| CUFFALERT (K081805) | Sunmed | 2008-11-14 |
| OBC BONE ANCHORED HEARING AID SYSTEM (K082108) | Oticon Medical AB | 2008-11-14 |
| SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE (K081986) | Oscor, Inc. | 2008-11-14 |
| GENEX (K082381) | Biocomposites, Ltd. | 2008-11-14 |
| CENTRICITY PACS WEB DIAGNOSTIC (K083018) | Ge Healthcare Dynamic Imaging Solutions | 2008-11-14 |
| RHAPSODY MRI (K082126) | Grantadler Corporation | 2008-11-13 |
| EZLASE 10W (K083069) | Biolase Technology, Inc. | 2008-11-13 |
| MODIFICATION TO: NUVASIVE SPHERX II SYSTEM (K083028) | Nuvasive, Inc. | 2008-11-13 |
| BONART ART-L5 LED CORDLESS CURING LIGHT (K082971) | Bonart Co., Ltd. | 2008-11-13 |
| EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392) | Advanced Sterilization Products | 2008-11-13 |
| SRI LP GOWN (K080723) | Sri/Surgical Express, Inc. | 2008-11-13 |
| LEP2000 THERAPY SYSTEM (K073689) | International Medical Instruments, Inc. | 2008-11-13 |
| BIOLOK MICRO-LOK IMPLANT SYSTEM (K081818) | BioHorizons Implant Systems, Inc. | 2008-11-13 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |
| BIOMET ANTERIOR LUMBAR PLATE (K082187) | Ebi, L.P. | 2008-11-13 |
| SERISCAFFOLD SURGICAL MESH (K080442) | Serica Technologies, Inc. | 2008-11-13 |
| COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (K082803) | Percutaneous Systems, Inc. | 2008-11-13 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K083035) | Sicel Technologies, Inc. | 2008-11-13 |
| SRI PLR GOWN (K080707) | Sri/Surgical Express | 2008-11-13 |
| A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR (K082734) | A&D Engineering, Inc. | 2008-11-13 |
| D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 (K083190) | Vascular Solutions, Inc. | 2008-11-12 |
| BENACEL, MODELS C-001, C-002 AND C-005 (K080532) | Unicare Biomedical, Inc. | 2008-11-12 |
| DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B (K082763) | Diazyme Laboratories | 2008-11-12 |
| SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503) | Advanced Medical Solutions Limited | 2008-11-12 |
| RHAPSODY CT (K081889) | Grantadler Corporation | 2008-11-12 |
| AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE (K082762) | Aardvark Medical | 2008-11-12 |
| MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K082457) | Ansell Healthcare Products, Inc. | 2008-11-10 |
| LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687) | DiaSorin, Inc. | 2008-11-10 |
| PROGENIX (K082463) | Medtronic Sofamor Danek | 2008-11-10 |
| VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 (K082412) | Mapquet Cardiopulmonary AG | 2008-11-10 |
| NEXUS I.V. FLUID TRANSFER DEVICE (K080976) | Nexus Medical, LLC | 2008-11-10 |
| FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (K082641) | Contec Medical System Co., Ltd. | 2008-11-10 |
| BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY (K082876) | Sharplight Technologies, Ltd. | 2008-11-10 |
| HOLLYWOOD, PACIFICA, REDONDO, VENTURA (K082310) | Seaspine, Inc. | 2008-11-10 |
| TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC (K080771) | Top Corp. | 2008-11-10 |
| CLUE MEDICAL AND CLUE MEDICAL BASIC (K082013) | Telovital GmbH Telemedizin | 2008-11-10 |
| SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES (K082624) | Synthes (Usa) | 2008-11-10 |
| SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM (K082335) | Synthes (Usa) | 2008-11-10 |
| COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) (K082606) | D3 Radiation Planning | 2008-11-10 |
| TELECTRODE WET GEL ECG ELECTRODE (K083148) | Bio Protech, Inc. | 2008-11-07 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K082475) | Medtronic, Inc. | 2008-11-07 |
| MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL (K082627) | Minxray, Inc. | 2008-11-07 |
| NOX T3, NOXTURNAL (PC APPLICATION) (K082113) | Nox Medical | 2008-11-07 |
| CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR (K082369) | Edan Instruments, Inc. | 2008-11-07 |
| DIGITAL CLINICAL THERMOMETER MODEL V9XX (K082266) | Amperor-Electronic(Sz) Co., Ltd. | 2008-11-07 |
| INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER (K082512) | Dimensional Dosing Systems, Inc. | 2008-11-07 |
| PRO HMPV+ ASSAY (K082688) | Prodesse, Inc. | 2008-11-07 |
| 1.5T ATLAS SPEEDER HEAD-NECK COIL (K083160) | Quality Electrodynamics | 2008-11-07 |
| SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072) | Synthes (Usa) | 2008-11-07 |
| ONCENTRA RT VIEWER 1.0 (K082642) | Nucletron Corporation | 2008-11-07 |
