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510(k) Premarket List for AUGUST
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DECISION DATE DEVICE APPLICANT 510(k) NUMBER
08-01-2003 HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II HYGIA HEALTH SERVICES, INC. K012715
08-01-2003 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D ALSIUS CORP. K014241
08-01-2003 CARDIODIRECT, MODELS 12M, 12I, 12S REYNOLDS MEDICAL LTD. K024283
08-01-2003 R 72 RALCO S.R.L. K030487
08-01-2003 BALL RECORDING ELECTRODE/STIMULATION PROBE VIASYS HEALTHCARE, INC. K030517
08-01-2003 GUGLIELMI DETACHABLE COIL (GDC) BOSTON SCIENTIFIC, TARGET K031049
08-01-2003 DBT, DYNAMIC BUBBLE TRAP CONVERGENZA AG K031323
08-01-2003 ISOLETTE INFANT INCUBATOR, MODEL C2000E HILL-ROM MANUFACTURING, INC. K031387
08-01-2003 XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. K031451
08-01-2003 SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR METRO OPTICS OF AUSTIN, INC. K031532
08-01-2003 MEDRAD MANUAL SYRINGE LOADER MEDRAD, INC. K031483
08-01-2003 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K031561
08-01-2003 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR MICRUS CORP. K031578
08-01-2003 WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 NIHON SEIMITSU SOKKI CO., LTD. K031582
08-01-2003 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD K031625
08-01-2003 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM VASCULAR ARCHITECTS, INC. K031641
08-01-2003 SK MED M201 PLUS MIXER SK MED K031707
08-01-2003 BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD K031768
08-01-2003 DENTISEPTIC HPC BETHEL, INC K031851
08-01-2003 EMBRACE WET-BOND RESTORATIVE MATERIAL PULPDENT CORPORATION K031877
08-01-2003 AURORA DS SYNERON MEDICAL LTD. K031988
08-01-2003 AURORA SR SYNERON MEDICAL LTD. K031993
08-01-2003 MODIFICATION TO THERMACOOL TC SYSTEM THERMAGE, INC. K032088
08-01-2003 TERUMO AL8X ARTERIAL FILTER WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. K032128
08-01-2003 IQ HYDROPHILIC GUIDE WIRE BOSTON SCIENTIFIC CORP. K032183
08-01-2003 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I PLANAR SYSTEMS, INC. K032202
08-04-2003 ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD ACON LABORATORIES, INC. K031759
08-04-2003 SQUEEZE-EASE MAMMOGRAPHY CUSHION S & S X-RAY PRODUCTS, INC. K031574
08-04-2003 BONESOURCE BVF HOWMEDICA OSTEONICS K031435
08-04-2003 GLUCOLEADER VALUE HMD BIOMEDICAL, INC. K023279
08-04-2003 PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 VELOCIMED K023548
08-05-2003 DIGITAL TEMPERATURE MONITOR; MODEL KY-01 KANG YING MEDICAL APPLIANCES INC. K030219
08-05-2003 LIFESYNE SYSTEMS GMP/COMPANIES, INC. K030795
08-05-2003 CARRIER TIPS DENTSPLY INTL. K031461
08-05-2003 ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS LIFESCAN, INC. K031472
08-05-2003 OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LEMAITRE VASCULAR, INC. K031282
08-05-2003 COLTOSOL F COLTENE/WHALEDENT INC. K031752
08-05-2003 TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM VISION-SCIENCES, INC. K031786
08-05-2003 ELECSYS SHBG IMMUNOASSAY ROCHE DIAGNOSTICS CORP. K031717
08-05-2003 PULPDENT ETCH-RITE ROYALE PULPDENT CORPORATION K031915
08-05-2003 PRECISET DAT PLUS I CALIBRATORS ROCHE DIAGNOSTICS CORP. K031775
08-05-2003 SAFEPRO PLUS SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. K031830
08-05-2003 TINA-QUANT CRP (LATEX) ROCHE DIAGNOSTICS CORP. K032336
08-05-2003 UNITY NETWORK IS PATIENT VIEWER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032346
08-06-2003 SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. K032329
