| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K000741 |
10/24/2001 |
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 |
138 MEDICAL SUPPLIES, INC. |
SUSAN D GOLDSTEIN-FALK |
| K010127 |
10/05/2001 |
W & H ASSISTINA |
A-DEC, INC. |
LOVENA STANDRIDGE |
| K011337 |
10/16/2001 |
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) |
ACCUMETRICS, INC. |
RHONDA MOE |
| K012595 |
10/15/2001 |
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K011248 |
10/29/2001 |
CW DISPOSABLE ACUPUNCTURE NEEDLE |
ACUSUPPLY, INC. |
FERES DAGER |
| K011247 |
10/17/2001 |
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE |
ACUSUPPLY, INC. |
FERES DAGER |
| K002632 |
10/25/2001 |
OXYGENATOR |
ADJUNCTIVE THERAPEUTICS, INC. |
MYRON Z BERNSTEIN |
| K011265 |
10/30/2001 |
ULTRASOUND TRANSDUCER COVER |
ADVANCE MEDICAL DESIGNS, INC. |
BILL GILL |
| K012928 |
10/09/2001 |
ABI VEST AIRWAY CLEARANCE SYSTEM |
ADVANCED RESPIRATORY |
ERIC J LARSON |
| K012986 |
10/03/2001 |
BIPOLAR IRRIGATION FORCEPS |
AESCULAP, INC. |
LISA M MILLINGTON |
| K013176 |
10/16/2001 |
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE |
AFP IMAGING CORP. |
MARY MCNAMARA-CULLINANE |
| K012383 |
10/02/2001 |
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K012335 |
10/01/2001 |
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K012625 |
10/22/2001 |
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K011814 |
10/22/2001 |
AMEDITECH IMMUTEST DRUG SCREEN COC |
AMEDITECH, INC. |
JOHN WU |
| K011813 |
10/22/2001 |
AMEDITECH IMMUTEST DRUG SCREEN THC |
AMEDITECH, INC. |
JOHN WU |
| K012127 |
10/04/2001 |
PULSEMASTER ERBIUM DENTAL LASER SYSTEM |
AMERICAN DENTAL TECHNOLOGIES, INC. |
SHEILA HEMEON-HEYER |
| K013355 |
10/26/2001 |
SPARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
GINGER S GLASER |
| K012464 |
10/10/2001 |
HELIX HYDRO-JET |
ANDREAS PEIN MEDIZINTECHNIK GMBH |
ROBERT N CLARK |
| K010729 |
10/26/2001 |
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A |
ANDROMED, INC. |
JULIA LALE AKTIK |
| K012643 |
10/29/2001 |
APEX MEDICAL LCD TENS-VII |
APEX MEDICAL CORP. |
ALAN CHANG |
| K012140 |
10/05/2001 |
COM-PATCH |
APEX MEDICAL CORP. |
ALAN CHANG |
| K010869 |
10/11/2001 |
EPOCA CUSTOM OFFSET SHOULDER SYSTEM |
ARGOMEDICAL AG |
DONALD A STEVENS |
| K011056 |
10/24/2001 |
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K011761 |
10/31/2001 |
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K012923 |
10/04/2001 |
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 |
ARTHREX, INC. |
ANN WATERHOUSE |
| K012519 |
10/25/2001 |
ARTHROCARE ELECTROSURGERY WANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K010477 |
10/09/2001 |
AUTO-LOCK |
AUTO-LOCK |
DIETRICH W GRABIS |
| K012435 |
10/02/2001 |
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 |
BAUSCH & LOMB, INC. |
VANADA JOHNSON |
| K012777 |
10/22/2001 |
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS |
BAYER CORP. |
KENNETH T EDDS |
| K013272 |
10/25/2001 |
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY |
BAYER CORP. |
KENNETH T EDDS |
| K012340 |
10/01/2001 |
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) |
BAYER CORP. |
KENNETH T EDDS |
| K012900 |
10/16/2001 |
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS |
BECKMAN COULTER, INC. |
MARA CALER |
| K013235 |
10/16/2001 |
MODIFICATION TO SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K012384 |
10/15/2001 |
EAR MUFFINS |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K012997 |
10/25/2001 |
COLLATEK FOAM |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
AJAY KUMAR |
| K012990 |
10/24/2001 |
COLLATEK POWDER |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
AJAY KUMAR |
| K012995 |
