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510(k) Premarket List for OCTOBER
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DECISION DATE DEVICE APPLICANT 510(k) NUMBER
10-01-2003 CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, NOUVAG AG K022505
10-01-2003 ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER ESSEX MEDICAL SYSTEMS PLUS K024023
10-01-2003 CLS-2000 UNIT DENTSPLY INTL. K024133
10-01-2003 CYNOSURE SMART 2940D ER:YAG LASER CYNOSURE, INC. K031389
10-01-2003 SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER CYNOSURE, INC. K031440
10-01-2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. K031523
10-01-2003 CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W MERIT MEDICAL SYSTEMS, INC. K031922
10-01-2003 W.O.M. LASER U100PLUS W.O.M. WORLD OF MEDICINE AG K032023
10-01-2003 LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE ARTHROTEK, INC. K032072
10-01-2003 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. K032144
10-01-2003 APPOLLO 3 ALLOY DENTSPLY INTERNATIONAL K032320
10-01-2003 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. K032705
10-01-2003 TRIGEN STRAIGHT HUMERAL NAIL SYSTEM SMITH & NEPHEW, INC. K032722
10-01-2003 BIOSIGN STEAM-24 BIOLOGICAL INDICATOR GETINGE USA, INC K032723
10-01-2003 MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. K032805
10-02-2003 OPTICAL SEPARATOR APPLIED MEDICAL RESOURCES K032889
10-02-2003 HL888 AF HEALTH & LIFE CO., LTD. K032913
10-02-2003 CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA CORDIS EUROPA N.V. K032737
10-02-2003 VAXCEL PLUS CHRONIC DIALYSIS CATHETER BOSTON SCIENTIFIC CORP. K032712
10-02-2003 HL888BF HEALTH & LIFE CO., LTD. K032695
10-02-2003 MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE FRIANDENT GMBH K032750
10-02-2003 MICROMLC SIEMENS MEDICAL SOLUTIONS USA, INC. K032790
10-02-2003 EDWARDS PERIPHERAL DILATATION CATHETER EDWARDS LIFESCIENCES, LLC. K032587
10-02-2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES ELITE INTERNATIONAL, INC. K032616
10-02-2003 IMMIX PLASTIFILM OSTEOBIOLOGICS, INC. K032673
10-02-2003 XIVE TG ABUTMENTS FRIADENT GMBH K032302
10-02-2003 MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K MK-DENT GMBH K032234
10-02-2003 MINICAT DENTOCAT XORAN TECHNOLOGIES, INC. K032243
10-02-2003 ECHOENCODER ICARDIOGRAM, INCORPORATED K032324
10-02-2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 IMPLEX CORP. K032344
10-02-2003 AQUABOSS ECORO DIA 50 LAUER LTD., HONG KONG K032004
10-02-2003 I-BEAM COMPUTERIZED MEDICAL SYSTEMS, INC. K032100
10-02-2003 HLS NOETOS SYSTEM TORNIER K032079
10-02-2003 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. K032140
10-02-2003 GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I OLYMPUS OPTO-ELECTRONICS CO., LTD. K032177
10-02-2003 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM ALARA, INC. K032210
10-02-2003 3D INVIVO BY CSIST CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY K031567
10-02-2003 SECTRA ORTHOPEDIC PACKAGE SECTRA-IMTEC AB K031590
10-02-2003 ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) HARRY J. BOSWORTH CO. K031439
10-03-2003 EPSILON DURASUL CONSTRAINED ACETABULAR LINER CENTERPULSE ORTHOPEDICS, INC. K030923
10-03-2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. K030279
10-03-2003 ANS AXXESS PERCUTANEOUS LEAD ADVANCED NEUROMODULATION SYSTEMS K032034
10-03-2003 MEDS-4-INF+ MEDICAL EQUIPMENT DEVICE SPECIALISTS K032055
10-03-2003 SONOSURG SYSTEM THE OLYMPUS OPTICAL CO. K032066
10-03-2003 ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH REMCO ITALIA S.P.A. K032200
10-03-2003 GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 NIDEK, INC. K032085
10-03-2003 PLACER ADVANCED NEUROMODULATION SYSTEMS K032349
10-03-2003 MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER MEDX ELECTRONICS, INC. K032231
10-03-2003 ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 LIN-ZHI INTERNATIONAL, INC. K032461
10-03-2003 DISPOSABLE POWDER FREE VINYL EXAM GLOVES KINGSWELL INTERNATIONAL INC. K032630
