| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K000821 |
03/24/2000 |
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION |
ABBOTT LABORATORIES |
JILL SACKETT |
| K000013 |
03/28/2000 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K993946 |
03/09/2000 |
PEGASYS ULTRA |
ADAC LABORATORIES |
JANICE BROWN |
| K000054 |
03/13/2000 |
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN |
ADRI |
GEORGE H SCHERR |
| K000550 |
03/17/2000 |
OTW MEGALINK SDS BILIARY STENT SYSTEM |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
SANDRA SUNDELL |
| K992524 |
03/01/2000 |
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES |
ADVANTAGE MEDICAL ELECTRONICS, INC. |
KENNETH E KENDRICKS |
| K000021 |
03/24/2000 |
AESCULAP BONE WAX |
AESCULAP, INC. |
STEVE REITZLER |
| K000635 |
03/20/2000 |
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K000417 |
03/17/2000 |
CONVERTORS EQUIPMENT DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K000697 |
03/30/2000 |
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K991798 |
03/06/2000 |
ACME MEDICAL AESTHETIC ND:YAG LASER |
ALTUS MEDICAL |
MICHAEL LEVERNIER |
| K994368 |
03/14/2000 |
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K000279 |
03/01/2000 |
STAPLETAC2 BONE ANCHOR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
SYLVIA L GUBBE |
| K000165 |
03/10/2000 |
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
ANSELL PERRY |
JAMES R CHATTERTON |
| K000026 |
03/31/2000 |
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER |
APPLE MEDICAL CORP. |
JOHN PULFORD |
| K993691 |
03/08/2000 |
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K000511 |
03/13/2000 |
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K992180 |
03/20/2000 |
VISAGE COSMETIC SURGERY, MODEL V5000 |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K994319 |
03/20/2000 |
MODULAP |
ATC TECHNOLOGIES, INC. |
MARIAN HARDING COCHRAN |
| K994373 |
03/24/2000 |
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) |
ATL ULTRASOUND, INC. |
TERRANCE J SWEEENEY |
| K000499 |
03/01/2000 |
ADVANTA SUPER SOFT GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K000504 |
03/01/2000 |
ADVANTA SUPER SOFT GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K000103 |
03/20/2000 |
AVL OPTI R ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K000567 |
03/09/2000 |
ULTRASOUND SCANNER TYPE 2102 |
B & K MEDICAL A/S |
VILLY BRAENDER |
| K994375 |
03/08/2000 |
HORIZON LIGHT |
B. BRAUN MEDICAL, INC. |
GARY GULYAS |
| K993024 |
03/13/2000 |
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER |
B. BRAUN OF AMERICA, INC. |
MARK S ALSBERGE |
| K000495 |
03/28/2000 |
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES |
BALLARD MEDICAL PRODUCTS |
E. MARTIN CHAMBERLAIN |
| K000293 |
03/29/2000 |
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY |
BARCO NV |
FRANK FERGUSON |
| K000292 |
03/29/2000 |
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY |
BARCO NV |
FRANK FERGUSON |
| K000014 |
03/14/2000 |
BARCOMED 5MP1H |
BARCO NV |
FRANK FERGUSON |
| K000016 |
03/14/2000 |
BARCOMED 5MP2 |
BARCO NV |
FRANK FERGUSON |
| K000291 |
03/27/2000 |
MFCD 118 |
BARCO NV |
FRANK FERGUSON |
| K000294 |
03/27/2000 |
MFCD 120 |
BARCO NV |
FRANK FERGUSON |
| K994125 |
03/03/2000 |
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES |
BAUSCH & LOMB, INC. |
GLENN A DAVIES |
| K000657 |
03/08/2000 |
LUER ACCESS UNIVERSAL VIAL ADAPTER |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
| K982558 |
03/08/2000 |
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE |
BD/PREEFIL |
GREG MORGAN |
| K993552 |
03/31/2000 |
ISOSEED PD-103 |
BEBIG ISOTOPENTECHNIK GMBH |
SVEN LANGER |
| K000716 |
03/20/2000 |
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN COULTER, INC. |
ANGELA M BYLAND |
| K994278 |
03/28/2000 |
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY |
BECKMAN COULTER, INC. |
JILL KULL |
| K991840 |
03/20/2000 |
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER |
BERNARD B. FRESCO |
BERNARD B FRESCO |
| K993805 |
03/10/2000 |
