MDRWeb Log-in
Username:
Password:
Remember Me
Subscribe

Search 510(k) Database | Monthly 510(k) Lists | Search PMA Database | Monthly PMA Lists



510(k) Premarket List for OCTOBER
View: Previous Month | Next Month          Jump to:
DECISION DATE DEVICE APPLICANT 510(k) NUMBER
10-01-2001 DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM MEDTRONIC SOFAMOR DANEK, INC. K012081
10-01-2001 ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 ETHICON ENDO-SURGERY, INC. K012176
10-01-2001 DOSERIGHT PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. K012238
10-01-2001 BIS/EEG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN K012466
10-01-2001 BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS ALBERT BROWNE LTD. K012335
10-01-2001 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) BAYER CORP. K012340
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 K012709
10-01-2001 CTS-485 ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS K012772
10-01-2001 POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) SHAMROCK MANUFACTURING COMPANY K012786
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. K012876
10-01-2001 EXHALE PROBE BRONCUS TECHNOLOGIES, INC. K013111
10-01-2001 CODMAN BACTISEAL CATHETERS CODMAN & SHURTLEFF, INC. K003322
10-01-2001 CYTOFLEX UNICARE BIOMEDICAL, INC. K012144
10-01-2001 MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 ONCOLOGY DATA SYSTEMS, INC. K012227
10-01-2001 SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE SAFEGARD MEDICAL PRODUCTS, INC. K012283
10-01-2001 NAVIGUS II TRAJECTORY GUIDE IMAGE-GUIDED NEUROLOGICS, INC. K012366
10-01-2001 SONICWAVE SONIC PLAQUE REMOVER HOMEDICS, INC. K012914
10-01-2001 BELLEGLASS HP ENAMEL 2 SYBRON DENTAL SPECIALTIES, INC. K013007
10-01-2001 EXPRESSSUITE VIDAR SYSTEMS CORP. K011049
10-01-2001 SOLID STATE X-RAY IMAGING DEVICES CARES BUILT, INC. K003238
10-01-2001 XLTEK LED GOGGLES, MODEL LED-01 EXCEL TECH. LTD. K011794
10-02-2001 NEXUS 2 MODIFIED SYBRON DENTAL SPECIALTIES, INC. K013008
10-02-2001 COOLTOUCH VARIZOOM NEW STAR LASERS, INC. K012982
10-02-2001 ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 BAUSCH & LOMB, INC. K012435
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. K012383
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. K013104
10-02-2001 SUNLITELED MODEL #2810 KINETIC INSTRUMENTS, INC. K012946
10-02-2001 SMARTFLOW FLORENCE MEDICAL LTD. K012947
10-02-2001 HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT BOSTON SCIENTIFIC/MEDI-TECH K012952
10-03-2001 MODIFICATION TO FLOUROLAB PLUS Z-KAT, INC. K013025
10-03-2001 MODIFICATION TO VAXCEL DIALYSIS CATHETER BOSTON SCIENTIFIC/MEDI-TECH K012948
10-03-2001 NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR BROMAC ASSISTIVE TECHNOLOGY K012345
10-03-2001 MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 MEDICAL DATA ELECTRONICS K012336
10-03-2001 ATAC PAK CPK REAGENT KIT ELAN HOLDINGS, INC. K012474
10-03-2001 OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI CHARLES A. SMITH K012446
10-03-2001 PRO-FEMUR WRIGHT MEDICAL TECHNOLOGY, INC. K012091
10-03-2001 MEDCOMP EXCELL SPLIT TIP CATHETER MEDCOMP K010306
10-03-2001 THE SALICEPT ORAL PATCH CARRINGTON LABORATORIES, INC. K012126
10-03-2001 EASYTRAVEL TZORA ACTIVE SYSTEMS LTD. K012592
10-03-2001 BIPOLAR IRRIGATION FORCEPS AESCULAP, INC. K012986
10-03-2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES MASIMO CORP. K012992