10/25/2001 |
COLLATEK SHEET |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
AJAY KUMAR |
| K012955 |
10/22/2001 |
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER |
BIOFORM, INC. |
VICTOR M BOWERS |
| K010804 |
10/04/2001 |
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS |
BIOLITEC, INC. |
CAROL J MORELLO |
| K012503 |
10/22/2001 |
METAL SCREW ANCHOR |
BIOMET MANUFACTURING, INC. |
SARA B SHULTZ |
| K013042 |
10/10/2001 |
DISCOVERY ELBOW |
BIOMET ORTHOPEDICS, INC. |
SARA B SHULTZ |
| K012559 |
10/16/2001 |
POLY STAT HCG TEST |
BION DIAGNOSTIC SCIENCES |
HELEN LANDICHO |
| K013147 |
10/24/2001 |
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE |
BIONOSTICS, INC. |
KATHY STORRO |
| K013057 |
10/12/2001 |
BIOCUFF,C, MODELS 236018, 236028, 236036 |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K013002 |
10/03/2001 |
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K012999 |
10/03/2001 |
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K013194 |
10/10/2001 |
UNIMARK HCG COMBO PREGNANCY TEST |
BIOTECH ATLANTIC, INC. |
FRANCIS LEE |
| K012465 |
10/29/2001 |
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K013153 |
10/19/2001 |
AUTOTOME RX MODEL # 4515, 4516 |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K012864 |
10/24/2001 |
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 |
BOSTON SCIENTIFIC CORP. |
JAMES D MCMAHON |
| K012883 |
10/12/2001 |
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K012822 |
10/24/2001 |
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX |
BOSTON SCIENTIFIC SCIMED, INC. |
TODD KORNMANN |
| K012952 |
10/02/2001 |
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT |
BOSTON SCIENTIFIC/MEDI-TECH |
JENNIFER BOLTON |
| K012948 |
10/03/2001 |
MODIFICATION TO VAXCEL DIALYSIS CATHETER |
BOSTON SCIENTIFIC/MEDI-TECH |
NICHOLAS CONDAKES |
| K012345 |
10/03/2001 |
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR |
BROMAC ASSISTIVE TECHNOLOGY |
DAVID K BROWN |
| K013111 |
10/01/2001 |
EXHALE PROBE |
BRONCUS TECHNOLOGIES, INC. |
TIMOTHY R WILLIAMS |
| K013144 |
10/19/2001 |
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W |
C.R. BARD, INC. |
MARION GORDON |
| K012206 |
10/12/2001 |
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K013043 |
10/11/2001 |
CANDELA CLEARBEAM PULSED DYE LASER |
CANDELA CORP. |
JOAN CLIFFORD |
| K013175 |
10/30/2001 |
TM2000 EASYTRACE PLUS RECEIVING CENTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K010396 |
10/04/2001 |
C. NET 2100 |
CARDIONETICS, LTD. |
BARRY SALL |
| K003238 |
10/01/2001 |
SOLID STATE X-RAY IMAGING DEVICES |
CARES BUILT, INC. |
TIMOTHY D TELYMONDE |
| K012126 |
10/03/2001 |
THE SALICEPT ORAL PATCH |
CARRINGTON LABORATORIES, INC. |
KENNETH M YATES |
| K013336 |
10/29/2001 |
XANTALGIN CRONO |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K012886 |
10/09/2001 |
CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE |
CBYON, INC. |
KRISHNA SUDHAKARAN |
| K012446 |
10/03/2001 |
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI |
CHARLES A. SMITH |
CHARLES A SMITH |
| K013458 |
10/29/2001 |
CRANIAL HELMET |
CHILDREN'S HOSPITAL |
CONNIE FICKLIN |
| K012265 |
10/17/2001 |
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 |
CIRCON VIDEO |
WAYNE B STERNER |
| K001509 |
10/26/2001 |
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K003322 |
10/01/2001 |
CODMAN BACTISEAL CATHETERS |
Codman & Shurtleff, Inc. |
JAMES M FLAHERTY |
| K003661 |
10/05/2001 |
SOCRATES ROBOTIC TELEMONITORING SYSTEM |
COMPUTER MOTION, INC. |
DAVID THOMAS |
| K003431 |
10/05/2001 |
ZEUS ROBOTIC SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
DAVID THOMAS |
| K010954 |
