| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K001163 |
10/23/2000 |
DMLC IV-ERGO |
3D LINE USA, INC. |
KAREN H RIGAMONTI |
| K000886 |
10/05/2000 |
SPIROL EPIDURAL CATHETER |
ABBOTT LABORATORIES |
JILL N SACKETT |
| K001703 |
10/03/2000 |
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE |
ABBOTT VASCULAR INC. |
DENISE C SUNGLETON |
| K002646 |
10/26/2000 |
ABX MICROS CRP |
ABX DIAGNOSTICS |
BRUCE DAVIS |
| K002909 |
10/13/2000 |
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K003022 |
10/13/2000 |
AERONEB PORTABLE NEBULIZER |
AEROGEN, INC. |
TRACI V.A. EDWARDS |
| K002871 |
10/13/2000 |
MODIFICATION TO YASARGIL ANEURYSM CLIPS |
AESCULAP, INC. |
JOYCE THOMAS |
| K003107 |
10/19/2000 |
M2376A DEVICELINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K002967 |
10/18/2000 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K001493 |
10/25/2000 |
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 |
AIR FORCE, INC. |
PIERO POLICICCHIO |
| K000963 |
10/20/2000 |
DA VINCHI EEG AND EMG/EP SYSTEMS |
AIRSEP CORP. |
PETER WEISENBORN |
| K002589 |
10/23/2000 |
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION |
ALCON UNIVERSAL, LTD. |
MICHAEL E PFLEGER |
| K001578 |
10/13/2000 |
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K002745 |
10/12/2000 |
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K002746 |
10/11/2000 |
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K003006 |
10/27/2000 |
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K002355 |
10/10/2000 |
ATOM INFA WARMER V-505 |
ATOM MEDICAL CORP. |
SHEILA HEMEON-HEYER |
| K994321 |
10/25/2000 |
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K000632 |
10/19/2000 |
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE |
AVITRO LLC. |
JOHN BRDA |
| K001795 |
10/19/2000 |
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD |
AVITRO LLC. |
JOHN BRDA |
| K002316 |
10/26/2000 |
PHOENIX DIGITAL EEG |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K002557 |
10/06/2000 |
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K002823 |
10/17/2000 |
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K003225 |
10/19/2000 |
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
| K002376 |
10/26/2000 |
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY |
BAYER CORP. |
William J Pignato |
| K002389 |
10/23/2000 |
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K002905 |
10/19/2000 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER |
BECKMAN COULTER, INC. |
MARA CALER |
| K002799 |
10/05/2000 |
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K002233 |
10/13/2000 |
BVI SLING |
BIO-VASCULAR, INC. |
DAISY P SIN |
| K002855 |
10/12/2000 |
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER |
BIOCARE CORP. |
PAUL W MCDONALD |
| K002294 |
10/02/2000 |
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K002325 |
10/30/2000 |
WUJIN #3 TIBIAL NAIL |
BIOLOGICALLY ORIENTED PROSTHESES |
ANGENA PAREKH |
| K001460 |
10/04/2000 |
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 |
BIOMERIEUX, INC. |
JANET CONNOLLY |
| K002278 |
10/23/2000 |
BROOKER FEMORAL NAILS |
BIOMET ORTHOPEDICS, INC. |
PATRICIA SANDBORN BERES |
| K002057 |
10/04/2000 |
BROOKER TIBIA NAILS |
BIOMET ORTHOPEDICS, INC. |
PATRICIA SANDBORN BERES |
| K002772 |
10/04/2000 |
ASCENT XXL CLOSED BOX FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K002998 |
10/06/2000 |
BIOMET BI-POLAR SHOULDER SYSTEM |
BIOMET, INC. |
TRACY J BICKE; |
| K002423 |
10/20/2000 |
LACTOSORB PUSH SCREW |
BIOMET, INC. |
TRACY BICKEL |
| K002879 |
10/05/2000 |
