| DEPUY GLOBAL AP CTA HUMERAL HEAD (K082715) | DePuy Orthopaedics, Inc. | 2008-12-18 |
| STERILE FIELD SALINE PRE-FILLED SYRINGE(S) (K082837) | Excelsior Medical Corp. | 2008-12-18 |
| WOUND FLUSH, STERILE WATER & NORMAL SALINE (K083042) | Nurse Assist, Inc. | 2008-12-18 |
| BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 (K080172) | Medicult A/S | 2008-12-18 |
| MODIFICATION TO T2 RECON NAIL SYSTEM (K083437) | Howmedica Osteonics Corp. | 2008-12-18 |
| VIKY (K082233) | Endocontrol | 2008-12-18 |
| ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS (K082527) | Zimmer, Inc. | 2008-12-18 |
| ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM (K082809) | Lumenis, Inc. | 2008-12-18 |
| PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498) | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 |
| SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES (K082625) | Synthes (Usa) | 2008-12-17 |
| PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K081412) | Hospira, Inc. | 2008-12-17 |
| FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE (K083610) | 3M Company | 2008-12-17 |
| GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) | Maquet Cardiovascular, LLC | 2008-12-17 |
| SYMPHONY METER REMOTE (K082590) | Lifescan, Inc. | 2008-12-17 |
| CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE (K082783) | Smiths Medical MD, Inc. | 2008-12-17 |
| STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) (K082344) | Sorin Group Deutschland GmbH | 2008-12-17 |
| TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 (K081498) | Biocomfort Diagnostics GmbH & Co. KG | 2008-12-17 |
| FLOWPICC CATHETER (K082481) | Vasonova, Inc. | 2008-12-17 |
| FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM (K081715) | Taidoc Technology Corporation | 2008-12-17 |
| POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K080794) | Polyvue Distribution, Inc. | 2008-12-17 |
| A-DEC 334/335 DELIVERY SYSTEM (K082985) | A-Dec, Inc. | 2008-12-17 |
| INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 (K081788) | Innochips Technology Co., Ltd. | 2008-12-17 |
| NOVATION 12/14 CEMENTED FEMORAL STEMS (K083392) | Exactech, Inc. | 2008-12-17 |
| REPROCESSED ENT SHAVERS (K081814) | Sterilmed, Inc. | 2008-12-17 |
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |
| BARD PTFE (TEFLON) COATED GUIDE WIRES (K082094) | C.R. Bard Inc., Bard Electrophysiology Division | 2008-12-17 |
| HEMOSTASYL PASTE (K082116) | Satelec | 2008-12-17 |
| MODIFICATION TO MINISPIR, SPIROLAB III (K082766) | Mir Medical Intl. Research Srl | 2008-12-17 |
| MIS CREST WIDENER (K080458) | Mis - Implant Technologies , Ltd. | 2008-12-17 |
| THROMBO TEK PSE, MODEL 90-480 (K082631) | R2 Diagnostics, Inc. | 2008-12-17 |
| PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 (K082180) | Angelus Industria DE Productos Odontologicos | 2008-12-17 |
| STASYS MOTION CORRECTION SOFTWARE (K082904) | Digirad Corp. | 2008-12-17 |
| ML24000 UVA-1 PHOTOTHERAPY CABINET (K082731) | Daavlin Distributing Co. | 2008-12-17 |
| ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM (K081165) | Spineart | 2008-12-17 |
| INVISALIGN SYSTEM (K081960) | Align Technology | 2008-12-17 |
| SKINCLEAR Q-SWITCHED ND:YAG LASER (K083272) | Global USA Distribution, LLC | 2008-12-16 |
| NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM (K082724) | Newport Medical Instruments, Inc. | 2008-12-16 |
| MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (K080741) | Megadyne Medical Products, Inc. | 2008-12-16 |
| STRYKER VIDEOSCOPE (K082451) | Stryker Endoscopy | 2008-12-16 |
| TOGGLELOC SYSTEM (K083070) | Biomet Sports Medicine | 2008-12-16 |
| BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (K083063) | Mennen Medical , Ltd. | 2008-12-16 |
| NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 (K083538) | Neuronetics | 2008-12-16 |
| INTROL CF PANEL I CONTROL, MODEL: G106 (K083171) | Maine Molecular Quality Controls, Inc. | 2008-12-16 |
| TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 (K082210) | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 |
| PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION (K083555) | Emsoma Co., Ltd. | 2008-12-16 |
| UNITED U2 TOTAL KNEE SYSTEM (K082424) | United Orthopedic Corp. | 2008-12-16 |
| SYSTEM-ARMS, MODELS 390, X60 (K083164) | Bio-Medical Research, Ltd. | 2008-12-16 |
| NEURO III-SV (K083137) | Imris, Inc. | 2008-12-16 |
| MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS (K082278) | Ethicon Endo-Sugery, LLC | 2008-12-16 |
| VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (K081929) | Greiner Bio-One North America, Inc. | 2008-12-16 |
| CHEETAH RELIANT (K083093) | Cheetah Medical, Inc. | 2008-12-15 |
| EOS SPINAL SYSTEM (K082509) | Korea Bone Bank Co., Ltd. | 2008-12-15 |
| EMBOZENE MICROSPHERES (K073417) | Celonova Biosciences, Inc. | 2008-12-15 |
| MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (K083335) | Omnisonics Medical Technologies | 2008-12-15 |
| AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K083211) | Surgiquest, Inc. | 2008-12-15 |
| SEDAT FLAMINGO (K082755) | Sedat | 2008-12-15 |
| SHARPS COMPLIANCE CONTAINER (K083129) | Sharps Compliance, Inc. | 2008-12-15 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 (K083402) | St Jude Medical | 2008-12-15 |
| CENEFOM PVA SURGICAL SPEAR (K082460) | Longtek Scientific Co., Ltd. | 2008-12-15 |
| VISIONSENSE STEREOSCOPIC VISION SYSTEM (K082355) | Visionsense, Ltd. | 2008-12-15 |
| HEARTRAK SMART ECAT (K083535) | Universal Medical, Inc. | 2008-12-15 |
| BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (K082705) | Biopro, Inc. | 2008-12-15 |
| DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (K082224) | Shimadzu Medical Systems | 2008-12-15 |
| DISTRAX (K080542) | John W. King | 2008-12-15 |
| COMBOCARE 2000 (K083202) | Xanacare Technologies, LLC | 2008-12-15 |
| MARVEL WHEELCHAIR, MODEL EDCAL01 (K082970) | Rogue Wheels, Inc. | 2008-12-12 |
| DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K083505) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-12-12 |
| D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 (K083370) | Artegraft, Inc. | 2008-12-12 |
| STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER (K082248) | Diagnostica Stago, Inc. | 2008-12-12 |
| VISAGE PACS, VERSION 6.0/CS 3.1 (K082269) | Visage Imaging, Inc. | 2008-12-12 |
| 9131 DEFIBRILLATION ELECTRODES (K082090) | Cardiac Science Corporation | 2008-12-12 |
| HUBANG, MODEL HBL13/HBG12-S (K083044) | Shanghai Hubang Medical Appliances Co., Ltd. | 2008-12-12 |
| FROG (K072831) | Newby-Coombs, LLC | 2008-12-12 |
| CPS AIM SL SLITTABLE INNER CATHETER (K082932) | St Jude Medical | 2008-12-12 |
| CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE (K083379) | Cynosure, Inc. | 2008-12-12 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K082382) | Possis Medical, Inc. | 2008-12-12 |
| MODEL TSX-301B AQUILION CT SYSTEM (K083282) | Toshiba America Medical Systems, In.C | 2008-12-12 |
| PROLITE III TOWER AND PR AND HR HANDPIECE (K081095) | Quantel S.A. | 2008-12-12 |
| PRIMATRIX DERMAL REPAIR SCAFFOLD (K083440) | Tei Biosciences, Inc. | 2008-12-12 |
| TRIMIRA OCS 3000 (K082603) | Remicalm, LLC | 2008-12-12 |
| SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (K082795) | Interventional Spine, Inc. | 2008-12-12 |
| GE DISCOVERY NM/CT 570C (K083504) | Ge Medical Systems F.I. Haifa | 2008-12-12 |
| TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 (K081852) | Truly Instrument Limited | 2008-12-12 |
| IBA PROTON THERAPY SYSTEM- PROTEUS 235 (K082416) | Ion Beam Applications S.A. | 2008-12-12 |
| CONSERVE PRESSFIT FEMORAL COMPONENT (K082673) | Wrightmedicaltechnologyinc | 2008-12-12 |
| 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 (K083364) | DePuy Orthopaedics, Inc. | 2008-12-11 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY (K081825) | Becton, Dickinson & CO | 2008-12-11 |
| CLAMPFIX (K082914) | Synthes Spine | 2008-12-11 |
| IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (K070541) | Ivivi Technologies, Inc. | 2008-12-11 |
| BEAUTIBOND (K082744) | Shofu Dental Corp. | 2008-12-11 |
| CAPSURE(R) PS SYSTEM (K083353) | Spine Wave, Inc. | 2008-12-11 |
| CHAPERON GUIDING CATHETER (K082385) | MicroVention, Inc. | 2008-12-11 |
| SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K082559) | Spectranetics Corp. | 2008-12-11 |
| BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES (K081972) | Nitritex (M) Sdn. Bhd. | 2008-12-11 |
| ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL (K082770) | Zimmer, Inc. | 2008-12-11 |
| EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X (K083560) | Lighthouse Technical Innovations, Inc. | 2008-12-11 |
| MESA AND RANGE SPINAL SYSTEMS (K082769) | K2m, Inc. | 2008-12-11 |
| CUSTOM COMFORT NIGHTGUARD (K083400) | Den Tek Oral Care, Inc. | 2008-12-11 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824) | Becton, Dickinson & CO | 2008-12-11 |
| BIONET BM3PLUS PATIENT MONITOR (K082008) | Bionet Co., Ltd. | 2008-12-11 |