| ARSTASIS ACCESS SYSTEM (K102728) | Arstasis, Inc. | 2010-10-07 |
| ELECSYS IGE CALCHECK 5 (K102269) | Roche Diagnostics | 2010-10-07 |
| DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE (K092973) | Bionen S.A.S. | 2010-10-07 |
| TELERADPRO (K102476) | Vidar Systems Corp. | 2010-10-07 |
| IMMULISA MPO ANTIBODY ELISA (K092599) | Immco Diagnostics, Inc. | 2010-10-07 |
| D2RF DIGITAL DYNAMIC REMOTE SYSTEM (K102529) | Stephanix Radiological Systems | 2010-10-07 |
| ORTHOPANTOMOGRAPH OP300 (K093683) | Instrumentarium Dental, Palodex Group OY | 2010-10-06 |
| ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES (K101760) | Profit Point Manufacturing Sdn Bhd | 2010-10-06 |
| ACUMED WRIST ARTHRODESIS PLATE SYSTEM (K100123) | Acumed, LLC | 2010-10-06 |
| INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (K102277) | Vertebral Technologies, Inc. | 2010-10-06 |
| CRYOMEGA (K102006) | Stc Consulting, LLC | 2010-10-06 |
| PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES (K102092) | Prestige Ameritech | 2010-10-06 |
| HSV STRAW (K092398) | Cryo Bio System | 2010-10-06 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102099) | Hong DI Plastic Products Co., Ltd. | 2010-10-06 |
| CONSENSUS CS2 PLUS ACETABULAR INSERT (K100933) | Consensus Orthopedics, Inc. | 2010-10-06 |
| GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102089) | Grand Work Plastic Products Co., Ltd. | 2010-10-06 |
| PARADIGM INTERSPINOUS FUSION PLATE (K093438) | Paradigm Spine, LLC | 2010-10-06 |
| TDS PRECISION DENTAL BAR (K100356) | Pou YU Biotechnology Co., Ltd. | 2010-10-05 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| JOURNEY UNICONDYLAR TIBIAL BASEPLATES (K102069) | Smith & Nephew, Inc. | 2010-10-05 |
| MIE SCINTRON GAMMA CAMERA SYSTEMS (K101768) | Miegmbh | 2010-10-05 |
| ELECSYS CEA CALCHECK 5 (K101856) | Roche Diagnostics | 2010-10-05 |
| ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (K102596) | Atrium Medical Corp. | 2010-10-05 |
| ANTI-HAV (K100903) | Roche Professional Diagnostics | 2010-10-05 |
| IMC SURGICAL DRAPE (K100991) | International Medsurg Connection | 2010-10-05 |
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K093893) | Idev Technologies, Inc. | 2010-10-05 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102094) | Grand Work Plastic Products Co., Ltd. | 2010-10-05 |
| GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND (K102256) | Ge Medical Systems China Co., Ltd. | 2010-10-05 |
| IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO (K101813) | Imris, Inc. | 2010-10-05 |
| DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 (K093816) | Medien International Co, Ltd. | 2010-10-05 |
| RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 (K101657) | Boston Scientific Corp | 2010-10-05 |
| SYNGO DYNAMICS, VERSION 9.0 (K102150) | Siemens Medical Solutions USA, Inc. | 2010-10-05 |
| GE LOGIQ P6/P6 PRO (K101874) | GE Healthcare | 2010-10-05 |
| GE ECHOPAC MODEL BT10 (K101324) | Ge Vingmed Ultrasound AS | 2010-10-05 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 (K101809) | Fujirebio Diagnostics,Inc. | 2010-10-05 |
| XTRA AUTOTRANSFUSION SYSTEM (K101586) | Sorin Group Italia S.R.L. | 2010-10-05 |
| ZIP'R MANTIS POWERED WHEELCHAIR (K102355) | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010-10-04 |
| MIRADA RT (K102687) | Mirada Medical, Ltd. | 2010-10-04 |
| ZIP'R3/ ZIP'R3 XTRA SCOOTER (K102358) | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010-10-04 |
| STRETCH VINYL EXAMINATION GLOVE POWDER FREE (K102160) | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-04 |
| KAIYANG ALUMINUM WHEELCHAIR (K101998) | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010-10-04 |
| NO!NO! SKIN (K102477) | Radiancy (Israel) , Ltd. | 2010-10-04 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102362) | Jiangsu Huayuan Gloves Co., Ltd. | 2010-10-04 |
| KAIYANG STEEL WHEELCHAIR (K101999) | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010-10-04 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K102096) | Syntex Healthcare Products Co., Ltd. | 2010-10-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102431) | Tangshan Fuqiang Glove Co., Ltd. | 2010-10-04 |
| EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) (K101598) | Exact Medical Manufacturing, Inc. | 2010-10-04 |
| LUMANOSITY CELEBRITY, MODEL 204 (K100213) | Lumanosity, Inc. | 2010-10-04 |
| CASPIAN SPINAL SYSTEM (K101084) | K2m, Inc. | 2010-10-04 |
| POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101828) | Gx Corporation Sdn Bhd | 2010-10-04 |
| AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM (K092723) | Skeletal Dynamics, LLC | 2010-10-04 |
| TRUSIGNAL SPO2 FINGERTIP SENSOR (K101871) | GE Healthcare Finland Oy | 2010-10-04 |
| ZIP'R4/ ZIP'R4 XTRA SCOOTER (K102361) | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010-10-04 |
| WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (K101148) | Cincinnati Sub-Zero Products, Inc. | 2010-10-01 |
| ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (K101831) | Bionostics, Inc. | 2010-10-01 |
| PERFADEX AND PERFADEX WITH THAM (K091989) | Xvivo Perfusion AB | 2010-10-01 |
| BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT (K101849) | Bicon, LLC | 2010-10-01 |
| SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA (K101223) | Heidelberg Engineering | 2010-10-01 |
| ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS (K101622) | Zimmer, Inc. | 2010-10-01 |
| MAGNETOM AERA; MAGNETOM SKYRA (K101347) | Siemens Medical Solutions USA, Inc. | 2010-10-01 |
| XIO RTP SYSTEM (K102216) | Computerized Medical Systems, Inc. | 2010-10-01 |
| TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT (K101880) | Zimmer Dental, Inc. | 2010-10-01 |
| XELIS DENTAL (K102684) | Infinitt Co., Ltd. | 2010-10-01 |
| GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K102104) | Wipro GE Healthcare Private, Ltd. | 2010-10-01 |
| 3D SCANNER, MODEL 1230 (K101992) | Sun Nuclear Corp. | 2010-10-01 |
| DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM (K100042) | Difusion Technologies | 2010-10-01 |
| MICROMED PD-8K INSULATION DEFECT DETECTOR (K101606) | Mcgan Technology, LLC | 2010-10-01 |
| 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM (K101528) | 3M Company | 2010-10-01 |
| ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837) | Zeus Scientific, Inc. (Zeus) | 2010-10-01 |
| CALYPSO SYSTEM WITH DYNAMIC EDGE GATING (K102373) | Calypso Medical Technologies, Inc. | 2010-09-30 |
| PRIMALOK FACET FIXATION SYSTEM (K102438) | Osteomed LP | 2010-09-30 |
| MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS (K102156) | Orthohelix Surgical Designs, Inc. | 2010-09-30 |
| PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE (K101200) | Given Imaging , Ltd. | 2010-09-30 |
| SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM (K102090) | Spine Smith Partners L.P. | 2010-09-30 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K093107) | Siemens Healthcare Diagnostics | 2010-09-30 |
| A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K101337) | Sonoscape Company Limited | 2010-09-30 |
| M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 (K102495) | Philips Medical Systems | 2010-09-30 |
| TSRH(R) SPINAL SYSTEM (K101772) | Medtronic Sofamor Danek | 2010-09-30 |
| EP NAVIGATOR R3 (K101311) | Philips Medical Systems North America Co. | 2010-09-30 |
| ZOLL PROPAQ MD (K102468) | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 |
| P200MAAF (K102492) | Optos Plc. | 2010-09-30 |
| AIM 200, MAJOR SURGICAL LIGHT (K101537) | Burton Medical Products Corp. | 2010-09-30 |
| FAT CONCENTRATION SYSTEM (K100114) | Biomet, Inc. | 2010-09-29 |
| CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) | Hema Metrics, LLC | 2010-09-29 |
| AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (K101958) | Amsino International, Inc. | 2010-09-29 |
| C2000 POWERED WHEELCHAIR (K101524) | Otto Bock Healthcare LP | 2010-09-29 |
| LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM (K102265) | Ldr Spine USA | 2010-09-29 |
| CRYOBALLOON ABLATION SYSTEM (K101825) | C2 Therapeutics | 2010-09-29 |
| PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) (K101869) | Silmet , Ltd. | 2010-09-29 |
| DEPUY UNIVERSAL GRIPTION TF CONES (K100391) | DePuy Orthopaedics, Inc. | 2010-09-29 |
| EBERLE SHAVER SYSTEM ACCESSORIES (K092977) | Efs Eberle Feinwerktechnische Systeme | 2010-09-29 |
| RELAY POWER WHEELCHAIR (K101611) | Dalton Instrument Corp. | 2010-09-29 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956) | Encore Medical L.P. | 2010-09-28 |
| MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS (K102716) | Alma Lasers, Inc. | 2010-09-28 |
| SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) (K100112) | Sonoma Orthopedic Products, Inc. | 2010-09-28 |
| VITEK 2 YEAST CASPOFUNGIN (K101566) | bioMerieux, Inc. | 2010-09-28 |
| LUXATEMP ULTRA /STAR (K101710) | Dmg USA, Inc. | 2010-09-28 |
| K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (K093137) | Kamiya Biomedical Co. | 2010-09-28 |
| POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550) | Polymedco, Inc. | 2010-09-28 |
| APEX KNEE MODULAR TIBIA SYSTEM (K101994) | Omnlife Science | 2010-09-28 |