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
ERIC V HOHENSTEIN |
| K994281 |
10/20/2000 |
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) |
BIOPRO (M) SDN BHD |
JAMES H LALE |
| K994276 |
10/20/2000 |
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) |
BIOPRO (M) SDN BHD |
JAMES H LALE |
| K002133 |
10/12/2000 |
NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENNIZEN |
| K002802 |
10/05/2000 |
RAPID EXCHANGE TAPERTOME |
BOSTON SCIENTIFIC CORP. |
CAROL J HOLLOWAY |
| K002078 |
10/02/2000 |
BETA GLUCAN GEL (MACROPRO GEL) |
BRENNEN MEDICAL, INC. |
PHILLIP LAWIN |
| K002077 |
10/02/2000 |
GLUCANPRO CREAM |
BRENNEN MEDICAL, INC. |
PHILLIP LAWIN |
| K002094 |
10/06/2000 |
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE |
C.R. BARD, INC. |
MARION GORDON |
| K002684 |
10/11/2000 |
COMPOSIX E/X MESH |
C.R. BARD, INC. |
RUTH C FORSTADT |
| K994320 |
10/20/2000 |
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES |
CANTOR & SILVER LTD. |
MARTIN DALSING |
| K002590 |
10/31/2000 |
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER |
CEDARA SOFTWARE CORP. |
CAROL NAKAGAWA |
| K002296 |
10/02/2000 |
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K002546 |
10/31/2000 |
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
J. WILLIAM JONES |
| K003057 |
10/13/2000 |
AUTOSTAT II ENA-4 PROFILE ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE KNIGHT |
| K003054 |
10/13/2000 |
AUTOSTAT II ENA-6 PROFILE ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE KNIGHT |
| K002147 |
10/13/2000 |
FOCUS |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
| K000855 |
10/18/2000 |
GUNTHER TULIP VENA CAVA MREYE FILTER SET |
COOK, INC. |
MARY GOSSARD |
| K003159 |
10/30/2000 |
CORDIS SLALOM PTA BALLOON CATHETER |
CORDIS CORP. |
CHUCK RYAN |
| K002188 |
10/30/2000 |
SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, |
CORE-VENT CORP. |
WILL FISHER |
| K002479 |
10/19/2000 |
BIOMESH P1 AND BIOMESH PLUG AND PATCH |
COUSIN BIOTECH S.A.R.L |
HOWARD M HOLSTEIN |
| K002715 |
10/31/2000 |
ECAT PET SCANNER |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K002898 |
10/17/2000 |
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST |
CURON MEDICAL, INC. |
THOMAS C WEHMAN |
| K001668 |
10/19/2000 |
GLOBAL SPINAL FIXATION SYSTEM |
D.K.M. CO.,LTD. |
ANDREW PAENG |
| K002551 |
10/11/2000 |
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL |
DADE BEHRING, INC. |
PAUL L ROGERS |
| K002974 |
10/11/2000 |
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
DADE BEHRING, INC. |
PAUL L ROGERS |
| K002804 |
10/05/2000 |
N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K002949 |
10/20/2000 |
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC |
DATASCOPE CORP. |
JOANNE WOLF |
| K002478 |
10/05/2000 |
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K001990 |
10/23/2000 |
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES |
DEPILASE GROUP LTD. |
MARIO LUCA RUSSO |
| K002883 |
10/13/2000 |
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL K HASTINGS |
| K002980 |
10/23/2000 |
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K002229 |
10/20/2000 |
WACKERS-LIU CQ SOFTWARE |
ECLIPSE SYSTEMS, INC. |
ROSINA ROBINSON |
| K002631 |
10/23/2000 |
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
SCOTT PEASE |
| K002484 |
10/04/2000 |
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL |
ELECTRO MEDICAL SYSTEMS SA |
SHEILA HEMEON-HEYER |
| K002959 |
10/16/2000 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K002437 |
10/02/2000 |
ENDIUS ENDOSCOPIC ACCESS SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K002396 |
