| MODIFICATION TO: APEXPRO TELEMETRY SYSTEM (K032369) | Ge Medical Systems Information Technologies | 2003-08-15 |
| NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 (K032372) | Nucletron Corporation | 2003-08-15 |
| VPAP III (K030843) | Resmed, Ltd. | 2003-08-15 |
| VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 (K023140) | Epimed International, Inc. | 2003-08-15 |
| MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 (K031958) | Microlife Intellectual Property GmbH | 2003-08-15 |
| POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED (K031157) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2003-08-15 |
| PHILIPS FRESCO RELEASE 1 (K031836) | Philips Medical Systems North America Co. | 2003-08-14 |
| DVNET MDV-PACS (K031816) | Dvnet International Technology Co., Ltd. | 2003-08-14 |
| MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC (K031866) | Med-Tec,Inc. | 2003-08-14 |
| MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K021560) | Ameriwater | 2003-08-14 |
| ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS (K032080) | Rostam , Ltd. | 2003-08-14 |
| XIVE DENTAL IMPLANT SYSTEM MULTIPLE (K032158) | Friadent GmbH | 2003-08-14 |
| STATCO2METER, MODEL 10-55372 (K031814) | Mercury Medical | 2003-08-14 |
| MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION (K031957) | Ciba Vision Corporation | 2003-08-14 |
| ORTHOVIEW (K032401) | Omsbar, Ltd. | 2003-08-14 |
| VIANOX DELIVERY SYSTEM, MODEL I (K023014) | Pulmonox Medical, Inc. | 2003-08-14 |
| MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM (K031674) | Friadent GmbH | 2003-08-14 |
| DISPOSABLE POWDERED VINYL EXAM GLOVES (K032190) | Synmertex Co, Ltd. | 2003-08-14 |
| XIVE TG DENTAL IMPLANT SYSTEM (K032284) | Friadent GmbH | 2003-08-14 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K032172) | Synmertex Co, Ltd. | 2003-08-14 |
| AUSAM TOTAL ALBUMIN ASSAY (K013643) | Ausam Biotecthnologies, Inc. | 2003-08-14 |
| MODIFICATION TO CERASORB ORTHO (K031651) | Curasan AG | 2003-08-13 |
| MODIFICATION TO E-SCAN XQ (K032121) | Esaote, S.p.A. | 2003-08-13 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K032073) | W. L. Gore & Associates, Inc. | 2003-08-13 |
| CONDUCTION CATHETER (K031600) | Micor, Inc. | 2003-08-13 |
| VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE (K031865) | bioMerieux, Inc. | 2003-08-13 |
| IUR FLUID MANAGEMENT SYSTEM (K031616) | W.O.M. World of Medicine AG | 2003-08-13 |
| CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370) | Ge Medical Systems Information Technologies | 2003-08-13 |
| MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246) | Starplex Scientific, Inc. | 2003-08-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (K032296) | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 |
| IVENT 201 PORTABLE VENTILATOR (K021981) | Versamed , Ltd. | 2003-08-13 |
| COULTER LH 500 HEMATOLOGY ANALYZER (K032000) | Beckman Coulter, Inc. | 2003-08-13 |
| PBN GUIDEWIRES (K031442) | Medical Device Technologies, Inc. | 2003-08-13 |
| XIVE 3.0 DENTAL IMPLANT SYSTEM (K030639) | Friandent GmbH | 2003-08-12 |
| IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX (K031106) | Imtec Corp. | 2003-08-12 |
| CRYOCARE CS SURGICAL SYSTEM (K032333) | Endocare, Inc. | 2003-08-12 |
| STRYKER VISUM SURGICAL LIGHTING SYSTEM (K031068) | Stryker Endoscopy | 2003-08-12 |
| EVOLVE CERAMIC RADIAL HEAD IMPLANT (K030384) | Wrightmedicaltechnologyinc | 2003-08-12 |
| AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS (K031713) | Viasys Healthcare, Inc. | 2003-08-12 |
| ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL (K032367) | Zimmer, Inc. | 2003-08-12 |
| CI TKR/UKR (K031770) | Brainlab AG | 2003-08-12 |
| PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES (K032146) | Precision Vascular Systems, Inc. | 2003-08-12 |
| WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM (K031331) | Abbott Vascular, Inc. | 2003-08-12 |
| SOLID STATE LAMP [LED] HEADLIGHT (K031549) | Welch Allyn, Inc. | 2003-08-11 |
| CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX (K031636) | Datascope Corp. | 2003-08-11 |
| MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS (K030055) | Biomet, Inc. | 2003-08-11 |
| POLY Q (GARANT L, PENTA M, PENTA H) (K032001) | 3M Espe AG Dental Products | 2003-08-11 |
| LORENZ 2.4 SELF DRILLING SCREWS (K032228) | Walter Lorenz Surgical, Inc. | 2003-08-11 |
| DEROYAL SURGICAL DRAPES BACKTABLE COVER (K030908) | Deroyal | 2003-08-11 |
