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510(k) Premarket List for SEPTEMBER
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DECISION DATE DEVICE APPLICANT 510(k) NUMBER
09-02-2003 SAFETYWAND DISPOSABLE HANDPIECE SPINTECH, INC. K023722
09-02-2003 VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 BIOMERIEUX, INC. K030328
09-02-2003 ARKIT HBA1C ARKRAY, INC. K030553
09-02-2003 MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT" MEDTRONIC AVE, INC. K030633
09-02-2003 TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. K031729
09-02-2003 I-STAT CARDIAC TROPONIN (CTNI) TEST I-STAT CORPORATION K031739
09-02-2003 ACMI M4 TELESCOPES ACMI CORPORATION K031758
09-02-2003 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW IIYAMA CORPORATION K032020
09-02-2003 DIGITAL IMAGER PYRAMID MEDICAL, INC. K032022
09-02-2003 ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT WFR/AQUAPLAST CORP. K032156
09-02-2003 VP-1000; MED CAM 100; VP-3000A; MED CAM 300 MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) K032544
09-02-2003 ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) K032545
09-03-2003 ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS MEDTRONIC VASCULAR K032622
09-03-2003 HOMOCYSTEINE MICROTITER PLATE ASSAY DIAZYME LABORATORIES K032012
09-03-2003 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. K032173
09-03-2003 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. K032345
09-03-2003 SYNTHES (USA) NEW/STERIAL ORBITAL PLATES SYNTHES (USA) K031761
09-03-2003 MERIT MAK (MINI ACCESS KIT) MERIT MEDICAL SYSTEMS, INC. K031691
09-03-2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK K031833
09-03-2003 MEDRO SPD U.S. FILTER/IONPURE, INC. K030652
09-03-2003 PATHWAY ACCESS SHEATH CATHETER VERTELINK CORPORATION K030662
09-03-2003 EDWARDS DIRECTIONAL CATHETER EDWARDS LIFESCIENCES, LLC. K030630
09-04-2003 TMC ELECTRICAL SCOOTER, EASY 405 TMC TECHNOLOGY CORP. K031313
09-04-2003 TMC ELECTRICAL SCOOTER, EASY 411 TMC TECHNOLOGY CORP. K031314
09-04-2003 TMC ELECTRICAL SCOOTER, EASY 321 TMC TECHNOLOGY CORP. K031315
09-04-2003 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER DOLPHIN MEDICAL INC. K030629
09-04-2003 PIT & FISSURE SEALANT WITH FLUORIDE HARRY J. BOSWORTH CO. K031811
09-04-2003 MACROPORE CARDIO-WRAP (TS) MACROPORE BIOSURGERY, INC. K031785
09-04-2003 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY BAYER DIAGNOSTICS CORP. K031857
09-04-2003 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) MEDTRONIC SOFAMOR DANEK K032037
09-04-2003 SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES SYNTHES (USA) K032032
09-04-2003 EBI XFIX DFS SYSTEM EBI, L.P. K031919
09-04-2003 ALANTECH GRAFT FIXATION SCREW ARTHROCARE CORP. K031937
09-04-2003 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. K032457
09-04-2003 HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS HOWMEDICA OSTEONICS CORP. K032479
09-04-2003 ALEXANDER IVOCLAR VIVADENT, INC. K032493
09-04-2003 ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR IMAGYN MEDICAL TECHNOLOGIES, INC. K032491
09-04-2003 WIROBOND C BEGO U.S.A. K032136
09-05-2003 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY ACCESS BIO INCORPORATE K032159
09-05-2003 N/T PROTEIN CONTROL DADE BEHRING, INC. K032237
09-05-2003 PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER PRECISION VASCULAR SYSTEMS, INC. K032494
09-05-2003 ACUEITY MEDICAL LIGHT SOURCE ACUEITY, INC. K032430
09-05-2003 BENZODIAZEPINE ENZYME IMMUNOASSAY LIN-ZHI INTERNATIONAL, INC. K032365
09-05-2003 INTERLOK BIO-MODULAR HUMERAL STEMS BIOMET, INC. K032507
09-05-2003 ENCLOSE II ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC. K032589