10/13/2000 |
ENDOCARE PERCUTANEOUS ACCESS SET |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K002913 |
10/17/2000 |
HEADBAND FOR BAHA |
ENTIFIC MEDICAL SYSTEMS, INC. |
CONSTANCE G BUNDY |
| K002431 |
10/24/2000 |
ELRAN 01 SYSTEM |
ENVISION ADVANCED MEDICAL SYSTEM LTD |
GERARD J PRUD'HOMME |
| K002534 |
10/18/2000 |
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 |
EUPALAMUS, LLC. |
ANNE LAURITZEN |
| K003060 |
10/31/2000 |
PLASMAKINETIC GENERATOR |
EVEREST MEDICAL CORP. |
DAVID KAY |
| K002332 |
10/06/2000 |
EEG SPIKE AND EVENT DETECTOR MODULE |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K001884 |
10/25/2000 |
DIRECT CROWN |
FLEXIBLE DIMENSIONS LLC. |
CAROL PATTERSON |
| K002198 |
10/17/2000 |
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS |
FLUORO SCAN IMAGING SYSTEMS, INC. |
WILLIAM J ENGEL |
| K002490 |
10/03/2000 |
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
LUCIANO BONANNI |
| K003065 |
10/31/2000 |
SEEDNET, MODEL EP6T5, EP5E5 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K994390 |
10/26/2000 |
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
| K002978 |
10/10/2000 |
LIGTHSPEED 3.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K002611 |
10/31/2000 |
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K000638 |
10/30/2000 |
RESPONDER 3000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
KLAUS RUDOLF |
| K002341 |
10/23/2000 |
THERMAL CAUTERY UNIT, MODEL 150 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K002957 |
10/18/2000 |
SOLAR SPO2 MODULE WITH MASIMO SET |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K002542 |
10/23/2000 |
REUSABLE CANNULA |
GENICON, LC |
GARY HABERLAND |
| K001125 |
10/04/2000 |
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING |
GEUDER GMBH |
HILLARD W WELCH |
| K000861 |
10/30/2000 |
CRANIOCAP |
GILLETTE CHILDREN'S SPECIALTY HEALTHCARE |
LINDA VALERI |
| K002777 |
10/05/2000 |
VACUETTE WITH PPACK |
GREINER VACUETTE NORTH AMERICA, INC. |
Judi Smith |
| K002676 |
10/30/2000 |
ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER |
GUIDANT CARDIAC AND VASCULAR SURGERY |
KRISTEN HONL |
| K002143 |
10/12/2000 |
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SUSAN SILAVIN, PH.D. |
| K002702 |
10/26/2000 |
NEUROTOLOGY DRAPE, MODEL TBD |
GYRUS ENT L.L.C. |
GREG SREDIN |
| K003214 |
10/31/2000 |
SMITH & NEPHEW PISTONS |
GYRUS ENT L.L.C. |
JEFFREY W COBB |
| K002737 |
10/12/2000 |
SMITH & NEPHEW PORPS & TORPS |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K002074 |
10/04/2000 |
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES |
H&C MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
| K003219 |
10/25/2000 |
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST |
HARALD NORDIN S.A |
JAMES DELANEY |
| K003221 |
10/25/2000 |
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST |
HARALD NORDIN S.A |
JAMES DELANEY |
| K002367 |
10/26/2000 |
HARDY DISK CEFTIZOXIME, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002661 |
10/26/2000 |
HARDYDISK CEFOTETAN, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002656 |
10/25/2000 |
HARDYDISK CEFUROXIME, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002369 |
10/26/2000 |
HARDYDISK GENTAMICIN, 120MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002664 |
10/26/2000 |
HARDYDISK LEVOFLOXACIN, 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002660 |
10/26/2000 |
HARDYDISK LOMEFLOXACIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002663 |
10/19/2000 |
HARDYDISK NETILMICIN, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002368 |
