| COMPEX SPORT PLUS (K083140) | Chattanooga Group | 2009-02-09 |
| MASTERGRAFT RESORBABLE CERAMIC GRANULES (K082918) | Medtronic Sofamor Danek | 2009-02-09 |
| TEMPOSIL 2 (K083304) | Coltene/Whaledent AG | 2009-02-06 |
| ECHOTIP ULTRA ULTRASOUND NEEDLE (K083330) | Cook Endoscopy | 2009-02-06 |
| CORRIDOR FIXATION SYSTEM (K083442) | Globus Medical, Inc. | 2009-02-06 |
| EQ-PRC LC WARFARIN GENOTYPING KIT (K073071) | Trimgen Corporation | 2009-02-06 |
| CRYOVALVE SG PULMONARY VALVE AND CONDUIT (K083106) | Cryolife, Inc. | 2009-02-06 |
| APLIO ARTIDA V2.0 SSH-880CV (K090158) | Toshiba America Medical Systems, In.C | 2009-02-06 |
| HI-TORQUE VERSACORE GUIDE WIRE (K083706) | Abbott Vascular | 2009-02-06 |
| ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES (K081398) | Advanced Medical Innovations, Inc. | 2009-02-06 |
| GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ (K082462) | Diamond Diagnostics, Inc. | 2009-02-06 |
| CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX (K082268) | Oridion Capnography, Inc. | 2009-02-06 |
| MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 (K083447) | Memometal Technologies | 2009-02-06 |
| ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM (K082825) | Energist, Ltd. | 2009-02-06 |
| MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP (K081463) | Medel S.P.A. | 2009-02-06 |
| FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN (K082727) | Vitrolife Sweden AB | 2009-02-06 |
| BIOEMG III (K082927) | Bio-Research Associates, Inc. | 2009-02-06 |
| MEDTRONIC ANGIOGRAPHIC GUIDE WIRES (K082873) | Medtronic Vascular | 2009-02-06 |
| CLEARCORRECT (K082556) | Clearcorrect, Inc. | 2009-02-06 |
| INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES (K090159) | Incisive Surgical, Inc. | 2009-02-06 |
| RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (K090040) | Terumo Medical Corp. | 2009-02-06 |
| BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES (K080987) | Bridgepoint Medical | 2009-02-06 |
| AWBAT-S, AWBAT-D, AWBAT-M (K082869) | Aubrey, Inc. | 2009-02-06 |
| MODEL PC-860 FETAL DOPPLER (K082055) | Shenzhen Creative Industry Co., Ltd. | 2009-02-06 |
| FREEDOM TOTAL KNEE SYSTEM (K082019) | Maxx Orthopedics, Inc. | 2009-02-06 |
| STANDARD WHEELCHAIR PLATFORM (K073565) | Design Specific , Ltd. | 2009-02-06 |
| DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE (K081888) | Spineart | 2009-02-06 |
| KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED (K081886) | Karex Industries Sdn. Bhd. | 2009-02-06 |
| 6F TAIGA GUIDING CATHETER (K083422) | Medtronic Vascular | 2009-02-06 |
| SMART DILATOR (K082995) | Safestitch Medical | 2009-02-06 |
| RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (K081927) | Renu Medical, Inc. | 2009-02-06 |
| PORTABLE X-RAY SYSTEM, MODEL DXR -1 (K082875) | Exaro Co., Ltd. | 2009-02-05 |
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K090173) | Neusoft Medical Systems Co., Ltd. | 2009-02-05 |
| TENS-EMS-14 (K083030) | Emsi | 2009-02-05 |
| NUOVOGUARD (K090122) | U.S. Safety Syringes Co., Inc. | 2009-02-05 |
| SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM (K083439) | Synthes (Usa) | 2009-02-05 |
| ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX (K083684) | Manufacturing & Research, Inc. | 2009-02-05 |
| BIODRIVE CANNULATED SCREW SYSTEM (K082874) | Biomet Trauma | 2009-02-05 |
| NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER (K082833) | Nutek Orthopaedics, Inc. | 2009-02-05 |
| SICAT IMPLANT (K090119) | Sicat GmbH & Co. KG | 2009-02-05 |
| GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (K082082) | Gish Biomedical, Inc. | 2009-02-04 |
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |
| GORE FLOW REVERSAL SYSTEM (K083300) | W. L. Gore & Associates, Inc. | 2009-02-04 |
| MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE (K083523) | Merit Medical Systems, Inc. | 2009-02-04 |
| SURGIMEND (K083898) | Tei Biosciences, Inc. | 2009-02-04 |
| FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F (K083034) | Fotona D.D. | 2009-02-04 |
| IRRISEPT WOUND CLEANSING SYSTEM (K080779) | Irrimax Corporation | 2009-02-04 |
| EEA HEMORRHOID STAPLER & ACCESSORIES (K083781) | Surgical Devices, A Global Business Unit Covidien | 2009-02-04 |
| ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (K083153) | Hollister, Inc. | 2009-02-04 |
| PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (K080910) | Bioimagene, Inc. | 2009-02-04 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082691) | Hebei Handform Plastic Products Co., Ltd. | 2009-02-04 |