10/09/2001 |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 |
CONCENTRIC MEDICAL, INC. |
KEVIN MACDONALD |
| K010016 |
10/09/2001 |
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER |
COOK, INC. |
LISA HOPKINS |
| K012993 |
10/05/2001 |
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K011502 |
10/22/2001 |
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM |
CRYSTAL-SEAL DENTAL IMPLANTS |
CLINT FOLSOM |
| K013504 |
10/31/2001 |
MODIFICATION TO: ECAT LSO PET/CT SCANNER |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K010615 |
10/12/2001 |
CYCLOTEC AMT CTI TENS DEVICE |
CYCLOTEC |
STEPHEN A MICHELSON |
| K013130 |
10/18/2001 |
N LP(A) CONTROL SY |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K012354 |
10/10/2001 |
SNOWPOST, SNOWLIGHT |
DANVILLE MATERIALS, INC. |
CRAIG R BRUNS |
| K013156 |
10/19/2001 |
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
| K010715 |
10/04/2001 |
AL-40 |
DDC TECHNOLOGIES, INC. |
DMITRY DONSKOY |
| K013230 |
10/25/2001 |
CERCON BASE |
DEGUSSA - NEY DENTAL, INC. |
THOMAS CAMERON |
| K013154 |
10/19/2001 |
MARK II/MARK III MANOMETRIC PERFUSION PUMP |
DENTSLEEVE PTY., LTD. |
ROBERT N CLARK |
| K012235 |
10/04/2001 |
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER |
DENVER BIOMEDICAL, INC. |
BONNIE B VIVIAN |
| K012971 |
10/05/2001 |
ISOLA SPINAL SYSTEMS |
DEPUY ACROMED |
LISA GILMAN |
| K013294 |
10/09/2001 |
MONARCH SPINAL SYSTEMS |
DEPUY ACROMED |
LISA GILMAN |
| K013296 |
10/09/2001 |
MOSS MIAMI SPINAL SYSTEMS |
DEPUY ACROMED |
LISA GILMAN |
| K013295 |
10/09/2001 |
TIMX SPINAL SYSTEMS |
DEPUY ACROMED |
LISA GILMAN |
| K012364 |
10/19/2001 |
AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K013134 |
10/15/2001 |
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARDS M LEVINE |
| K013135 |
10/19/2001 |
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K012450 |
10/26/2001 |
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K012449 |
10/26/2001 |
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K004001 |
10/04/2001 |
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR |
DIDECO |
BARBARA WATSON |
| K012967 |
10/04/2001 |
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
ELAD MAGAL |
| K013236 |
10/17/2001 |
LUXABITE |
DMG USA, INC. |
PAMELA PAPINEAU |
| K013179 |
10/12/2001 |
LUXAGLAZE |
DMG USA, INC. |
PAMELA PAPINEAU |
| K013237 |
10/22/2001 |
STATUSBLUE |
DMG USA, INC. |
PAMELA PAPINEAU |
| K012821 |
10/22/2001 |
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K013142 |
10/05/2001 |
DIASUS |
DYNAMIC IMAGING LTD. |
ALLEN FINDLAY |
| K012474 |
10/03/2001 |
ATAC PAK CPK REAGENT KIT |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K012906 |
10/09/2001 |
ANIMEC, MODELS AM-2S-4 AND AM-2S-5 |
ELLTEC CO., LTD. |
GENSHIRO OGAWA |
| K013191 |
10/24/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K003811 |
10/11/2001 |
CRYOCARE SURGICAL SYSTEM |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K012333 |
10/17/2001 |
FLEXI-SITE SP02 EAR SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K013348 |
10/26/2001 |
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 |
ERBE USA, INC. |
JOHN TARTAL |
| K012176 |
10/01/2001 |
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 |
ETHICON ENDO-SURGERY, INC. |
RUTH A WOOD |
| K011794 |
10/01/2001 |
XLTEK LED GOGGLES, MODEL LED-01 |
EXCEL TECH. LTD. |
SONJA MARKEZ |
| K012141 |
10/25/2001 |
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE |
EXTERNAL COUNTERPULSATION LAB |
AHAVA STEIN |
| K012641 |
10/15/2001 |
FAS ENDOLUMINAL BRUSH |
FAS MEDICAL LTD. |
THOMAS KROENKE |
| K012230 |
10/09/2001 |
PHEM-ALERT |
FEMTEK,LLC. |
JOEL S FADEN |
| K011530 |
10/16/2001 |
VERTRAN STANDING WHEELCHAIR |
FENA DESIGN, INC. |