10/25/2000 |
HARDYDISK STREPTOMYCIN, 300MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994059 |
10/13/2000 |
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 |
HDC CORP. |
JAMES ABILLA |
| K002882 |
10/13/2000 |
HL168B |
HEALTH & LIFE CO., LTD. |
PAUL YANG |
| K003012 |
10/25/2000 |
RAICHEM PHOSPORUS REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
| K000995 |
10/11/2000 |
NARKOMAT, MODEL 2000 |
HEYER AMERICA, INC. |
ART WARD |
| K002420 |
10/17/2000 |
HITACHI ALTAIRE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K002921 |
10/18/2000 |
SUREONE INSULIN SYRINGE |
HOSUK CO., LTD. |
Y. H KIM |
| K002505 |
10/05/2000 |
XIA SPINE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K002858 |
10/13/2000 |
XIA SPINE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K002213 |
10/03/2000 |
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID |
HUNTER RESEARCH LABORATORIES, INC. |
BARBARA PEDIGO |
| K001387 |
10/05/2000 |
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 |
I-STAT CORP. |
PAUL VANDERWERF |
| K001096 |
10/25/2000 |
BURR HOLE COVER, MODEL XX |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K002330 |
10/18/2000 |
NAVIGUS PEEL AWAY INTRODUCER |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K002125 |
10/11/2000 |
PINS AND WIRES |
IMPLANT RESOURCE, INC. |
AL LIPPINCOTT |
| K000730 |
10/19/2000 |
IMPOAID |
IMPOAID, INC. |
ELAIN DUNCAN |
| K000252 |
10/17/2000 |
INSIGHT 4000 ENDOSCOPE |
INSIGHT INSTRUMENTS MFG., INC. |
K. PETER LULOH |
| K002467 |
10/13/2000 |
COALIZA PROTEIN S-FREE |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K002592 |
10/06/2000 |
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K002284 |
10/24/2000 |
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX |
INVACARE CORP. |
EDWARD A KROLL |
| K001522 |
10/18/2000 |
TRANSQ3 |
IOMED, INC. |
W. TIM MILLER |
| K002645 |
10/19/2000 |
JEL BIOS PURE |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K002826 |
10/24/2000 |
EQUITY |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K002673 |
10/11/2000 |
EZ-COMFORT TRANSPORTER 2000 SERIES |
JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
JAMES CHU |
| K002669 |
10/11/2000 |
EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR |
JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
JAMES CHU |
| K002671 |
10/11/2000 |
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR |
JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
JAMES CHU |
| K002670 |
10/11/2000 |
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR |
JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
JAMES CHU |
| K002857 |
10/05/2000 |
ELS CANNULA (KIT), MODEL M1210-88,M1510-88 |
JOSTRA AG |
KATHLEEN JOHNSON |
| K002558 |
10/25/2000 |
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K002788 |
10/23/2000 |
KSEA NEURO-FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K002700 |
10/18/2000 |
KSEA UNIMAT 12 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K001408 |
10/30/2000 |
KSEA VASCULAR FIBERSCOPES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K002152 |
10/10/2000 |
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION |
KLS-MARTIN L.P. |
ART WARD |
| K001742 |
10/06/2000 |
RESUSCI INFLATE-A-SHIELD CPR BARRIER |
LAERDAL MEDICAL CORP. |
CYNTHIA J NOLTE |
| K001179 |
10/27/2000 |
SUPER NOVA, ACUBEAM |
LIGHT FORCE THERAPY, INC. |
KIM PETERSON |
| K002523 |
10/06/2000 |
ADVANTAGE DRIVE SYSTEM |
LINVATEC CORP. |
LAURA D SENEFF |
| K002566 |
10/19/2000 |
LUMALITE CURE LIGHT, MODEL 2100 |
LUMALITE, INC. |
JOSEPH M FOREHAND |
| K000696 |