10-03-2001 BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 SYBRON DENTAL SPECIALTIES, INC. K013009
10-03-2001 TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 BIOSITE INCORPORATED K012999
10-03-2001 TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 BIOSITE INCORPORATED K013002
10-03-2001 HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 MEDICAL COMPONENTS, INC. K994105
10-04-2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC. K012923
10-04-2001 AL-40 DDC TECHNOLOGIES, INC. K010715
10-04-2001 MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS BIOLITEC, INC. K010804
10-04-2001 PULSEMASTER ERBIUM DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. K012127
10-04-2001 THE QUIET SLEEPER PRECISION DENTAL LABORATORIES, INC. K012142
10-04-2001 END EXPIRATORY FILTER, MODEL RT020 FISHER & PAYKEL HEALTHCARE, LTD. K002839
10-04-2001 C. NET 2100 CARDIONETICS, LTD. K010396
10-04-2001 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR DIDECO K004001
10-04-2001 DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMEDICAL, INC. K012235
10-04-2001 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM MEDTRONIC SOFAMOR DANEK, INC. K013014
10-04-2001 DISPOSABLE POWDERED VINYL EXAMINATION GLOVES SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. K012710
10-04-2001 THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 THERMO DMA, INC. K012525
10-04-2001 URETEX SUP PUBOURETHRAL SLING SOFRADIM PRODUCTION K012949
10-04-2001 MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC. K012950
10-04-2001 MODIFICATION TO: THERMACOOL IIA THERMAGE, INC. K013034
10-04-2001 MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. K012967
10-05-2001 ISOLA SPINAL SYSTEMS DEPUY ACROMED K012971
10-05-2001 INION CPS 2.0 ORTHOGNATHIC PLATE INION LTD. K013039
10-05-2001 ALWAYS DUETS PROCTER & GAMBLE CO. K012629
10-05-2001 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. K013214
10-05-2001 DIASUS DYNAMIC IMAGING LTD. K013142
10-05-2001 INTERCOSTAL LOCKABLE-DIRECTABLE PORT MEDCANICA, INC. K011349
10-05-2001 SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. K003661
10-05-2001 COM-PATCH APEX MEDICAL CORP. K012140
10-05-2001 MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. K012993
10-05-2001 THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER MEASUREMENT SPECIALTIES, INC. K010706
10-05-2001 SOPRO595 INTRA ORAL CAMERA SOPRO K012505
10-05-2001 ZEUS ROBOTIC SURGICAL SYSTEM COMPUTER MOTION, INC. K003431
10-05-2001 W & H ASSISTINA A-DEC, INC. K010127
10-09-2001 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST TREK DIAGNOSTIC SYSTEMS, INC. K991810
10-09-2001 MU PHOTONICS PAIN THERAPIST NU PHOTONICS, INC. K012508
10-09-2001 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM PHOENIX DIAGNOSTICS, INC. K012509
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. K012485
10-09-2001 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D NICHOLS INSTITUTE DIAGNOSTICS K012367
10-09-2001 PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT SPECIALITES SEPTODONT K012427
10-09-2001 CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE CBYON, INC. K012886
10-09-2001 ANIMEC, MODELS AM-2S-4 AND AM-2S-5 ELLTEC CO., LTD. K012906
10-09-2001 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 CONCENTRIC MEDICAL, INC. K010954