ELAINE DUNCAN |
| K013395 |
10/30/2001 |
LIFEJET VIDEO LINK |
FERRANIA S.P.A. |
ING. MANNELLA PAOLO |
| K013229 |
10/12/2001 |
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE |
FERRANIA USA, INC. |
DOUG HALE |
| K013118 |
10/15/2001 |
MODIFICATION TO ALPHA DX SYSTEM |
FIRST MEDICAL, INC. |
GREG HOLLAND |
| K002839 |
10/04/2001 |
END EXPIRATORY FILTER, MODEL RT020 |
FISHER & PAYKEL HEALTHCARE, LTD. |
CHRIS MANDER |
| K012947 |
10/02/2001 |
SMARTFLOW |
FLORENCE MEDICAL LTD. |
SHOSHANA FRIEDMAN |
| K012497 |
10/30/2001 |
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K010985 |
10/10/2001 |
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
GAMBRO RENAL PRODUCTS |
JEFFREY R SHIDEMAN |
| K011221 |
10/31/2001 |
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET |
GAMBRO RENAL PRODUCTS |
SUZANNE DENNIS |
| K013198 |
10/29/2001 |
FUJI VII CAPSULE |
GC AMERICA, INC. |
TERRY L JORITZ |
| K012542 |
10/16/2001 |
REVOTEK LC |
GC AMERICA, INC. |
TERRY L JORITZ |
| K013422 |
10/30/2001 |
CARDIQ FUNCTION |
GE MEDICAL SYSTEMS |
STEVEN J KACHELMEYER |
| K013381 |
10/26/2001 |
ADVANCED LUNG ANALYSIS-1 |
GENERAL ELECTRIC CO. |
STEVEN J KACHELMEYER |
| K012466 |
10/01/2001 |
BIS/EEG MODULE |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K012532 |
10/30/2001 |
SEPRAGEL SINUS |
GENZYME CORP. |
NANCY A IMMEL |
| K013026 |
10/15/2001 |
POWDERED LATEX EXAMINATION GLOVES |
GREAT GLOVE (THAILAND) CO. LTD. |
KM LEE |
| K012628 |
10/26/2001 |
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM |
GYNECARE CENTER |
GREGORY JONES |
| K013033 |
10/23/2001 |
MODIFICATION TO: HL168W TOUCH SCREEN |
HEALTH & LIFE CO., LTD. |
PAUL YANG |
| K012649 |
10/15/2001 |
RAICHEM BUN RATE REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
| K012668 |
10/15/2001 |
RAICHEM GLUCOSE UV REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
| K012914 |
10/01/2001 |
SONICWAVE SONIC PLAQUE REMOVER |
HOMEDICS, INC. |
DAVID VANDERLIN |
| K011916 |
10/31/2001 |
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES |
HORIZON MEDICAL PRODUCTS, INC. |
PENNY M NORTHCUTT |
| K012726 |
10/18/2001 |
PROSAFE SAFETY SYRINGE |
HOU-SE MEDICAL INC |
JOSEPH J CHANG |
| K012172 |
10/10/2001 |
DURACON PS LIPPED TIBIAL INSERT |
HOWMEDICA OSTEONICS |
MARY-CATHERINE DILLON |
| K012719 |
10/22/2001 |
NAVIGUS II MR |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K012366 |
10/01/2001 |
NAVIGUS II TRAJECTORY GUIDE |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K012419 |
10/24/2001 |
CONFORM SHEETING, MODEL IGEL |
IMPLANTECH ASSOCIATES, INC. |
STEPHEN MEADE |
| K010997 |
10/15/2001 |
PAM-RL |
INDIVIDUAL MONITORING SYSTEMS, INC. |
DAVID T KRAUSMAN |
| K013039 |
10/05/2001 |
INION CPS 2.0 ORTHOGNATHIC PLATE |
INION LTD. |
HANNA MARTTILA |
| K003229 |
10/26/2001 |
BIOPATCH ANTIMICROBIAL DRESSING |
INTEGRA LIFESCIENCES CORP. |
WILLIAM GOELLER |
| K002132 |
10/18/2001 |
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS |
INTELLIGENT INSTRUMENTS PVT. LTD. |
S.L. KAPOOR |
| K012909 |
10/24/2001 |
XTERRA GT POWER WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K011365 |
10/26/2001 |
VITALSAT PULSE OXIMETER, MODEL IC32000 |
ISLAND CRITICAL CARE CORP. |
SEAN FLANIGAN |
| K012358 |
10/15/2001 |
CHIBA NEEDLE |
ISPG, INC. |
LORETTA F LUHMAN |
| K013275 |
10/19/2001 |
ASTRALIS 10, MODELS # 559588, 561859 |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K013277 |
10/22/2001 |
ASTRALIS 7, MODEL 557545 |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K012482 |
10/16/2001 |
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JENNIFER PORTUGAL |
| K012404 |
10/12/2001 |
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 |
KATECHO, INC. |
WARREN R WALTERS |