08-06-2003 SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC. K032281
08-06-2003 BENCO ADMIX SOUTHERN DENTAL INDUSTRIES, INC. K032152
08-06-2003 PRECISET TDM I AND PRECISET TDM II CALIBRATORS ROCHE DIAGNOSTICS CORP. K031856
08-06-2003 CADSTREAM CONFIRMA, INC. K031779
08-06-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML BECTON, DICKINSON & CO. K031943
08-06-2003 TRI-LOOP MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. K032047
08-06-2003 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. K031401
08-06-2003 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. K031354
08-06-2003 THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS IMPLEX CORP. K031462
08-06-2003 HEMOGLOBIN A1C REAGENT SET POINTE SCIENTIFIC, INC. K031539
08-06-2003 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS CLINIQA CORPORATION K031577
08-06-2003 CARDIOQ, MODEL 9051-7005 DELTEX MEDICAL K031706
08-06-2003 TOX AMMONIA CALIBRATOR BAYER HEALTHCARE, LLC K031683
08-06-2003 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA BIOMET, INC. K031693
08-06-2003 SOFT-CELL DUAL LUMEN CATHETERS C.R. BARD, INC. K030277
08-06-2003 NANMA ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. K030119
08-07-2003 LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 MEDSYS, S.A. K023735
08-07-2003 AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) INOVISE MEDICAL, INC. K030316
08-07-2003 SPINAL CONCEPTS, INC. INFIX SYSTEM SPINAL CONCEPTS, INC. K031672
08-07-2003 CORRESTORE PATCH SYSTEM SOMANETICS CORP. K031586
08-07-2003 BIFURCATED ALLERGY SKIN TESTING NEEDLE PRECISION MEDICAL PRODUCTS, INC. K031630
08-07-2003 HEATER COOLER UNIT, MODEL HCU 30 JOSTRA AB K031544
08-07-2003 KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II HK SURGICAL, INC. K031432
08-07-2003 OTP 1.2 NUCLETRON CORP. K031349
08-07-2003 SWIFT 2.0, MODEL 132.001 NUCLETRON CORP. K031158
08-07-2003 SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI BECKMAN COULTER, INC. K032035
08-07-2003 N LATEX IGM DADE BEHRING, INC. K032014
08-07-2003 VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 ORTHO-CLINICAL DIAGNOSTICS K031924
08-07-2003 ECHELON MICRO CATHETER, MODEL 105-5091 MICRO THERAPEUTICS, INC. K031992
08-07-2003 PRACTICEBUILDER 1-2-3 ERAD IMAGEMEDICAL CORP. K031778
08-08-2003 HANDMASTER NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS K031900
08-08-2003 OMNIFIT HFX HIP STEM SERIES HOWMEDICA OSTEONICS CORP. K031744
08-08-2003 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. K031789
08-08-2003 EMBRYON ULTRASOUND NEEDLE GUIDE ROCKET MEDICAL PLC K032015
08-08-2003 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 BIO-RAD K032017
08-08-2003 PERIVAC KIT BOSTON SCIENTIFIC CORP. K032050
08-08-2003 ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY BECKMAN COULTER, INC. K032162
08-08-2003 DATACAPTOR CAPSULE TECHNOLOGIE K032142
08-08-2003 INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. K032095
08-08-2003 DEPUY ACE VERSANAIL TIBIAL NAIL DEPUY ORTHOPAEDICS, INC. K032097
08-08-2003 STRYKER TOTAL PERFORMANCE (TPS) SYSTEM STRYKER INSTRUMENTS K032117
08-08-2003 TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 SMITH & NEPHEW, INC. K032197
08-08-2003 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION EV3 INC K032206
08-08-2003 VKS/TC-PLUS REVISION KNEE PLUS ORTHOPEDICS K032215
08-08-2003 BIORCI SCREW SMITH & NEPHEW, INC. K032224
08-08-2003 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM HOWMEDICA OSTEONICS CORP. K032264
08-08-2003 GAMMA 3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. K032244
08-08-2003 CARDIOVATIONS PORTABLE VIDEO SYSTEM ETHICON, INC. K032339