10-09-2001 MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER COOK, INC. K010016
10-09-2001 AUTO-LOCK AUTO-LOCK K010477
10-09-2001 LASER 20 YA-MAN LTD K011021
10-09-2001 MONARCH SPINAL SYSTEMS DEPUY ACROMED K013294
10-09-2001 TIMX SPINAL SYSTEMS DEPUY ACROMED K013295
10-09-2001 MOSS MIAMI SPINAL SYSTEMS DEPUY ACROMED K013296
10-09-2001 ABI VEST AIRWAY CLEARANCE SYSTEM ADVANCED RESPIRATORY K012928
10-09-2001 PHEM-ALERT FEMTEK,LLC. K012230
10-09-2001 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 THERMO DMA, INC. K012518
10-09-2001 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 ST. JUDE MEDICAL K013029
10-10-2001 DISCOVERY ELBOW BIOMET ORTHOPEDICS, INC. K013042
10-10-2001 MODIFICATION TO A620 EEG STOELTING CO. K012011
10-10-2001 HELIX HYDRO-JET ANDREAS PEIN MEDIZINTECHNIK GMBH K012464
10-10-2001 DURACON PS LIPPED TIBIAL INSERT HOWMEDICA OSTEONICS K012172
10-10-2001 MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 NATIONAL CUSTOM ENT., INC. K012263
10-10-2001 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC NATIONAL CUSTOM ENT., INC. K012264
10-10-2001 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL RHODIA INC. K013140
10-10-2001 UNIMARK HCG COMBO PREGNANCY TEST BIOTECH ATLANTIC, INC. K013194
10-10-2001 RHODIA DENTAL PUTTY IMPRESSION MATERIAL RHODIA INC. K013129
10-10-2001 TITANIUM CEMENT RESTRICTOR MATERIAL PEEK MEDTRONIC SOFAMOR DANEK USA, INC. K010528
10-10-2001 WIENER LAB. CREATININA CINETICA AA WIENER LABORATORIES S.A.I.C. K012065
10-10-2001 SNOWPOST, SNOWLIGHT DANVILLE MATERIALS, INC. K012354
10-10-2001 GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L GAMBRO RENAL PRODUCTS K010985
10-11-2001 BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM MEDTRONIC AVE, INC. K011080
10-11-2001 EPOCA CUSTOM OFFSET SHOULDER SYSTEM ARGOMEDICAL AG K010869
10-11-2001 CRYOCARE SURGICAL SYSTEM ENDOCARE, INC. K003811
10-11-2001 LEVEEN ELECTRODE RADIOTHERAPEUTICS CORP. K012315
10-11-2001 CANDELA CLEARBEAM PULSED DYE LASER CANDELA CORP. K013043
10-11-2001 THECURVE, ITEM 507 SELECT MEDICAL SYSTEMS, INC. K012935
10-11-2001 MODIFICATION TO: COMPEL SURGICAL DRAPES STANDARD TEXTILE CO., INC. K012807
10-12-2001 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM BOSTON SCIENTIFIC CORP. K012883
10-12-2001 CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA TILLOTSON HEALTHCARE CORP. K013286
10-12-2001 LUXAGLAZE DMG USA, INC. K013179
10-12-2001 LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE FERRANIA USA, INC. K013229
10-12-2001 INSTRUMENT DAMPING PORT MEDCANICA, INC. K011373
10-12-2001 SDI SB OFFICE, MODEL 29- SDI DIAGNOSTICS, INC. K011470
10-12-2001 MAGELLAN-2200, MODEL 1 OCEANIC MEDICAL PRODUCTS, INC. K010613
10-12-2001 CYCLOTEC AMT CTI TENS DEVICE CYCLOTEC K010615
10-12-2001 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) MENTOR CORP. K004005
10-12-2001 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM CAMBRIDGE HEART, INC. K012206
10-12-2001 LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES THE LUDLOW COMPANY LP K012218
10-12-2001 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 KATECHO, INC. K012404
10-12-2001 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. K012402
10-12-2001 BIOCUFF,C, MODELS 236018, 236028, 236036 BIONX IMPLANTS, INC. K013057
10-12-2001 BIOMEDICS UV MULTIFOCAL OCULAR SCIENCES PUERTO RICO, INC. K012425
10-15-2001 CHIBA NEEDLE ISPG, INC. K012358
