEDICS, INC. |
BRIAN P LOGAN |
| K001031 |
06/29/2000 |
URANUS, COMFORTOUCH LASER SYSTEM |
LASER MAX MEDICAL TECHNOLOGIES CORP. |
PAUL Y FANG |
| K000707 |
06/27/2000 |
LEICA COLPOSCOPE |
LEICA MICROSCOPY SYSTEMS LTD. |
SUSAN D GOLDSTEIN-FALK |
| K994074 |
06/08/2000 |
TRI-BALL |
LEVENTON, S.A. |
JOAQUIM SORIANO |
| K000987 |
06/01/2000 |
VFSS IMAGER, MODEL SIS-300 |
LIFECARE IMAGING INTL., LTD. |
RICHARD A ADAMS |
| K001261 |
06/08/2000 |
L720 EXAMINATION CHAIR |
LUNEAU GYNECOLOGIE SA |
BERNARD HOEL |
| K000992 |
06/26/2000 |
MACROPOREDX DISTRACTOR SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K000377 |
06/09/2000 |
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES |
MASIF HEALTHCARE PRODUCTS SDN. BHD. |
YEOH SENG GUAN |
| K001252 |
06/12/2000 |
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 |
MAXHEALTH CORP. |
LEWIS WARD |
| K001343 |
06/12/2000 |
EUDERMIC PF POWDER-FREE SURGICAL GLOVES |
MAXXIM MEDICAL, INC. |
PALLIE STODDARD |
| K001584 |
06/13/2000 |
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT |
MED VICE CONSULTING, INC. |
MARTIN DALSING |
| K993518 |
06/12/2000 |
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K000433 |
06/16/2000 |
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K991334 |
06/20/2000 |
MEDI-CULT HYALURONIDASE; |
MEDICULT A/S |
RONALD G LEONARDI |
| K991331 |
06/20/2000 |
MEDI-CULT M3 MEDIUM |
MEDICULT A/S |
RONALD G LEONARDI |
| K000744 |
06/05/2000 |
MEDTRONIC AVE BRIDGE X3 STENT |
MEDTRONIC AVE, INC. |
SUSAN WALTON |
| K001066 |
06/22/2000 |
CD HORIZON ECLIPSE |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K001532 |
06/16/2000 |
DYNA-LOK CLASSIC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE, PH.D. |
| K994239 |
06/19/2000 |
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K001801 |
06/30/2000 |
STEATHSTATION TREATMENT GUIDANCE PLATFORM |
MEDTRONIC SURGICAL NAVIGATION |
VICTORIA RENDON |
| K001284 |
06/12/2000 |
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA RENDON |
| K000955 |
06/16/2000 |
PLACER MODEL 6232 STEERABLE STYLET |
MEDTRONIC VASCULAR |
MIKE JOHNSON |
| K000767 |
06/05/2000 |
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 |
MEMCATH TECHNOLOGIES LLC. |
MARC JAKER |
| K001620 |
06/13/2000 |
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN |
METRO OPTICS OF AUSTIN, INC. |
MARTIN D ALSING |
| K001454 |
06/07/2000 |
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D |
MICRO THERAPEUTICS, INC. |
MARIBELLE AGUINALDO |
| K001178 |
06/09/2000 |
CEDIA DAU 6-ACETYLMORPHINE ASSAY |
MICROGENICS CORP. |
CYNTHIA MERRELL |
| K001545 |
06/15/2000 |
PIPET CURET |
MILEX PRODUCTS, INC. |
CARA FURLONG |
| K991137 |
06/08/2000 |
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER |
MINNTECH CORP. |
LYNN LUEDERS |
| K000844 |
06/16/2000 |
ABSOLUTE HCG PREGNANCY TEST |
MIZUHO USA, INC. |
BENEDICT ZIN |
| K000906 |
06/23/2000 |
KLINIDRAPE SURGICAL DRAPES |
MOLNLYCKE HEALTH CARE, INC. |
MIGUEL A NEGRON |
| K001303 |
06/20/2000 |
BREAST IMMOBILIZATION DEVICE MR-BY 160 |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K001713 |
06/14/2000 |
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K001546 |
06/08/2000 |
ALLON 2001 |
MTRE ADVANCED TECHNOLOGY LTD. |
PAUL DRYDEN |
| K990519 |
06/02/2000 |
PHOENIX EPIDURAL & SPINAL NEEDLES |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
| K001068 |
06/14/2000 |
NBS CONNECTING TUBE SET |
NBS PRODUCTS CO |
CHARLES E MEISCH |
| K000565 |
06/27/2000 |
MODIFICATION TO NC-STAT |
NEUROMETRIX, INC. |
CYNTHIA J.M. NOLTE |
| K993939 |
06/29/2000 |
NICOLET EME LEGEND TC22 |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
| K993176 |
06/20/2000 |
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY |
NORLAND MEDICAL SYSTEMS, INC. |
TERRY SCHWALENBERG |
| K992980 |
06/08/2000 |
ENGAGE JAW INSERTS |
NOVARE SURGICAL SYSTEMS, INC. |
NOEL MESSENGER |
| K001151 |
06/27/2000 |
ELECTROSURGICAL ELECTRODE FAMILY |
NOVASYS MEDICAL, INC. |
THOMAS WEHMAN |
| K001150 |
06/29/2000 |
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE |
NOVASYS MEDICAL, INC. |
THAMAS WEHMAN |
| K001059 |
06/30/2000 |
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS |
NOVEX PHARMA |
JOSSEPH W BEYGER |
| K001326 |
06/13/2000 |
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON |
OCULAR CONCEPTS LLC. |
KEVIN SCHOU |
| K994106 |
06/02/2000 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS- TYLER |
| K994069 |
06/02/2000 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K001670 |
06/30/2000 |
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 |
OMRON HEALTHCARE, INC. |
OSAMU SHIRASAKI |
| K001671 |
06/30/2000 |
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 |
OMRON HEALTHCARE, INC. |
OSAMU SHIRASAKI |
| K001227 |
06/29/2000 |
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT |
OPTI-CENTRE LABORATORIES |
MARTIN DALSING |
| K000998 |
06/05/2000 |
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES |
OPTISONIC, INC. |
JOHN M SZABOCSIK |
| K000990 |
06/23/2000 |
OPUS 10 DENTAL DIODE LASER |
OPUSDENT LTD. |
SHOSHANA FRIEDMAN |
| K000492 |
06/07/2000 |
MDA D-DIMER |
ORGANON TEKNIKA CORP. |
RON SANYAL |
| K000358 |
06/09/2000 |
MULTI ADJUSTABLE FACE MASK |
ORTHO TECHNOLOGY |
BRIAN LEAGHTY |
| K001769 |
06/21/2000 |
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT |
ORTHO-CLINICAL DIAGNOSTICS |
Darlene J Phillips |
| K001679 |
06/28/2000 |
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K000817 |
06/08/2000 |
OMEGA II MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K001274 |
06/23/2000 |
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K001180 |
06/27/2000 |
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 |
PACE MEDICAL |
ROBERT C MACE |
| K000952 |
06/30/2000 |
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K001674 |
06/30/2000 |
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K001672 |
06/23/2000 |
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K993895 |
06/02/2000 |
OPTIRAD |
PERMEDICS, INC. |
GREG HOLLAND |
| K001529 |
06/12/2000 |
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHANG |
| K001331 |
06/09/2000 |
SYNERGY HEAD/NECK COIL |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K001088 |
06/22/2000 |
ULTRASIM CT SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K001069 |
06/30/2000 |
MODEL 4000 EEG MONITOR WITH PSI (PSA4000) |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K001240 |
06/21/2000 |
SERAGARD INJECTION PATCH |
PLATINUM SERVICES, INC. |
NANCY Y STREET |
| K001377 |
06/08/2000 |
SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LIM KOI-YONG |
| K993874 |
06/05/2000 |
BOFOR REVISION COUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K001762 |
06/13/2000 |
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM |
PULSION MEDICAL SYSTEMS, INC. |
ULF BORG |
| K001485 |
06/13/2000 |
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES |
PWA INDUSTRIES SDN. BHD. |
AZHARSYAH M YASSIN |
| K001475 |
06/13/2000 |
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR |
PWA INDUSTRIES SDN. BHD. |
AZHARSYAH M YASSIN |
| K994419 |
06/28/2000 |
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM |
QUALISYS DIAGNOSTICS, INC. |
VIJAY K MAHANT |
| K000754 |
06/19/2000 |
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT |
QUANTASE LTD. |
R. STEWART CAMPBELL |
| K001700 |
06/28/2000 |
XPLAN 2.1 |
RADIONICS, INC. |