08-08-2003 SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE SYNTHES (USA) K031428
08-08-2003 SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) SYNTHES (USA) K031654
08-08-2003 RANDOX LIQUID PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD. K031608
08-08-2003 REFLEX ANTERIOR CERVICAL PLATE SYSTEM HOWMEDICA OSTEONICS K031702
08-08-2003 ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. K030109
08-08-2003 HBS HEADLESS BONE SCREW SCHOENING & ASSOC., INC. K030302
08-08-2003 OPUS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. K030369
08-08-2003 LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE JDA (TIANJIN) PLASTIC RUBBER CO., LTD. K030529
08-08-2003 IMMUNICON CELLSAVE PRESERVATIVE TUBE IMMUNICON CORP. K030596
08-08-2003 VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 VISTA SCIENTIFIC, LLC K024359
08-11-2003 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS BIOMET, INC. K030055
08-11-2003 BOWIE-DICK MINI PAK, MODEL BD 115 STERITEC PRODUCTS, INC. K024293
08-11-2003 DEROYAL SURGICAL DRAPES BACKTABLE COVER DEROYAL K030908
08-11-2003 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX DATASCOPE CORP. K031636
08-11-2003 LED HEADLIGHT WELCH ALLYN, INC. K031548
08-11-2003 SOLID STATE LAMP [LED] HEADLIGHT WELCH ALLYN, INC. K031549
08-11-2003 RAMSOFT PACS, MODEL 3.0 RAMSOFT, INC. K031562
08-11-2003 LORENZ 2.4 SELF DRILLING SCREWS WALTER LORENZ SURGICAL, INC. K032228
08-11-2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK K032265
08-11-2003 POLY Q (GARANT L, PENTA M, PENTA H) 3M ESPE AG DENTAL PRODUCTS K032001
08-11-2003 ULTRASITE VALVE B. BRAUN MEDICAL, INC. K031923
08-12-2003 CI TKR/UKR BRAINLAB, AG K031770
08-12-2003 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. K032333
08-12-2003 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES PRECISION VASCULAR SYSTEMS, INC. K032146
08-12-2003 WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM ABBOTT VASCULAR INC. K031331
08-12-2003 AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS VIASYS HEALTHCARE, INC. K031713
08-12-2003 STRYKER VISUM SURGICAL LIGHTING SYSTEM STRYKER ENDOSCOPY K031068
08-12-2003 IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX IMTEC CORP. K031106
08-12-2003 XIVE 3.0 DENTAL IMPLANT SYSTEM FRIANDENT GMBH K030639
08-12-2003 EVOLVE CERAMIC RADIAL HEAD IMPLANT WRIGHT MEDICAL TECHNOLOGY, INC. K030384
08-12-2003 ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL ZIMMER, INC. K032367
08-13-2003 CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032370
08-13-2003 IVENT 201 PORTABLE VENTILATOR VERSAMED LTD. K021981
08-13-2003 MODIFICATION TO CERASORB ORTHO CURASAN AG K031651
08-13-2003 IUR FLUID MANAGEMENT SYSTEM W.O.M. WORLD OF MEDICINE AG K031616
08-13-2003 CONDUCTION CATHETER MICOR, INC. K031600
08-13-2003 PBN GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. K031442
08-13-2003 MODIFICATION TO E-SCAN XQ ESAOTE S.P.A. K032121
08-13-2003 COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. K032000
08-13-2003 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS, INC. K032296
08-13-2003 MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM STARPLEX SCIENTIFIC, INC. K032246
08-13-2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE BIOMERIEUX, INC. K031865
08-13-2003 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. GORE & ASSOCIATES, INC. K032073
08-14-2003 MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION K031957
08-14-2003 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC MED-TEC,INC. K031866
08-14-2003 PHILIPS FRESCO RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. K031836
08-14-2003 STATCO2METER, MODEL 10-55372 MERCURY MEDICAL K031814