10-15-2001 EAR MUFFINS BIO-LOGIC SYSTEMS CORP. K012384
10-15-2001 ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. K012595
10-15-2001 RAICHEM BUN RATE REAGENT HEMAGEN DIAGNOSTICS, INC. K012649
10-15-2001 RAICHEM GLUCOSE UV REAGENT HEMAGEN DIAGNOSTICS, INC. K012668
10-15-2001 PAM-RL INDIVIDUAL MONITORING SYSTEMS, INC. K010997
10-15-2001 TORAYSULFONE DIALYZER TORAY INDUSTRIES (AMERICA), INC. K002512
10-15-2001 IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. K013134
10-15-2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. K013118
10-15-2001 MT ALERT INFUSION MONITOR SIERRA BIOSEARCH INC K013121
10-15-2001 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE THE KENDALL COMPANY K011283
10-15-2001 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL CORP. K013164
10-15-2001 MERTEX-PLUS REUSABLE SURGICAL DRAPE MERCAN AB K012237
10-15-2001 MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE MERCAN AB K012240
10-15-2001 POWDERED LATEX EXAMINATION GLOVES GREAT GLOVE (THAILAND) CO. LTD. K013026
10-15-2001 FAS ENDOLUMINAL BRUSH FAS MEDICAL LTD. K012641
10-16-2001 REVOTEK LC GC AMERICA, INC. K012542
10-16-2001 ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW SHANGHAI ANTARES INDUSTRIES, INC. K012339
10-16-2001 VANGUARD REPROCESSED ARTHROSCOPIC BLADES VANGUARD MEDICAL CONCEPTS, INC. K012346
10-16-2001 THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 THERMO DMA, INC. K012878
10-16-2001 VBR OSTEOTECH, INC. K012254
10-16-2001 ALGO 3 NEWBORN HEARING SCREENER NATUS MEDICAL, INC. K013137
10-16-2001 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE AFP IMAGING CORP. K013176
10-16-2001 MODIFICATION TO SYNCHRON CONTROL BECKMAN COULTER, INC. K013235
10-16-2001 HRH-63-8 HEAD ARRAY COIL MRI DEVICES CORP. K013159
10-16-2001 MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM NUVASIVE, INC. K013215
10-16-2001 HAC-420 HEAD ARRAY COIL MRI DEVICES CORP. K013322
10-16-2001 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) ACCUMETRICS, INC. K011337
10-16-2001 VERTRAN STANDING WHEELCHAIR FENA DESIGN, INC. K011530
10-16-2001 ACCESS UNCONJUGATED ESTRIOL CALIBRATORS BECKMAN COULTER, INC. K012900
10-16-2001 ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES SHANGHAI ANTARES INDUSTRIES, INC. K012499
10-16-2001 POLY STAT HCG TEST BION DIAGNOSTIC SCIENCES K012559
10-16-2001 STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION KARL STORZ ENDOSCOPY-AMERICA, INC. K012482
10-17-2001 HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE ACUSUPPLY, INC. K011247
10-17-2001 SEED SELECTRON MODEL V. 1.0 NUCLETRON CORP. K010032
10-17-2001 VANGUARD REPROCESSED COMPRESSION GARMENT VANGUARD MEDICAL CONCEPTS, INC. K012403
10-17-2001 THEKEN SMALL CEMENT RESTRICTOR THEKEN SURGICAL,LLC K012278
10-17-2001 SONICATOR PLUS 930, MODEL ME 930 METTLER ELECTRONICS CORP. K013192
10-17-2001 LUXABITE DMG USA, INC. K013236
10-17-2001 METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 CIRCON VIDEO K012265
10-17-2001 FLEXI-SITE SP02 EAR SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. K012333
10-18-2001 WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL NATIONAL THERAPY PRODUCTS INC. K012522
10-18-2001 PROSAFE SAFETY SYRINGE HOU-SE MEDICAL INC K012726
10-18-2001 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. K012961
10-18-2001 MR-GUIDE 2000 ULTRAGUIDE LTD. K013150
10-18-2001 MOSFET AUTOSENSE, MODEL TN-RD-60 THOMSON & NIELSEN ELECTRONICS, LTD. K013279
