| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102930) | Andon Health Co, Ltd. | 2010-11-03 |
| IOLMASTER 500 (K101182) | Carl Zeiss Meditec, AG | 2010-11-03 |
| FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (K100917) | Biomedical Diagnostics (Bmd) SA | 2010-11-03 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) (K102074) | Gx Corporation Sdn Bhd | 2010-11-02 |
| MUCHECK, VERSION 9.0 (K102583) | Oncology Data Systems, Inc. | 2010-11-02 |
| GRANDIO SO (K102351) | Voco GmbH | 2010-11-02 |
| RANDOX ETHANOL ASSAY (K092273) | Randox Laboratories, Ltd. | 2010-11-01 |
| ELECSYS CA 125 II CALCHECK 5 (K102086) | Roche Diagnostics | 2010-11-01 |
| VASCUCLEAR PRECISION BIPOLAR (K102983) | Sorin Group USA, Inc. | 2010-11-01 |
| FULACCESS MODEL 1.0 (K101707) | Fulcrum Medical, Inc. | 2010-10-29 |
| WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 (K101035) | Wmi Enterprises, LLC | 2010-10-29 |
| MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (K100589) | Bio-Rad | 2010-10-29 |
| COMFORT RUBBER GLOVES IND.SDN.BHD. (K101917) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2010-10-29 |
| ALL-BOUND 3 (K102844) | Bisco, Inc. | 2010-10-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102906) | Andon Health Co, Ltd. | 2010-10-29 |
| 3M INTEGRATED CYCLER (110V) & (220V) (K102314) | Focus Diagnostics, Inc. | 2010-10-29 |
| DX-D 300 (K103050) | Agfa Healthcare N.V. | 2010-10-29 |
| GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE (K101540) | Novocol Inc. Dba Septodont and Confi-Dental Produc | 2010-10-29 |
| REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (K092896) | Nemoto Kyorindo Co., Ltd. | 2010-10-29 |
| GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) (K102905) | Mediguide, Ltd. | 2010-10-29 |
| DIGITAL RETINAL CAMERA (K102013) | Canon Inc. -Medical Equipment Group | 2010-10-29 |
| TI-CORE FLOW (K101504) | Essential Dental Systems, Inc. | 2010-10-29 |
| ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) (K102575) | Do Co., Ltd. | 2010-10-29 |
| ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (K101305) | Ark Diagnostics, Inc. | 2010-10-29 |
| SPEEDFIX SUTURE SYSTEM (K101437) | Arthrocare Corp. | 2010-10-29 |
| GRANDTEC (K102347) | Voco GmbH | 2010-10-29 |
| INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER (K092451) | Intersurgical, Inc. | 2010-10-29 |
| ARROWHEAD FIXATION DEVICE (K100926) | Arrow Products, Inc. | 2010-10-29 |
| DEPUY PINNACLE ALTRX ACETABULAR LINERS (K102423) | DePuy Orthopaedics, Inc. | 2010-10-29 |
| TIGERPAW SYSTEM (K101961) | Laax, Inc. | 2010-10-29 |
| BLADEVIEW (K101042) | Accogent, LLC | 2010-10-29 |
| NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (K092477) | Neurowave Systems, Inc. | 2010-10-29 |
| FDR IMAGE STITCHING OPTION (K101686) | Fujifilm Medical System U.S.A., Inc. | 2010-10-29 |
| POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) (K102655) | Ever Light Plastic Products Co., Ltd. | 2010-10-29 |
| METRO SOFT (K100244) | Metro Optics of Austin, Inc. | 2010-10-28 |
| CVUE ADVANCED DEFINITIVE (K100456) | Unilens Corp., USA | 2010-10-28 |
| COLLEXA (K100574) | Innocoll Pharmaceuticals | 2010-10-28 |
| DEFINITIVE, FLEXLENS - SILICONE HYDROGEL (K100443) | X-Cel Contacts, Inc. | 2010-10-28 |
| NEXFIN MODEL 2 (K101123) | Bmeye B.V. | 2010-10-28 |
| GENESIS IMPLANT SYSTEM (K101545) | Keystone Dental | 2010-10-28 |
| ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (K102138) | Edan Instruments, Inc. | 2010-10-28 |
| ENDOVASCULAR LAER VEIN SYSTEM KIT (K101712) | Biolitec, Inc. | 2010-10-27 |
| HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER (K102901) | Hitachi Medical Systems America, Inc. | 2010-10-27 |
| ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI (K102538) | Jyoti Ceramic Industries Private Limited | 2010-10-27 |
| FM-02 BONE GRAFT SUBSTITUTE (K102545) | Orthovita, Inc. | 2010-10-27 |
| CENTERVUE DIGITAL RETINOGRAPHY SYSTEM (K101935) | Centervue S.P.A. | 2010-10-27 |
| ORGENTEC RHEUMATOID FACTOR EIA (K100499) | Orgentec Diagnostika GmbH | 2010-10-27 |
| PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (K092333) | Bioimagene, Inc. | 2010-10-27 |
| XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS (K101571) | Witt Biomedical Corp | 2010-10-26 |
| ECO-S (K103121) | Vericom Co., Ltd. | 2010-10-26 |
| TSC (K101756) | Kerr Corporation | 2010-10-26 |
| PHTIP DISPOSABLE ISFET CATHETER (K102801) | E-Cath Co., Ltd. | 2010-10-26 |
| EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA (K102420) | Edwards Lifesciences, LLC | 2010-10-26 |
| AUGEASE VASCULAR AUGMENTATION DEVICE (K101355) | Augdvt, LLC | 2010-10-26 |
| MULTI-LEAD TRIALING CABLE MODEL 355531 (K102523) | Medtronic, Inc. | 2010-10-26 |
| TRULIGHT 5520 AND TRULIGHT 5320 (K102758) | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 |
| 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN (K102110) | Foshan Shunde Jaeyong Hardware Co., Ltd. | 2010-10-26 |
| LIGHT CURE RETAINER (K101951) | Reliance Orthodontic Products, Inc. | 2010-10-26 |
| DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 (K100489) | Beckman Coulter Cellular | 2010-10-26 |
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K103010) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 |
| ELEKTA NEUROMAG WITH MAXFILTER (K091393) | Elekta Neuromag OY | 2010-10-26 |
| OSSEOCONDUCT (K101718) | Steiner Laboratories Div of Steiner Healthcare, LLC | 2010-10-26 |
| CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (K101235) | Neos Surgery S.L | 2010-10-25 |
| INFINITI CYP2C19 ASSAY (K101683) | Autogenomics, Incorporated | 2010-10-25 |
| NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE (K093069) | Nxstage Medical, Inc. | 2010-10-23 |
| SIRONA CAD/CAM SYSTEM (K100152) | Sirona Dental Systems GmbH | 2010-10-22 |
| M5 DIAGNOSTIC ULTRASOUND SYSTEM (K102991) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-10-22 |
| DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S (K100248) | Drfp , Ltd. | 2010-10-22 |
| KYPHON ANCHOR FACET SCREW SYSTEM (K101765) | Medtronic Spine, LLC | 2010-10-22 |
| VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM (K102135) | Nuvon, Inc. | 2010-10-22 |
| INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 (K100660) | Innochips Technology Co., Ltd. | 2010-10-22 |
| ARTHREX PUSHLOCK ANCHORS (K101679) | Arthrex, Inc. | 2010-10-22 |
| BLO2X OXYGEN BLOCKER (K102526) | Pascal Co., Inc. | 2010-10-22 |
| CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 (K100744) | Neuwave Medical, Inc. | 2010-10-22 |
| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
| QUANTUM RING FIXATION SYSTEM MODEL ISF (K101759) | Quantum Medical Concepts, LLC | 2010-10-22 |
| SENSEI X ROBOTIC CATHETER SYSTEM (K102168) | Hansen Medical, Inc. | 2010-10-22 |
| DENTACENTER/EXPEDITION, MODEL SAF-430 (K100212) | Safari Dental, Inc. | 2010-10-22 |
| KANEKA PHARMA AMERICA XPRESS-WAY RX (K101839) | Kaneka Pharma America, LLC | 2010-10-22 |
| PIONEER SPINOUS PROCESS FUSION PLATE (K101525) | Pioneer Surgical Technology | 2010-10-22 |
| CLAVICLE LOCKING PLATE SYSTEM (K100944) | Newclip Technics | 2010-10-22 |
| VANGUARD 360 REVISION KNEE SYSTEM (K093293) | Biomet, Inc. | 2010-10-22 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921) | Ortho-Clinical Diagnostics | 2010-10-22 |
| XPRESS BALLOON DEVICE (K102003) | Entellus Medical, Inc. | 2010-10-22 |
| DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102124) | VATECH Co., Ltd. | 2010-10-22 |
| Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102680) | Control-X Medical, Inc. | 2010-10-22 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102611) | Shijiazhuang Hyland Plastic Co., Ltd. | 2010-10-21 |
| REMIN PRO (K101104) | Voco GmbH | 2010-10-21 |
| INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (K102562) | Philips Medizin Systeme Boblingen GmbH | 2010-10-21 |
| ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (K102262) | Arthrocare Corp. | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102570) | Tangshan Kangjie Glove Co., Ltd. | 2010-10-21 |
| CHARMCARE TABLETOP PULSE OXIMETER (K092641) | Charmcare Co., Ltd. | 2010-10-21 |
| T2 XVBR 1.5 SPINAL SYSTEM (K100976) | Medtronic Sofamor Danek USA, Inc. | 2010-10-21 |
| K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) (K102890) | Kawasumi Laboratories America, Inc. | 2010-10-21 |
| WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (K101006) | Alcon Research, Ltd. | 2010-10-21 |
| TOKUYAMA SHIELD FORCE (K100172) | Tokuyama Dental Corporation | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102569) | Tangshan Kangyuan Glove Co., Ltd. | 2010-10-21 |
| BOND BONE (K101014) | Mis Implants Technologies , Ltd. | 2010-10-21 |
| VITEK 2 GRAM POSITIVE DOXCYCLINE (K093076) | bioMerieux, Inc. | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102559) | Tangshan Hengda Plastic Products Co., Ltd. | 2010-10-21 |