| AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE (K123314) | Medtronic, Inc. | 2013-01-22 |
| CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (K123967) | Catheter Connections, Inc. | 2013-01-22 |
| SYNGO.VIA MI WORKFLOWS (K123577) | Siemens Medical Solutions USA, Inc. | 2013-01-22 |
| SYNAPSE 3D COLON ANALYSIS (K123566) | Fujifilm Medical Systems U.S.A, Inc. | 2013-01-22 |
| TBA (K121269) | Migada Plant | 2013-01-22 |
| BACT/ALERT FA PLUS CULTURE BOTTLE (K121461) | bioMerieux, Inc. | 2013-01-22 |
| PERMASORB DISPOSABLE FIXATION DEVICE (K123718) | C.R. Bard, Inc. | 2013-01-22 |
| INTENSE PULSED LIGHT (IPL) SYSTEMS (K122995) | Beijing Kes Biology Technology Co., Ltd. | 2013-01-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK (K123328) | Nitrilist Gloves Manufacturing Sdn Bhd | 2013-01-18 |
| GEMINUS FOSSA SPECIFIC PLATE SYSTEM (K122310) | Skeletal Dynamics, LLC | 2013-01-18 |
| XGEO GC80 (K123098) | Samsung Electronics Co., Ltd. | 2013-01-18 |
| SYNGO.VIA (K123920) | Siemens AG Medical Solutions | 2013-01-18 |
| POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS (K121592) | Tekmedic (M) Sdn Bhd | 2013-01-18 |
| CARDIAC VX (K121762) | Ge Medical Systems, LLC | 2013-01-18 |
| PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (K123828) | Hitachi Aloka Medical, Ltd. | 2013-01-18 |
| IVUE WITH NORMATIVE DATABASE (K121739) | Optovue, Inc. | 2013-01-18 |
| GENESIS (K122768) | Dornier Medtech America, Inc. | 2013-01-18 |
| VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE (K123813) | Vasonova, Inc. | 2013-01-18 |
| INNESIS PEEK CAGE (K120464) | Bk Meditech, Co., Ltd. | 2013-01-18 |
| MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS (K123299) | St. Jude Medical Neuromodulation | 2013-01-18 |
| CALIBER SPACERS (K123231) | Globus Medical, Inc. | 2013-01-18 |
| NEUROPACE BURR HOLE COVER MODEL 8110 (K123163) | NeuroPace, Inc. | 2013-01-18 |
| BD PEN NEEDLE (K123300) | Becton, Dickinson & CO | 2013-01-18 |
| AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM (K122132) | Molnlycke Health Care | 2013-01-17 |
| HERO I DENTAL IMPLANT SYSTEM (K121098) | Kj Meditech Co., Ltd. | 2013-01-17 |
| MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE (K124003) | Med-Fibers, Inc. | 2013-01-17 |
| CRUX VENA CAVA FILTER SYSTEM (K122585) | Crux Biomedical | 2013-01-17 |
| PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 (K123110) | Surgical Innovations Plc | 2013-01-17 |
| BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (K123734) | Becton Dickinson Infusion Therapy Systems, Inc. | 2013-01-17 |
| RESORB-X G (K121606) | KLS-Martin L.P. | 2013-01-17 |
| ZEPHYR 'X-SERIES PATIENT TRANSFER SLED (K121929) | Diacor, Inc. | 2013-01-17 |
| POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) (K122408) | Hongye Plastic Products Co., Ltd. | 2013-01-17 |
| BRIVO MR355, OPTIMA MR360 (K123417) | Ge Hangwei Medical Systems Co., Ltd. | 2013-01-17 |
| FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA (K123612) | Fujirebio Diagnostics,Inc. | 2013-01-17 |
| FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) (K121421) | Fresenius Medical Care North America, Design Cente | 2013-01-17 |
| WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (K123946) | Cincinnati Sub-Zero Products, Inc. | 2013-01-17 |
| CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM (K102689) | Conventus Orthopaedics | 2013-01-17 |
| TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O (K122788) | Northstar Healthcare Holdings | 2013-01-17 |
| XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 (K122951) | Icad, Inc. | 2013-01-17 |
| PROGASTRO SSCS ASSAY (K123274) | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| DK-PTCA BALLOON CATHETER (K123264) | Intuit Medical, LLC | 2013-01-16 |
| MERIT HYDROPHILIC GUIDE WIRE (K123609) | Merit Medical Systems, Inc. | 2013-01-16 |
| PRO HMPV+ ASSAY (K123838) | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| AURIGA QI (K121570) | Starmedtec GmbH | 2013-01-16 |
| SYNGO DYNAMICS (K123922) | Siemens Medical Solutions USA, Inc. | 2013-01-16 |
| SWISS LITHOBREAKER (K123038) | E.M.S Electro Medical Systems S.A | 2013-01-16 |
| NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE (K121392) | Exactech, Inc. | 2013-01-16 |
| OCS-B (K113246) | Nibec Company, Limited | 2013-01-16 |
| WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM (K123671) | Sanitas, Inc. | 2013-01-16 |