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) |
BEST MANUFACTURING COMPANY |
DAVID C YOUNG |
| K994170 |
03/02/2000 |
HYLASHIELD CL |
BIOMATRIX, INC. |
NADINE M QASHU |
| K993362 |
03/13/2000 |
HYLASINE |
BIOMATRIX, INC. |
MARIO J RERES |
| K000538 |
03/15/2000 |
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL |
BIOMET, INC. |
DALENE T BINKLEY |
| K000616 |
03/23/2000 |
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K000231 |
03/02/2000 |
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K993225 |
03/20/2000 |
BLADEWORKS MICROKERATOME BLADE |
BLADE WORKS, INC. |
GARY S MOCNIK |
| K994242 |
03/15/2000 |
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J MEEUWSEN |
| K994203 |
03/06/2000 |
ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 |
BONART CO. LTD. |
BANKSON TSAI |
| K994299 |
03/06/2000 |
ART-P3, MODEL P3-1-ART-A1 |
BONART CO. LTD. |
BANKSON TSAI |
| K993303 |
03/23/2000 |
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
| K000397 |
03/07/2000 |
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL |
BOSTON SCIENTIFIC CORP. |
ABBY LIPMAN |
| K993292 |
03/23/2000 |
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC, TARGET |
GOWAN LEE |
| K000286 |
03/17/2000 |
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG |
BRAHMS DIAGNOSTICA, LLC. |
H. LEE HERRON |
| K000287 |
03/17/2000 |
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO |
BRAHMS DIAGNOSTICA, LLC. |
H. LEE HERRON |
| K994290 |
03/20/2000 |
BARD ENDOSCOPIC SUTURING SYSTEM |
C.R. BARD, INC. |
BETH A ZIS |
| K990504 |
03/16/2000 |
MEMOTHERM COLORECTAL STENT |
C.R. BARD, INC. |
MARION GORDON |
| K994144 |
03/02/2000 |
TOOTHBRUSH WASH |
CAL HUECH, INC. |
CHERYL A LITTLE |
| K992912 |
03/08/2000 |
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH |
CARDIAC PATHWAYS CORP. |
DEBRA S ECHT |
| K994194 |
03/28/2000 |
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
| K993357 |
03/20/2000 |
IOLMASTER |
CARL ZEISS, INC. |
SCOTT A MARGOLIN |
| K991271 |
03/08/2000 |
OOCYTE ASPIRATION NEEDLE |
CASMED UK |
DEBORAH CASTLE |
| K000171 |
03/13/2000 |
CBYON SURGICAL OPERATING SYSTEM (SOS) |
CBYON, INC. |
RORY RANDALL |
| K994389 |
03/27/2000 |
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K993557 |
03/03/2000 |
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K000311 |
03/14/2000 |
PARAPOST FIBER WHITE |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K000068 |
03/13/2000 |
COMPUMEDICS E-SERIES EEG SYSTEM |
COMPUMEDICS NEURO SCIENCE PTY LTD. |
CONSTANCE G BUNDY |
| K994417 |
03/01/2000 |
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K000384 |
03/06/2000 |
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K000564 |
03/23/2000 |
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY |
CORDIS CORP. |
KAREN WILK |
| K000715 |
03/31/2000 |
ENVOY AND VISTA BRITE TIP |
CORDIS CORP. |
DENNIS S GRIFFIN |
| K000634 |
03/10/2000 |
ROD TO ROD CROSS BRACES |
CORIN U.S.A. |
JOEL BATTS |
| K994152 |
03/06/2000 |
THE LIGAMENT ANCHOR SOFT SCREW |
CORIN U.S.A. |
CRAIG CORRANCE |
| K000197 |
03/03/2000 |
CORTEK CYSTOSCOPE |
CORTEK ENDOSCOPY, INC. |
CORNEL M TOPALA |
| K000202 |
03/31/2000 |
CORTEK LAPAROSCOPES |
CORTEK ENDOSCOPY, INC. |
CORNEL M TOPALA |
| K000200 |
03/03/2000 |
CORTEK URETHEROSCOPE |
CORTEK ENDOSCOPY, INC. |
CORNEL M TOPALA |
| K000276 |
03/01/2000 |
MPT 24 AND VITAL VIEW 24 |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K000490 |
03/13/2000 |
CYNOSURE PHOTOGENICA VLS-STAR |
CYNOSURE, INC. |
GEORGE CHO |
| K994296 |
03/01/2000 |
DIMENSION C3 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994293 |
03/01/2000 |
DIMENSION C4 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994291 |
03/01/2000 |
DIMENSION SPECIAL PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994341 |
03/03/2000 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K993957 |
03/03/2000 |
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR |
DAKO CORP. |
GRETCHEN M MURRAY |
| K994157 |
03/13/2000 |
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 |
DATASCOPE CORP. |