10-18-2001 SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM SHIMADZU CORP. K012424
10-18-2001 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS WALTER LORENZ SURGICAL, INC. K012409
10-18-2001 ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS INTELLIGENT INSTRUMENTS PVT. LTD. K002132
10-18-2001 N LP(A) CONTROL SY DADE BEHRING, INC. K013130
10-18-2001 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES STERILMED, INC. K003857
10-19-2001 IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. K013135
10-19-2001 RIWO SYSTEM TRAYS RICHARD WOLF MEDICAL INSTRUMENTS CORP. K012309
10-19-2001 MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC. K012510
10-19-2001 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. K012364
10-19-2001 AUTOTOME RX MODEL # 4515, 4516 BOSTON SCIENTIFIC CORP. K013153
10-19-2001 MARK II/MARK III MANOMETRIC PERFUSION PUMP DENTSLEEVE PTY., LTD. K013154
10-19-2001 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. K013156
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 K013162
10-19-2001 DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W C.R. BARD, INC. K013144
10-19-2001 ASTRALIS 10, MODELS # 559588, 561859 IVOCLAR VIVADENT, INC. K013275
10-19-2001 WILSON-COOK ULTRASOUND BIOPSY NEEDLE WILSON-COOK MEDICAL, INC. K013356
10-19-2001 TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE TILLOTSON HEALTHCARE CORP. K013016
10-19-2001 POWERPRO BATTERY SYSTEM LINVATEC CORP. K012320
10-22-2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) SODEM SYSTEMS K012453
10-22-2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) SODEM SYSTEMS K012457
10-22-2001 REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS ALLIANCE MEDICAL CORP. K012625
10-22-2001 ICE SOUTHERN DENTAL INDUSTRIES, LTD. K012528
10-22-2001 ROK SOUTHERN DENTAL INDUSTRIES, LTD. K012529
10-22-2001 NAVIGUS II MR IMAGE-GUIDED NEUROLOGICS, INC. K012719
10-22-2001 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER BIOFORM, INC. K012955
10-22-2001 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS BAYER CORP. K012777
10-22-2001 STATUSBLUE DMG USA, INC. K013237
10-22-2001 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. K013173
10-22-2001 ASTRALIS 7, MODEL 557545 IVOCLAR VIVADENT, INC. K013277
10-22-2001 AMEDITECH IMMUTEST DRUG SCREEN COC AMEDITECH, INC. K011814
10-22-2001 METAL SCREW ANCHOR BIOMET MANUFACTURING, INC. K012503
10-22-2001 D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM DUTCH OPHTHALMIC USA, INC. K012821
10-22-2001 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) STONY BROOK SURGICAL INNOVATIONS, INC. K013059
10-22-2001 CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM CRYSTAL-SEAL DENTAL IMPLANTS K011502
10-22-2001 AMEDITECH IMMUTEST DRUG SCREEN THC AMEDITECH, INC. K011813
10-22-2001 MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER MICRA INSTRUMENTS K011392
10-23-2001 TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII MERIDIAN MEDICAL TECHNOLOGIES LTD. K011058
10-23-2001 ERO50, ORDER-NO.: 2070 WIELAND EDELMETALLE GMBH & CO. K012838
10-23-2001 EURO 45, ORDER-NO.: 2064 WIELAND EDELMETALLE GMBH & CO. K012840
10-23-2001 POINT 4 FLOWABLE 2 KERR DENTAL MATERIALS CENTER K013325
10-23-2001 MODIFICATION TO BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. K013202
10-23-2001 MODIFICATION TO: HL168W TOUCH SCREEN HEALTH & LIFE CO., LTD. K013033