NANCY C MACDONALD |
| K000994 |
06/22/2000 |
BIPAP DUET LX BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K001017 |
06/02/2000 |
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC |
RETRAX SAFETY SYSTEMS, INC. |
DAVID GARVIN |
| K000336 |
06/09/2000 |
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E |
RHIGENE, INC. |
DAVE KOLESAR |
| K994223 |
06/05/2000 |
NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K001014 |
06/01/2000 |
ELECSYS ANTI-TPO CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K001846 |
06/28/2000 |
ELECSYS INSULIN CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY TAYLOR |
| K001417 |
06/29/2000 |
ONTRAK TESTCUP 502, MODEL 3016641 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K993125 |
06/20/2000 |
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM |
SAFETY MEDICAL SUPPLY INT,., INC. |
YOVETTE MUMFORD |
| K992799 |
06/07/2000 |
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT |
SANGUI BIOTECH, INC. |
JOHN J KIANG |
| K001427 |
06/02/2000 |
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
CAROL A ADILETTO |
| K001549 |
06/12/2000 |
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K001601 |
06/23/2000 |
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES |
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. |
PETER WANG |
| K001611 |
06/30/2000 |
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE |
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. |
PETER WANG |
| K001637 |
06/23/2000 |
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR |
SHEEN MORE ENT. CO., LTD. |
KEN HUANG |
| K000860 |
06/30/2000 |
FUTURA SAFETY SYRINGE |
SHEILA W. PICKERING |
SHEILA W PICKERING |
| K001862 |
06/30/2000 |
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. |
JAMES CHU |
| K001834 |
06/30/2000 |
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. |
JAMES CHU |
| K001517 |
06/27/2000 |
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K001201 |
06/01/2000 |
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MALGORZATA STANEK |
| K994130 |
06/30/2000 |
RECTOSIGHT RS 300-04 |
SIGHTLINE TECHNOLOGIES LTD. |
AHAVA STEIN |
| K001569 |
06/26/2000 |
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K000842 |
06/08/2000 |
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM |
SIMS DELTEC, INC. |
LISA STONE |
| K001507 |
06/14/2000 |
MICROPERFORATION INSTRUMENT |
SMITH & NEPHEW, INC. |
NICHOLAS CONDAKES |
| K001226 |
06/26/2000 |
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM |
SMITH & NEPHEW, INC. |
MARK KIERAS |
| K001287 |
06/09/2000 |
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML |
SORENSON MEDICAL, INC. |
R. DOUGLAS JACOB |
| K992404 |
06/06/2000 |
THE WAND |
SPINTECH, INC. |
DANIEL J MANELLI |
| K001082 |
06/15/2000 |
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 |
STACKHOUSE, INC. |
TOM GUTIERREZ |
| K000893 |
06/14/2000 |
AC POWERED THERMAL CAUTERY UNIT |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K001273 |
06/14/2000 |
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K001262 |
06/14/2000 |
THERMAL CAUTERY FORCEPS |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K001649 |
06/23/2000 |
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K001443 |
06/29/2000 |
SUGAR CHEX ONE |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K001786 |
06/21/2000 |
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG |
SULZER CALCITEK, INC. |
FOSTER BOOP |
| K001078 |
06/23/2000 |
SULZER ORTHOPEDICS MS-30 FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
| K001594 |
06/12/2000 |
3.5 MM LAPAROSCOPE (LG100, LG103) |
SURGICAL IMAGE LABORATORIES, INC. |
ZOLTAN BALAZS |
| K993700 |
06/02/2000 |
