| CD HORIZON SPINAL SYSTEM (K102807) | Medtronic Sofamor Danek, Inc. | 2010-11-17 |
| MOUNTAINEER OCT SPINAL SYSTEM (K103100) | Depuy Spine, Inc. | 2010-11-17 |
| DIODE LASER THERAPY SYSTEM (K102669) | China Daheng Group, Inc. | 2010-11-17 |
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K102650) | Accuray Incorporated | 2010-11-17 |
| POWERPICC SV CATHETERS (K102159) | C.R. Bard, Inc. | 2010-11-17 |
| ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668) | BIOMERIEUX | 2010-11-17 |
| CONCENTRIC BALLOON GUIDE CATHETER (K102657) | Concentric Medical, Inc. | 2010-11-17 |
| BGM GALECTIN -3 (K093758) | Bg Medicine, Inc. | 2010-11-17 |
| CD HORIZON SPINAL SYSTEM (K102555) | Medtronic Sofamor Danek USA, Inc. | 2010-11-17 |
| CHITOGAUZE (K102546) | Hem Con Medical Technologies, Inc. | 2010-11-17 |
| SA FLOWABLE ADHESIVE (K102603) | Dmg USA, Inc. | 2010-11-17 |
| MUCOGRAFT (K102531) | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010-11-17 |
| PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) (K101436) | Shen Wei (Usa), Inc. | 2010-11-17 |
| LAPAROSCOPIC DISSECTOR (K103282) | Applied Medical Resources Corp. | 2010-11-16 |
| PTFE PORTABLE INTRODUCER (K102540) | Great Batch Medical | 2010-11-16 |
| MINIATURIZE CHEST COMPRESSOR (MCC) (K102068) | Resuscitation International | 2010-11-16 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102171) | Wuxi Bingfa Gainlite Gloves Cp., Ltd. | 2010-11-16 |
| DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 (K100565) | Bio-Detek, Inc. | 2010-11-16 |
| SCALP DURA RETRACTOR, MODEL KS00474 (K093054) | KARL STORZ Endoscopy-America, Inc. | 2010-11-15 |
| VIPER F2 FACET FIXATION SYSTEM (K101762) | Depuy Spine, Inc. | 2010-11-15 |
| MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K100888) | Lanx, Inc. | 2010-11-15 |
| PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR (K102326) | Parcus Medical, LLC | 2010-11-15 |
| CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT (K103215) | Cianna Medical | 2010-11-15 |
| CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM (K102204) | Choicespine, LP | 2010-11-15 |
| CONSTELLATION VISION SYSTEM (K101285) | Alcon Manufacturing, Ltd. | 2010-11-12 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K102558) | Tangshan Hengda Plastic Products Co., Ltd. | 2010-11-12 |
| ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 (K101174) | AtriCure, Inc. | 2010-11-12 |
| WELCH ALLYN 1500 PATIENT MONITOR (K101619) | Schiller AG | 2010-11-12 |
| VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 (K102626) | Vega Technologies, Inc. | 2010-11-12 |
| DIO STEADY EXTERNAL IMPLANT SYSTEM (K100100) | Dio Corporation | 2010-11-10 |
| POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 (K101106) | Best Putra Gloves Sdn Bhd | 2010-11-10 |
| FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS (K100797) | Edan Instruments, Inc. | 2010-11-10 |
| EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS (K103012) | Exactech, Inc. | 2010-11-10 |
| VONFLEX HEAVY, VINFLEX LIGHT (K103164) | Vericom Co., Ltd. | 2010-11-10 |
| NIVO NEBULIZER SYSTEM (K102240) | Aerogen Ireland, Ltd. | 2010-11-10 |
| SILK'N FLASH N GO (K103184) | Home Skinovations , Ltd. | 2010-11-10 |
| V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE (K103052) | Covidien, LLC | 2010-11-10 |
| BIOSIGN FLU A+B (K083746) | Princeton BioMeditech Corp. | 2010-11-10 |
| THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 (K101912) | Hubdic Co., Ltd. | 2010-11-10 |
| EDGE CO2 LASER SYSTEM (K100590) | Jm System Co., Ltd. | 2010-11-10 |
| POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 (K101105) | Best Putra Gloves Sdn Bhd | 2010-11-10 |
| BLOOD SAMPLING SET (K103165) | Acacia, Inc. | 2010-11-10 |
| PARCUS PEEK CF PUSH-IN SUTURE ANCHOR (K102162) | Parcus Medical, LLC | 2010-11-10 |
| IMPROVIS IMAGING SYSTEM (K101654) | American Dental Partners, Inc. | 2010-11-10 |
| ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS (K102445) | Rostam , Ltd. | 2010-11-10 |
| MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS (K102344) | Philips Medical Systems Nederland B.V. | 2010-11-09 |
| KIRSCHNER WIRES, STEINMAN PINS (K102215) | Evergreen Orthopedic Research Lab | 2010-11-09 |
| RANDOX METABOLITE (EDDP) ASSAY (K092258) | Randox Laboratories, Ltd. | 2010-11-09 |
| ELECTRONIC BLOOD PRESURE MONITOR (K102988) | Shenzhen Pango Electronic Co., Ltd. | 2010-11-09 |
| LOCKING COMPRESSION PLATE (K101400) | Changzhou Orthmed Medical Instrument Co., Ltd. | 2010-11-09 |
| ATRAUMATIC VASCULAR CLAMPS (K102048) | Geomed Medizin-Technik GmbH & Co. KG | 2010-11-09 |
| KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM (K102666) | Kimberly-Clark Corp. | 2010-11-09 |
| AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM (K103007) | Tornier, Inc. | 2010-11-09 |
| INTERFACE (K092541) | Biostructures | 2010-11-09 |
| CARE ZY5BA OXYGEN CONCENTRATOR (K102245) | Foshan Care Medical Technology Co., Ltd. | 2010-11-09 |
| AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM (K103003) | Aesculap, Inc. | 2010-11-09 |
| EMATRIX CO2 (K101321) | Syneron Medical, Ltd. | 2010-11-09 |
| DPL NUVE (K101382) | Led Technologies, LLC | 2010-11-09 |
| VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR (K103041) | Greiner Bio-One North America, Inc. | 2010-11-09 |
| MODIFICATION TO: OASYS SYSTEM (K101183) | Stryker Spine | 2010-11-09 |
| SEQURE SNARE SYSTEM (K102484) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2010-11-09 |
| SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER (K101808) | Medshape Solutions | 2010-11-08 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (K102337) | Curon Scientific Co., Ltd. | 2010-11-08 |
| SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES (K101943) | Tangshan Jiteng Plastic Products Co., Ltd. | 2010-11-08 |
| GRANDIO SO HEAVY FLOW (K102354) | Voco GmbH | 2010-11-08 |
| MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS (K102073) | Benlan, Inc. | 2010-11-08 |
| NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 (K102487) | Exactech, Inc. | 2010-11-08 |
| DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (K102581) | Byrne Medical, Inc. | 2010-11-08 |
| CAM STRUCTSURE BARS (K101582) | Biomet 3i, Inc. | 2010-11-08 |
| LIFE SPINE INTERSPINOUS FIXATION SYSTEM (K100407) | Life Spine | 2010-11-05 |
| NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE (K102975) | Exactech, Inc. | 2010-11-05 |
| ENDOSKELETON TO (K102067) | Titan Spine, LLC | 2010-11-05 |
| LIFENET SYSTEM (K102757) | Physio-Control, Inc. | 2010-11-05 |
| IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER (K102527) | Boston Scientific Corporation | 2010-11-05 |
| HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538) | Philips Electronics UK Limited | 2010-11-05 |
| APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (K102820) | Alphatec Spine, Inc. | 2010-11-05 |
| EXPLORER 4D TREATMENT PLANNING SYSTEM (K101220) | American Radiosurgery, Inc. | 2010-11-05 |
| COMPACT TOUCH STS (K102198) | Quantel Medical S.A. | 2010-11-05 |
| VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM (K102393) | Ge Medical System Israel , Ltd. | 2010-11-05 |
| PARIETEX PLUG AND PATCH (K101519) | Sofradim Production | 2010-11-05 |
| EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) (K102951) | Exactech, Inc. | 2010-11-04 |
| VIVID I DIAGNOSTIC ULTRASOUND SYSTEM (K102388) | Ge Medical System Israel , Ltd. | 2010-11-04 |
| RELIANCE SPINAL SCREW SYSTEM (K101112) | Reliance Medical Systems | 2010-11-04 |
| HEPARIN DOSE RESPONSE CARTRIDGE (K102953) | Medtronic, Inc. | 2010-11-04 |
| INTEGRITY MODEL 1014284 (K102200) | Elekta , Ltd. | 2010-11-04 |
| SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 (K102967) | Smith & Newphew, Inc. | 2010-11-04 |
| KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102631) | Andon Health Co, Ltd. | 2010-11-04 |
| DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 (K102409) | Byrne Medical, Inc. | 2010-11-04 |
| STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING (K102500) | Cardinal Health, Inc. | 2010-11-04 |
| K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR (K102994) | Kawasumi Laboratories, Inc. | 2010-11-03 |
| SPIDER FLEX MONOPOLAR HOOK (K102646) | Transenterix, Inc. | 2010-11-03 |
| GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (K100364) | Gambro Renal Products, Inc. | 2010-11-03 |
| OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB (K102372) | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2010-11-03 |
| CLEARFLUX DIALYZER REPROCESSING SYSTEM (K091360) | Novaflux Technologies | 2010-11-03 |
| MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) (K102072) | Memometal Technologies | 2010-11-03 |
| PRONTOSAN ANTIMICROBIAL WOUND GEL (K101882) | B.Braun Medical, Inc. | 2010-11-03 |
| DISCOVERY NM 750B (K102231) | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102093) | Shijiazhuang Great Vision Plastic Products Co., LT | 2010-11-03 |
| OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (K102478) | Southwest Technologies, Inc. | 2010-11-03 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K102865) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-11-03 |