10-03-2003 VACURECT VACUUM CONSTRICTION DEVICE VACURECT MANUFACTURING (PTY) LTD. K032776
10-03-2003 HEART 2006 AEROTEL MEDICAL SYSTEMS (1998) LTD. K032736
10-03-2003 VIVATIP MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. K032702
10-03-2003 MOSFET AUTOSENSE WIRELESS THOMSON & NIELSEN ELECTRONICS, LTD. K032725
10-06-2003 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. K032721
10-06-2003 MODIFICATION TO RENEW LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS K032751
10-06-2003 NORMED COMPRESSION BONE SCREW SYSTEM NOVIACE CORPORATION K032634
10-06-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML BECTON, DICKINSON & CO. K032655
10-06-2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES KINGSWELL INTERNATIONAL INC. K032668
10-06-2003 ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. K032687
10-06-2003 DIMENSION DRUG CALIBRATOR II, MODEL DC49C DADE BEHRING, INC. K032574
10-06-2003 ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT ABBOTT LABORATORIES K032458
10-06-2003 OPTIBAND LC SYBRON DENTAL SPECIALTIES, INC. K032407
10-06-2003 F-10 FOLDING POWER CHAIR WHEELCHAIR & SCOOTER EXPRESS K032441
10-06-2003 CSF400 AND CSF600 INMED LTDA. K030081
10-06-2003 COACH 777-3 WHEELCHAIR & SCOOTER EXPRESS K030756
10-06-2003 COACH 777-4 WHEELCHAIR & SCOOTER EXPRESS K030757
10-06-2003 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM DUCKWORTH & KENT, LTD. K024072
10-06-2003 LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX LALAN GLOVES (PVT) LTD. K031386
10-06-2003 EXTERNAL DRAINAGE SET INTEGRA NEUROSCIENCES IMPLANTS S.A. K032817
10-06-2003 C.T.M. MOBILITY SCOOTER, MODEL HS-235 C.T.M. HOMECARE PRODUCT, INC. K032918
10-07-2003 MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS MCKINLEY, INC. K033039
10-07-2003 VIGORMIST COMPRESSOR NEBULIZER VEGA TECHNOLOGIES, INC. K031413
10-07-2003 NICO WITH MARS, MODEL 7300 RESPIRONICS NOVAMETRIX, INC. K030886
10-07-2003 3M LIQUID BANDAGE, MODEL 120-LB 3M COMPANY K031263
10-07-2003 DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS DATEX-OHMEDA, INC. K023366
10-07-2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC. K032098
10-07-2003 DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT DENTAURUM K032195
10-07-2003 NUVASIVE CEMENT RESTRICTOR NUVASIVE, INC. K032180
10-07-2003 I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-STAT CORPORATION K031873
10-07-2003 BETEC RETRACTABLE SAFETY SYRINGE (5ML) BETEC MEDICAL SCIENCE CO., LTD. K031909
10-07-2003 CSS MEDICAL SCIENTIFIC, INC. K031564
10-07-2003 JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE JS VASCULAR, INC. K032411
10-07-2003 BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW LONG FIRST (XIAMEN) PLASTICS CO., LTD. K032323
10-07-2003 METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING META BIOMED CO., LTD. K032603
10-08-2003 METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING META BIOMED CO., LTD. K032605
10-08-2003 ENDOTINE FOREHEAD DEVICE COAPT SYSTEMS, INC. K032770
10-08-2003 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM HILL-ROM MANUFACTURING, INC. K032772
10-08-2003 GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS, LLC K032795
10-08-2003 CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS ROCHE DIAGNOSTICS CORP. K032437
10-08-2003 WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A WIDE CORPORATION K032960
10-09-2003 MAS PAR TDM MEDICAL ANALYSIS SYSTEMS, INC. K032826
10-09-2003 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. K032898
10-09-2003 UNOMEDICAL MONICA INFUSION SET UNOMEDICAL A/S K032854
10-09-2003 SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES SYNTHES (USA) K033160
10-09-2003 FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM MERIDAN MEDICAL K032427
10-09-2003 SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM SANARUS MEDICAL, INC. K032506
10-09-2003 ACCOLADE-J HIP STEM SERIES HOWMEDICA OSTEONICS CORP. K032300
10-09-2003 DESENS-IONOMER MILTON HODOSH, M.D. K032175
10-09-2003 NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES LUMENIS, INC. K032357