08-14-2003 DVNET MDV-PACS DVNET INTERNATIONAL TECHNOLOGY CO.,LTD. K031816
08-14-2003 XIVE TG DENTAL IMPLANT SYSTEM FRIADENT GMBH K032284
08-14-2003 ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS ROSTAM LTD. K032080
08-14-2003 XIVE DENTAL IMPLANT SYSTEM MULTIPLE FRIADENT GMBH K032158
08-14-2003 DISPOSABLE POWDERED VINYL EXAM GLOVES SYNMERTEX CO, LTD K032190
08-14-2003 DISPOSABLE POWDER FREE VINYL EXAM GLOVES SYNMERTEX CO, LTD K032172
08-14-2003 MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM FRIADENT GMBH K031674
08-14-2003 VIANOX DELIVERY SYSTEM, MODEL I PULMONOX MEDICAL, INC. K023014
08-14-2003 AUSAM TOTAL ALBUMIN ASSAY AUSAM BIOTECTHNOLOGIES INC K013643
08-14-2003 MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS AMERIWATER K021560
08-14-2003 ORTHOVIEW OMSBAR LTD K032401
08-15-2003 NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 NUCLETRON CORPORATION K032372
08-15-2003 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032369
08-15-2003 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 EPIMED INTERNATIONAL, INC. K023140
08-15-2003 VPAP III RESMED LTD. K030843
08-15-2003 POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD K031157
08-15-2003 GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC. K032168
08-15-2003 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 MICROLIFE INTELLECTUAL PROPERTY GMBH K031958
08-18-2003 PEM 2400 PET SCANNER PEM TECHNOLOGIES K032063
08-18-2003 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER BCI, INC. K031742
08-18-2003 BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. K032131
08-18-2003 MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 BECKMAN COULTER, INC. K032287
08-18-2003 FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT DIAGNOSTICS BIOCHEM CANADA, INC. K030730
08-18-2003 STERRAD 200 STERILIZER ADVANCED STERILIZATION PRODUCTS K030429
08-18-2003 JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET JMS NORTH AMERICA CORP. K030479
08-19-2003 ADVISOR, MODEL 9200 BCI, INC. K030407
08-19-2003 NX SYSTEM AMERICAN TELECARE, INC. K030222
08-19-2003 MIRAGE VISTA MASK RESMED LTD. K031047
08-19-2003 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 BIOMEDICAL LIFE SYSTEMS, INC. K031427
08-19-2003 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS SIEMENS MEDICAL SOLUTIONS USA, INC. K031433
08-19-2003 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 BAXTER HEALTHCARE CORP. K031566
08-19-2003 PITANGA SYNERON MEDICAL LTD. K031489
08-19-2003 SIROTORQUE L SIRONA DENTAL SYSTEMS GMBH K031584
08-19-2003 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL MEDICAL ANALYSIS SYSTEMS, INC. K032335
08-19-2003 PASCO MIC AND MIC/ID PANELS BD DIAGNOSTIC SYSTEMS K032259
08-19-2003 MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S MEDTRONIC MINIMED K031917
08-19-2003 CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) SEAL POLYMER INDUSTRIES BHD. K032077
08-19-2003 GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE PT. WRP BUANA MULTICORPORA K032010
08-19-2003 GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE PT. WRP BUANA MULTICORPORA K032011
08-19-2003 VAXCEL PORT, MODELS 45-336 AND 45-338 BOSTON SCIENTIFIC CORP. K032375
08-20-2003 ELECSYS PRECICONTROL TROPONIN T ROCHE DIAGNOSTICS CORP. K031990
08-20-2003 SAPPHIRE DETACHABLE FIBER COILS MICRO THERAPEUTICS, INC. K031852
08-20-2003 DESIGNS FOR VISION FIBEROPTIC LIGHT DESIGNS FOR VISION, INC. K032283
08-20-2003 TISSUELINK FLOATING BALL MODEL 23-201-1 TISSUELINK MEDICAL, INC. K032132
08-20-2003 MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. K032204
08-20-2003 OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM LUXSANO AB K032191