| K013375 |
10/29/2001 |
BELLEGLASS HP OPAQUE 2 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K013325 |
10/23/2001 |
POINT 4 FLOWABLE 2 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K012946 |
10/02/2001 |
SUNLITELED MODEL #2810 |
KINETIC INSTRUMENTS, INC. |
WILLIAM J BECKER |
| K012485 |
10/09/2001 |
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE |
KING SYSTEMS CORP. |
CHARLES A BURT |
| K012714 |
10/31/2001 |
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR |
KOON SENG SDN.BHD |
LIM WENG HENG |
| K010202 |
10/31/2001 |
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES |
LESLIE W. ORGAN |
LESLIE W ORGAN |
| K012320 |
10/19/2001 |
POWERPRO BATTERY SYSTEM |
LINVATEC CORP. |
LAURA D SENEFF |
| K013290 |
10/24/2001 |
MODIFIED 650 MAMMOGRAPHY SYSTEM |
LORAD, A HOLOGIC CO. |
ROAIDA RIZKALLAH |
| K012491 |
10/24/2001 |
MACHNET CAROTIDS COIL ARRAY ASSEMBLY |
MACHNET BV |
DANIEL KAMM |
| K012769 |
10/25/2001 |
MACROPORE ENT RECONSTRUCTION FILM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K012992 |
10/03/2001 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K001974 |
10/24/2001 |
EZ-ON CONDOM |
MAYER LABORATORIES |
DAVID P MAYER |
| K010706 |
10/05/2001 |
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER |
MEASUREMENT SPECIALTIES, INC. |
CAROL PATTERSON |
| K011373 |
10/12/2001 |
INSTRUMENT DAMPING PORT |
MEDCANICA, INC. |
AL WEISENBORN |
| K011349 |
10/05/2001 |
INTERCOSTAL LOCKABLE-DIRECTABLE PORT |
MEDCANICA, INC. |
CHRISTIAN L MAZZOLA |
| K013162 |
10/19/2001 |
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH |
MEDCOMP |
JEANNE M CUSH |
| K010306 |
10/03/2001 |
MEDCOMP EXCELL SPLIT TIP CATHETER |
MEDCOMP |
JEANNE M CUSH |
| K994105 |
10/03/2001 |
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K012336 |
10/03/2001 |
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 |
MEDICAL DATA ELECTRONICS |
GREGORY R ALKIRE |
| K012632 |
10/26/2001 |
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
| K012950 |
10/04/2001 |
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
MEDRAD, INC. |
LORRAINE R FREDES |
| K011080 |
10/11/2001 |
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM |
MEDTRONIC AVE, INC. |
JOHN RIOLO |
| K012143 |
10/24/2001 |
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
MELISSA HARRIGER |
| K010528 |
10/10/2001 |
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
| K013014 |
10/04/2001 |
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K012081 |
10/01/2001 |
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K010930 |
10/24/2001 |
LIFT VB SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K004005 |
10/12/2001 |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) |
MENTOR CORP. |
DONNA A CRAWFORD |
| K012240 |
10/15/2001 |
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE |
MERCAN AB |
JEFFREY O STULL |
| K012237 |
10/15/2001 |
MERTEX-PLUS REUSABLE SURGICAL DRAPE |
MERCAN AB |
JEFFERY O STULL |
| K010586 |
10/30/2001 |
PALAMED BONE CEMENT |
MERCK BIOMATERIAL GMBH |
THOMAS KIEWITT |
| K011058 |
10/23/2001 |
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
RHONA LOVE |
| K013192 |
10/17/2001 |
SONICATOR PLUS 930, MODEL ME 930 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K011392 |
10/22/2001 |
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER |
MICRA INSTRUMENTS |
JOHN A.K. BASKERVILLE |
| K011952 |
10/25/2001 |
DRUGS OF ABUSE MULTI-TEST STRIP |
MICRODIAGNOSTICS, INC. |
JUNE SHOZI |
| K012868 |
10/29/2001 |
MICROMEDICS FIBRIJET AEROSOL APPLICATOR |
MICROMEDICS, INC. |
CHARLES GROTE |
| K011318 |
10/25/2001 |
VENODYNE DVT ADVANTAGE PLUS |
MICROTEK MEDICAL, INC. |
TOM BONNER |
| K012145 |
10/29/2001 |