WHITNEY TORNING |
| K993656 |
03/15/2000 |
DATEX-OHMEDA TONOMETRY MODULE M-TONO |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K993512 |
03/31/2000 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
DALE THANIG |
| K000169 |
03/24/2000 |
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K994285 |
03/14/2000 |
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH |
DENTSPLY INTL. |
WILLIAM T COUSINS |
| K000575 |
03/10/2000 |
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K000306 |
03/23/2000 |
PINNACLE ACETABULAR SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K994079 |
03/01/2000 |
REFLEX TREATMENT SYSTEM |
DESCHUTES MEDICAL PRODUCTS, INC. |
DENISE BESTWICK |
| K000012 |
03/03/2000 |
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K000005 |
03/03/2000 |
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K993129 |
03/28/2000 |
UCLA/UNIVERSAL ABUTMENT |
DIAMODENT |
JEFF RASSOLI |
| K993826 |
03/23/2000 |
NARKOMED 6000 |
DRAEGER MEDICAL, INC. |
GALE E WINARSKY |
| K000154 |
03/29/2000 |
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 |
E. BENSON HOOD LAB, INC. |
ANTHONY M SACCHETTI |
| K000513 |
03/07/2000 |
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K000425 |
03/07/2000 |
ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K994226 |
03/22/2000 |
STERICHEK TOTAL CHLORINE REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
DAVID A MORRIS |
| K992215 |
03/29/2000 |
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED |
ENVITEC-WISMAR GMBH |
STEPHEN H GORSKI |
| K994011 |
03/23/2000 |
EP MEDSYSTEMS, EP-WORKMATE |
EP MEDSYSTEMS, INC. |
JOSEPH C GRIFFIN III |
| K993343 |
03/20/2000 |
ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS |
ERECXEL ENTERPRISES |
PACIFICO R BURGOS |
| K000648 |
03/29/2000 |
SPIRO PRO |
ERICH JAEGER GMBH |
LARRY MURDOCK |
| K000588 |
03/30/2000 |
DIMENSION GARANT L, DIMENSION GARANT L QUICK |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K000591 |
03/30/2000 |
DIMENSION PENTA H, DIMENSION PENTA H QUICK |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K994280 |
03/17/2000 |
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
| K993412 |
03/31/2000 |
BITX PROBES |
EVEREST MEDICAL CORP. |
FREDERICK G MADES |
| K993199 |
03/28/2000 |
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER |
FERRARIS MEDICAL, INC. |
JONATHAN S KAHAN |
| K994287 |
03/16/2000 |
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
LUCIANO BONANNI |
| K994267 |
03/16/2000 |
FRESENIUS 2008K |
FRESENIUS MEDICAL CARE |
ARTHUR EILINSFELD |
| K994376 |
03/24/2000 |
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA |
FRIADENT GMBH |
CAROL PATTERSON |
| K000315 |
03/27/2000 |
VENTRICULAR ANALYSIS TOOLKIT OPTION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K994167 |
03/07/2000 |
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K000695 |
03/16/2000 |
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K994430 |
03/28/2000 |
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K993757 |
03/23/2000 |
SOLAR 7/8000 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K000239 |
03/21/2000 |
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL |
GENZYME CORP. |
BARBARA PIZZA |
| K994328 |
03/02/2000 |
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX |
GENZYME CORP. |
JOHN A DELUCIA |
| K994142 |
03/06/2000 |
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM |
GRASS INSTRUMENT CO. |
STEPHEN E JOHNSON |
| K000598 |
03/24/2000 |
5F GUIDING CATHETER |
GUIDANT CORP. |
MARGARET ANDERSON |
| K000302 |
03/24/2000 |
HARDY DISK, PENICILLIN, 10 UNITS |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000175 |
03/02/2000 |
HARDYDISK TICARILLIN 75MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000181 |
03/02/2000 |
HARDYDISK, CARBENICILLIN, 100MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAY |
| K000305 |
03/31/2000 |
HARDYDISK, CEFOXITIN, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000259 |
03/21/2000 |
HARDYDISK, CEFTAZIDIME, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000258 |
03/21/2000 |