08-20-2003 AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP AESCULAP, INC. K032198
08-20-2003 EP-WORKMATE WITH RPM SYSTEM EP MEDSYSTEMS K032225
08-20-2003 COBRA COOLED SURGICAL PROBE, MODEL M004159670 BOSTON SCIENTIFIC CORP. K032207
08-20-2003 ELECYS SHBG CALCHECK ROCHE DIAGNOSTICS CORP. K031698
08-20-2003 NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) VYTERIS, INC. K031551
08-20-2003 S & C -BRACKET ADHESIVES S & C POLYMER GMBH K031420
08-20-2003 CRYOTRON 2 CRYOTHERAPY DEVICE CRYONIC MEDICAL NORTH AMERICA K030281
08-20-2003 DUET SYSTEM BIOVIEW LTD. K030192
08-20-2003 MODIFICATION ORIA SPINAL SYSTEM ORTHOTEC, L.L.C. K023884
08-20-2003 SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE USGI MEDICAL, INC. K023902
08-20-2003 QUANTIX/OR DEVICE CARDIOSONIX, LTD. K030357
08-20-2003 ISM1+, IMS2+, AND UTM+ MEDICULT A/S K030490
08-20-2003 PERFECT CAPSULE MILVELLA PTY. LTD. K030957
08-21-2003 GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER GLUSTITCH, INC. K030574
08-21-2003 COLUMBUS (PS) AESCULAP, INC. K030367
08-21-2003 DENTAPORT ZX J. MORITA USA, INC. K031204
08-21-2003 SYNTHES (USA) CALVICLE HOOK PLATE SYNTHES (USA) K031677
08-21-2003 NOMOS CORVUS 5.0M NOMOS CORP. K032209
08-21-2003 14G CORMARK BIOPSY SITE IDENTIFIER ARTEMIS MEDICAL, INC. K032217
08-21-2003 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 MRI DEVICES CORP. K032090
08-21-2003 GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT SMITH & NEPHEW, INC. K032295
08-21-2003 NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 NEOGEN TECHNOLOGIES, INC K032301
08-21-2003 BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. K032347
08-21-2003 MODEL 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES K032252
08-21-2003 OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 OLYMPUS AMERICA, INC. K032285
08-21-2003 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP. K032282
08-21-2003 NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 NORM PACIFIC AUTOMATION CORP. K031907
08-21-2003 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX IMAGE-GUIDED NEUROLOGICS, INC. K031885
08-21-2003 BODYGUARD INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. K031749
08-21-2003 CENTURION SES EPIKERATOME CIBA VISION CORPORATION K031735
08-21-2003 SHIMADZU COLLIMATOR R-30H SHIMADZU CORP. K031771
08-21-2003 COOLTOUCH INCORPORATED MODEL"CT3" ND:YAG SURGICAL LASER SYSTEMS NEW STAR LASERS, INC. K031954
08-21-2003 LINVATEC 300W XENON LIGHT SOURCE LINVATEC CORP. K031994
08-21-2003 TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC BRANAN MEDICAL CORP. K032057
08-21-2003 ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID ROCHE DIAGNOSTICS CORP. K032377
08-21-2003 RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS BIOMET, INC. K032396
08-21-2003 QSC-127 SHOULDER ARRAY COIL SET MRI DEVICES CORP. K032429
08-21-2003 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 STELLARTECH RESEARCH CORP. K032452
08-21-2003 TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. K032490
08-21-2003 ARTHROCARE SYSTEM ARTHROCARE CORP. K032504
08-22-2003 EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. K032503
08-22-2003 ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 WRP ASIA PACIFIC SDN. BHD. K032464
08-22-2003 SPIDERVIEW ELA MEDICAL, INC. K032466
08-22-2003 ALTATEC CERAMIC ABUTMENT ALTATEC BIOTECHNOLOGIES K032448
08-22-2003 VIATRONIX V3D EXPLORER, REVISION 1.2 VIATRONIX, INC. K032483
08-22-2003 CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 CARDIOVENTION, INC. K032068
08-22-2003 ROCHE ONLINE TDM VALPROIC ACID ROCHE DIAGNOSTICS CORP. K032049