10/19/2000 |
MACROPOREMX MANDIBULAR FIXATION SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K002943 |
10/23/2000 |
WHEELCHAIR, MECHANICAL SERIES MODEL 3100 |
MADA MEDICAL PRODUCTS, INC. |
JEFFERY W ADAM |
| K993094 |
10/23/2000 |
AERO-CLICK |
MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH |
TORSTEN SCHLICHTHOLZ |
| K002104 |
10/10/2000 |
COMBINED PHYSIOLOGICAL MONITORING SYSTEM |
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF |
MARYROSE CUSIMANO |
| K002751 |
10/05/2000 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K002939 |
10/06/2000 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER |
MASIMO CORP. |
JAMES J CRONIN |
| K002933 |
10/19/2000 |
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
MAXXIM MEDICAL |
PALLIE STODDARD |
| K000929 |
10/17/2000 |
PROLITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K000620 |
10/30/2000 |
PBN FALLOPIAN TUBE CATHETER SYSTEM |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K002130 |
10/30/2000 |
NIR BILIARY STENT |
MEDINOL LTD. |
NASR SALMAN |
| K003121 |
10/20/2000 |
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS |
MEDISON AMERICA, INC. |
GARY J ALLSEBROK |
| K002372 |
10/25/2000 |
ACCESS ALERT GAUGE |
MEDISYSTEMS CORP. |
FREDRIC SWINDLER |
| K002577 |
10/26/2000 |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS |
MEDIVANCE, INC. |
ROBERT A KLINE |
| K003091 |
10/24/2000 |
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K002140 |
10/10/2000 |
MENICON PROGENT REMOVER |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K002310 |
10/25/2000 |
CARDIOBEEPER CB12/12, MODEL CB12/12 |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
GERARD LYNN |
| K002289 |
10/04/2000 |
INQWIRE DIAGNOSTIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K002358 |
10/19/2000 |
MDI GLIADIN A TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K002359 |
10/19/2000 |
MDI GLIADIN G TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K003090 |
10/18/2000 |
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM |
MIDMARK CORP. |
MIKE SNYDER |
| K000927 |
10/10/2000 |
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 |
MISONIX, INC. |
ALBERT F CLANCY JR. |
| K003076 |
10/27/2000 |
MITEK CUFFTACK |
MITEK PRODUCTS |
CHRISTINE KUNTZ-NASSIF |
| K002191 |
10/12/2000 |
CARRIAZO BARRAQUER II MICROKERATOME |
MORIA, INC. |
DAVID CONRAD |
| K002850 |
10/05/2000 |
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K002686 |
10/18/2000 |
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E |
NELLCOR PURITAN BENNETT, INC. |
CHERYL NORTON |
| K001811 |
10/25/2000 |
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM |
NEU-ION, INC. |
LEE A HEIKKINEN |
| K002888 |
10/20/2000 |
NICHOLS ADVANTAGE THYROGLOB |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K001693 |
10/24/2000 |
LIFE SCOPE P, MODEL BSM-4100 SERIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K002690 |
10/11/2000 |
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K002808 |
10/31/2000 |
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY |
NORDISKA DENTAL AB |
RICHARD KIRSCHNER |
| K002810 |
10/31/2000 |
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY |
NORDISKA DENTAL AB |
RICHARD KIRSCHNER |
| K002811 |
10/31/2000 |
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY |
NORDISKA DENTAL AB |
RICHARD KIRSCHNER |
| K002613 |
10/19/2000 |
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K001464 |
10/02/2000 |
DISPOSABLE H-PE MICROKERATOME BLADES |
OASIS |
YVONNE FERNANDEZ |
| K002443 |
10/18/2000 |
COLLAGEN WOUND DRESSING |
OASIS RESEARCH, LLC. |