MICROPLEX COIL SYSTEM |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K013322 |
10/16/2001 |
HAC-420 HEAD ARRAY COIL |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K013159 |
10/16/2001 |
HRH-63-8 HEAD ARRAY COIL |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K012263 |
10/10/2001 |
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 |
NATIONAL CUSTOM ENT., INC. |
DON PELLETIER |
| K012264 |
10/10/2001 |
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC |
NATIONAL CUSTOM ENT., INC. |
DON PELLETIER |
| K012522 |
10/18/2001 |
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL |
NATIONAL THERAPY PRODUCTS INC. |
PAUL L HOOEY |
| K013137 |
10/16/2001 |
ALGO 3 NEWBORN HEARING SCREENER |
NATUS MEDICAL, INC. |
SHEILA RAMERMAN |
| K012982 |
10/02/2001 |
COOLTOUCH VARIZOOM |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K012367 |
10/09/2001 |
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K012416 |
10/26/2001 |
CONFOSCAN 2 CONFOCAL MICROSCOPE |
NIDEK TECHNOLOGIES SRL |
CAROL PATTERSON |
| K010053 |
10/23/2001 |
HUMI-FLOW, MODEL 6-850-00/ 01/02 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K012508 |
10/09/2001 |
MU PHOTONICS PAIN THERAPIST |
NU PHOTONICS, INC. |
WILLIAM M BROCK |
| K010032 |
10/17/2001 |
SEED SELECTRON MODEL V. 1.0 |
NUCLETRON CORP. |
RALPH E SHUPING |
| K013257 |
10/30/2001 |
HEMI-ARC SURGICAL NAVIGATOR |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K013215 |
10/16/2001 |
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
NUVASIVE, INC. |
SEAN M CURRY |
| K012832 |
10/24/2001 |
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 |
NXSTAGE MEDICAL, INC. |
KAREN ST. ONGE |
| K012510 |
10/19/2001 |
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM |
NXSTAGE MEDICAL, INC. |
KAREN ST.ONGE |
| K010613 |
10/12/2001 |
MAGELLAN-2200, MODEL 1 |
OCEANIC MEDICAL PRODUCTS, INC. |
WILLIAM M GATES |
| K012425 |
10/12/2001 |
BIOMEDICS UV MULTIFOCAL |
OCULAR SCIENCES PUERTO RICO, INC. |
RICHARD LIPPMAN |
| K012402 |
10/12/2001 |
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM |
OMNIGRACE (THAILAND) LTD. |
WILLIAM E PATTON |
| K012227 |
10/01/2001 |
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 |
ONCOLOGY DATA SYSTEMS, INC. |
GREGORY G MILLER |
| K012254 |
10/16/2001 |
VBR |
OSTEOTECH, INC. |
KIM THURMAN |
| K012238 |
10/01/2001 |
DOSERIGHT |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
FRANK GIANELLI |
| K012509 |
10/09/2001 |
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
| K012475 |
10/24/2001 |
CAAS II QVA |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
| K013173 |
10/22/2001 |
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K012809 |
10/26/2001 |
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 |
POWER MEDICAL INTERVENTIONS, INC. |
LAURENCE A POTTER |
| K012142 |
10/04/2001 |
THE QUIET SLEEPER |
PRECISION DENTAL LABORATORIES, INC. |
SHARON LAMONT |
| K012673 |
10/24/2001 |
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K012629 |
10/05/2001 |
ALWAYS DUETS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
| K012709 |
10/01/2001 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
| K012315 |
10/11/2001 |
LEVEEN ELECTRODE |
RADIOTHERAPEUTICS CORP. |
KIRSTEN VALLEY |
| K011046 |
10/25/2001 |
AUTOPULSE, MODEL 100 |
REVIVANT CORP. |
BOB KATZ |
| K013129 |
10/10/2001 |
RHODIA DENTAL PUTTY IMPRESSION MATERIAL |
RHODIA INC. |
ALAIN MORIN |
| K013140 |
10/10/2001 |
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL |
RHODIA INC. |
ALAIN MORIN |
| K012848 |
10/25/2001 |
WINNER CM4 COMBINATION UNIT |
RICH-MAR CORP. |
DAVID RICHARDS |
| K012309 |
10/19/2001 |
RIWO SYSTEM TRAYS |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K012121 |