09-05-2003 ONE DIMENSIONAL WATER PHANTOM, WP 1D WELLHOFER DOSIMETRIE K032594
09-05-2003 GEL MARK III BIOPSY SITE MARKER SENORX, INC. K031938
09-05-2003 BPCARD QRS DIAGNOSTIC, LLC. K031964
09-05-2003 PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 QUINTON, INC. K032038
09-05-2003 CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) CHOLESTECH CORP. K032027
09-05-2003 SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE SYNTHES (USA) K031973
09-05-2003 ENDOSCOPIC APPLICATOR BAXTER HEALTHCARE CORP. K031882
09-05-2003 ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES SIEMENS MEDICAL SOLUTIONS USA, INC. K031764
09-05-2003 TI FENESTRATED PLATE INTERPORE CROSS INTL. K031772
09-05-2003 COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E SIEMENS ELEMA AB K023354
09-08-2003 MARQUETTE HUBER TRAP SAFETY INFUSION SET MARQUETTE MEDICAL, INC. K021471
09-08-2003 I-STAT KAOLIN ACT TEST I-STAT CORPORATION K023582
09-08-2003 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT K031108
09-08-2003 SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 DADE BEHRING, INC. K031377
09-08-2003 DURASIS DURAL SUBSTITUTE COOK BIOTECH, INC. K031850
09-08-2003 IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. K032039
09-08-2003 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES MATANG MFG. SDN. BHD. K032549
09-08-2003 ADVIA 60 HEMATOLOGY ANALYZER BAYER HEALTHCARE, LLC K032524
09-09-2003 BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC K032525
09-09-2003 BD ECLIPSE BIFURCATED NEEDLE BECTON DICKINSON & CO. K032528
09-09-2003 VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 BOSTON SCIENTIFIC CORP. K032600
09-09-2003 TRIUMPH VTX WITH LIFEVALVE CATHETER HORIZON MEDICAL PRODUCTS, INC. K032557
09-09-2003 BLOOD PRESSURE MONITOR, MODEL KP-7000 K-JUMP HEALTH CO., LTD. K032492
09-09-2003 TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER NEUROSEL (MEDICAL) LIMITED K032238
09-09-2003 MEDLEY PCA MODULE, MODEL 8120 ALARIS MEDICAL SYSTEMS, INC. K032233
09-09-2003 COMP. E PARKELL, INC. K032179
09-09-2003 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR RITA MEDICAL SYSTEMS INC K032149
09-09-2003 AUDIT MICROCONTROLS MICROFD BNP CONTROL AALTO SCIENTIFIC LTD. K032122
09-09-2003 INFINITY MEGACARE SIEMENS MEDICAL SOLUTIONS USA, INC. K031970
09-09-2003 BLU-U, MODEL 4170 DUSA PHARMACEUTICALS, INC. K031805
09-09-2003 AMPLATZER VASCULAR PLUG AGA MEDICAL CORP. K031810
09-09-2003 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX DATASCOPE CORP. K031849
09-09-2003 AXIOM BIOLASER LLLT SERIES-1 AXIOM USA. INC K030622
09-09-2003 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA IMMCO DIAGNOSTICS, INC. K030701
09-09-2003 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA IMMCO DIAGNOSTICS, INC. K030702
09-09-2003 PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 HDC CORP. K022752
09-09-2003 ARABELLA NCPAP MASKS HAMILTON MEDICAL AG K030563
09-10-2003 PATHWAY ACCESS SHEATH CATHETER VERTELINK CORPORATION K030734
09-10-2003 OSTEOMED ALVEOLAR DISTRACTION SYSTEM OSTEOMED L.P. K030790
09-10-2003 STERI-DRAPE SURGICAL DRAPES 3M COMPANY K031287
09-10-2003 INTERA-SENSATION FAMILY PHILIPS MEDICAL SYSTEMS K031815
09-10-2003 SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: SOLARC SYSTEMS, INC. K031800
09-10-2003 BINDAZYME CLQ CIC EIA KIT THE BINDING SITE, LTD. K031563
09-10-2003 UNIVERSAL NEURO SYSTEM STRYKER INSTRUMENTS K031659
09-10-2003 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. K032134
09-10-2003 SELDINGER SAFETY NEEDLE INTRODUCER HDC CORP. K032404
09-10-2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN BIOMERIEUX, INC. K032399
