| SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM (K043455) | Medison Co., Ltd. | 2004-12-21 |
| MIMIX MP BONE VOID FILLER (K043280) | Biomet, Inc. | 2004-12-21 |
| CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (K041038) | Churchill Medical Systems, Inc. | 2004-12-21 |
| OLYMPUS ENDOARM (K043128) | Olympus Corporation | 2004-12-21 |
| MODIFICATION TO: PNEUTON VENTILATOR (K043085) | Airon Corporation | 2004-12-20 |
| WILLI GELLER CREATION CP PORCELAIN (K043221) | Jensen Industries, Inc. | 2004-12-20 |
| SYSTEMP.LINK (K042846) | Ivoclar Vivadent, Inc. | 2004-12-20 |
| FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR (K043244) | Fresenius Medical Care North America | 2004-12-20 |
| MODIFICATION TO: VIEWSTATION (K043412) | Impac Medical Systems, Inc. | 2004-12-20 |
| BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 (K041658) | Bio-Rad Laboratories, Inc. | 2004-12-20 |
| POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043159) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2004-12-20 |
| OSS/(SCARF)- AND OSW-SCREW (K042079) | O.M.T. Oberflachen-Und Materialtechnologie GmbH | 2004-12-20 |
| CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592) | Cordis Corp. | 2004-12-17 |
| CLEAFIL DC CORE AUTOMIX (K043177) | Kuraray Medical, Inc. | 2004-12-17 |
| DOC BAND-POSTOP (K042385) | Cranial Technologies, Inc. | 2004-12-17 |
| MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM (K043181) | Vertebron, Inc. | 2004-12-17 |
| ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM (K042783) | The Anspach Effort, Inc. | 2004-12-17 |
| INFINITY ELECTROTHERAPY SYSTEM (K042057) | Empi | 2004-12-17 |
| IS 40 MICROMOTOR (K042787) | Satelec | 2004-12-17 |
| RADIANCE PORCELAIN (K042638) | Aurident, Inc. | 2004-12-17 |
| FLEXITIME XTREME (K042878) | Heraeus Kulzer, Inc. | 2004-12-17 |
| MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U (K043293) | Acrorad Co., Ltd. | 2004-12-17 |
| MD-6W WIRELESS CRITICAL DATA VIEWER (K042923) | The Microoptical Corporation | 2004-12-17 |
| PROTECTION PLUS EARLOOP PROCEDURE MASK (K042654) | Safety-Med Products, Inc. | 2004-12-17 |
| MODIFICATION TO SHORT INTRODUCER SHEATH (K042399) | Rex Medical, L.P. | 2004-12-17 |
| NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (K042676) | Nichols Institute Diagnostics | 2004-12-17 |
| POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (K040047) | Osteobiologics, Inc. | 2004-12-17 |
| TRANS1 AXIAL FIXATION SYSTEM (K040426) | Trans1, Inc. | 2004-12-17 |
| TORAYGUIDE GUIDEWIRE (K042370) | Toray Industries (America), Inc. | 2004-12-17 |
| BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (K041619) | Biocheck, Inc. | 2004-12-17 |
| CONSERVE PLUS HA ACETABULAR SHELLS (K042530) | Wrightmedicaltechnologyinc | 2004-12-17 |
| SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (K042734) | St. Jude Medical, Inc. | 2004-12-17 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II (K043320) | Roche Diagnostics Corp. | 2004-12-17 |
| CRANEX D (K043307) | Soredex Palodex Group OY | 2004-12-17 |
| CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES (K043319) | Novalis Medical, LLC | 2004-12-17 |
| PERMACOL SURGICAL IMPLANT (K043366) | Tissue Science Laboratories, Plc | 2004-12-17 |
| MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM (K043077) | Tornier | 2004-12-17 |
| KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT (K042248) | Kronus Market Development Associates, Inc. | 2004-12-17 |
| SYSTEMP.CEM (K042847) | Ivoclar Vivadent, Inc. | 2004-12-17 |
| AMELOGEN PLUS (K043119) | Ultradent Products, Inc. | 2004-12-17 |
| NOUVAG AG - VACUSON 40 AND VACUSON 60 (K042943) | NOUVAG AG | 2004-12-17 |
| CORTRAK (K041987) | Viasys Medsystems | 2004-12-17 |
| THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (K040049) | STERIS Corporation | 2004-12-17 |
| SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X (K043355) | Sintea Biotech, Inc. | 2004-12-17 |
| EMG MODEL SUA01 SUCTION UNIT (K042349) | Emg Technology Co., Ltd. | 2004-12-16 |
| OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM (K040270) | Lumenis, Ltd. | 2004-12-16 |
| VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS (K033266) | Medical Imaging Applications, LLC | 2004-12-16 |
| COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (K041679) | Onyx Medical, Inc. | 2004-12-16 |
| FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE (K042239) | Pt. Mandiri Inti Buana | 2004-12-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE (K042805) | Perusahaan Getah Asas Sdn. Bhd. | 2004-12-16 |
| MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 (K043258) | Teleflex Medical | 2004-12-16 |
| GERBER DOUBLE ELECTRIC BREAST PUMP (K043098) | Gerber Products Co. | 2004-12-15 |
| GENTLEWAVES LED PHOTOMODULATION DEVICE (K031425) | Light Bioscience, LLC | 2004-12-15 |
| MISTAR, MODEL V3.2 (K043350) | Apollo Medical Imaging Technology Pty. , Ltd. | 2004-12-15 |
| VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM (K043333) | Vital Images, Inc. | 2004-12-15 |
| SOMATOM CARE CONTRAST CT (K043087) | Siemens Medical Solutions USA, Inc. | 2004-12-15 |
| NEWPORT C250 AIR COMPRESSOR MODEL C250 (K041406) | Newport Medical Instruments | 2004-12-15 |
| SCENIUM (K042863) | Siemens Molecular Imaging, Ltd. | 2004-12-15 |
| TORPICALGIN (K043131) | Zhermack S.P.A. | 2004-12-15 |
| DIRECT DIGITIZER, REGIUS MODEL 190 (K042386) | Konica Minolta Medical & Graphic, Inc. | 2004-12-15 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 (K043153) | Intuitive Surgical, Inc. | 2004-12-15 |
| ANEMIAPRO SELF-SCREENER (K042379) | Biosafe Laboratories, Inc. | 2004-12-15 |
| INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 (K042592) | American Medical Systems, Inc. | 2004-12-14 |
| POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 (K042481) | Sophysa SA | 2004-12-14 |
| PLLA CANNULATED INTERFERENCE SCREW (K032830) | Advanced Biomaterials | 2004-12-14 |
| SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (K043190) | Innova Life Sciences Corp. | 2004-12-14 |
| EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES (K040671) | Anthogyr | 2004-12-14 |
| ULTRALIGHT II ND:YAG LASER SYSTEM (K041011) | Sandstone Medical Technologies, LLC | 2004-12-14 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K042962) | Medtronic Sofamor Danek | 2004-12-14 |
| BIO-CORE INTERFERENCE SCREW (K042552) | Biomet, Inc. | 2004-12-14 |
| BIOPLUS (K042636) | Berkeley Advanced Biomaterials, Inc. | 2004-12-14 |
| MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 (K042785) | Nidek, Inc. | 2004-12-14 |
| OPUS MINIMAGNUM ANCHOR WITH INSERTER (K042584) | Opus Medical, Inc. | 2004-12-14 |
| SYSTEMP.C&B PLUS (K042820) | Ivoclar Vivadent, Inc. | 2004-12-14 |
| ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR (K043337) | Arthrex, Inc. | 2004-12-14 |
| DAPTOMYCIN (K042392) | Ab Biodisk | 2004-12-13 |
| VYSIS AUTOVYSION SYSTEM (DEN040010) | Vysis | 2004-12-13 |
| EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE (K042772) | Ebi, L.P. | 2004-12-13 |
| BIOCARE SYSTEMS PREMIR 818 (K042532) | Biocare Systems, Inc. | 2004-12-13 |
| OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (K033973) | Nellcor Puritan Bennett, Inc. | 2004-12-13 |
| TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES (K043278) | Teratech Corp. | 2004-12-13 |
| METRX WORKSTATION (K043134) | Medical Metrx Solutions, Inc. | 2004-12-13 |
| ML830 LASER SYSTEM (K041364) | Microlight Corporation of America | 2004-12-13 |
| HELICOBACTER PYLORI IGG ELISA (K041238) | Biohit Plc | 2004-12-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM (K042963) | bioMerieux, Inc. | 2004-12-13 |
| WHEELCHAIR, MODEL 8500-II (K043332) | Cycling and Health Tech. Industry R&D Center | 2004-12-13 |
| ALL FLOW PULMONARY FUNCTION FILTER (K043148) | Alliance Tech Medical, Inc. | 2004-12-13 |
| MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM (K043062) | Source-Ray, Inc. | 2004-12-13 |
| PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 (K043092) | Progeny, Inc. | 2004-12-13 |
| REUSABLE STERILCONTAINER FILTER MODEL #JK090 (K041623) | Aesculap, Inc. | 2004-12-13 |
| 6F Z4 GUIDE CATHETER (K042489) | Medtronic Vascular | 2004-12-13 |
| PROMEDICAL SURGICAL GOWNS (K042111) | Promedical Products Co., Ltd. | 2004-12-10 |
| PERIARTICULAR LOCKING PLATES, 2358 SERIES (K043227) | Zimmer, Inc. | 2004-12-10 |
| PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 (K043287) | Micromedical Devices, Inc. | 2004-12-10 |
| PANALIGHT-BLU, MODEL 4175 (K043164) | Dusa Pharmaceuticals, Inc. | 2004-12-10 |
| UNICRYL M (K042285) | United Medical Industries Co. , Ltd. | 2004-12-10 |
| K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241) | Kamiya Biomedical Co. | 2004-12-10 |
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| ENZYGNOST F+2 (MONOCLONAL) TEST KIT (K042687) | Dade Behring, Inc. | 2004-12-10 |
| CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER (K041833) | Consolidated Machine Corp. | 2004-12-10 |