JAMES CHRISTENSEN |
| K002510 |
10/18/2000 |
SMARTLENS |
ODC OPHTHALMIC DEVELOPMENT CO. AG |
Kevin Walls |
| K002982 |
10/25/2000 |
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K002918 |
10/25/2000 |
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K002922 |
10/16/2000 |
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) |
OMNIGRACE (THAILAND) LTD. |
WILLIAM E PATTON |
| K000848 |
10/05/2000 |
TDK HANDPIECES |
ORASYSTEMS |
BERNARD SESSMAN |
| K003104 |
10/20/2000 |
BACT/ALERT CSR |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K000739 |
10/24/2000 |
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR |
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. |
WILLIAM JACKSON |
| K002622 |
10/23/2000 |
BIOSLEEP |
OXFORD BIOSIGNALS LIMITED |
PAULINE A HOBDAY |
| K000838 |
10/23/2000 |
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
| K002497 |
10/10/2000 |
MODEL 4810 ANALYZER OUTPUT ADAPTER |
PACE MEDICAL |
ROBERT C MACE |
| K002496 |
10/10/2000 |
MODEL 4815 ADAPTER |
PACE MEDICAL |
ROBERT C MACE |
| K002204 |
10/18/2000 |
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V |
PACE MEDICAL |
ROBERT C MACE |
| K002228 |
10/06/2000 |
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X |
PARADIGM MEDICAL INDUSTRIES, INC. |
TRACY S BEST |
| K983783 |
10/24/2000 |
HEATED HUMIDIFIER |
PEGASUS RESEARCH CORP. |
E J SMITH |
| K002471 |
10/19/2000 |
JETCAN HUBER NEEEDLE SET |
PFM PRODUKTE FUR DIE MEDIZIN AG |
SALVADORE F PALOMARES |
| K002556 |
10/31/2000 |
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 |
PHARMACIA & UPJOHN CO. |
TONI D ELLIOTT |
| K001552 |
10/19/2000 |
TREPCHEK TREPONEMAL ANTIBODY EIA |
PHOENIX BIOTECH CORP. |
Gary Lehnus |
| K002880 |
10/26/2000 |
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC |
PIE MEDICAL |
COLLEEN J HITTLE |
| K002110 |
10/06/2000 |
SPL CRIMP SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
AMY H MOMMAERTS |
| K000666 |
10/13/2000 |
TC-PLUS SOLUTION KNEE |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K002651 |
10/13/2000 |
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K002025 |
10/31/2000 |
RIGID GAS PERMEABLE CONTACT LENS |
POLYMER TECHNOLOGY |
DEBRA L.B. KETCHUM |
| K980974 |
10/13/2000 |
SAFE MINI |
POLYSTAN A/S |
THOMAS ANDERSEN |
| K002675 |
10/25/2000 |
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM |
PRODUCT DEVELOPMENT INDUSTRIES, INC. |
RODOLFO A CARBALLO |
| K002500 |
10/23/2000 |
X-POSURE SYSTEM VERSION 2 RAD |
PRONOSCO A/S |
JONATHAN KAHAN |
| K002881 |
10/11/2000 |
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 |
PULMONETIC SYSTEMS, INC. |
ROBERT HANKINS |
| K001646 |
10/20/2000 |
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION |
PURITAN BENNETT CORP. |
MARY E FUNK |
| K003094 |
10/25/2000 |
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER |
Qualigen, Inc. |
DOROTHY DEINZER |
| K002962 |
10/04/2000 |
PRESSURE WIRE SENSOR, MODEL 12003/12303 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K001070 |
10/24/2000 |
RADIOMED SOURCE |
RADIOMED CORP. |
JOHN SCHWAMB |
| K002773 |
10/23/2000 |
NEUROMAP WITH NEURO 100 |
RADIONICS, INC. |
NANCY C MACDONALD |
| K001741 |
10/23/2000 |
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM |
RADIONICS, INC. |
Kristine Canavan |
| K002674 |
10/05/2000 |
RANDOX MICROALBUMIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K001607 |
10/05/2000 |
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) |
REPROMEDIX CORP. |
HAN-SOO KIM |
| K001603 |
10/05/2000 |
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) |
REPROMEDIX CORP. |
HAN-SOO KIM |
| K001606 |
