| STRAUMANN DENTAL IMPLANT SYSTEM (K081419) | Institut Straumann AG | 2009-02-20 |
| CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB (K083786) | Corpak Medsystems | 2009-02-20 |
| CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS (K090133) | Cook, Inc. | 2009-02-20 |
| NEUROSCAPE (K083491) | Olea Medical | 2009-02-19 |
| PRESCISION OPTION (K082775) | Siemens Medical Solutions USA, Inc. | 2009-02-19 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) (K083600) | Quantum Co., Ltd. | 2009-02-19 |
| ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 (K083009) | Stryker Leibinger GmbH & Co KG | 2009-02-19 |
| MAC 800 RESTING ECG ANALYSIS SYSTEM (K090212) | Ge Medical Syst. Information Technologies | 2009-02-19 |
| ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS (K083497) | Zimmer, Inc. | 2009-02-19 |
| JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT (K083488) | Audifon-USA, Inc. | 2009-02-19 |
| MODIFICATION TO AUTO-BAND LIGATOR (K083556) | Scandimed International | 2009-02-19 |
| ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 (K090296) | Biodex Medical Systems, Inc. | 2009-02-19 |
| SMOOTHSHAPES (K083629) | Eleme Medical, Inc. | 2009-02-19 |
| ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K090276) | Siemens Medical Solutions USA, Inc. | 2009-02-19 |
| CARDITTE MICROTEL (K082124) | Et Medical Devices Spa | 2009-02-19 |
| EMS AIR-FLOW MASTER (K082791) | E.M.S Electro Medical Systems S.A | 2009-02-18 |
| GELPORT SINGLE INCISION ACCESS SYSTEM (K090275) | Applied Medical Resources Corp. | 2009-02-18 |
| NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM (K083252) | Dentalez Group, Stardental Division | 2009-02-18 |
| ANATOMIC LOCKING PLATING SYSTEM (K082300) | DePuy Orthopaedics, Inc. | 2009-02-18 |
| COTTONS 100% NATURAL COTTON TAMPONS (K080733) | Cottons Pty, Ltd. | 2009-02-18 |
| QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 (K082117) | Maquet Cardiopulmonary, AG | 2009-02-18 |
| AXXION LIGHT GUIDE (K082992) | Spinal Elements, Inc. | 2009-02-18 |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |
| VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K083383) | bioMerieux, Inc. | 2009-02-18 |
| MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) (K083262) | Siemens Healthcare Diagnostics | 2009-02-18 |
| APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) (K082468) | Omni Life Science, Inc. | 2009-02-18 |
| ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS (K083735) | Medtechs, LLC | 2009-02-18 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 (K083855) | Acumen Medical, Inc. | 2009-02-17 |
| RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (K082921) | Rad Source Technologies, Inc. | 2009-02-17 |
| TRIMIRA IDENTAFI 3000 (K090135) | Remicalm, LLC | 2009-02-17 |
| NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 (K090202) | Ncontact Surgical, Inc. | 2009-02-17 |
| PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE (K083259) | Tangshan Zhongying Plastic Products Co., Ltd. | 2009-02-17 |
| MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639) | Ge Medical Systems Information Technologies | 2009-02-17 |
| ECHELON C MRI SYSTEM (K083533) | Hitachi Medical Systems America, Inc. | 2009-02-17 |
| THE IC-PRO SYSTEM, MODEL VERSION 3.2 (K083745) | Paieon, Inc. | 2009-02-17 |
| REVAC AUTO RETRACTABLE SAFETY SYRINGE (K083193) | Revolutions Medical Corporation, Inc. | 2009-02-13 |
| CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE (K082930) | Cardiva Medical, Inc. | 2009-02-13 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K090016) | Suqian Clean Glove Co., Ltd. | 2009-02-13 |
| METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 (K083469) | Metasurg | 2009-02-13 |
| CARDIAC TRIGGER, MODEL: CTM300 (K083854) | Ivy Biomedical Systems, Inc. | 2009-02-13 |
| AIRSTRIP OB (K090269) | Airstrip Technologies, LP | 2009-02-13 |
| PALOMAR ASPIRE LASER PLATFORM (K083165) | Palomar Medical Products, Inc. | 2009-02-13 |
| NOBELACTIVE 8.5 MM & 18.0 MM (K083205) | Nobel Biocare AB | 2009-02-13 |
| ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES (K083827) | Biomet Manufacturing Corp | 2009-02-13 |
| LUCENT MAGNUM (K083475) | Spinal Elements, Inc. | 2009-02-13 |
| FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 (K082027) | Genesis Bps, LLC | 2009-02-13 |
| MEDTOXSCAN (K080635) | Medtox Diagnostics, Inc. | 2009-02-13 |
| DRAD30003/RADREX-I (K083503) | Toshiba America Medical Systems, In.C | 2009-02-13 |
| MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT (K082988) | Medivators Reprocessing Systems | 2009-02-13 |