PHARMASEED, MODEL BT-103-2 |
SYNCOR INTERNATIONAL, INC. |
GARY GILMORE |
| K993701 |
06/09/2000 |
PHARMASEED, MODEL BT-125-2 |
SYNCOR INTERNATIONAL, INC. |
GARY GILMORE |
| K001311 |
06/20/2000 |
SYNTHES (USA) ORIBITAL MESH PLATES |
SYNTHES (USA) |
BONNIE J SMITH |
| K000972 |
06/16/2000 |
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS |
SYNTHES (USA) |
BONNIE J SMITH |
| K993335 |
06/12/2000 |
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K984376 |
06/07/2000 |
ENDOR 2000 |
T.C. MEDICAL, INC. |
LINCOLN ONG |
| K001095 |
06/30/2000 |
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 |
TELEDYNE ANALYTICAL INSTRUMENTS |
RAY KHAJAVI |
| K001474 |
06/09/2000 |
TERUMO U-100 INSULIN SYRING |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K993772 |
06/05/2000 |
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR |
TERUMO MEDICAL CORP. |
GARRY A COURTNEY |
| K001026 |
06/20/2000 |
3D-MSPECT |
THE REAGENTS OF THE UNIVERSITY OF MICHIGAN |
SHEILA HEMEON-HEYER |
| K001592 |
06/16/2000 |
ECHOCOM, IMAGECOM, DOKUCOM |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
| K994393 |
06/22/2000 |
AEQUALIS UNIVERSAL SHOULDER GLENOID |
TORNIER |
DAVID W SCHLERF |
| K001036 |
06/06/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K993316 |
06/09/2000 |
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE |
UEDA AVANCER CORP. |
E.J. Smith |
| K001718 |
06/21/2000 |
MILLENNIA ACUPUNCTURE NEEDLE |
UNITED PACIFIC CO., LTD. |
DANIEL YE HUA |
| K000747 |
06/08/2000 |
UNIVEC TWO PIECE SYRINGE |
UNIVEC, INC. |
S. LEVINSON |
| K001210 |
06/09/2000 |
HI-RES 9000 PHASED ARRAY CAROTID COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K001209 |
06/01/2000 |
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K001643 |
06/23/2000 |
VARIS 1.4G |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K001682 |
06/30/2000 |
VSCORE WITH EKG SIGNAL GATING |
VITAL IMAGES, INC. |
ROBERT C SAMEC |
| K000619 |
06/27/2000 |
SCANDINAVIAN IVF SCIENCES AB, G2.2 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY L YINGLING |
| K000627 |
06/13/2000 |
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 |
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB |
GARY L YINGLING |
| K000278 |
06/23/2000 |
VIVANT MEDICAL BIOPSY MARKER SYSTEM |
VIVANT MEDICAL, INC. |
JACK W MOORMAN |
| K001004 |
06/01/2000 |
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K001005 |
06/01/2000 |
WAKO HDL-C/LDL-C CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993697 |
06/09/2000 |
DELFIA NEONATAL IRT KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
| K000827 |
06/23/2000 |
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K001012 |
06/13/2000 |
DIGITAL INTEGRATION SYSTEM, DIS2000 |
WELLINGTON MEDICAL SYSTEMS, INC. |
SCOTT AUGUST |
| K992221 |
06/07/2000 |
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING |
WESTAIM BIOMEDICAL, INC. |
SALLY L MAHER |
| K993663 |
06/23/2000 |
FIRST CHECK HOME DRUG TEST (THC) |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K994139 |
06/23/2000 |
FIRST CHECK HOME DRUG TEST PANEL 2 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K994138 |
06/23/2000 |
FIRST CHECK HOME DRUG TEST PANEL 3 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K000313 |
06/16/2000 |
TEARAWAY INTRODUCER SHEATH |
XENTEK MEDICAL, INC. |
JIM EDDINGS |
| K001148 |
06/03/2000 |
MEROGEL OTOLOGIC PACK |
XOMED, INC. |
DAVE TIMLIN |
| K993653 |
06/09/2000 |
MICRO-FRANCE TROCARS AND ACCESSORIES |
XOMED, INC. |
MARTIN D SARGENT |
| K001393 |
06/07/2000 |
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K001733 |
06/20/2000 |
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES |
ZIMMER, INC. |
FRED MCCLURE |
