| HANAROSTENT BILIARY (NNN) (K111149) | M.I.Tech Co., Ltd. | 2011-12-30 |
| MYOGUIDE SYSTEM MODEL 8008 (K111985) | Intronix Technologies Corp. | 2011-12-30 |
| VISIA DYNAMIC REVIEW (K113337) | MeVis Medical Solutions AG | 2011-12-30 |
| MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES (K111403) | Masimo Corporation | 2011-12-30 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K112522) | Flexible Stenting Solutions, Inc. | 2011-12-30 |
| STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (K111068) | Skeletal Dynamics, LLC | 2011-12-30 |
| FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES (K112944) | Fresenius Medical Care South Asia Pacific Pty , Ltd. | 2011-12-30 |
| DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL (K113373) | Siemens Healthcare Diagnostics, Inc. | 2011-12-30 |
| TRIMOTION INJECTOR (K102999) | Kaneka Corp. | 2011-12-29 |
| SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING (K112778) | Varian Medical Systems | 2011-12-29 |
| SOMATOM DEFINITION FLASH (K113342) | Siemens Medical Systems, Inc. | 2011-12-29 |
| WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM (K112543) | Boston Scientific Corporation | 2011-12-29 |
| ELITTECH CLINICAL SYSTEMS ALP IFCC SL (K113269) | Elitechgroup | 2011-12-29 |
| DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA (K113630) | Rayence Co., Ltd. | 2011-12-29 |
| SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT (K113680) | Soma Access Systems, LLC | 2011-12-29 |
| LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS (K113559) | Ldr Spine USA, Inc. | 2011-12-29 |
| VPAP TX (K112914) | Resmed, Ltd. | 2011-12-29 |
| MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM (K113381) | Samsung Medison Co., Ltd. | 2011-12-29 |
| GE LOGIQ I, LOGIQ E AND VIVID E (K113690) | GE Healthcare | 2011-12-29 |
| ENDOWRIST ONE VESSEL SEALER (K110639) | Intuitive Surgical, Inc. | 2011-12-28 |
| GEISTLICH COMBI-KIT COLLEGEN (K112572) | Geistlich Pharma AG | 2011-12-28 |
| NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS (K113283) | Straumann USA | 2011-12-28 |
| ARTS2 SPINAL FIXATION SYSTEM (K103573) | Advanced Medical Technologies | 2011-12-28 |
| PRESERVE HIP STEM (K112080) | Wrightmedicaltechnologyinc | 2011-12-28 |
| AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION (K111618) | Natus Medical Incorporated | 2011-12-28 |
| SEASPINE MONOPOLAR PROBE SYSYEM (K111671) | Seaspine, Inc. | 2011-12-28 |
| CERAMIR CROWN & BRIDGE (K113040) | Doxa Dental AB | 2011-12-28 |
| LIFECHOICE OXYGEN CONCENTRATOR (K113317) | Inova Labs, Inc. | 2011-12-28 |
| DELTAVIEW MODEL 2.1 (K111776) | Riverain Medical Group,Llc | 2011-12-28 |
| GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO (K112575) | Geistlich Pharma AG | 2011-12-27 |
| SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM (K112923) | Suspension Orthopaedic Solutions, LLC | 2011-12-27 |
| SLEEPSTRIP II (K112822) | S.L.P. , Ltd. | 2011-12-27 |
| O_TWO CPAP SYSTEM (K112546) | O-Two Medical Technologies, Inc. | 2011-12-27 |
| ACCESS THYROGLOBULIN ANITBODY (K112933) | Beckman Coulter, Inc. | 2011-12-27 |
| PROCEDURE REHEARSAL STUDIO(TM) (K112387) | Simbionix , Ltd. | 2011-12-27 |
| BIOMERIX COMPOSITE SURGICAL MESH (K112499) | Biomerix Corporation | 2011-12-23 |
| BIOMERIX ASSURE (K112567) | Biomerix Corporation | 2011-12-23 |
| GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (K112352) | Bionostics, Inc. | 2011-12-23 |
| 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL (K111673) | Invivo Corporation | 2011-12-23 |
| EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112901) | Eps Bio Technology Corp. | 2011-12-23 |
| ZAVATION IBF SYSTEMS (K112664) | Zavation, LLC | 2011-12-23 |
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |
| MED-RX EXTENSION SET WITH T-CONNECTOR (K112799) | Benlan, Inc. | 2011-12-23 |
| DR. GREENSBURG'S HYBRID (K111680) | Always More Marketing, Inc. | 2011-12-23 |
| ROCHE ACETAMINOPHEN ASSAY (K110726) | Roche Diagnostics | 2011-12-23 |
| STRYKER RESORBABLE FIXATION SYSTEM (K113109) | Stryker | 2011-12-23 |
| EASY TOUCH (K112789) | Mhc Medical Products, LLC | 2011-12-23 |
| 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) (K113443) | Totoku Electric Co., Ltd. | 2011-12-23 |
| KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (K110717) | Konica Minolta Medical & Graphic, Inc. | 2011-12-23 |
| TINA-QUANT HBA1C GEN.2 (K110313) | Roche Diagnostics | 2011-12-23 |
| THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE (K112109) | Ortho Kinematics, Inc. | 2011-12-22 |
| KOO SMALL VOLUME NEBULIZER (SVN) (K112041) | Koo (Shanghai) Industries Co., Ltd. | 2011-12-22 |
| SENOGRAPHE DS, SENOGRAPHE ESSENTIAL (K110798) | General Electric Company | 2011-12-22 |
| SYNAPSE MPR FUSION (K113244) | Fujifilm Medical System U.S.A., Inc. | 2011-12-22 |
| CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER (K111324) | Agfa Healthcare N.V. | 2011-12-22 |
| CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G (K112907) | Medos International SARL | 2011-12-22 |
| HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME (K111159) | Cardiocomm Solutions, Inc. | 2011-12-22 |
| MANUJET III (K112783) | VBM Medizintechnik GmbH | 2011-12-22 |
| CELL-DYN 22 PLUS CONTROL (K111211) | Streck | 2011-12-22 |
| COLLAGEN TENDON SHEET (K112423) | Rotation Medical, Inc. | 2011-12-22 |
| PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 (K111617) | Acare Technology Co., Ltd. | 2011-12-22 |
| TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER (K112776) | Tomotherapy Incorporated | 2011-12-22 |
| CELL-DYN EMERALD 22 SYSTEM (K110381) | Abbott Laboratories | 2011-12-22 |
| PENCAN SPINAL NEEDLE (K112515) | B.Braun Medical, Inc. | 2011-12-22 |
| VARI-LASE WIREFIBER LASER FIBER (K113140) | Vascular Solutions, Inc. | 2011-12-22 |
| QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K112172) | Quidel Corp. | 2011-12-22 |
| IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (K111919) | Phadia US, Inc. | 2011-12-22 |
| BLUE SKY BIO TCP (K110198) | Blue Sky Bio, LLC | 2011-12-22 |
| U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM (K112216) | Taidoc Technology Corporation | 2011-12-22 |
| COLS PEEK (K113591) | Fournitures Hospitalieres Industrie | 2011-12-22 |
| CELL-DYN 22 PLUS CALIBRATOR (K111204) | Streck | 2011-12-22 |
| ARTHREX FRACTURE SYSTEM (K112437) | Arthrex, Inc. | 2011-12-21 |
| AUREFLO MONITORING SYSTEM (K112657) | Transonic Systems, Inc. | 2011-12-21 |
| RANGE SPINAL SYSTEM (MESA AND DENALI) (K112920) | K2m, Inc. | 2011-12-21 |
| FM-9000 PLUS FETAL AND MATERNAL MONITOR (K112317) | Advanced Instrumentations, Inc. | 2011-12-21 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| SYNTHES MIRS (K113044) | Synthes Spine | 2011-12-21 |
| DERMATOLOGICAL TREATMENT DEVICE FAMILY (K111303) | Sharplight Technologies, Ltd. | 2011-12-21 |
| GALAXY SYSTEM; JUPITER (K111055) | Personal Health Institute International | 2011-12-21 |
| EMBRYO VIEWER SOFTWARE (K113075) | Unisense Fertilitech A/S | 2011-12-21 |
| OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K113479) | Optimedica Corporation | 2011-12-21 |
| MYSENSE HEART (K113176) | Cardiac Science Corporation | 2011-12-21 |
| FUKUDA DENSHI VASERA MODEL VS-1500 (K112521) | Fukuda Denshi USA, Inc. | 2011-12-21 |
| TCX-I REMOTE CARE MANAGEMENT SYSTEM (K113493) | Bl Healthcare, Inc. | 2011-12-21 |
| SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES (K113251) | Synthes, Inc. | 2011-12-21 |
| N-HYBRIDE-COMPOSITE LC FLOW (K113444) | Voco GmbH | 2011-12-21 |
| SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (K111446) | Abbott Medical Optics, Inc. | 2011-12-21 |
| U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM (K112274) | Taidoc Technology Corporation | 2011-12-21 |
| N-HYBRIDE-COMPOSITE LC (K113563) | Voco GmbH | 2011-12-21 |
| PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES (K112302) | CooperVision, Inc. | 2011-12-21 |
| AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS (K110794) | Ameco Medical Industries | 2011-12-21 |
| XPRESS MULTI-SINUS DILATION TOOL (K112506) | Entellus Medical, Inc. | 2011-12-21 |
| MICHELE SLEEP SCORING SYSTEMS (K112102) | Younes Sleep Technologies | 2011-12-20 |
| ELM PTA BALLON DILATATION CATHETER (K113468) | Creagh Medical, Ltd. | 2011-12-20 |
| VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 (DEN100013) | Vioguard | 2011-12-20 |
| DIRECT ANTIBIOTIC INFUSION KIT (K113043) | Summit Medical Products, Inc. | 2011-12-20 |
| KIM (K103022) | Neomedic International S.L. | 2011-12-20 |
| FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K101926) | Taidoc Technology Corporation | 2011-12-20 |
| HEALIX KNOTLESS ANCHOR (K113534) | Depuy Mitek, A Johnson & Johnson Company | 2011-12-20 |
| 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) (K113136) | Totoku Electric Co., Ltd. | 2011-12-20 |