08-22-2003 MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 MEDTRONIC MINIMED K032005
08-22-2003 MODIFICATION TO TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH), TRELLIS RESERVE INFUSION BACCHUS VASCULAR, INC. K032261
08-22-2003 VERSATREK TREK DIAGNOSTIC SYSTEMS, INC. K032306
08-22-2003 VITEK 2 GRAM POSITIVE GATIFLOXACIN BIOMERIEUX, INC. K032314
08-22-2003 SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 INTRALUMINAL THERAPEUTICS, INC. K031692
08-22-2003 STRYKER SPINE OASYS BONE SCREW HOWMEDICA OSTEONICS CORP. K031657
08-22-2003 INNOVA 3100 GE MEDICAL SYSTEMS K031637
08-22-2003 INTERMED ZOOM COLPOSCOPE INTERMED GROUP, INC. K031639
08-22-2003 TRAXIS CEMENT RESTRICTOR SPINAL CONCEPTS, INC. K031318
08-22-2003 ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 MONOBIND K030860
08-22-2003 OSTEOMED SUBTALAR IMPLANT SYSTEM OSTEOMED L.P. K031155
08-22-2003 MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS MEDTRADE PRODUCTS LTD. K022587
08-22-2003 FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT FCI OPHTHALMICS, INC. K023400
08-22-2003 ANKYLOS DENTSPLY CERAMCO K012681
08-25-2003 NEUROTECH BAXOLVE TYPE 294 BIO-MEDICAL RESEARCH, LTD. K023913
08-25-2003 MATCH PRESS PRESSABLE CERAMIC DAVIS SCHOTTLANDER & DAVIS, LTD. K024250
08-25-2003 VISUALINE METHADONE DIPSTRIPTEST SUN BIOMEDICAL LABORATORIES, INC. K023856
08-25-2003 DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE DENTAURUM K030977
08-25-2003 DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE DENTAURUM K030980
08-25-2003 SONIK LDI 20 AIR EVIT LABS, INC. K030374
08-25-2003 INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 SOTA PRECISION OPTICS, INC. K032341
08-25-2003 STARBOND DENTAL BONDING ALLOYS STAR REFINING PRECIOUS METALS SOUTH AFRICA K032106
08-25-2003 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 HEMOCUE, INC. K032203
08-25-2003 EASY PULSE II OXYGEN CONSERVER PRECISION MEDICAL, INC. K032018
08-25-2003 MITEK MICRO QUICKANCHOR MITEK WORLDWIDE K032078
08-25-2003 LYRA NASAL MASK SENSORMEDICS CORP. K031883
08-25-2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION K031921
08-25-2003 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL USA INSTRUMENTS, INC. K032474
08-25-2003 MODIFICARION TO WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC. K032500
08-25-2003 MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL USA INSTRUMENTS, INC. K032415
08-26-2003 ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. K032376
08-26-2003 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES WELCH ALLYN PROTOCOL, INC. K031740
08-26-2003 DISPOSABLE N-PE MICKROKERATOME BLADES OASIS MEDICAL, INC. K032297
08-26-2003 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. K032298
08-26-2003 GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 EDWARDS LIFESCIENCES, LLC. K032250
08-26-2003 DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR EST INTERNATIONAL CORPORATION K032236
08-26-2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR EST INTERNATIONAL CORPORATION K032272
08-26-2003 OASYS-ORAL AIRWAY SYSTEM MARK ABRAMSON, D.D.S., INC K030440
08-26-2003 TSO3 OZONE STERILIZER, MODEL 125L TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC K020875
08-26-2003 UROPOWER W.O.M. WORLD OF MEDICINE AG K022721
08-26-2003 HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. K031678
08-27-2003 IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS IRIDEX CORP. K031665
08-27-2003 HEARTSTART MRX, MODEL M3535A PHILIPS MEDICAL SYSTEMS K031187
08-27-2003 DRI METHADONE METABOLITE ENZYME IMMUNOASSAY MICROGENICS CORP. K023617