| SPYSCOPE ACCESS AND DELIVERY CATHETER (K090170) | Boston Scientific Corp | 2009-02-04 |
| MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (K082150) | Preanalytix GmbH | 2009-02-04 |
| GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (K081947) | Gish Biomedical, Inc. | 2009-02-04 |
| GELX ORAL GEL (K081372) | Bmg Pharma, LLC | 2009-02-04 |
| MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM (K082407) | Sandstone Medical Technologies, LLC | 2009-02-03 |
| CROSSOVER (K083269) | Thomas Medical Products, Inc. | 2009-02-03 |
| X-CAL (K083200) | Streck | 2009-02-03 |
| BLAZER DX-20 DIAGNOSTIC CATHETER (K081576) | Boston Scientific Corp | 2009-02-03 |
| SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002) | Sysmex America, Inc. | 2009-02-03 |
| ASAHI CORSAIR MICROCATHETER (K083127) | Asahi Intecc Co., Ltd. | 2009-02-03 |
| MEDONIC M SERIES (K083420) | Boule Medical AB | 2009-02-03 |
| COULTER BODY FLUID CONTROL (K082162) | Beckman Coulter, Inc. | 2009-02-03 |
| JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 (K083265) | Agamatrix, Inc. | 2009-02-03 |
| DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K082400) | Culligan Soft Water Service Co. | 2009-02-03 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM (K083287) | Corventis, Inc. | 2009-02-03 |
| MEDPOR CUSTOMIZED SURGICAL IMPLANT (K083621) | Porex Surgical, Inc. | 2009-02-03 |
| AIDERA DIASEND (K083221) | Aidera AB | 2009-02-03 |
| MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 (K083711) | Barrx Medical, Incorporated | 2009-02-02 |
| BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 (K090027) | Zen Strong Medical Technology Co., Ltd. | 2009-02-02 |
| MS SYSTEM (K083067) | Osstem Implant Co., Ltd. | 2009-02-02 |
| LDR SPINE ROI INTERBODY FUSION SYSTEM (K082262) | Ldr Spine USA | 2009-02-02 |
| CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (K083338) | Seaspine, Inc. | 2009-02-02 |
| NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 (K083667) | B-K Medical Aps | 2009-02-02 |
| EQUASHIELD SYSTEM (K083152) | Plastmed, Ltd. | 2009-02-02 |
| WILDCAT 7F GUIDEWIRE SUPPORT CATHETER (K083313) | Avinger, Inc. | 2009-02-02 |
| IPULSE, MODEL: I150 (K083748) | Cyden Limited | 2009-02-02 |
| IMMULITE 2000 FREE T4 (K083373) | Siemens Healthcare Diagnostics, Inc. | 2009-02-02 |
| ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 (K083918) | Advanced Technology Laser Co., Ltd. | 2009-02-02 |
| CADSTREAM, VERSION 5.0 (K081556) | Confirma, Inc. | 2009-02-02 |
| KAT IMPLANT SYSTEM (K083544) | Kat Implants, LLC | 2009-02-02 |
| VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (K080708) | Gish Biomedical, Inc. | 2009-02-02 |
| OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM (K090091) | Mylad Orthopedic Solutions, LLC | 2009-02-01 |
| SMITH & NEPHEW PEEK INTERFERENCE SCREW (K083226) | Smith & Nephew Endoscopy, Inc. | 2009-01-30 |
| SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (K083635) | Smith & Nephew Endoscopy, Inc. | 2009-01-30 |
| RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP (K083771) | Clarity Medical Systems | 2009-01-30 |
| NITI-S ESOPHAGEAL STENT (K080782) | Taewoong Medical Co., Ltd. | 2009-01-30 |
| CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS (K083496) | Altatec GmbH | 2009-01-30 |
| MYLABFIVE (K083882) | Esaote Europe B.V. | 2009-01-30 |
| PREMIER CAMPY, MODEL 618096 (K083464) | Meridian Bioscience, Inc. | 2009-01-30 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK (K083717) | Gx Corporation Sdn Bhd | 2009-01-30 |
| MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083258) | Dornier Medtech America, Inc. | 2009-01-30 |
| ALL-IN-ONE CONTAINER (K090096) | Baxter Healthcare Corporation | 2009-01-30 |
| IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (K090023) | Well-Life Healthcare Limited | 2009-01-30 |
| PATIENT ISOLATION UNIT, MODEL G019-1000 (K080117) | Gentex Corporation | 2009-01-30 |
| AIR SONIC SCALER (K083059) | Dpm USA Corp. | 2009-01-30 |
| S-TEST C-REACTIVE PROTEIN (CRP) (K083040) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 |
| NOVEL SPINAL SYSTEM (K081153) | Medyssey Co, Ltd. | 2009-01-30 |
| ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM (K083286) | OrthoPediatrics Corp. | 2009-01-30 |
| FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 (K082482) | Taidoc Technology Corporation | 2009-01-30 |