09-10-2003 WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) WARTNER USA B.V. K032271
09-10-2003 SIREMOBIL ISO-C 3D SIEMENS AG K032280
09-10-2003 MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP. K032535
09-10-2003 IP-XS COMPRESSION NAIL SYSTEM PLUS ORTHOPEDICS K032548
09-10-2003 MICRUS MICROCATHETER MICRUS CORP. K032624
09-11-2003 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY PLANAR SYSTEMS, INC. K032638
09-11-2003 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM U-SYSTEMS, INC. K032640
09-11-2003 MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER MICROLIFE INTELLECTUAL PROPERTY GMBH K032658
09-11-2003 RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR MEDTRONIC VASCULAR K032561
09-11-2003 DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP. K032418
09-11-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML BD DIAGNOSTIC SYSTEMS K032153
09-11-2003 COMPOSITE RESTORATION MATERIAL MILTON HODOSH, M.D. K031721
09-11-2003 PANTOS, MODELS: PANTOS 16, AND PANTOS DG BLUE X IMAGING SRL K031801
09-11-2003 QUICKVUE INFLUENZA A+B TEST QUIDEL CORP. K031899
09-11-2003 TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 BAYLIS MEDICAL CO., INC. K031951
09-11-2003 SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. K031985
09-11-2003 LATEX ULTRASONIC PROBE COVER PLEASURE LATEX PRODUCTS SDN. BHD. K022156
09-11-2003 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. K022258
09-12-2003 THERMOSKIN CONDUCTIVE PADS UNITED PACIFIC, INC. K030564
09-12-2003 HANDYDOP ELCAT, GMBH K030466
09-12-2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION K030522
09-12-2003 S-MONOVETTE EDTA K2-GEL SARSTEDT, INC. K031359
09-12-2003 MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 MICROLIFE CORP. K030961
09-12-2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK K032033
09-12-2003 SAFETY-MULTIFLY SARSTEDT, INC. K032150
09-12-2003 QUANTUM WARP 10 LIGHT DELIVERY SYSTEM QUANTUM DEVICES, INC. K032229
09-12-2003 DURACON TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. K032163
09-12-2003 INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) ELCAM MEDICAL ACAL K032393
09-12-2003 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. K032588
09-12-2003 ACCU-CHEK ADVANTAGE SYSTEM ROCHE DIAGNOSTICS CORP. K032552
09-12-2003 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL USA INSTRUMENTS, INC. K032538
09-12-2003 POLESTAR N-20 ODIN MEDICAL TECHNOLOGIES LTD. K032541
09-12-2003 RS-4I MUSCLE STIMULATOR FAMILY RS MEDICAL K032652
09-12-2003 E275 MICRO CURRENT TECHNOLOGY, INC. K032653
09-12-2003 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL USA INSTRUMENTS, INC. K032618
09-12-2003 VORTEX MP HORIZON MEDICAL PRODUCTS, INC. K032754
09-15-2003 PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) BD DIAGNOSTIC SYSTEMS K032518
09-15-2003 NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP THE FIRST YEARS, INC. K032566
09-15-2003 PRISMA M60/M100 SETS GAMBRO, INC. K032431
09-15-2003 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A KYPHON, INC. K032212
09-15-2003 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP K032054
09-15-2003 INOVO, INC, ECONOMIZER CONSERVING REGULATOR INOVO, INC. K031983
09-15-2003 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, ASAP ENDOSCOPIC PRODUCTS GMBH K031972
09-15-2003 FLUORIDE VARNISH DENTSPLY INTL. K031932
09-15-2003 ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. K031337
09-15-2003 3I DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. K030614
09-15-2003 LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA PRINCETON BIOMEDITECH CORP. K023837
09-15-2003 SALINUM, ORCLAIR SINCLAIR PHARMACEUTICALS, LTD. K024148