10/05/2000 |
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) |
REPROMEDIX CORP. |
HAN-SOO KIM |
| K000418 |
10/24/2000 |
PDT DOSECALCULATOR, MODEL 80000 |
RETINALABS.COM |
FRANK TIGHE |
| K003232 |
10/26/2000 |
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K001468 |
10/23/2000 |
ELECSYS CA 15-3 TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K002760 |
10/05/2000 |
ELECSYS DHEA-S CALSET |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K001719 |
10/10/2000 |
Q-LUX PLASMA 100 LIGHT CURE UNIT |
ROLENCE ENTERPRISE CO. LTD. |
STERLING CHENG |
| K002168 |
10/13/2000 |
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE |
RONVIG INSTRUMENTS, LTD. |
ANNETTE RAVN NEILSEN |
| K001295 |
10/25/2000 |
PIPER |
RTEK MEDICAL SYSTEMS, LLC. |
ROBERT C JACKSON |
| K002836 |
10/03/2000 |
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE |
SAGE BIOPHARMA |
GREG HOLLAND |
| K002169 |
10/19/2000 |
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM |
SCIMEDX CORP. |
Gary Lehnus |
| K002189 |
10/19/2000 |
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM |
SCIMEDX CORP. |
GARY L EHNUS |
| K002936 |
10/17/2000 |
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM |
SECTRA-IMTEC AB |
HERMAN OOSTERWIJK |
| K002867 |
10/12/2000 |
INVERNESS MEDICAL OVULATION PREDICTOR TEST |
SELFCARE, INC. |
CAROL A ADILETTO |
| K002814 |
10/20/2000 |
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI PM PLASTICS ENTERISE CO., LTD. |
CHANG T SUN |
| K002870 |
10/16/2000 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. |
PETER WANG |
| K002137 |
10/05/2000 |
CATHCOR DESKTOP |
SIEMENS ELEMA AB |
DAVE SIMARD |
| K002179 |
10/11/2000 |
MAGNETOM ALLEGRA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K003014 |
10/12/2000 |
SOMATOM EMOTION MS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K003152 |
10/24/2000 |
SOMATOM SMILE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K003125 |
10/20/2000 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDI HOFFMAN |
| K002568 |
10/03/2000 |
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SMART GLOVE CORP. SDN BHD |
FOO K PU |
| K002261 |
10/23/2000 |
MR-III |
SMITH & NEPHEW, INC. |
DEMETRIOS TSAKONAS |
| K002082 |
10/06/2000 |
SPEEDLINK TRANSVERSE CONNECTOR |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K002069 |
10/05/2000 |
ASCEND SPINAL FIXATION SYSTEM |
SPINAL INNOVATIONS, LLC. |
KEN RUSSELL |
| K003194 |
10/26/2000 |
STACKHOUSE LENS HOOD, MODEL SA-700/FS |
STACKHOUSE, INC. |
TOM GUTIERREZ |
| K002547 |
10/20/2000 |
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K002180 |
10/13/2000 |
SIMPLICITY DISPOSABLE PEN NEEDLE |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K002492 |
10/24/2000 |
SIMPLICITY SOFT INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K002732 |
10/02/2000 |
STRYKER NAVIGATION SYSTEM - ENT MODULE |
STRYKER CORP. |
NICOLE PETTY |
| K002876 |
10/11/2000 |
JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM |
SUITER MEDICAL L.L.C. |
JAMES P SUITER |
| K002581 |
10/20/2000 |
DURAGARD SODIUM FLUORIDE VARNISH |
SULTAN DENTAL PRODUCTS, LTD. |
GEORGE WOLFE |
| K002356 |
10/30/2000 |
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K002335 |
10/25/2000 |
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA |
SULZER ORTHOPEDICS, INC. |
MITCHELL DHORITY |
| K002444 |
10/18/2000 |
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 |
SUN NUCLEAR CORP. |
THOMAS L POWERS |
| K002446 |
10/23/2000 |
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D |
SUN NUCLEAR CORP. |
THOMAS L POWERS |
| K003004 |
10/25/2000 |