08-27-2003 TSO3 OZONE CHEMICAL INDICATOR TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC K021161
08-27-2003 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA PORTEX LTD. K030381
08-27-2003 CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES MID-ATLANTIC DIAGNOSTICS, INC. K030525
08-27-2003 D-10 HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. K031043
08-27-2003 MOBILE BATTERY SERVICE STATION (MBSS) AD ELEKTRONIK GMBH K030898
08-27-2003 MICROPEAK MICRO DIRECT, INC. K030586
08-27-2003 KENTEX DISPOSABLE VAGINAL SPECULUM KENTRON HEALTH CARE, INC. K030693
08-27-2003 CLICK HOLTER REMCO ITALIA S.P.A. K032276
08-27-2003 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT BOSTON SCIENTIFIC CORP. K032360
08-27-2003 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES VITALCARE GROUP, INC. K031748
08-27-2003 WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC. K032069
08-27-2003 ELCACAM A-DEC, INC. K032070
08-27-2003 LCD MONITOR, RADIFORCE G11, G31, G51 EIZO NANAO CORPORATION K032026
08-27-2003 DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LEMAITRE VASCULAR, INC. K032041
08-27-2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML BECTON, DICKINSON & CO. K031984
08-27-2003 DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) STRAUMANN USA K032498
08-28-2003 ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL BIONOSTICS, INC. K032453
08-28-2003 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER BUSSE HOSPITAL DISPOSABLES, INC. K032432
08-28-2003 JOBST TRAVEL SOCKS BSN-JOBST, INC. K032325
08-28-2003 NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN SGMP CO., LTD. K032293
08-28-2003 NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING SGMP CO., LTD. K032294
08-28-2003 INION OTPS BIODEGRADABLE PIN INION LTD. K031712
08-29-2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. K031710
08-29-2003 MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 MEDTRONIC PERFUSION SYSTEMS K031700
08-29-2003 MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 ASPECT MEDICAL SYSTEMS, INC. K031694
08-29-2003 DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. K031697
08-29-2003 OMNIPRO I'MRT WELLHOFER DOSIMETRIE K031634
08-29-2003 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYO VASCULAR SYSTEMS INC. K030742
08-29-2003 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT COOK OB/GYN K030441
08-29-2003 APLAB, MODEL 801D0030 SECTOR MEDICAL CORP. K030379
08-29-2003 V SET P.T. GREENLEAF K020419
08-29-2003 V SET HENNIG ENTERPRISES EUROPE S.R.L. K020424
08-29-2003 MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM PISHARODI SURGICALS, INC. K024313
08-29-2003 CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 NUCLEAR ASSOCIATES K030066
08-29-2003 KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT KAPP SURGICAL INSTRUMENT, INC. K030237
08-29-2003 IBL C1Q-CIC CIA TEST IBL GMBH K032254
08-29-2003 QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE NO 7 CONTACT LENS LABORATORY LTD. K032256
08-29-2003 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP STOCKERT INSTRUMENTE GMBH K032213
08-29-2003 IMSURE PRODIGM, INC. K031975
08-29-2003 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS HOWMEDICA OSTEONICS CORP. K031730
08-29-2003 VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER ORTHOVITA, INC. K032409
08-29-2003 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC. K032382
08-29-2003 MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P. K032390
08-29-2003 BINDER CO2 INCUBATOR SERIE CB BINDER GMBH K032526
08-29-2003 S2 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. K032579
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