HARDYDISK, CIPROFLOXACIN, 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000203 |
03/21/2000 |
HARDYDISK, KANAMYCIN, 30MCG |
HARDY DIAGNOSTICS |
MELISSA TRAYLOR |
| K000304 |
03/29/2000 |
HARDYDISK, TETRACYCLINE 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994026 |
03/29/2000 |
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER |
| K994378 |
03/07/2000 |
AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS J THISTLETHWAITE |
| K993938 |
03/15/2000 |
THE HOMMED SENTRY, MODEL 1 SENTRY |
HOMMED LLC. |
HERSCHEL PEDDICORD |
| K994347 |
03/15/2000 |
CENTAUR SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K000091 |
03/10/2000 |
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K994207 |
03/13/2000 |
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K994128 |
03/06/2000 |
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K994366 |
03/16/2000 |
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K994352 |
03/22/2000 |
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 |
HUDSON RESPIRATORY CARE, INC. |
JEANNIE DENNING |
| K991383 |
03/31/2000 |
HYDROCISION DEBDRIDEMENT SYSTEM |
HYDROCISION, INC. |
DEBBIE IAMPIETRO |
| K994374 |
03/03/2000 |
SOAKER CATHETER |
I-FLOW CORP. |
STANLEY E FRY |
| K000589 |
03/14/2000 |
MODEL 445SI-64E QUADRATURE WRIST COIL |
IGC-MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K000359 |
03/17/2000 |
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO |
IMATRON, INC. |
J.A. CODUTO |
| K991133 |
03/27/2000 |
MLC FIT |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS FARIS |
| K994317 |
03/21/2000 |
I-PLANT, MODEL 3500 |
IMPLANT SCIENCES CORP. |
HOWARD L SCHRAYER |
| K990330 |
03/01/2000 |
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ |
IMPLEX CORP. |
ROBERT POGGIE |
| K000040 |
03/21/2000 |
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K000038 |
03/21/2000 |
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K000039 |
03/21/2000 |
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K992392 |
03/31/2000 |
RTLX |
INFIMED, INC. |
RALPH FLATAU |
| K000053 |
03/15/2000 |
ACL 9000 SYSTEM |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K994254 |
03/14/2000 |
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
DONNA WARD |
| K000309 |
03/13/2000 |
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
| K000675 |
03/14/2000 |
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 |
JAWON MEDICAL CO., LTD. |
ROBERT D WAXHAM |
| K994359 |
03/21/2000 |
BOND 1 C & B |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K000211 |
03/17/2000 |
BUILD-IT FR |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K991413 |
03/13/2000 |
CODMAN ETHISORB DURA PATCH |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
DEANA BOUSHELL |
| K000058 |
03/10/2000 |
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES |
KAOHSIUNG BROTHERS PRODUCTS CORP. |
STONE CHEN |
| K994348 |
03/03/2000 |
KSEA SCB-RUI |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K994323 |
03/08/2000 |
KAWASUMI LABORATORIES PHILEBOTOMY SET |
KAWASUMI LABORATORIES CO., LTD. |
DONALD R STONE |
| K000544 |
03/09/2000 |
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 |
LABTICIAN OPHTHALMICS, INC. |
R. DAVID SCULATI |
| K000011 |
03/01/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
JIM KLOSTERMAN |
| K990718 |
03/08/2000 |
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL H HARDIMAN |
| K993894 |
03/08/2000 |
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
| K000498 |
03/13/2000 |
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER |
LUMENIS, INC. |
EDWARD C YU |
| K993568 |
03/13/2000 |
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L |
MACHIDA ENDOSCOPE CO., LTD. |
GENICHI KANAI |
| K993941 |
03/02/2000 |
UBAS |
MARUKIN DIAGNOSTICS |
GREG HOLLAND |
| K993604 |
03/03/2000 |
ENDOSCOPIC ANTI FOG DEVICE |
MECTRA LABS, INC. |
CHARLES E ALLGOOD |
| K994097 |
03/01/2000 |
MEDAMICUS EPIDURAL INTRODUCER |
MEDAMICUS, INC. |
DENNIS MANSON |
| K994232 |
03/01/2000 |
PHALANGEAL FIXATION SYSTEM |
MEDCANICA, INC. |
AL WEISENBORN |
