| STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (K121315) | Howmedica Osteonics Corp. | 2012-11-01 |
| LEVANT, HOMEGLIDE (K121560) | Thyssenkrupp Accessibility B.V. | 2012-11-01 |
| EXTENDED LIFE BATTERY (K120350) | Aed Battery Exchange, LLC | 2012-11-01 |
| AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON (K121793) | Audifon-USA, Inc. | 2012-11-01 |
| FRONTIER SADL INTERBODY FUSION DEVICE (K112700) | Frontier Medical Devices, Inc. | 2012-11-01 |
| TAP PAP NASAL PILLOW MASK (K122350) | Airway Management, Inc. | 2012-11-01 |
| AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K122496) | Bio-Logic Systems Corp. | 2012-11-01 |
| PRESSURIZED INFUSION PUMP (K122294) | Mui Scientific | 2012-11-01 |
| COLLAGEN DENTAL WOUND DRESSINGS (K122115) | Collagen Matrix, Inc. | 2012-11-01 |
| ERGOSELECT/GE (K112121) | Ergoline GmbH | 2012-10-31 |
| MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (K122434) | Medtronic Xomed | 2012-10-31 |
| CERTEX SPINAL IMPLANT SYSTEM (K122163) | X-Spine Systems, Inc. | 2012-10-31 |
| QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (K122314) | Cayenne Medical, Inc. | 2012-10-31 |
| DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS (K122395) | DePuy Orthopaedics, Inc. | 2012-10-31 |
| MODIFIED TREVO RETRIEVER (K122478) | Concentric Medical, Inc. | 2012-10-31 |
| COSENSE (K121768) | Capnia, Inc. | 2012-10-31 |
| REX ANTERIOR CERVICAL PLATE SYSTEM (K121862) | Dio Medical Co., Ltd. | 2012-10-31 |
| STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM (K122313) | Stryker | 2012-10-31 |
| CANOPY LAMINOPLASTY FIXATION SYSTEM (K121732) | Globus Medical, Inc. | 2012-10-31 |
| LOFRIC PRIMO, LOFRIC HYDRO-KIT (K122078) | Astra Tech, Inc. | 2012-10-31 |
| MULTIFLEX TINNITUS TECHNOLOGY (K122876) | Starkey Laboratories | 2012-10-31 |
| AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM (K113602) | Aap Implantate AG | 2012-10-31 |
| WINX SLEEP THERAPY SYSTEM (K122130) | Apnicure, Inc. | 2012-10-31 |
| BIOPRO HEMI-EDGE TOE SYSTEM (K121973) | Biopro, Inc. | 2012-10-30 |
| THE CANARY SYSTEM (K112139) | Quantum Dental Technologies, Inc. | 2012-10-26 |
| SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS (K121201) | St. shine Optical Co., Ltd. | 2012-10-26 |
| ECHONAVIGATOR RELEASE 1 (K121781) | Philips Medical Systems Nederland B.V. | 2012-10-26 |
| CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING (K120930) | Medtrade Products , Ltd. | 2012-10-26 |
| VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM (K122472) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012-10-26 |
| SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM (K120127) | Swan Valley Medical, Incorporated | 2012-10-26 |
| SKINTEMP II (K122325) | Human Biosciences, Inc. | 2012-10-26 |
| SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER (K120796) | Superdimension, Inc. | 2012-10-26 |
| LIQUIDBAND FLOW CONTROL (K122446) | Advanced Medical Solutions (Plymouth), Ltd. | 2012-10-26 |
| TORQUE DEVICE (K123024) | Boston Scientific Corporation | 2012-10-26 |
| ABL90 FLEX (K122642) | Radiometer Medical Aps | 2012-10-26 |
| COLUMBUS REVISION KNEE SYSTEM (K122985) | Aesculap Implant System, Inc. | 2012-10-26 |
| LEGACY-500 (K111588) | Mt Tables, LLC | 2012-10-26 |
| RENEW INSERT (K122003) | Renew Medical, Inc. | 2012-10-26 |
| NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K122215) | Carticept Medical, Inc. | 2012-10-26 |
| SPERMFREEZE SOLUTION (K113786) | Vitrolife Sweden AB | 2012-10-26 |
| ZOLL FULLY AUTOMATIC AED PLUS (K120406) | Zoll Medical Corporation, World Wide Headquarters | 2012-10-26 |
| ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM (K123001) | Siemens Medical Solutions USA, Inc. | 2012-10-26 |
| FLOW2, SWING (K121561) | Thyssenkrupp Accessibility B.V. | 2012-10-26 |
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137) | Accuray Incorporated | 2012-10-26 |
| AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE (K121637) | Sunwell Biotech Co., Ltd. | 2012-10-25 |
| IRMA C02 MODEL 200101; IRMA AX 200601 (K123043) | Phasein AB | 2012-10-25 |
| ANCHOR-L LUMBAR CAGE (K120869) | Stryker Spine | 2012-10-25 |
| COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) (K121594) | Tekmedic (M) Sdn Bhd | 2012-10-25 |
| CLICKFINE PEN NEEDLE (K122969) | P/L Biomedical | 2012-10-25 |
| SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR (K122299) | Transenterix, Inc. | 2012-10-25 |
| INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS (K121921) | Intuitive Surgical, Inc. | 2012-10-25 |
| CLICKFINE PEN NEEDLE (K122971) | P/L Biomedical | 2012-10-25 |
| IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS (K113020) | Immco Diagnostics, Inc. | 2012-10-25 |
| STEALTH 360 ORBITAL PAD SYSTEM (K122987) | Cardiovascular Systems, Inc. | 2012-10-25 |
| DIGITAL ELECTROCARDIOGRAPH (K122712) | Shenzhen Biocare Electronics Co., Ltd. | 2012-10-25 |
| ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM (K122262) | Haemonetics Corp. | 2012-10-25 |
| OMNI 3 OXYGEN SYSTEM (K120785) | Caire, Inc. | 2012-10-25 |
| SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT (K121993) | Heidelberg Engineering GmbH | 2012-10-25 |
| GE 8CH FOOT ANKLE COIL (K122694) | Ge Hangwei Medical Systems Co., Ltd. | 2012-10-25 |
| FUSELOX LUMBAR INTERBODY FUSION DEVICE (K122956) | Captiva Spine | 2012-10-25 |
| ENSEAL TRIO TISSUE SEALING DEVICE (K123141) | Ethicon Endo-Surgery, LLC | 2012-10-25 |
| SHAPEMATCH CUTTING GUIDE (K122053) | Stryker Corp. | 2012-10-24 |
| HOFFMANN 3 (K122284) | Stryker Corp. | 2012-10-24 |
| PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER (K122422) | Care Fusion | 2012-10-24 |
| ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT (K121636) | Tgm Medical, Inc. | 2012-10-24 |
| IMAGE-COM 5.0 (K122289) | Tomtec Imaging Systems GmbH | 2012-10-24 |
| RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM (K122292) | Reliance Medical Systems, LLC | 2012-10-24 |
| SMITH & NEPHEW SMF HIP STEM (K123012) | Smith & Nephew, Inc. | 2012-10-24 |
| CDC ZIRCONIA BLANKS (K122972) | Continental Dental Ceramics, Inc. (Dba Continental | 2012-10-24 |
| BIOMET LATERAL SPACER SYSTEM (K122989) | Biomet Spine (Aka Ebi, LLC) | 2012-10-24 |
| VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (K120765) | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 |
| CRE FIXED WIRE BALLON DILATION CATHETER (K122924) | Boston Scientific Corp | 2012-10-24 |
| INTRAMEDULLARY NAIL SYSTEM (K121312) | Weigao Orthopaedic Device Co., Ltd. | 2012-10-24 |
| IMAGEN3D (K122241) | Cardiovascular Imaging Technologies | 2012-10-24 |
| HX-461 (K120545) | Seers Technology Co., Ltd. | 2012-10-23 |
| OSSEOFLEX SB INFLATABLE BONE TAMP (K122533) | Osseon Therapeutics, Inc. | 2012-10-23 |
| CARESTREAM VUE PACS (K122523) | Carestream Health, Inc. | 2012-10-23 |
| IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM (K122280) | Cyden Limited | 2012-10-23 |
| MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM (K122092) | Medrange Corporation | 2012-10-23 |
| RESOLUTE FACET SCREW SYSTEM (K121551) | Neurostructures, LLC | 2012-10-23 |
| ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE (K123109) | Covidien | 2012-10-23 |
| GEO (K121705) | Resmed, Ltd. | 2012-10-23 |
| NUVASIVE SAGE LATERAL PLATE SYSTEM (K121815) | Nuvasive, Inc. | 2012-10-23 |
| AURICAL HIT (K122028) | Gn Otometrics | 2012-10-23 |
| FORTEX PEDICLE SCREW SYSTEM (K120832) | X-Spine Systems, Inc. | 2012-10-23 |
| PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR (K121657) | Proton Systems | 2012-10-23 |
| CPRMETER CPR FEEDBACK DEVICE (K122050) | Laerdal Medical A/S | 2012-10-22 |
| PHASIX PLUG AND PATCH (K120728) | C.R. Bard, Inc. | 2012-10-22 |
| LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS (K123019) | Zimmer, Inc. | 2012-10-22 |
| QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K122898) | Surgical Specialties Corp. Dba Angiotech | 2012-10-22 |
| DYNASTY BIOFOAM SHELL (K122382) | Wrightmedicaltechnologyinc | 2012-10-22 |
| XN CAL PF (K120747) | Streck | 2012-10-22 |
| TRANSTEK WRIST BLOOD PRESSURE MONITOR (K122482) | Zhongshan Transtek Electronics Co., Ltd. | 2012-10-22 |
| ATLAS GOLD PTA DILATATION CATHETER (K122984) | C.R. Bard, Inc. | 2012-10-22 |
| OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM (K122277) | Biomet Manufacturing Corp | 2012-10-22 |
| VENUS FACET SCREW SYSTEM (K120340) | Apollo Spine, Inc. | 2012-10-19 |
| AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 (K122913) | Medtronic, Inc. | 2012-10-19 |
| XN CHECK BF (K120744) | Streck | 2012-10-19 |
| LACRICATH LACRIMAL DUCT CATHETER (K113867) | Quest Medical, Inc. | 2012-10-19 |
| ZIRPRIME (K121980) | Kuraray Noritake Dental, Inc. | 2012-10-19 |