10-23-2001 HUMI-FLOW, MODEL 6-850-00/ 01/02 NORTHGATE TECHNOLOGIES, INC. K010053
10-24-2001 EZ-ON CONDOM MAYER LABORATORIES K001974
10-24-2001 C.T.M. MOBILITY SCOOTER MODEL # HS-320 WAREPALMY ENTERPRISE LLC (USA) K012791
10-24-2001 C.T.M. MOBITIY SCOOTER MODEL #HS-360 WAREPALMY ENTERPRISE LLC (USA) K012792
10-24-2001 INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 BOSTON SCIENTIFIC CORP. K012864
10-24-2001 CAAS II QVA PIE MEDICAL IMAGING B.V. K012475
10-24-2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. K013191
10-24-2001 GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE BIONOSTICS, INC. K013147
10-24-2001 MODIFIED 650 MAMMOGRAPHY SYSTEM LORAD, A HOLOGIC CO. K013290
10-24-2001 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX BOSTON SCIENTIFIC SCIMED, INC. K012822
10-24-2001 COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 NXSTAGE MEDICAL, INC. K012832
10-24-2001 XTERRA GT POWER WHEELCHAIR INVACARE CORP. K012909
10-24-2001 PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM PRIME DENTAL MANUFACTURING, INC. K012673
10-24-2001 MACHNET CAROTIDS COIL ARRAY ASSEMBLY MACHNET BV K012491
10-24-2001 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD" ARROW INTL., INC. K011056
10-24-2001 COLLATEK POWDER BIOCORE MEDICAL TECHNOLOGIES, INC. K012990
10-24-2001 LIFT VB SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. K010930
10-24-2001 CONFORM SHEETING, MODEL IGEL IMPLANTECH ASSOCIATES, INC. K012419
10-24-2001 EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 138 MEDICAL SUPPLIES, INC. K000741
10-24-2001 SECUREGUARD RETRACTABLE SAFETY SYRINGE SAFEGARD MEDICAL PRODUCTS, INC. K012121
10-24-2001 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 MEDTRONIC CARDIAC SURGICAL PRODUCTS K012143
10-25-2001 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB K012141
10-25-2001 DRUGS OF ABUSE MULTI-TEST STRIP MICRODIAGNOSTICS, INC. K011952
10-25-2001 COLLATEK SHEET BIOCORE MEDICAL TECHNOLOGIES, INC. K012995
10-25-2001 COLLATEK FOAM BIOCORE MEDICAL TECHNOLOGIES, INC. K012997
10-25-2001 AUTOPULSE, MODEL 100 REVIVANT CORP. K011046
10-25-2001 VENODYNE DVT ADVANTAGE PLUS MICROTEK MEDICAL, INC. K011318
10-25-2001 MONOJECT SAFETY NEEDLE TYCO HEALTHCARE K012736
10-25-2001 CERCON BASE DEGUSSA - NEY DENTAL, INC. K013230
10-25-2001 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY BAYER CORP. K013272
10-25-2001 ARTHROCARE ELECTROSURGERY WANDS ARTHROCARE CORP. K012519
10-25-2001 MACROPORE ENT RECONSTRUCTION FILM MACROPORE BIOSURGERY, INC. K012769
10-25-2001 LIFE 2 SYBRON DENTAL SPECIALTIES, INC. K012717
10-25-2001 WINNER CM4 COMBINATION UNIT RICH-MAR CORP. K012848
10-25-2001 OXYGENATOR ADJUNCTIVE THERAPEUTICS, INC. K002632
10-26-2001 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE COBE CARDIOVASCULAR, INC. K001509
10-26-2001 NU-SPEC D SOL WEISS MD INC K012859
10-26-2001 SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 POWER MEDICAL INTERVENTIONS, INC. K012809
10-26-2001 GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM GYNECARE CENTER K012628
10-26-2001 TOURNIQUET CUFF; PNEUMATIC TOURNIQUET MEDICAL INSTRUMENTS TECHNOLOGY, INC. K012632
10-26-2001 BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC. K012636
10-26-2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. K013355
10-26-2001 ADVANCED LUNG ANALYSIS-1 GENERAL ELECTRIC CO. K013381