09-16-2003 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 IDEV TECHNOLOGIES, INC. K030504
09-16-2003 PENTACAM SCHEIMPFLUG CAMERA OCULUS OPTIKGERATE GMBH K030719
09-16-2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. K030846
09-16-2003 MEDLINE REUSABLE SURGICAL GOWNS (100X) MEDLINE INDUSTRIES, INC. K031933
09-16-2003 PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 PM DEVICES, INC. K031948
09-16-2003 SOPRO 61D SOPRO K031593
09-16-2003 OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS IMPLANT INNOVATIONS, INC. K031632
09-16-2003 DIOBEAM 830 SOFT-CORE TEXAS, INC. K031499
09-16-2003 VINTAGE AL SHOFU DENTAL CORP. K032165
09-16-2003 SHORT INTRODUCER SHEATH REX MEDICAL K032569
09-16-2003 ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 ASAHI INTECC CO., LTD. K032615
09-16-2003 MODIFICATION TO CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. K032542
09-16-2003 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 HYDROCISION, INC. K032529
09-16-2003 BEDSIDE MONITOR, MODEL OPV-1500 NIHON KOHDEN AMERICA, INC. K032749
09-16-2003 BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 BELMONT INSTRUMENT CORP. K032674
09-17-2003 APAX PACS SYSTEM TIS, INC. K032760
09-17-2003 LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 BIO-RAD K032611
09-17-2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. K032578
09-17-2003 UNITY NETWORK PATIENT DATA SERVER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032582
09-17-2003 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 RUBICOR MEDICAL, INC. K032584
09-17-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE BECTON, DICKINSON & CO. K032567
09-17-2003 R&D DESIGNATION AP-052-5 JENSEN INDUSTRIES, INC. K032267
09-17-2003 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA) K032269
09-17-2003 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. K032137
09-17-2003 CONDUCTIVITY STANDARD SOLUTION-METERCARE IBP INSTRUMENTS GMBH K032075
09-17-2003 THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM LIFECORE BIOMEDICAL, INC. K032495
09-17-2003 ONLINE TDM CARBAMAZEPINE ROCHE DIAGNOSTICS CORP. K031902
09-17-2003 SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM SPINAL CONCEPTS, INC. K031855
09-17-2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. K031967
09-17-2003 PROCEED TRILAMINATE SURGICAL MESH ETHICON, INC. K031925
09-17-2003 AKERS LABORATORIES INC. BLOOD CELL SEPARATOR AKERS LABORATORIES, INC. K030815
09-17-2003 SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 SIMUPLAN S.L. K030821
09-17-2003 PRIMOSPLINT SYSTEM COSMEDENT, INC. K030832
09-17-2003 D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE VASCULAR SOLUTIONS, INC. K030836
09-17-2003 FETAL SPIRAL ELECTRODE, MODEL FSE07000 CLINICAL INNOVATIONS, INC. K030691
09-17-2003 FLEX-NECK PD CATHETER, INFANT MEDIGROUP, INC. K031351
09-17-2003 SORB+HISORB+CARTRIDGE RENAL SOLUTIONS, INC. K031099
09-17-2003 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE PORTEX LTD. K030570
09-17-2003 GALIX WINTER GALIX BIOMEDICAL INSTRUMENTATION, INC. K030145
09-17-2003 CRESCENT TINNITUS RETAINING SOUND GENERATOR STARKEY LABORATORIES, INC. K030180
09-17-2003 BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) FCI OPHTHALMICS, INC. K023758
09-22-2003 MODIFICATION TO HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS K023983
09-22-2003 HALM ZIELKE INSTRUMENTATION SYSTEM MICOMED ORTHO GMBH K024125
09-22-2003 ESKA MODULAR HIP SYSTEM CEMENTED ESKA IMPLANTS GMBH K030867
09-22-2003 ULTRA-DRIVE 3 BIOMET, INC. K031280
09-22-2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC. K031945
09-22-2003 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET MACROPORE BIOSURGERY, INC. K031955