| MIRA LASERS (K123004) | Mira Lasers, LLC | 2013-01-15 |
| VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS (K122873) | Caremed Supply, Inc. | 2013-01-15 |
| ILAB ULTRASOUND IMAGING SYSTEM (K123535) | Boston Scientific Corp | 2013-01-15 |
| INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) (K123788) | Varian Medical Systems, Inc. | 2013-01-15 |
| ERGO IMAGING SYSTEM (K123408) | Digirad Corp. | 2013-01-15 |
| PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING (K123878) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2013-01-15 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905) | Centers for Disease Control and Prevention | 2013-01-14 |
| REMESENSE FOR SENSITIVE TEETH (K122708) | Sylphar N.V. | 2013-01-14 |
| ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122870) | Conformis, Inc. | 2013-01-14 |
| VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM (K123898) | Volcano Corporation | 2013-01-14 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) (DEN130003) | Luminex Molecular Diagnostics, Inc. | 2013-01-14 |
| ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (K123372) | Abbott Laboratories | 2013-01-14 |
| ACCULIF TL AND PL CAGE (K123752) | Coalign Innovations, Inc. | 2013-01-14 |
| FORA V10 BLOOD GLUCOSE MONITORING SYSTEM (K121706) | Foracare, Inc. | 2013-01-14 |
| QXMEDICAL ACCESS & SUPPORT CATHETER (K123311) | Qxmedical, LLC | 2013-01-14 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K122685) | Angioscore, Inc. | 2013-01-11 |
| IB CLINIC (K123302) | Imaging Biometrics, LLC | 2013-01-11 |
| SELECTRA 7F CATHETERS (K123324) | Biotronik, Inc. | 2013-01-11 |
| VIVIX-S WITH VXVUE (K122866) | Vieworks Co., Ltd. | 2013-01-11 |
| SCULPTOR ROBOTIC GUIDANCE ARM (RGA) (K121765) | Stanmore Implants Worldwide , Ltd. | 2013-01-11 |
| ICAM FUNDUS CAMERA (K122572) | Optovue, Inc. | 2013-01-11 |
| INFRASCANNER (K120949) | Infrascan, Inc. | 2013-01-11 |
| 1.5T GEM RT OPEN ARRAY (K123327) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2013-01-11 |
| HD-IVUS ULTRASOUND IMAGING SYSTEM (K122878) | Silicon Vally Medical Instruments, Inc. | 2013-01-11 |
| TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT (K122576) | Stryker Neurovascular | 2013-01-11 |
| VIZION + DR (K123644) | Viztek, LLC | 2013-01-11 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836) | Lorad, A Hologic Co. | 2013-01-11 |
| PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO (K123048) | Advanced Instrumentations, Inc. | 2013-01-11 |
| MTF NEW BONE VOID FILLER (K121313) | Musculoskeletal Transplant Foundation | 2013-01-11 |
| WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 (K123839) | Ningbo Diaier Electronic Co., Ltd. | 2013-01-11 |
| SPECBOARD JR. (K123414) | Macbrud Corp., Medical Division | 2013-01-11 |
| CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE (K121254) | Camber Spine Technologies | 2013-01-11 |
| POWEREASE SYSTEM (K123270) | Medtronic Sofamor Danek USA, Inc. | 2013-01-11 |
| ME (K123845) | Syneron Beauty , Ltd. | 2013-01-10 |
| INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874) | Baxter Healthcare Corp | 2013-01-10 |
| CRYO-TOUCH IV (K123516) | Myoscience, Inc. | 2013-01-10 |
| SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K122771) | Spinal Elements, Inc. | 2013-01-10 |
| I.FLEX BY TCS (K123396) | Thermoplastic Comfort Systems, Inc. | 2013-01-10 |
| DETECT (K121206) | Forum Engineering Technologies, Ltd. | 2013-01-10 |
| E-BEAM ND: YAG LASER (K122922) | Eclipse Aesthetics, LLC | 2013-01-10 |
| OPTETRAK LOGIC CRC TIBIAL INSERT (K123342) | Exactech, Inc. | 2013-01-10 |
| EVIS EXERA III VIDEO SYSTEM (K121959) | Olympus Medical Systems Corp. | 2013-01-10 |
| EM3 AEM MONITOR AEM CONNECTORS (K122383) | Encision, Inc. | 2013-01-10 |
| EC SINGLE USE, POLYPECTOMY SNARE (K123223) | Endochoice, Inc. | 2013-01-10 |
| MEDTRONIC XOMED, INC. (K122391) | Medtronic Xomed, Inc. | 2013-01-10 |
| NEW COMFORT-FIT DENTAL GUARD (K123849) | Den Tek Oral Care, Inc. | 2013-01-10 |
| BLOOD CULTURE HOLDER (K122687) | Greiner Bio-One North America, Inc. | 2013-01-10 |
| AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER (K123201) | Medtronic Advanced Energy, LLC | 2013-01-10 |
| MANOMETER (K122077) | Intersurgical, Inc. | 2013-01-10 |
| SENOMARK ULTRA BREAST TISSUE MARKER (K123911) | C.R. Bard, Inc. | 2013-01-10 |
| XENX STONE MANAGEMENT DEVICE (K123438) | Xenolith Medical | 2013-01-10 |