| RAMSOFT PACS, MODEL 3.0 (K031562) | Ramsoft, Inc. | 2003-08-11 |
| BOWIE-DICK MINI PAK, MODEL BD 115 (K024293) | Steritec Products, Inc. | 2003-08-11 |
| CD HORIZON SPINAL SYSTEM (K032265) | Medtronic Sofamor Danek | 2003-08-11 |
| ULTRASITE VALVE (K031923) | B.Braun Medical, Inc. | 2003-08-11 |
| LED HEADLIGHT (K031548) | Welch Allyn, Inc. | 2003-08-11 |
| EMBRYON ULTRASOUND NEEDLE GUIDE (K032015) | Rocket Medical Plc | 2003-08-08 |
| HANDMASTER (K031900) | Ness-Neuromuscular Electrical Stimulation Systems | 2003-08-08 |
| GAMMA 3 NAIL SYSTEM (K032244) | Howmedica Osteonics Corp. | 2003-08-08 |
| STRYKER TOTAL PERFORMANCE (TPS) SYSTEM (K032117) | Stryker Instruments | 2003-08-08 |
| PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION (K032206) | Ev3, Inc. | 2003-08-08 |
| REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K031702) | Howmedica Osteonics | 2003-08-08 |
| VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (K024359) | Vista Scientific, LLC | 2003-08-08 |
| LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 (K032017) | Bio-Rad | 2003-08-08 |
| SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) (K031654) | Synthes (Usa) | 2003-08-08 |
| INTERPORE CROSS CEMENT RESTRICTOR (K032095) | Interpore Cross Intl. | 2003-08-08 |
| PERIVAC KIT (K032050) | Boston Scientific Corp | 2003-08-08 |
| MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM (K032264) | Howmedica Osteonics Corp. | 2003-08-08 |
| TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 (K032197) | Smith & Nephew, Inc. | 2003-08-08 |
| OPUS SPINAL SYSTEM (K030369) | Howmedica Osteonics Corp. | 2003-08-08 |
| HBS HEADLESS BONE SCREW (K030302) | Schoening & Assoc., Inc. | 2003-08-08 |
| DATACAPTOR (K032142) | Capsule Technologie | 2003-08-08 |
| LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE (K030529) | Jda (Tianjin) Plastic Rubber Co., Ltd. | 2003-08-08 |
| CARDIOVATIONS PORTABLE VIDEO SYSTEM (K032339) | ETHICON, Inc. | 2003-08-08 |
| IMMUNICON CELLSAVE PRESERVATIVE TUBE (K030596) | Immunicon Corp. | 2003-08-08 |
| EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (K031789) | Pentax Precision Instrument Corp. | 2003-08-08 |
| ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY (K032162) | Beckman Coulter, Inc. | 2003-08-08 |
| OMNIFIT HFX HIP STEM SERIES (K031744) | Howmedica Osteonics Corp. | 2003-08-08 |
| ELECTROPHYSIOLOGY CATHETER (K030109) | Alliance Medical Corp. | 2003-08-08 |
| SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE (K031428) | Synthes (Usa) | 2003-08-08 |
| RANDOX LIQUID PROTEIN CALIBRATOR (K031608) | Randox Laboratories, Ltd. | 2003-08-08 |
| BIORCI SCREW (K032224) | Smith & Nephew, Inc. | 2003-08-08 |
| VKS/TC-PLUS REVISION KNEE (K032215) | Plus Orthopedics | 2003-08-08 |
| DEPUY ACE VERSANAIL TIBIAL NAIL (K032097) | DePuy Orthopaedics, Inc. | 2003-08-08 |
| PRACTICEBUILDER 1-2-3 (K031778) | Erad Imagemedical Corp. | 2003-08-07 |
| AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) (K030316) | Inovise Medical, Inc. | 2003-08-07 |
| N LATEX IGM (K032014) | Dade Behring, Inc. | 2003-08-07 |
| SWIFT 2.0, MODEL 132.001 (K031158) | Nucletron Corp. | 2003-08-07 |
| BIFURCATED ALLERGY SKIN TESTING NEEDLE (K031630) | Precision Medical Products, Inc. | 2003-08-07 |
| VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924) | Ortho-Clinical Diagnostics | 2003-08-07 |
| SPINAL CONCEPTS, INC. INFIX SYSTEM (K031672) | Spinal Concepts, Inc. | 2003-08-07 |
| ECHELON MICRO CATHETER, MODEL 105-5091 (K031992) | Micro Therapeutics, Inc. | 2003-08-07 |
| KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II (K031432) | Hk Surgical, Inc. | 2003-08-07 |
| LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 (K023735) | Medsys, S.A. | 2003-08-07 |
| OTP 1.2 (K031349) | Nucletron Corp. | 2003-08-07 |
| CORRESTORE PATCH SYSTEM (K031586) | Somanetics Corp. | 2003-08-07 |
| SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035) | Beckman Coulter, Inc. | 2003-08-07 |
| HEATER COOLER UNIT, MODEL HCU 30 (K031544) | Jostra AB | 2003-08-07 |
| SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM (K032329) | Medison America, Inc. | 2003-08-06 |
| MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA (K031693) | Biomet, Inc. | 2003-08-06 |
| THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS (K031462) | Implex Corp. | 2003-08-06 |
| EBI OMEGA21 SPINAL FIXATION SYSTEM (K031354) | Ebi, L.P. | 2003-08-06 |