| K993358 |
03/15/2000 |
SIGHTSURE OPERATION INDICATOR, MODEL SS301 |
MEDEVICES, INC. |
MICHELE H VOVOLKA |
| K994057 |
03/03/2000 |
SLENDAIR 4000 COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
SHOSHANA FRIEDMAN |
| K000660 |
03/28/2000 |
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 |
MEDICAL DATA ELECTRONICS |
Cedric Navarro |
| K000551 |
03/16/2000 |
IMAGE X-70 PLUS DENTAL X-RAY UNIT |
MEDICAL DEVICE CONSULTANTS, INC. |
MARY MCNAMARA-CULLINANE |
| K994367 |
03/17/2000 |
UMBILICAL CORD CLAMP |
MEDICAL SALES CO. |
JOHN E LINCOLN |
| K993122 |
03/16/2000 |
MSP M/K BLADE |
MEDICAL STERILE PRODUCTS, INC. |
GARY C DIONNE |
| K991470 |
03/07/2000 |
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) |
MEDICULT A/S |
RONALD G LEONARDI |
| K994282 |
03/02/2000 |
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K993896 |
03/27/2000 |
MCA-601, C-ARM MOBILE |
MEDISON RADIOLOGY SYSTEMS, INC. |
JOHN W LEE |
| K000019 |
03/29/2000 |
SINGLE SIZE TENDON SPACER |
MEDIST INTERNATIONAL |
BERNARD F GRISONI |
| K994306 |
03/20/2000 |
REVERSO |
MEDISYSTEMS CORP. |
FREDRIC G SWINDLER |
| K993170 |
03/02/2000 |
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
BETTY A LOCK |
| K000369 |
03/30/2000 |
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER |
MEDPRO TECHNOLOGIES, INC. |
ART WARD |
| K993735 |
03/20/2000 |
DOUBLE SPRINGERS |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K993733 |
03/20/2000 |
LOVE LOCKERS |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K993737 |
03/20/2000 |
MIGHTY MAN (DYNAMIC LINKERS) |
MEDTECH PRODUCTS LTD. |
A.V.K. REDDY |
| K000453 |
03/10/2000 |
MODIFICATION TO CD SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K000476 |
03/10/2000 |
MODIFICATION TO CD SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K000677 |
03/29/2000 |
ZUMA GUIDE CATHETERS |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K000728 |
03/21/2000 |
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE |
MEDTRONIC XOMED |
DAVID TIMLIN |
| K000073 |
03/01/2000 |
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA |
MERCURY MEDICAL |
MATTHEW NEKOROSKI |
| K990975 |
03/15/2000 |
IN-LINE HEMOSTASIS VALVE |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K000659 |
03/29/2000 |
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K993970 |
03/30/2000 |
MICRINS MICROSURGICAL SUTURE |
MICRINS SURGICAL, INC. |
BERNHARD TEITZ |
| K000477 |
03/01/2000 |
MDI DS-DNA TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K993694 |
03/01/2000 |
MIKRO-TIP ANGIOGRAPHIC CATHETER |
MILLAR INSTRUMENTS, INC. |
MIRIELLE ARCE |
| K992386 |
03/07/2000 |
ALLON 2000 |
MTRE ADVANCED TECHNOLOGY LTD. |
SHOSHANA FRIEDMAN |
| K993811 |
03/02/2000 |
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE |
MULTISAFE SDN BHD |
GOH SEOK HUEI |
| K993584 |
03/07/2000 |
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 |
NELLCOR PURITAN BENNETT FRANCE DVPT. |
MOUSTAFA ANKI |
| K000018 |
03/30/2000 |
BRANEMARK NOVUM |
NOBEL BIOCARE UAS INC |
KATHLEEN DRAGOVICH |
| K000393 |
03/27/2000 |
NOVA CORDLESS CURING LIGHT |
NOVA/DA VINCI SYSTEMS, INC. |
ALAN A CREAMER |
| K992303 |
03/27/2000 |
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 |
NUCLETRON CORP. |
RALPH E SHUPING |
| K993060 |
03/28/2000 |
GAS FILTER |
OLSON MEDICAL SALES, INC. |
GARRY A COURTNEY |
| K000378 |
03/02/2000 |
BACT/ALERT MB CULTURE BOTTLE |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K994370 |
03/24/2000 |
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K000566 |
03/09/2000 |
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
JOSEPH FALVO |
| K992856 |
03/10/2000 |
MAGELLAN HUMERAL INTRAMEDULLARY NAIL |
ORTHOMATRIX, INC. |
BEN SHAPPLEY |
| K992850 |
03/10/2000 |
MAGELLAN TIBIAL INTRAMEDULLARY NAIL |
ORTHOMATRIX, INC. |
BEN SHAPPLEY |
| K993610 |
03/02/2000 |
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 |
OSTEOGENICS BIOMEDICAL, INC. |
RICHARD A HAMER |
| K000602 |
03/03/2000 |
PROTEGE WHEELCHAIR |
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. |
JOHN HENDRICKSON |
| K000497 |