| TACTIPEN (K083457) | Haselmeier GmbH | 2009-02-13 |
| MAMMODIAGNOST VU (K083740) | Philips Medical Systems Nederland B.V. | 2009-02-13 |
| TERUMO ROCSAFE HYBRID PERFUSION SYSTEM (K082321) | Terumo Cardiovascular Systems Corp. | 2009-02-13 |
| BIFIX SE (K083438) | Voco GmbH | 2009-02-13 |
| STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264) | Children'S Health First, Inc. | 2009-02-13 |
| ENDOTRACHEAL TUBE (K080105) | Chilecom Medical Devices Co., Ltd. | 2009-02-13 |
| DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 (K080636) | Hubdic Co., Ltd. | 2009-02-13 |
| ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 (K083309) | Zargis Medical Corp. | 2009-02-13 |
| NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS (K090102) | C.R. Bard, Inc. | 2009-02-12 |
| NUBRACE INVISIBLE REMOVABLE ORTHODONTICS (K073121) | Nubrace, Inc. | 2009-02-12 |
| MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 (K090085) | Concentric Medical, Inc. | 2009-02-12 |
| LIQUIBAND ULTIMA, MODEL LB0004 (K083531) | Medlogic Global , Ltd. | 2009-02-12 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K083180) | Avantis Medical Systems, Inc. | 2009-02-12 |
| BELMONT HYPERTHERMIA PUMP (K090089) | Belmont Instrument Corp. | 2009-02-12 |
| SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX (K083742) | Collagen Matrix, Inc. | 2009-02-12 |
| LDR SPINE ROI-C IMPLANT (K083857) | Ldr Spine USA | 2009-02-12 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K083047) | Zibo Wanci Plastic & Rubber Co., Ltd. | 2009-02-12 |
| MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 (K082565) | Microsurgeon, Inc. | 2009-02-12 |
| TORNIER, INC., INSITE SUTURE ANCHORS (K083268) | Tornier, Inc. | 2009-02-12 |
| INFINITI VISION SYSTEM WITH OZIL IP (K082845) | Alcon Research, Ltd. | 2009-02-12 |
| ELECSYS TOXO IGG CALCHECK (K083655) | Roche Diagnostics | 2009-02-12 |
| MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083500) | Dornier Medtech America, Inc. | 2009-02-12 |
| SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT (K083828) | Transoma | 2009-02-11 |
| WATERLASE MD (K090181) | Biolase Technology, Inc. | 2009-02-11 |
| NEOSS PROACTIVE IMPLANT (K083561) | Neoss, Ltd. | 2009-02-11 |
| KERATEC WOUND DRESSINGS (K080949) | Keratec Limited | 2009-02-11 |
| CD4 COUNT (K083926) | Streck | 2009-02-11 |
| RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 (K080436) | Quantrx Biomedical Corporation | 2009-02-11 |
| COLON VIEW, MODEL CSCV-001A (K090220) | Toshibamedical Systems Corporation | 2009-02-11 |
| 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (K090103) | Biomet, Inc. | 2009-02-11 |
| AXXENT SURFACE APPLICATOR, MODEL 710257 (K083734) | Xoft, Inc. | 2009-02-11 |
| NEO MAPCATH SENSOR STYLET (K083121) | Corpak Medsystems | 2009-02-11 |
| HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (K082129) | The Binding Site, Ltd. | 2009-02-10 |
| DLMS-ZIRBLOCKS (K082137) | Dental Milling Laboratory Supplies (Dlms) | 2009-02-10 |
| EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS (K090101) | C.R. Bard, Inc. | 2009-02-10 |
| PRO QR ADVANCED FORMULA POWDER (K080210) | Biolife, LLC | 2009-02-10 |
| FLUOROCORE 2 (K083326) | Dentsply International, Inc. | 2009-02-10 |
| BLOOD TUBING SETS (STERILE FLUID PATH) (K090255) | Nxstage Medical, Inc. | 2009-02-10 |
| HUMANSCAN M5S-D ULTRASOUND TRANSDUCER (K083824) | Humanscan Company, Ltd. | 2009-02-10 |
| N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE (K082428) | Best Glove, Inc. | 2009-02-10 |
| HALO ABLATION CATHETER (K083737) | Barrx Medical, Incorporated | 2009-02-10 |
| CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) (K083468) | I-Sens, Inc. | 2009-02-10 |
| VASCUTEK CANNULA GRAFT, MODEL CGS2008S (K081560) | Vascutek, Ltd. | 2009-02-10 |
| POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES (K083624) | Comfort Rubber Gloves Ind. Sdn. Bhd. | 2009-02-10 |
| MODIFICATION TO DEPUY NEUFLEX PIP FINGER (K083107) | DePuy Orthopaedics, Inc. | 2009-02-09 |
| TENSCARE ITOUCH MODEL(S) EASY AND PLUS (K082377) | Tenscare, Ltd. | 2009-02-09 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082690) | Hebei Handform Plastic Products Co., Ltd. | 2009-02-09 |
| INTRAMEDULLARY FIXATION ROD (IFS) (K083458) | Novalign Orthopaedics, Inc. | 2009-02-09 |
| SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM (K082371) | Smith & Nephew, Inc. | 2009-02-09 |
| BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER (K083006) | Biopsy Sciences, LLC | 2009-02-09 |
| STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 (K082772) | Life-Tech, Inc. | 2009-02-09 |