10/24/2001 |
SECUREGUARD RETRACTABLE SAFETY SYRINGE |
SAFEGARD MEDICAL PRODUCTS, INC. |
MIKE DAYTON |
| K012283 |
10/01/2001 |
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE |
SAFEGARD MEDICAL PRODUCTS, INC. |
PATRICK GRANT, JR. |
| K011470 |
10/12/2001 |
SDI SB OFFICE, MODEL 29- |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
| K012935 |
10/11/2001 |
THECURVE, ITEM 507 |
SELECT MEDICAL SYSTEMS, INC. |
MONIQUE GIRARD |
| K012786 |
10/01/2001 |
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) |
SHAMROCK MANUFACTURING COMPANY |
EMMY TJOENG |
| K012339 |
10/16/2001 |
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K012499 |
10/16/2001 |
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K012772 |
10/01/2001 |
CTS-485 ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
ROBERT MORTON |
| K012710 |
10/04/2001 |
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES |
SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. |
HUAN CHUNG-LI |
| K012424 |
10/18/2001 |
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K011476 |
10/30/2001 |
SOVEREIGN |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
| K012495 |
10/31/2001 |
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K013121 |
10/15/2001 |
MT ALERT INFUSION MONITOR |
SIERRA BIOSEARCH INC |
RICHARD CITRENAUM |
| K012410 |
10/26/2001 |
INFINITY HBA KIT, MODELS 537-A, 537-B |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K012453 |
10/22/2001 |
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) |
SODEM SYSTEMS |
CAROLE BURNIER |
| K012457 |
10/22/2001 |
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) |
SODEM SYSTEMS |
CAROLE BURNIER |
| K012949 |
10/04/2001 |
URETEX SUP PUBOURETHRAL SLING |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
| K012859 |
10/26/2001 |
NU-SPEC D |
SOL WEISS MD INC |
SOL WEISS |
| K012505 |
10/05/2001 |
SOPRO595 INTRA ORAL CAMERA |
SOPRO |
PIERRE MONTILLOT |
| K012528 |
10/22/2001 |
ICE |
SOUTHERN DENTAL INDUSTRIES, LTD. |
SAMANTHA J CHEETHAM |
| K012529 |
10/22/2001 |
ROK |
SOUTHERN DENTAL INDUSTRIES, LTD. |
SAMANTHA J CHEETHAM |
| K012427 |
10/09/2001 |
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT |
SPECIALITES SEPTODONT |
PETER S REICHERTZ |
| K013029 |
10/09/2001 |
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 |
ST. JUDE MEDICAL |
JIM M TAUFEN |
| K012807 |
10/11/2001 |
MODIFICATION TO: COMPEL SURGICAL DRAPES |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K003857 |
10/18/2001 |
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K013104 |
10/02/2001 |
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K012011 |
10/10/2001 |
MODIFICATION TO A620 EEG |
STOELTING CO. |
KENNETH L BIRD |
| K013059 |
10/22/2001 |
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) |
STONY BROOK SURGICAL INNOVATIONS, INC. |
SUSAN D GOLDSTEIN-FALK |
| K012961 |
10/18/2001 |
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K011913 |
10/26/2001 |
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES |
SUN-RAIN SYSTEM CORP. |
YANG TIEN-HISING |
| K013009 |
10/03/2001 |
BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013007 |
10/01/2001 |
BELLEGLASS HP ENAMEL 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K012717 |
10/25/2001 |
LIFE 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013008 |
10/02/2001 |
NEXUS 2 MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K013164 |
10/15/2001 |
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K011283 |
10/15/2001 |
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
THE KENDALL COMPANY |
DAVID A OLSON |
| K012218 |
10/12/2001 |
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES |
THE LUDLOW COMPANY LP |