10-09-2003 SONOMA ANTERIOR CERVICAL PLATE SYSTEM SEASPINE K032368
10-09-2003 US-100 PORTABLE ULTRASOUND THERAPY UNIT ITO CO., LTD. K032793
10-09-2003 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 AMERICAN I.V. PRODUCTS, INC. K032789
10-09-2003 MEDTRONIC, INC. RACER BILIARY STENT SYSTEM ("RACER"), MODEL XD#YF(L) MEDTRONIC AVE, INC. K032768
10-09-2003 BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS BLACKSTONE MEDICAL, INC. K032700
10-09-2003 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES K032724
10-09-2003 GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP. K032581
10-09-2003 PORT CASSETTE OREX COMPUTED RADIOGRAPHY LTD K032654
10-09-2003 NBD DISPOSABLE RF CANNULAE NEW BUSINESS DEVELOPMENT, LLC K032196
10-09-2003 MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER MEDTRONIC VASCULAR K032138
10-09-2003 VELOPEX AQUACUT FLUID ABRASION UNIT VELOPEX INTERNATIONAL, INC. K024105
10-09-2003 MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM ETHICON ENDO-SURGERY, INC. K030472
10-09-2003 EM PROBE, EM PAD EM PROBE INC. K024361
10-09-2003 SHIRAZ-JAVA SPINAL FIXATION SYSTEM SPINE NEXT SA K031265
10-09-2003 CYNOSURE SMART FILE ND:YAG LASERS CYNOSURE, INC. K031125
10-09-2003 NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS ZIMMER, INC. K031061
10-10-2003 MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 HEALTHONICS, INC. K030998
10-10-2003 CLUED UP MULTIPURPOSE SOLUTION- NO RUB CLUED UP LIMITED K030910
10-10-2003 OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 CTF SYSTEMS (2001), INC. K030737
10-10-2003 CUF-COVER (TM) ETHOX CORP. K031195
10-10-2003 MODEL 2100 PULSE OXIMETER DOLPHIN MEDICAL INC. K031465
10-10-2003 ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 ORTHOTEC, L.L.C. K031471
10-10-2003 LASERSMILE BIOLASE TECHNOLOGY, INC. K030539
10-10-2003 INSIGHT MILLENNIUM III FASSTECH K023209
10-10-2003 NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 POLYGANICS BV K032115
10-10-2003 RUBBERCARE POWDERED LATEX EXAMINATION GLOVES PERUSAHAAN PELINDUNG GETAH (M) SDN BHD K032201
10-10-2003 ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL ORION DIAGNOSTICA, DIV. ORION CORP. K031607
10-10-2003 VIEWPOINT TELEMETRY SYSTEM DATASCOPE CORP. K031760
10-10-2003 METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) LIN-ZHI INTERNATIONAL, INC. K031797
10-10-2003 CAREMATIX WELLNESS SYSTEM CAREMATIX INC. K031840
10-10-2003 CARESTATION 126S VIDEOPHONE MOTION MEDIA TECHNOLOGY INC. K031863
10-10-2003 PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT STELKAST COMPANY K031901
10-10-2003 POWDER FREE VINYL EXAMINATION GLOVE SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. K032071
10-10-2003 GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM GENERAL ELECTRIC CO. K032620
10-10-2003 MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032577
10-10-2003 ONLINE TDM AMIKA ROCHE DIAGNOSTICS CORP. K032279
10-10-2003 FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC. K032290
10-10-2003 MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS KINETIC CONCEPTS, INC. K032310
10-10-2003 MAXTER STERILE POWDERED LATEX SURGICAL GLOVES MAXTER GLOVE MANUFACTURING SDN BHD K032467
10-10-2003 TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM TITRONICS RESEARCH & DEVELOPMENT CO. K032471
10-10-2003 KLS-MARTIN STERNAL PLATING SYSTEM KLS-MARTIN L.P. K032413
10-10-2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION K033162
10-10-2003 GE 0.2T SIGNA PROFILE/I MR SYSTEM GENERAL ELECTRIC CO. K033168
10-10-2003 KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL MRI DEVICES CORP. K033151
10-10-2003 HAC-12 AND HAC-30 HEAD ARRAY COIL MRI DEVICES CORP. K033152
10-10-2003 ORTHOPHOS XG DS/CEPH SIRONA DENTAL SYSTEMS GMBH K033073
10-10-2003 MODIFICATION TO HL168 HEALTH & LIFE CO., LTD. K033043
10-10-2003 BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. K033010
10-10-2003 THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH K032858
10-10-2003 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE DIAGNOSTIC PRODUCTS CORP. K032881