03/08/2000 |
VOYAGER/VIPER WHEELCHAIR |
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. |
JOHN HENDRICKSON |
| K000482 |
03/06/2000 |
MODIFICATION TO AUTOJECT MINI |
OWEN MUMFORD, LTD. |
ROBERT SHAW |
| K000679 |
03/24/2000 |
THROMBOSTRATE CONTROL PLASMAS |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K000722 |
03/31/2000 |
UNIPOLAR NEEDLES |
PAJUNK GMBH |
BURK A BRANDT |
| K993201 |
03/29/2000 |
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K000045 |
03/15/2000 |
POSITUBE |
PARAPRODUCTS, INC. |
JAMES FLORY |
| K000447 |
03/07/2000 |
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 |
PHAMATECH |
CARL A MONGIOVI |
| K000312 |
03/17/2000 |
VARELISA SM ANTIBODIES |
PHARMACIA & UPJOHN CO. |
KAREN MATIS |
| K992174 |
03/23/2000 |
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP |
PILLING WECK SURGICAL |
RICHARD G JONES |
| K000454 |
03/31/2000 |
DIMEX 2 |
PLANMECA OY |
BOB PIENKOWSKI |
| K994312 |
03/21/2000 |
MALE LATEX CONDOM 56MM |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LIM KOI YONG |
| K994311 |
03/21/2000 |
MALE LATEX CONDOM WITH VANILLA FLAVOR |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LIM KOI YONG |
| K000085 |
03/17/2000 |
PORTSETT |
PORTSETT, INC. |
SALVADORE F PALOMARES |
| K994353 |
03/22/2000 |
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 |
PRECISION DYNAMICS CORP. |
KALYNA SNYLYK |
| K992703 |
03/21/2000 |
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 |
PREMIER HEART, LLC. |
WILLIAM D HARE |
| K993280 |
03/14/2000 |
PROSTEC 125I BRACHYTHERAPY SEEDS |
PROSTEC LLC. |
AL WEISENBORN |
| K994180 |
03/02/2000 |
PULPDENT CAVITY PREPARATION III |
PULPDENT CORP. |
KENNETH J BERK |
| K990897 |
03/15/2000 |
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER |
PURITAN-BENNETT IRELAND, LTD. |
ROBBIE WALSH |
| K000554 |
03/14/2000 |
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET |
QUANTEL MEDICAL |
GEORGE MYERS |
| K992908 |
03/06/2000 |
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) |
QUINTON, INC. |
MATTHEW J HEDLUND |
| K000057 |
03/20/2000 |
RADIONICS LUMBOPERITONEAL SHUNT |
RADIONICS, INC. |
KEVIN K O'CONNELL |
| K000032 |
03/30/2000 |
LEVEEN NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
GARY CURTIS |
| K000483 |
03/31/2000 |
RANDOX ALBUMIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K000469 |
03/27/2000 |
RANDOX COMPLEMENT C3 |
RANDOX LABORATORIES, LTD. |
R ARMSTRONG |
| K000468 |
03/27/2000 |
RANDOX COMPLEMENT C4 |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K000288 |
03/23/2000 |
REICHERT CT200 CONTACT TONOMETER |
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. |
FRANK J DREXELIUS |
| K994351 |
03/22/2000 |
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM |
RESONANCE TECHNOLOGY, INC. |
MOKHTAR ZIARATI |
| K992530 |
03/20/2000 |
BIPAP SYNCHRONY HC |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K994363 |
03/06/2000 |
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K000046 |
03/30/2000 |
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983214 |
03/27/2000 |
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES |
RITA MEDICAL SYSTEMS |
DAN BALBIERZ |
| K000042 |
03/17/2000 |
ELECSYS B-CROSSLAPS CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A LAPS |
| K000576 |
03/21/2000 |
ELECSYS CORTISOL CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K000270 |
03/07/2000 |
ELECSYS CORTISOL TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMMILL |
| K000656 |
03/09/2000 |
EMBRYON GIFT TRANSFER CATHETERS/SETS |
ROCKET MEDICAL PLC |
LES TODD |
| K994344 |
03/21/2000 |
NEUROTHERM RF CANNULA |
ROCKET MEDICAL PLC |
LES TODD |
| K993194 |
03/24/2000 |
RUSCH MANUAL RESUSCITATOR BAG |
RUSCH, INC. |
RONALD YOUNG |
| K993456 |
03/07/2000 |
SAS STREP A TEST |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
| K993609 |
03/17/2000 |
SOLOGUARD LOCKING PLUS SYRINGE |
SAFEGUARD MEDICAL PRODUCTS, INC. |
PATRICK GRANT |
| K993117 |
03/02/2000 |
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG |
SAFESKIN CORP. |
EUGENE V GOORCHENKO |
| K993081 |