OSCAR 2, MODEL 222 |
SUNTECH MEDICAL INSTRUMENTS, INC. |
GEORGE MYERS |
| K002345 |
10/11/2000 |
SURGI-VISION URETHRAL COIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K000246 |
10/20/2000 |
RADIOCAMERAS EXTRACRANIAL SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER WHITE |
| K002849 |
10/18/2000 |
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES |
SURGICAL SPECIALTIES CORP. |
VIKKI M HOFFMAN |
| K003061 |
10/30/2000 |
SYNTHES USS (10.0MM SIDE OPENING SCREWS) |
SYNTHES |
JONATHAN GILBERT |
| K994121 |
10/17/2000 |
SMALL STATURE USS |
SYNTHES (USA) |
JONATHAN M GILBERT |
| K002361 |
10/31/2000 |
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
| K002729 |
10/06/2000 |
SYNTHES PROXIMAL HUMERAL NAIL |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K002257 |
10/19/2000 |
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 |
TECNO INSTRUMENTS (PVT.) LTD. |
SUSAN D GOLDSTEIN-FALK |
| K993101 |
10/26/2000 |
LITEAIRE |
THAYER MEDICAL CORP. |
DAVID T SLADEK |
| K002903 |
10/24/2000 |
ANSPACH ANGLED MICRONOSE ATTACHMENT |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH III |
| K002561 |
10/26/2000 |
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K002560 |
10/26/2000 |
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K002564 |
10/26/2000 |
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K002563 |
10/26/2000 |
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K002350 |
10/05/2000 |
REFACTO LABORATORY STANDARD |
THE GENETICS INSTITUTE |
MARYANN KRANE |
| K000317 |
10/27/2000 |
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM |
TISSUE MEDICAL LASERS, INC. |
DWIGHT ZURAWSKI |
| K000003 |
10/02/2000 |
TORNIER TOTAL ELBOW PROSTHESIS |
TORNIER |
DAVID W SCHLERF |
| K002424 |
10/27/2000 |
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DIANA THORSON |
| K002531 |
10/26/2000 |
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K002522 |
10/25/2000 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
BRUCE CLARK |
| K001835 |
10/11/2000 |
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE |
TRAC ABOUT, INC. |
Kevin Walls |
| K991296 |
10/06/2000 |
TUTOPATCH |
TUTOGEN MEDICAL U.S., INC. |
PJ PARDO |
| K002408 |
10/17/2000 |
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS |
UNILENS CORP., USA |
CHARLOTTE B COUECOU |
| K002318 |
10/11/2000 |
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES |
UNITED CHAIR MFG., LLC. |
DOUGLAS A HANBY |
| K003010 |
10/19/2000 |
SPIRIT ACUPUNCTURE NEEDLE |
UNITED PACIFIC CO., LTD. |
DANIEL YE HUA |
| K002483 |
10/25/2000 |
POWER 5000 GENERAL PURPOSE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K002482 |
10/17/2000 |
VISION 9000 PHASED ARRAY TORSO COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K002562 |
10/13/2000 |
PACIFIER THERMOMETER MODELS VT-901F, VT901C |
VALEO CORP. |
MARIAN HARDING COCHRAN |
| K001972 |
10/27/2000 |
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK |
VISICU, INC. |
CAROL PATTERSON |
| K991124 |
10/20/2000 |
VISIJET HYDROKERATOME, MODEL 50 |
VISIJET, INC. |
JUDY F GORDON |
| K002519 |
10/19/2000 |
VITREA 2, VERSION 2.1 |
VITAL IMAGES, INC. |
ROBERT C SAMEC |
| K002983 |
10/11/2000 |
C.T.M. POWER CHAIR, MODEL HS-5600 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K001519 |
10/06/2000 |
ACTICOAT 7 DRESSING |
WESTAIM BIOMEDICAL, INC. |
Steve Chartier |
| K002975 |
10/24/2000 |
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
| K002897 |
10/11/2000 |
TITANIUM MIDDLE EAR PROSTHESES |
XOMED, INC. |
DAVID TIMLIN |
| K002828 |
10/17/2000 |
XPS NITRO SYSTEM |
XOMED, INC. |
MARTIN D SARGENT |