10-10-2003 HL888BM HEALTH & LIFE CO., LTD. K032837
10-10-2003 HL888BA HEALTH & LIFE CO., LTD. K032839
10-10-2003 ACCUSONIC A-SCAN MODEL, 24-4000 ACCUTOME, INC. K032956
10-10-2003 RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 VOLUME INTERACTIONS PTE LTD K032924
10-14-2003 ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 DENTSPLY INTL. K032904
10-14-2003 REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 CORGENIX, INC. K032868
10-14-2003 PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS ROCHE DIAGNOSTICS CORP. K033165
10-14-2003 COBAS INTEGRA ALP IFCC GEN.2 ROCHE DIAGNOSTICS CORP. K033185
10-14-2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. K033214
10-14-2003 ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) ACON LABORATORIES, INC. K032661
10-14-2003 E-STRIP EEMSO, INC. K031769
10-14-2003 AUTOALIGN CORTECHS LABS, INC. K032186
10-15-2003 RHYTHM TOUCH Q 2-WAY SHOCKIM ENTERPRISES, LTD. K032178
10-15-2003 BIO-INTRAFIX TIBIAL SCREW AND SHEATH MITEK WORLDWIDE K032167
10-15-2003 EBI ACUMEN SURGICAL NAVIGATION SYSTEM EBI, L.P. K031732
10-15-2003 ACURA ELITE GRAVITY COMPENSATING RESERVOIR PHOENIX BIOMEDICAL CORP. K030468
10-15-2003 SC TOTAL HIP SYSTEM ORTHOPEDIC ALLIANCE LLC K031474
10-15-2003 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) DEROYAL K031408
10-15-2003 DIGITAL AMBULATORY ECG (HOLTER) RECORDER DATRIX K031074
10-15-2003 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING CARDINAL HEALTH K031301
10-15-2003 BREAS PV 10I CPAP SYSTEM, MODEL PV 10I VITAL SIGNS, INC. K030985
10-15-2003 GENESIS II POROUS PLUS HA KNEE SYSTEM SMITH & NEPHEW, INC. K032683
10-15-2003 PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW SHANGHAI JIAWANG INDUSTRIAL CO. LTD. K032792
10-15-2003 DAMON FT SYBRON DENTAL SPECIALTIES, INC. K032408
10-15-2003 COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH COOK VASCULAR, INC. K032223
10-15-2003 MEDELA CLARIO HOME CARE PUMP MEDELA AG K033179
10-15-2003 MODIFICATION TO: HORIZON 9000WS MENNEN MEDICAL LTD. K032997
10-15-2003 C.T.M. MOBILITY SCOOTER, MODEL HS-250 C.T.M. HOMECARE PRODUCT, INC. K032919
10-15-2003 EKG SPEAKS MEDTRONIC VASCULAR K032926
10-16-2003 ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 ROCHE DIAGNOSTICS CORP. K033009
10-16-2003 ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 APPLIED DIABETES RESEARCH, INCORPORATED K033099
10-16-2003 SONOLINE ANTARES WITH CLARIFY VE SIEMENS MEDICAL SOLUTIONS USA, INC. K033196
10-16-2003 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION GE MEDICAL SYSTEMS, INC. K033244
10-16-2003 EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. K033225
10-16-2003 LTV-1000 VENTILATOR PULMONETIC SYSTEMS, INC. K032226
10-16-2003 MODEL IR 1200 INSULIN PUMP ANIMAS CORP. K032257
10-16-2003 VISTAKON (GALYFILCON A) SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC. K032340
10-16-2003 MAGNETOM AVANTO MR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. K032428
10-16-2003 PROWESS PROWESS, INC. K032456
10-16-2003 AUTOSET SPIRIT SYSTEM RESMED LTD. K032480
10-16-2003 INTELEPACS INTELERAD MEDICAL SYSTEMS INC. K032533
10-16-2003 HOLOGIC DR IMAGEPRO HOLOGIC, INC. K032546
10-16-2003 ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK 3M COMPANY K031012
10-16-2003 STRYKER FLEXIBLE URETEROSCOPE STRYKER ENDOSCOPY K031278
10-16-2003 UUHC REPROCESSED COMPRESSION SLEEVE DEVICES UNIVERSITY OF UTAH HOSPITALS AND CLINICS K031189
10-16-2003 POWDER FREE LATEX EXAM GLOVES TAN SIN LIAN INDUSTRIES SDN. BHD. K031335
10-16-2003 EASYGLUCO, MODEL IGM0002 AMERICAN HEALTHCARE INC. K031501
10-16-2003 MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES MAHE INTL., INC. K030857
10-16-2003 ENK FIBEROPTIC ATOMIZER SET COOK, INC. K031966
10-17-2003 MODEL 3100 WRISTOX PULSE OXIMETER NONIN MEDICAL, INC. K030668
10-17-2003 EZ SPLINT & EZ SPLINT PM POWER PRODUCTS, INC.-SPLINTEK K022809
10-17-2003 AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST AMEDICA BIOTECH, INC. K031497
10-17-2003 VIEWMATE ULTRASOUND IMAGING SYSTEM EP MEDSYSTEMS K031066