03/03/2000 |
IO-DRIVE |
SELECTIVE MED COMPONENTS, INC. |
RICK FISHER |
| K000583 |
03/17/2000 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
CAROL A ADILETTO |
| K000060 |
03/27/2000 |
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 |
SENORX, INC. |
AMY BOUCLY |
| K000671 |
03/29/2000 |
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING |
SGMP CO., LTD. |
JANNA P TUCKER |
| K000488 |
03/20/2000 |
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB |
SGMP CO., LTD. |
JANNA P TUCKER |
| K000226 |
03/02/2000 |
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR |
SHEEN MORE ENT. CO., LTD. |
KEN HUANG |
| K992554 |
03/29/2000 |
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
KAREN ABEL |
| K992821 |
03/10/2000 |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
KAREN ABELL |
| K994431 |
03/23/2000 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K000628 |
03/13/2000 |
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 |
SIMS PORTEX LTD. |
GILES BISHOP |
| K994365 |
03/13/2000 |
DYONICS ELECTROBLADE |
SMITH & NEPHEW, INC. |
DEBORAH CONNORS |
| K000717 |
03/30/2000 |
SMITH & NEPHEW SUTURELOK, MODEL 7207321 |
SMITH & NEPHEW, INC. |
NICHOLAS CONDAKES |
| K000533 |
03/01/2000 |
VOCOM IMPLANT- 8MM |
SMITH & NEPHEW, INC. |
ALICIA FARAGE |
| K984360 |
03/30/2000 |
COLORADO II SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K000501 |
03/17/2000 |
ELECTROSURGICAL GENERATOR, MODEL S1 |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
STEVEN J OJALA |
| K994385 |
03/16/2000 |
BABY FACE |
SONORA MEDICAL SYSTEMS |
COLLEEN HITTLE |
| K992655 |
03/13/2000 |
FERTILOSCOPY KIT FH 1.29/FTO 1.40 |
SOPRANE S.A. |
HOWARD M HOLSTEIN |
| K000424 |
03/31/2000 |
S51D DIGITAL ENDOSCOPY CAMERA |
SOPRO |
PIERRE MONTILLOT |
| K000423 |
03/31/2000 |
S52D DIGITAL VIDEO LAPAROSCOPE |
SOPRO |
PIERRE MONTILLOT |
| K000422 |
03/31/2000 |
S57D DIGITAL OPERATING ROOM CAMERA |
SOPRO |
PIERRE MONTILLOT |
| K991881 |
03/16/2000 |
125-IMPLANT SEEDS, MODEL STM1250 |
SOURCETECH MEDICAL, L.L.C. |
DAVID T SIERACKI |
| K000376 |
03/21/2000 |
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT |
SPECIALTY ULTRAVISION, INC. |
GAROLD L EDWARDS |
| K000250 |
03/07/2000 |
CAUTERY FORCEPS WITH FOOTSWITCH |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K000296 |
03/07/2000 |
STARION CAUTERY HOOK |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K000608 |
03/07/2000 |
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM |
STD MFG., INC. |
JIM LOUSARARIAN |
| K000077 |
03/17/2000 |
STERIS AMSCO MILLENNIUM STEAM STERILIZER |
STERIS Corporation |
RAYMOND URSICK |
| K000502 |
03/14/2000 |
STEAM/EO RECORD CARD, MODEL CI 121 |
STERITEC PRODUCTS MFG. CO., INC. |
LINDA NELSON |
| K994119 |
03/17/2000 |
SYNOCTA ANGLED ABUTMENTS |
STRAUMANN USA |
LINDA JALBERT |
| K000076 |
03/03/2000 |
CELL-CHEX |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K000115 |
03/27/2000 |
RETIC CHEX LINEARITY |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K993259 |
03/10/2000 |
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K000644 |
03/17/2000 |
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K994436 |
03/14/2000 |
SURGI-VISION ESOPHAGEAL STYLET COIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K994355 |
03/22/2000 |
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ANGELIQUE S DESTRUEL |
| K994015 |
03/15/2000 |
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HARR |
| K994087 |
03/01/2000 |
SUPERSTITCH |
SUTURA, INC. |
DAVE BARRY |
| K000269 |
03/23/2000 |
BELLEGLASS HP OPACEOUS DENTIN |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K000436 |
03/24/2000 |
BELLEGLASS HP TRANSLUCENT DENTIN |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K994309 |
03/17/2000 |
SOLO ORTHO 2 |
SYBRON DENTAL SPECIALTIES, INC. |
WENDY URTEL |
| K000066 |
03/15/2000 |
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K994364 |
03/15/2000 |
SYNTHES BUTTON PLATE |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K000450 |
03/10/2000 |
MODIFICATION TO SYNTHES USS |
SYNTHES SPINE |