10-26-2001 GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. GORE & ASSOCIATES, INC. K013250
10-26-2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM DIAMEDIX CORP. K012449
10-26-2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM DIAMEDIX CORP. K012450
10-26-2001 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES SUN-RAIN SYSTEM CORP. K011913
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. K013348
10-26-2001 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A ANDROMED, INC. K010729
10-26-2001 OSTEOSET BVF KIT WRIGHT MEDICAL TECHNOLOGY, INC. K010532
10-26-2001 INFINITY HBA KIT, MODELS 537-A, 537-B SIGMA DIAGNOSTICS, INC. K012410
10-26-2001 CONFOSCAN 2 CONFOCAL MICROSCOPE NIDEK TECHNOLOGIES SRL K012416
10-26-2001 VITALSAT PULSE OXIMETER, MODEL IC32000 ISLAND CRITICAL CARE CORP. K011365
10-26-2001 BIOPATCH ANTIMICROBIAL DRESSING INTEGRA LIFESCIENCES CORP. K003229
10-29-2001 CW DISPOSABLE ACUPUNCTURE NEEDLE ACUSUPPLY, INC. K011248
10-29-2001 MICROPLEX COIL SYSTEM MICROVENTION, INC. K012145
10-29-2001 XANTALGIN CRONO CAVEX HOLLAND B.V. K013336
10-29-2001 FUJI VII CAPSULE GC AMERICA, INC. K013198
10-29-2001 CRANIAL HELMET CHILDREN'S HOSPITAL K013458
10-29-2001 BELLEGLASS HP OPAQUE 2 KERR DENTAL MATERIALS CENTER K013375
10-29-2001 APEX MEDICAL LCD TENS-VII APEX MEDICAL CORP. K012643
10-29-2001 THEKEN LARGE CEMENT RESTRICTOR THEKEN SURGICAL,LLC K012462
10-29-2001 MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR BONUTTI RESEARCH, INC. K012465
10-29-2001 MICROMEDICS FIBRIJET AEROSOL APPLICATOR MICROMEDICS, INC. K012868
10-30-2001 VANGUARD REPROCESSED ARTHROSCOPIC WANDS VANGUARD MEDICAL CONCEPTS, INC. K012695
10-30-2001 SEPRAGEL SINUS GENZYME CORP. K012532
10-30-2001 LIFEJET VIDEO LINK FERRANIA S.P.A. K013395
10-30-2001 HEMI-ARC SURGICAL NAVIGATOR NUVASIVE, INC. K013257
10-30-2001 TM2000 EASYTRACE PLUS RECEIVING CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. K013175
10-30-2001 CARDIQ FUNCTION GE MEDICAL SYSTEMS K013422
10-30-2001 ULTRASOUND TRANSDUCER COVER ADVANCE MEDICAL DESIGNS, INC. K011265
10-30-2001 PALAMED BONE CEMENT MERCK BIOMATERIAL GMBH K010586
10-30-2001 SOVEREIGN SHOPRIDER INTL., INC. K011476
10-30-2001 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 GALIL MEDICAL LTD. K012497
10-30-2001 HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE TREK DIAGNOSTIC SYSTEMS, INC. K012895
10-31-2001 OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. K012495
10-31-2001 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET GAMBRO RENAL PRODUCTS K011221
10-31-2001 MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC. K011761
10-31-2001 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES LESLIE W. ORGAN K010202
10-31-2001 MODIFICATION TO: ECAT LSO PET/CT SCANNER CTI PET SYSTEMS, INC. K013504
10-31-2001 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES HORIZON MEDICAL PRODUCTS, INC. K011916
10-31-2001 ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR KOON SENG SDN.BHD K012714
UBM Canon medical device and pharmaceutical media network includes:
Qmed
Medical Device & Diagnostic Industry
Medical Product & Manufacturing News
European Medical Device Technology
China Medical Device Manufacturer
In Vitro Diagnostic Technology
Med Ad News
R&D Directions
PharmaLive.com
Pharmalot.com
eKnowledgebase
Pharmaceutical & Medical Packaging News
Packaging Digest