| HEALIX TI ANCHOR (K082282) | Depuy Mitek, A Johnson & Johnson Co. | 2008-11-07 |
| AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (K081011) | Arex USA | 2008-11-07 |
| MICROMYST APPLICATOR, MODEL 20-5000 (K082454) | Covidien | 2008-11-07 |
| AIRSONNETT AIRSHOWER AIR 3 (K081062) | Airsonett, Inc. | 2008-11-07 |
| PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS (K082243) | General Medical Merate S.P.A | 2008-11-07 |
| DPL THERAPY SYSTEM (K081570) | Led Technologies, LLC | 2008-11-07 |
| SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM (K083141) | Simpact, LLC | 2008-11-07 |
| ENTERAL PUMP SET, MODEL 20-1010 (K081725) | Viasys Medsystems | 2008-11-07 |
| MOLAR IMPLANT (K081128) | Nobel Biocare AB | 2008-11-07 |
| VANISHPOINT I.V. CATHETER (K081420) | Retractable Technologies, Inc. | 2008-11-07 |
| ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (K082056) | Life-Tech, Inc. | 2008-11-07 |
| TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (K082066) | Cook Urological, Inc. | 2008-11-07 |
| IDI IMPLANT SYSTEM (K081806) | Idi Biomedical, LLC | 2008-11-07 |
| SILS PORT, MODELS SILSPT5, SILSPT12 (K082619) | Covidien Lp, Formerly Registered AS United States | 2008-11-07 |
| MYSTIQUE MB CERAMIC BRACKETS (K082974) | Dentsply Interntional | 2008-11-07 |
| SYNGO MR B17 (K082427) | Siemens Medical Solutions USA, Inc. | 2008-11-07 |
| MYRAY SKYVIEW (K081088) | Cefla S.C. | 2008-11-06 |
| VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE (K083033) | Orthovita, Inc. | 2008-11-06 |
| CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (K080613) | Minimally Invasive Devices, LLC | 2008-11-06 |
| DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS (K082261) | Dxrad Solutions , Ltd. | 2008-11-06 |
| ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE (K081979) | Apatech , Ltd. | 2008-11-06 |
| AGILIS NXT STEERABLE INTRODUCER (K083083) | St Jude Medical | 2008-11-06 |
| HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL (K082987) | Invivo | 2008-11-06 |
| INFINITT CARDIOLOGY PACS (K082706) | Infinitt Co., Ltd. | 2008-11-06 |
| OLYMPUS CHF TYPE V (K081456) | Olympus Medical Systems Corporation | 2008-11-06 |
| OSV II (K081773) | Integra Neurosciences Implants S.A. | 2008-11-06 |
| BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 (K081026) | Sport-Elec S.A. | 2008-11-05 |
| TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 (K082720) | Olympus Medical Systems Corporation | 2008-11-05 |
| INDEPENDENCE SPACER (K082252) | Globus Medical, Inc. | 2008-11-05 |
| ARTHROCARE ARTHROWANDS (K082980) | Arthrocare Corp. | 2008-11-05 |
| COMPONENT NEUROMONITORING SYSTEM (K080217) | Moberg Research, Inc. | 2008-11-05 |
| RETCAM 3 OPHTHALMIC IMAGING SYSTEM (K081858) | Clarity Medical Systems | 2008-11-05 |
| MODIFICATION TO 4CIS VANE SPINE SYSTEM (K081145) | Solco Biomedical Co., Ltd. | 2008-11-05 |
| DARCO SMALL SCREW (K082320) | Wrightmedicaltechnologyinc | 2008-11-05 |
| LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE (K082101) | Sandstone Medical Technologies, LLC | 2008-11-05 |
| DISCOVERY MR450 (K083147) | Ge Medical Systems, LLC | 2008-11-04 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (K080294) | Astoria-Pacific, Inc. | 2008-11-04 |
| OSTEORAPTOR SUTURE ANCHOR (K082215) | Smith & Nephew Inc., Endoscopy Division | 2008-11-03 |
| OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER (K082646) | Usci Ireland | 2008-11-03 |
| ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES (K082078) | Zimmer, Inc. | 2008-11-03 |
| PASSEO-35 PTA CATHETER (K082933) | Biotronik, Inc. | 2008-11-03 |
| LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM (K082050) | DiaSorin, Inc. | 2008-11-03 |
| SONIXTOUCH ULTRASOUND SYSTEM (K083095) | Ultrasonix Medical Corporation | 2008-10-31 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT (K082981) | Cardiovascular Systems, Inc. | 2008-10-31 |
| SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM (K082821) | Spine Smith Partners L.P. | 2008-10-31 |
| IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL (K080057) | Novx Systems, Inc. | 2008-10-31 |
| STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT (K080979) | Biomet Manufacturing Corp | 2008-10-31 |
| STARLIGHT (K082945) | Orthomerica Products, Inc. | 2008-10-31 |
| MODFICATION TO: EXPEDIUM SPINE SYSTEM (K082942) | Depuy Spine, Inc. | 2008-10-31 |
| MASTER3DS (K082410) | E-Woo Technology | 2008-10-31 |