KATHLEEN M TREMBLAY |
| K012462 |
10/29/2001 |
THEKEN LARGE CEMENT RESTRICTOR |
THEKEN SURGICAL,LLC |
RANDY THEKEN |
| K012278 |
10/17/2001 |
THEKEN SMALL CEMENT RESTRICTOR |
THEKEN SURGICAL,LLC |
RANDY THEKEN |
| K013034 |
10/04/2001 |
MODIFICATION TO: THERMACOOL IIA |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K012525 |
10/04/2001 |
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 |
THERMO DMA, INC. |
THOMAS DOLLAR |
| K012878 |
10/16/2001 |
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 |
THERMO DMA, INC. |
THOMAS DOLLAR |
| K012518 |
10/09/2001 |
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 |
THERMO DMA, INC. |
THOMAS DOLLAR |
| K013202 |
10/23/2001 |
MODIFICATION TO BRAIDED GUIDING INTRODUCER |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K013279 |
10/18/2001 |
MOSFET AUTOSENSE, MODEL TN-RD-60 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
NORMA THOMSON |
| K013286 |
10/12/2001 |
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA |
TILLOTSON HEALTHCARE CORP. |
THOMAS N TILLOTSON |
| K013016 |
10/19/2001 |
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE |
TILLOTSON HEALTHCARE CORP. |
F. W PERRELLA |
| K002512 |
10/15/2001 |
TORAYSULFONE DIALYZER |
TORAY INDUSTRIES (AMERICA), INC. |
LISA S JONES |
| K013214 |
10/05/2001 |
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K012895 |
10/30/2001 |
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KAPP |
| K991810 |
10/09/2001 |
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K012736 |
10/25/2001 |
MONOJECT SAFETY NEEDLE |
TYCO HEALTHCARE |
DAVID A OLSON |
| K012592 |
10/03/2001 |
EASYTRAVEL |
TZORA ACTIVE SYSTEMS LTD. |
YOEL ETZIONI |
| K013150 |
10/18/2001 |
MR-GUIDE 2000 |
ULTRAGUIDE LTD. |
GEORGE MYERS |
| K012144 |
10/01/2001 |
CYTOFLEX |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K012346 |
10/16/2001 |
VANGUARD REPROCESSED ARTHROSCOPIC BLADES |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012695 |
10/30/2001 |
VANGUARD REPROCESSED ARTHROSCOPIC WANDS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012403 |
10/17/2001 |
VANGUARD REPROCESSED COMPRESSION GARMENT |
VANGUARD MEDICAL CONCEPTS, INC. |
MICHAEL SAMMON |
| K011049 |
10/01/2001 |
EXPRESSSUITE |
VIDAR SYSTEMS CORP. |
MARY HARP |
| K012636 |
10/26/2001 |
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
VSM TECHNOLOGY, INC. |
DARYL WISDAHL |
| K013250 |
10/26/2001 |
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT |
W. L. GORE & ASSOCIATES, INC. |
TIMOTHY J RYNN |
| K012409 |
10/18/2001 |
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS |
WALTER LORENZ SURGICAL, INC. |
SHERYL MALMBERG |
| K012791 |
10/24/2001 |
C.T.M. MOBILITY SCOOTER MODEL # HS-320 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K012792 |
10/24/2001 |
C.T.M. MOBITIY SCOOTER MODEL #HS-360 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K012838 |
10/23/2001 |
ERO50, ORDER-NO.: 2070 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012840 |
10/23/2001 |
EURO 45, ORDER-NO.: 2064 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012065 |
10/10/2001 |
WIENER LAB. CREATININA CINETICA AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K013356 |
10/19/2001 |
WILSON-COOK ULTRASOUND BIOPSY NEEDLE |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
| K010532 |
10/26/2001 |
OSTEOSET BVF KIT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K012091 |
10/03/2001 |
PRO-FEMUR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K012876 |
10/01/2001 |
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
| K011021 |
10/09/2001 |
LASER 20 |
YA-MAN LTD |
ROBERT T HANDREN |
| K013025 |
10/03/2001 |
MODIFICATION TO FLOUROLAB PLUS |
Z-KAT, INC. |
WILLIAM F TAPIA |
