| SYNTHES ORACLE PLATE (K091159) | Synthes Spine | 2009-07-10 |
| SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM (K091689) | Synthes (Usa) | 2009-07-10 |
| LITHO LASER SYSTEM (K091909) | Quanta System Spa | 2009-07-09 |
| H-WAVE SPORT (K081998) | Electronic Waveform Laboratory, Inc. | 2009-07-09 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091523) | Shijiazhuang Century Plastic Co., Ltd. | 2009-07-09 |
| MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES (K091057) | Masimo Corporation | 2009-07-09 |
| AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 (K091793) | Aga Medical Corp. | 2009-07-09 |
| SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM (K091044) | Spinal USA | 2009-07-09 |
| NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 (K083130) | Perkinelmer, Inc. | 2009-07-09 |
| REFRESH OPTIVE LENS COMFORT REWETTING DROPS (K083812) | Allergan, Inc. | 2009-07-09 |
| SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (K091515) | Novadaq Technologies, Inc. | 2009-07-09 |
| DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM (K091219) | Allez Spine, LLC | 2009-07-09 |
| DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K091941) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-07-09 |
| XPERT C. DIFFICILE (K091109) | Cepheid | 2009-07-09 |
| EASY.TOUCH INSULIN SYRINGE (K091474) | Masters Healthcare, LLC | 2009-07-09 |
| RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 (K090165) | Masimo Corporation | 2009-07-09 |
| AIRCAST VENAFLOW ELITE SYSTEM (K091700) | Djo, LLC | 2009-07-09 |
| XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (K082871) | Sis Ltd., Surgical Instrument Systems | 2009-07-09 |
| OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S (K091224) | Somanetics Corp. | 2009-07-09 |
| RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 (K091470) | Smith & Nephew, Inc. | 2009-07-09 |
| ALARIS PC UNIT, MODELS 8000 AND 8015 (K091308) | Cardinal Health 303,Inc. | 2009-07-09 |
| ECSCOPE 200 (K091397) | Dyansys, Inc. | 2009-07-08 |
| FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) (K091681) | Entellus Medical, Inc. | 2009-07-08 |
| AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM (K091882) | MicroVention, Inc. | 2009-07-08 |
| ONCE-A-DAY VERTOS TEST PACK (K082620) | Propper Mfg. Co., Inc. | 2009-07-08 |
| REST ASSURED GENERATION II DENTAL PROTECTOR (K091792) | Ranir Corporation | 2009-07-08 |
| ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K091189) | Alphatec Spine, Inc. | 2009-07-08 |
| POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K091431) | Zibo Yusheng Plastic Products Co., Ltd. | 2009-07-08 |
| TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 (K090479) | Tanita Corporation of America | 2009-07-07 |
| SMARTSCREENER-PLUS2 (K090579) | Intelligent Hearing Systems | 2009-07-07 |
| PACSMATE, MODEL MMD-4300C/MMD-4300CX (K091687) | Iei Technology Corp. | 2009-07-07 |
| ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K090779) | Alphatec Spine, Inc. | 2009-07-07 |
| STREAMER POLYMER GUIDEWIRE (K083094) | Brivant, Ltd. | 2009-07-07 |
| MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (K090670) | Midmark Corp. | 2009-07-07 |
| PACS PLUS 5TH EDITION (K083658) | Medical Standard Co., Ltd. | 2009-07-07 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM (K091783) | Avantis Medical Systems, Inc. | 2009-07-07 |
| CORTEX DENTAL IMPLANT SYSTEM (K090709) | Cortex Dental Implants Industries , Ltd. | 2009-07-07 |
| POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR (K090194) | Shen Wei (Usa), Inc. | 2009-07-07 |
| MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) (K091694) | Tag Medical Products | 2009-07-07 |
| TIGRT MLC, TIGRT DMLC (K090802) | Linatech, LLC | 2009-07-07 |
| POWER STANDING DANI (K090256) | Davismade, Inc. | 2009-07-06 |
| HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 (K091482) | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2009-07-06 |
| ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 (K090901) | Osmetech Molecular Diagnostics | 2009-07-06 |
| MEDICAL TREATMENT CHAIR, T400, T500,T600 (K091727) | Fresenius Medical Care South Asia Pacific Pty , Ltd. | 2009-07-06 |
| MITAKA UNIARM (K090792) | Mitaka Kohki Co., Ltd. | 2009-07-06 |
| C.T.M. MOBILITY SCOOTER, HS-528 (K090735) | C.T.M. Homecare Product, Inc. | 2009-07-06 |
| BECE PRESS (K090434) | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 2009-07-06 |
| BANTAM (K091242) | Altimate Medical, Inc. | 2009-07-06 |
| FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 (K091723) | Freedom Sciences, LLC | 2009-07-06 |
| C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION (K091418) | C.T.M. Homecare Product, Inc. | 2009-07-06 |
| DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) (K090851) | Byrne Medical, Inc. | 2009-07-02 |
| MODIFICATION TO: NUVASIVE SPHERX SYSTEM (K090981) | Nuvasive, Inc. | 2009-07-02 |
| OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM (K090522) | Osteomed LP | 2009-07-02 |
| KOWA VX-10 A (K091683) | Kowa Co. , Ltd. | 2009-07-02 |
| DESTINY MAX COAGULATION ANALYZER (K083896) | Trinity Biotech | 2009-07-02 |
| SMITH & NEPHEW INSTRUMENT TRAYS (K091627) | Smith & Nephew, Inc. | 2009-07-02 |
| EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST (K091596) | Evalve, Inc. | 2009-07-02 |
| BD FLU+ SYRINGE (K091377) | Becton, Dickinson & CO | 2009-07-02 |
| MAMMOSITE II RADIATION THERAPY SYSTEM (K091378) | Hologic, Inc. | 2009-07-02 |
| AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 (K091007) | Sorin Group Deutschland GmbH | 2009-07-02 |
| CALCANEAL FRACTURE PLATE SYSTEM (K090582) | Tornier, Inc. | 2009-07-02 |
| VORTEX CANNULA (K091304) | Vortex Medical, Inc. | 2009-07-02 |
| BIS CLICK SENSOR/CABLE (K091854) | Aspect Medical Systems, Inc. | 2009-07-02 |
| ELECSYS PRECICONTROL UNIVERSAL (K090541) | Roche Diagnostics | 2009-07-02 |
| MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM (K083004) | Aesculap Implant Systems, Inc. | 2009-07-02 |
| ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE (K090554) | Boston Scientific Corp | 2009-07-02 |
| BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES (K083686) | Anhui Kangda Medical Products Co., Ltd. | 2009-07-02 |
| SPECTRANETICS TURBO-TANDEM SYSTEM (K091299) | Spectranetics Corp. | 2009-07-01 |
| PINNACLE STAIR WAY LIFT (K091858) | Summit Harmar, LLC | 2009-07-01 |
| APTUS 2.0/2.3 FOUR CORNER FUSION PLATE (K090983) | Medartis AG | 2009-07-01 |
| SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS (K090336) | Sunmax Enterprise Shanghai Co. , Ltd. | 2009-07-01 |
| BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER (K091670) | Becton, Dickinson & CO | 2009-07-01 |
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K083689) | B.Braun Medical, Inc. | 2009-07-01 |
| S12X WITH ESAX OPTION (K082629) | Chatten Associates, Inc. | 2009-07-01 |
| POLARIS SPINAL SYSTEM (K090523) | Ebi, L.P. | 2009-07-01 |
| CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (K090613) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-07-01 |
| REACTION SYSTEM (K090221) | Viora , Ltd. | 2009-07-01 |
| FLAATZ 500 (K091747) | Drtech Corp. | 2009-07-01 |
| RPL/CPL VERTICAL PLATFORM LIFTS (K091881) | Harmar Summit, LLC | 2009-07-01 |
| THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 (K091855) | Belmont Instrument Corp. | 2009-07-01 |
| MERCURY SPINAL SYSTEM (K091587) | Spinal Elements, Inc. | 2009-07-01 |
| INFLATABLE BONE TAMP (K090211) | Cardinal Health, Inc. | 2009-07-01 |
| ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD (K081923) | Glaxosmithkline Consumer Healthcare | 2009-07-01 |
| PLATELIA TOXO IGM KIT MODEL 26211 (K090847) | Bio-Rad Laboratories | 2009-07-01 |
| MINIME PEDIATRIC MASK (K090935) | Sleepnet Corporation | 2009-07-01 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K091816) | Boston Scientific Corporation | 2009-07-01 |
| IDR (K082450) | Icrco, Inc. | 2009-06-30 |
| PARCUS GRAFT FIXATION SYSTEM (K090923) | Parcus Medical, LLC | 2009-06-30 |
| UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 (K091391) | Uroplasty, Inc. | 2009-06-30 |
| SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION (K090268) | Shimadzu Corp. | 2009-06-30 |
| RETINA CAMERA TRC-NW7SF MARK II (K090115) | Topcon Corp. | 2009-06-30 |
| REGIONAL OXIMETER SYSTEM, MODEL 7600 (K090807) | Nonin Medical, Inc. | 2009-06-30 |
| HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) (K091641) | MicroVention, Inc. | 2009-06-30 |
| CONTRA-ANGLE HANDPIECE KOMET OS30 (K090548) | W&H Dentalwerk Buermoos GmbH | 2009-06-30 |
| ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM (K090565) | Globus Medical, Inc. | 2009-06-30 |
| INERTIA PEDICLE SCREW SYSTEM (K090984) | Nexxt Spine, LLC | 2009-06-30 |
| ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM (K090596) | Zimmer, Inc. | 2009-06-30 |
| XPRESSE INJECTION SYSTEM (K083583) | Nordson Efd | 2009-06-30 |
| NEWDEAL COMPRESSION PLATE (K091609) | Newdeal Sas | 2009-06-30 |
| HANSO ACUPUNCTURE NEEDLE (K090910) | Hansol Medical Co. | 2009-06-30 |