10-17-2003 VIVASENS IVOCLAR VIVADENT, INC. K030922
10-17-2003 SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES SHANGHAI GIANTMAX PLASTIC PRODUCT CORP. K032745
10-17-2003 SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES SHANGHAI GIANTMAX PLASTIC PRODUCT CORP. K032746
10-17-2003 MAXTER STERILE POWDER FREE SURGICAL GLOVES MAXTER GLOVE MANUFACTURING SDN BHD K032501
10-17-2003 PROPHY-MATE NAKANISHI, INC. K032395
10-17-2003 ROCHE DIAGNOSTICS OMNI S ANALYZER ROCHE DIAGNOSTICS CORP. K032311
10-17-2003 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 DOLPHIN MEDICAL INC. K032947
10-17-2003 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. K032801
10-17-2003 RADIUS COUGAR WIRE RADIUS MEDICAL TECHNOLOGIES, INC. K032899
10-17-2003 MICROGENICS CYCLOSPORINE CONTROL KIT MICROGENICS CORP. K032842
10-20-2003 GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM BIONOSTICS, INC. K032819
10-20-2003 EPT CERTAINTY PREGNANCY TEST UNIPATH LTD. K032939
10-20-2003 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES SYNTHES (USA) K033121
10-20-2003 MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME CIBA VISION CORPORATION K032978
10-20-2003 ITI SYNOCTA MESO ABUTMENTS STRAUMANN USA K033243
10-20-2003 HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. K033248
10-20-2003 FIT CHECKER II GC AMERICA, INC. K032289
10-21-2003 ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM MEDTRONIC VASCULAR K032312
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10-21-2003 HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 HEMEDEX INCORPORATED K032337
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10-21-2003 COMBI-SCREEN, MODELS 10SL AND 11SL ANALYTICON BIOTECHNOLOGIES AG K023885
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10-21-2003 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS CLINIQA CORPORATION K032074
10-21-2003 S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR MICRO CURRENT TECHNOLOGY, INC. K033253
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10-22-2003 MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 ABBOTT VASCULAR INC. K032929
10-22-2003 AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE RICH-MAR CORP. K032941
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10-22-2003 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M FOCUS TECHNOLOGIES, INC. K031952
10-22-2003 WEST NILE VIRUS ELISA IGG, MODEL EL0300G FOCUS TECHNOLOGIES, INC. K031953
10-22-2003 CONKLUSION PEDICLE SCREW SYSTEM SIGNUS MEDICAL LLC. K031455
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10-22-2003 MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC. K032420
10-22-2003 POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD K032374
10-23-2003 MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORPORATION K032530
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10-24-2003 DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205 TENGHI CO. LTD K033069
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10-24-2003 ADEPT 1064/532 LASER ADEPT MEDICAL CONCEPTS K032220
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10-24-2003 INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 INNOVATECH SURGICAL INC. K032704
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10-27-2003 SMARTMONITOR 2 PROFESSIONAL SERIES (PS) RESPIRONICS, INC. K032403
10-27-2003 FLUID SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING K030394
10-27-2003 EMBLA N7000 MEDCARE FLAGA K024322
10-27-2003 PERFADEX SOLUTION FOR LUNG PRESERVATION VITROLIFE AB K022730
10-27-2003 SWISS MASTER LIGHT (EMS SA) ELECTRO MEDICAL SYSTEMS K032099
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10-27-2003 VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER VIVOSONIC, INC. K033108
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10-28-2003 MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 MEDTRONIC MINIMED K032484
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10-29-2003 XTRAK SUPPORT CATHETER XTRAK MEDICAL INC. K032660
