| PIONEER U601 SERIES ASPIRATOR (K052650) | Merits Health Products Co., Ltd. | 2005-11-04 |
| SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. (K052182) | Shian Jia Meei Enterprise Co., Ltd. | 2005-11-04 |
| SYNGO NEURO DSA CT (K053024) | Siemens AG | 2005-11-04 |
| MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM (K052456) | Blue Sky Medical Group Incorporated | 2005-11-04 |
| MILTEX LIGATING CLIP (K052018) | Miltex, Inc. | 2005-11-04 |
| LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 (K050407) | Sciences For Bio Materials | 2005-11-04 |
| MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K052791) | Invatec Innovative Technologies, S.R.L. | 2005-11-04 |
| SYNTHES (USA) SPHERICAL WASHERS (K052483) | Synthes (Usa) | 2005-11-04 |
| CRYPTOSPORIDIUM II (K052932) | Techlab, Inc. | 2005-11-04 |
| PRIMECHAIR (K052496) | Dalton Medical Corp. | 2005-11-04 |
| OZONE GENERATOR (K043207) | Ge Infrastructure Water & Process Technologies | 2005-11-04 |
| KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (K051061) | Kronus Market Development Associates, Inc. | 2005-11-04 |
| GENEROS 80, GENEROS 60 (K051914) | Berkeley Advanced Biomaterials, Inc. | 2005-11-03 |
| PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS (K052435) | Pneumrx, Inc. | 2005-11-03 |
| MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM (K052541) | Avant Medical Systems | 2005-11-03 |
| MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE (K052704) | Invivo Corp. | 2005-11-03 |
| NOVABONE-BIOACTIVE SYNTHETIC GRAFT (K052494) | Novabone Products, LLC | 2005-11-03 |
| KOWA GENESIS-D HAND-HELD RETINAL CAMERA (K050271) | Kowa Co. , Ltd. | 2005-11-03 |
| ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT (K052736) | Arthrex, Inc. | 2005-11-03 |
| REGIUS MODEL 170 DIRECT DIGITIZER (K051998) | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 |
| ECLIPSE TREATMENT PLANNING SYSTEM (K050296) | Varian Medical Systems | 2005-11-03 |
| MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 (K052095) | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 |
| KIMBA SPINAL IMPLANT (K052533) | Signus Medizintechnik GmbH | 2005-11-03 |
| ASCENSION MUH (K052137) | Ascension Orthopedics, Inc. | 2005-11-03 |
| NAVIGATION SW HIP 3.1 ON CI (K052213) | Brainlab AG | 2005-11-02 |
| ASAHI ANGIOGRAPHIC CATHETER (K051561) | Asahi Intecc Co., Ltd. | 2005-11-02 |
| Y2K2 ENTERNAL TUBE FLUID FILTER (K051206) | Moss Medical Products | 2005-11-02 |
| INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 (K052801) | Philips Medizin Systeme Boeblingen GmbH | 2005-11-02 |
| EZ-MIO MANUAL DRIVER (K052195) | Vidacare Corporation | 2005-11-02 |
| DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS (K051799) | Coeur, Inc. | 2005-11-02 |
| LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS (K052722) | Hospira, Inc. | 2005-11-02 |
| SAUFLON FLAT COLOURED LENS CASE (K052809) | Sauflon Pharmaceuticals, Ltd. | 2005-11-02 |
| DATEX-OHMEDA S/5 INTERFACE MODULE E-INT (K052880) | GE Healthcare | 2005-11-02 |
| ABSOLUTE AMERICA (K050571) | Eurodent S.P.A. | 2005-11-02 |
| MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS (K052253) | Gambro Renal Products | 2005-11-02 |
| VISUCAM PRO NM (K052268) | Carl Zeiss Meditec, AG | 2005-11-02 |
| TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR (K052507) | The Lagado Corp. | 2005-11-02 |
| ABL80 FLEX ANALYZER (K051804) | Sendx Medical, Inc. | 2005-11-01 |
| F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT (K052470) | Shanghai Fimet Medical Instrument Co., Ltd. | 2005-11-01 |
| DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM (K052756) | GE Healthcare | 2005-11-01 |
| BIS EEG MONITOR, MODEL BISX4 (K052981) | Aspect Medical Systems, Inc. | 2005-11-01 |
| MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS (K052827) | Medrad, Inc. | 2005-11-01 |
| CARDIOSERVER (K052883) | Datrix | 2005-11-01 |
| QMS AMIKACIN REAGENTS (K052815) | Seradyn, Inc. | 2005-11-01 |
| EVENFLO ELAN BREAST PUMP (K052909) | Evenflo Company, Inc. | 2005-11-01 |
| CP BRACKET SYSTEM (K052370) | Dentsply International | 2005-11-01 |
| MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE (K052802) | Manan Medical Products, Inc. | 2005-11-01 |
| SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) (K052775) | Siemens AG Medical Solutions | 2005-10-31 |
| PATHFORMER (K052770) | Path Scientific, LLC | 2005-10-31 |
| 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (K052979) | Isolux, LLC | 2005-10-31 |
| NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E (K052890) | Siam Sempermed Corp., Ltd. | 2005-10-31 |
| ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM (K052911) | Medison Co., Ltd. | 2005-10-31 |
| SLIMMANAGER, MODEL SM-X, SM-E (K051589) | Aiia Communication, Inc. | 2005-10-31 |
| VP SHEATH (K051580) | Flowcardia, Inc. | 2005-10-31 |
| WATER FILLED TEETHER (K052105) | Royal Industries (Thailand) Public Co. , Ltd. | 2005-10-31 |
| DSNARE, MODEL 00711087 (K051637) | United States Endoscopy Group, Inc. | 2005-10-31 |
| SIMILE FLOW (K052106) | Pentron Clinical Technologies | 2005-10-31 |
| MIM 3.5 (CIRCA) (K052379) | Mimvista Corp. | 2005-10-31 |
| CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (DEN050006) | Cardiomems, Inc. | 2005-10-28 |
| STARSPEED SERIES CT SCANNER SYSTEMS (K052855) | GE Healthcare | 2005-10-28 |
| XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (K052112) | Excel Tech. , Ltd. | 2005-10-28 |
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |
| MODIFICATION TO:CD HORIZON SPINAL SYSTEM (K052747) | Medtronic Sofamor Danek | 2005-10-28 |
| BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) (K052028) | Bonart Co., Ltd. | 2005-10-28 |
| RESPCARE FACE MASK (K052227) | Respcare, Inc. | 2005-10-28 |
| CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 (K052473) | Inter Medical Medizintechnik GmbH | 2005-10-28 |
| UNI-VENT MODEL 73X (K051476) | Impact Instrumentation, Inc. | 2005-10-28 |
| MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (K052713) | Sechrist Industries, Inc. | 2005-10-28 |
| OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI (K050233) | Omron Healthcare, Inc. | 2005-10-28 |
| HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (K051276) | Richard Wolf Medical Instruments Corp. | 2005-10-28 |
| ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET (K052982) | Roche Diagnostics | 2005-10-28 |
| WRIST FUSION PLATE (K052754) | Dvo Extremity Solutions, LLC | 2005-10-27 |
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341) | Bio-Rad Laboratories, Inc. | 2005-10-27 |
| QUANTA LITE M2 EP (MIT3) ELISA (K052262) | Inova Diagnostics, Inc. | 2005-10-27 |
| MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX (K052783) | Boston Scientific Corp | 2005-10-27 |
| FOURSIGHT VIEWTOOL IMAGE VIEWER (K052895) | Siemens Medical Solutions USA, Inc. | 2005-10-27 |
| MINXRAY, MODEL HF100H+ (K052721) | Minxray, Inc. | 2005-10-27 |
| VYGON MICRO-ACCESS SAFETY INTRODUCER KIT (K051248) | Vygon Corp. | 2005-10-27 |
| MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191) | Veridex, LLC | 2005-10-27 |
| ORTHOPEDIC SALVAGE SYSTEM- OSS (K052685) | Biomet, Inc. | 2005-10-27 |
| N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 (K043383) | Physion, Inc. | 2005-10-27 |
| VCS, MODEL S4T (K052558) | Cycling and Health Tech. Industry R&D Center/Chc | 2005-10-27 |
| STOMA BONE SCREW (K051871) | Storz AM Mark GmbH | 2005-10-27 |
| VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (K052904) | Scientific Imaging, Inc. | 2005-10-27 |
| V40 BIOLOX DELTA CERAMIC FEMORAL HEADS (K052718) | Howmedica Osteonics Corp. | 2005-10-27 |
| SURGICAL FACE MASK (K050689) | China Surgical Dressings Center Co., Ltd. | 2005-10-26 |
| GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM (K051721) | Global Orthopaedic Technology, USA, Inc. | 2005-10-26 |
| INFRARED THERMOMETER, FDIR-V1 (K052849) | Famidoc Technology Co., Ltd. | 2005-10-26 |
| FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 (K052073) | Schutz-Dental GmbH | 2005-10-26 |
| AIMSTICK URINE REAGENT STRIPS (K051727) | Germaine Laboratories, Inc. | 2005-10-26 |
| GII SPINAL FIXATION SYSTEM (K051089) | Co-Ligne AG | 2005-10-26 |
| RAVE COMPOSITE BRACKET (K052714) | FDA Agents | 2005-10-26 |
| SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K052346) | Dade Behring, Inc. | 2005-10-26 |
| MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR (K052884) | Toshiba America Medical Systems, In.C | 2005-10-26 |
| PERIPRO PATCH (K052416) | Hancock/Jaffe Laboratories | 2005-10-25 |
| SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS (K050394) | Medtox Diagnostics, Inc. | 2005-10-25 |
| ATRICURE TRANSPOLAR SYSTEM (K052893) | AtriCure, Inc. | 2005-10-25 |
| HERACERAM ZIRKONIA (K052543) | Heraeus Kulzer, Inc. | 2005-10-25 |
| OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM (K051656) | Osteobiologics, Inc. | 2005-10-25 |
| SENTINEL CLIN CHEM CAL (K051452) | Sentinel Ch. Srl | 2005-10-25 |