JONATHAN GILBERT |
| K000742 |
03/29/2000 |
SYNTHES ANTERIOR CSLP SYSTEM |
SYNTHES SPINE |
JONATHAN GILBERT |
| K000536 |
03/15/2000 |
SYNTHES ANTERIOR CSLP SYSTEM |
SYNTHES SPINE |
JONATHAN GILBERT |
| K000600 |
03/27/2000 |
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS |
SYVA CO., DADE BEHRING, INC. |
PAUL L ROGERS |
| K000731 |
03/31/2000 |
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHAN |
| K993189 |
03/01/2000 |
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING |
TERUMO CORP. |
GARRY A COURTNEY |
| K000387 |
03/02/2000 |
TERUMO NEEDLE WITH LOCKING SHEATH |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
| K993191 |
03/24/2000 |
TFX MEDICAL INTRODUCER ASSEMBLY |
TFX MEDICAL, INC. |
JULIA A BEAUMONT |
| K994339 |
03/22/2000 |
HYCURE ORAL / HYCURE ORAL SMART GEL |
THE HYMED GROUP CORP. |
ANITA M PETITO |
| K000087 |
03/17/2000 |
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR |
THE KENDAL CO. |
REGINA YEH |
| K000343 |
03/01/2000 |
NAC Y-ADP |
THE KIPP GROUP |
GARY WERSCHMIDT |
| K000529 |
03/21/2000 |
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) |
THE LIFESTYLE CO., INC. |
MARTIN RIEHM |
| K993041 |
03/30/2000 |
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
ROBERT SHIFF |
| K994382 |
03/10/2000 |
NONLINEAR TAPER LAG SCREW |
THEKEN SURGICAL |
LUKAS EISERMANN |
| K994357 |
03/14/2000 |
BITEM LOCK, MODELS SW006, SW012 |
THERMOELASTIC TECHNOLOGIES, INC. |
ART WARD |
| K991684 |
03/01/2000 |
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 |
THERMOGEAR, INC. |
R. WAYNE FIELDS |
| K994392 |
03/10/2000 |
AEQUALIS SHOULDER FRACTURE SYSTEM |
TORNIER |
DAVID W SCHLERF |
| K990831 |
03/08/2000 |
SUPERGUARD SAFETY SYRINGE |
U.S. SAFETY SYRINGES CO., INC. |
JAMES GINESI |
| K994230 |
03/24/2000 |
ULTICARE DISPOSABLE SYRINGE |
ULTIMED, INC. |
CHARLES W ERICKSON |
| K983826 |
03/23/2000 |
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM |
UNIMACHS CORP. |
EDUARDO MARCH |
| K000037 |
03/30/2000 |
MONOFILAMENT BIOSYN SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SETH A SCHULMAN |
| K000009 |
03/10/2000 |
SPIRAL RADIUS RODDING SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
LUIS NESPRIDO |
| K993019 |
03/30/2000 |
PACIFIC SURGICAL PATTIES |
V. MUELLER NEURO/SPINE |
TERRY JOHNSTON |
| K994428 |
03/07/2000 |
E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE |
VALLEYLAB, INC. |
ROBERT C MOORE JR |
| K992762 |
03/09/2000 |
BRACHYVISION 6.0 |
VARIAN ASSOC., INC. |
LINDA S NASH |
| K992933 |
03/08/2000 |
LEMAITRE IRRIGATION CATHETER |
VASCUTECH, INC. |
TRENT G KAMKE |
| K992934 |
03/01/2000 |
LEMAITRE VENOUS THROMBECTOMY CATHETER |
VASCUTECH, INC. |
TRENT G KAMKE |
| K994429 |
03/03/2000 |
VENUSA, LTD. EXTENSION SET WITH FILTER |
VENUSA LTD. |
ROSS MAGLADRY |
| K993953 |
03/21/2000 |
OVES CERVICAL CAP |
VEOS LTD. |
PEGGY S DANNENBAUM |
| K000229 |
03/21/2000 |
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE |
VIDEOLABS, INC. |
FRANK B FREEDMAN |
| K994270 |
03/09/2000 |
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 |
VISUALIZATION TECHNOLOGY, INC. |
NORMA LEMAY |
| K994423 |
03/28/2000 |
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
VSM MEDTECH LTD. |
HOWARD M HOLSTEIN |
| K981093 |
03/28/2000 |
WESCO BLANKET |
WESCO, INC. |
ARLEN C WEST |
| K000439 |
03/20/2000 |
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K994335 |
03/20/2000 |
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K000086 |
03/15/2000 |
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
| K992481 |
03/17/2000 |
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
H. SEMM |
| K992513 |
03/17/2000 |
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
HORST SEMM |
| K994387 |
03/16/2000 |
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
| K994151 |
03/01/2000 |
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES |
XIMED/PROSURE/INJECTX |
LEE BUI |
| K994257 |
03/17/2000 |
LOCATOR IMPLANT ANCHOR |
ZEST ANCHORS, INC. |
PAUL ZUEST |
| K994286 |
03/10/2000 |
ZMR HIP SYSTEM-POROUS REVISION |
ZIMMER, INC. |
KAREN CAIN |