10-29-2003 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) SHEN WEI (USA), INC. K032024
10-29-2003 POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR SHEN WEI (USA), INC. K032084
10-29-2003 PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS PARAGON MEDICAL, INC. K032119
10-29-2003 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES HOME CARE TECHNOLOGY CO., LTD. K023000
10-29-2003 AMSURE FOLEY CATHETER AMSINO INTERNATIONAL, INC. K030120
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10-29-2003 "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM PHILIPS MEDICAL SYSTEMS, INC. K033326
10-29-2003 DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE DATEX-OHMEDA K033078
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10-29-2003 AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE ARROW INTL., INC. K032962
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10-30-2003 PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 MEDTRONIC NEUROLOGICAL K033016
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10-30-2003 NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 THE FIRST YEARS, INC. K033131
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10-30-2003 ENSITE SYSTEM ENDOCARDIAL SOLUTIONS, INC. K033211
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10-30-2003 POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 RICHARD WOLF MEDICAL INSTRUMENTS CORP. K030082
10-30-2003 DBB-05 HEMODIALYSIS DELIVERY SYSTEM DAVITA CLINICAL RESEARCH (TRRI) K023509
10-30-2003 ENDOHELIX ENDARTERECTOMY DEVICE ENDARX, INC. K032105
10-30-2003 FERTELL FEMALE FERTILITY TEST GENOSIS, INC. K032002
10-30-2003 STERISIL ANTIMICROBIAL TUBING AND BOTTLE STERISIL K031681
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10-30-2003 DIO-DENT 10 DENTAL DIODE LASER MSQ (M2) LTD. K031819
10-30-2003 PROFUSION BONE VOID FILLER KIT BIOGENERATION K031838
10-30-2003 GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC K032656
10-30-2003 ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR ETHICON ENDO-SURGERY, INC. K032676
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10-30-2003 A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. K032499
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10-30-2003 GLOBAL PRESS-FIT STEM GLOBAL MEDICAL CO. K032385
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10-31-2003 ZOLL M SERIES NIBP OPTION ZOLL MEDICAL CORP. K032363
10-31-2003 HEDROCEL VERTEBRAL BODY REPLACEMENT IMPLEX CORP. K032527
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10-31-2003 VITEK 2 GRAM POSITIVE LINEZOLID BIOMERIEUX, INC. K032766
10-31-2003 DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 DADE BEHRING, INC. K032573
10-31-2003 DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 DADE BEHRING, INC. K032564
10-31-2003 SPINERX-LDM SPINERX TECHNOLOGY K031862
10-31-2003 CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD WRIGHT MEDICAL TECHNOLOGY, INC. K031963
10-31-2003 AUDICOR UPGRADE SYSTEM INOVISE MEDICAL, INC. K032145
10-31-2003 DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS DANMAR PRODUCTS, INC. K013452
10-31-2003 SUN-RAIN ULTRASONIC THERAPY, SU-100 SUN-RAIN SYSTEM CORP. K024013
10-31-2003 KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., K030358
10-31-2003 NIPRO DISPOSABLE SYRINGES NIPRO MEDICAL CORP. K030683
10-31-2003 JABES ELECTRONIC STETHOSCOPE GS TECHNOLOGY CO., LTD. K031446
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10-31-2003 FUKUDA DENSHI MODEL FF SONIC UF-750XT FUKUDA DENSHI USA, INC. K033209
10-31-2003 K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT TRACK CORPORATION K033263
10-31-2003 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES MEDTRONIC PERFUSION SYSTEMS K033264
10-31-2003 PHERON PTA CATHETER BIOTRONIK, INC. K033217
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10-31-2003 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. K032993
10-31-2003 IONOFIL COLOR AC VOCO GMBH K033068
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