09-22-2003 MEDLINE BAND BAGS AND EQUIPMENT COVERS MEDLINE INDUSTRIES, INC. K032065
09-22-2003 ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES CORP. K031889
09-22-2003 GLYCOMARK TOMEN AMERICA INC. K031604
09-22-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML BECTON, DICKINSON & CO. K032299
09-22-2003 WAGNER CONE PROSTHESIS CENTERPULSE ORTHOPEDICS, INC. K032380
09-22-2003 PROCLASS PRESS FIT HIP STEM STELKAST COMPANY K032110
09-22-2003 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) CYBERORTHOLOGY, INC. K032169
09-22-2003 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM ARTHREX, INC. K032187
09-22-2003 ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST ACON LABORATORIES, INC. K032510
09-22-2003 LARGE VOLUME FLUID RESERVOIR BELMONT INSTRUMENT CORP. K032778
09-23-2003 EYESOPEN TONOMETER EYE-DEAS, LLC K032769
09-23-2003 MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC. K032771
09-23-2003 DIAMOND D HIGH IMPACT DENTURE ACRYLIC MYCONE DENTAL SUPPLY CO., INC. K032773
09-23-2003 CONTOUR SE MICROSPHERES (SYRINGE) BOSTON SCIENTIFIC CORP. K032707
09-23-2003 MODULAR PLUS HIP STEM PLUS ORTHOPEDICS K032709
09-23-2003 BEELINE SYSTEM MCKINLEY, INC. K032642
09-23-2003 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. K032553
09-23-2003 OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS EXACTECH, INC. K032606
09-23-2003 PERSONNA PLUS SAFETY SCALPEL SYSTEM OMI MANUFACTURING PTY., LTD. K032242
09-23-2003 MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) MICROLIFE INTELLECTUAL PROPERTY GMBH K032364
09-23-2003 F-11 FOLDING POWER CHAIR WHEELCHAIR & SCOOTER EXPRESS K032440
09-23-2003 SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE SUTURTEK INCORPORATED K032468
09-23-2003 S&T MICROSURGICAL SUTURE S & T AG K031531
09-23-2003 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION IMPLEX CORP. K031449
09-23-2003 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING P.T. SAPTINDO SURGICA K031669
09-23-2003 STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING P.T. SAPTINDO SURGICA K031670
09-23-2003 KSEA OPSERVER LAP KARL STORZ ENDOSCOPY-AMERICA, INC. K031895
09-23-2003 PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER IMC-HEARTWAY, LLC K031897
09-23-2003 VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. K031944
09-23-2003 PALACOS R HERAEUS KULZER GMBH & CO. KG K030902
09-23-2003 OSTEOPAL HERAEUS KULZER GMBH & CO. KG K030903
09-23-2003 PALAMED HERAEUS KULZER GMBH & CO. KG K030904
09-23-2003 CYCLONE ANTERIOR CERVICAL PLATE SYSTEM ENCORE MEDICAL, L.P. K031214
09-23-2003 CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER BOSTON SCIENTIFIC CORP. K030966
09-23-2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM OLYMPUS OPTICAL CO., LTD. K031305
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09-29-2003 TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 GFE MEDIZINTECHNIK GMBH K031225
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09-30-2003 VASCUPUNCTURE PICC GUIDEWIRE NEO METRICS, INC. K031652
09-30-2003 EXTENDED RANGE HS CRP KIT, CAT NO:9200 REFERENCE DIAGNOSTICS, INC. K030044
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09-30-2003 MINERVA 58 ALLOY DENTSPLY INTERNATIONAL K032318
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09-30-2003 U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE U.S. TECHNOLOGIES, INC. K032247
09-30-2003 PHEM-ALERT FEMTEK,LLC. K032161
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09-30-2003 ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM ALOKA CO. LTD USA K032875
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