| OMNIVISION (K110040) | Modern Module, Inc. | 2011-01-26 |
| SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101) | Surgivision, Inc. | 2011-01-26 |
| CONSENSUS KNEE SYSTEM (K102927) | Consensus Orthopedics, Inc. | 2011-01-26 |
| VANTAGE VIEW SYSTEM (K110085) | St Jude Medical | 2011-01-26 |
| MODEL LTV 1100 VENTILATOR (K101643) | Care Fusion | 2011-01-26 |
| NEODENT IMPLANT SYSTEM (K101945) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-01-26 |
| LEFORTE NEURO SYSTEM BONE PLATE (K103778) | Jeil Medical Corporation | 2011-01-26 |
| CERSR ELECTROMYOGRAPHY SYSTEM (K110048) | Spinematrix, Inc. | 2011-01-26 |
| KOWA NONMYD WX (K101628) | Kowa Co. , Ltd. | 2011-01-26 |
| PENUMBRA EMBOLIZATION COIL SYSTEM (K103305) | Penumbra, Inc. | 2011-01-26 |
| SEDECAL (K103522) | Sedecal., Sa. | 2011-01-26 |
| STAYHEALTHY BODY COMPOSITION MONITOR-BCM (K101807) | Stayhealthy, Inc. | 2011-01-26 |
| FLUORCANASITE DENTAL CERAMIC (K100794) | Dr Sarah Pollington | 2011-01-25 |
| DIATRON PICTUS 400 (K101741) | Diatron Group | 2011-01-25 |
| MSC LIPID CONTROL (K103271) | Maine Standards Co. | 2011-01-25 |
| PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER (K103616) | Aktina Medical Physics Corp. | 2011-01-25 |
| FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE (K103450) | Fujirebio Diagnostics,Inc. | 2011-01-25 |
| CEROX, MODEL 321OF (K100875) | Or-Nim Medical , Ltd. | 2011-01-25 |
| ORTHOVITA PEEK SPACER (K101171) | Orthovita, Inc. | 2011-01-25 |
| MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE (K103805) | Medical Wire & Equipment Company (Bath), Ltd. | 2011-01-25 |
| ORTHODONTIC CERAMIC BRACKET (K102561) | Ht Co., Ltd. | 2011-01-25 |
| LITECURE THERAPY SYSTEM (K103511) | Litecure, LLC | 2011-01-25 |
| PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 (K101225) | Promimic AB | 2011-01-25 |
| FLAMENCO SPINAL FIXATION SYSTEM (K102853) | Ulrich GmbH & Co. KG | 2011-01-25 |
| TIGER FLAT SURGICAL MASK (K102713) | Tiger Medical Products, Ltd. | 2011-01-25 |
| SURECALL EMG LABOR MONITOR (K090145) | Reproductive Research Technologies, LP | 2011-01-25 |
| ORAL FLUID PHENCYCLIDINE (K093989) | Roche Diagnostics | 2011-01-25 |
| Q-STATION (K103815) | Philips Ultrasound, Inc. | 2011-01-25 |
| DIMENSION VISA ENZ 2 CAL (K103612) | Siemens Healthcare Diagnostics, Inc. | 2011-01-25 |
| CHEETAH RELIANT (K103166) | Cheetah Medical, Inc. | 2011-01-25 |
| KYPHON INFLATION SYRINGE (K103231) | Medtronic Spine, LLC | 2011-01-24 |
| TOTAL SHOULDER SYSTEM (K102670) | Shoulder Innovations, LLC | 2011-01-24 |
| WOUND PRO APEX (K100823) | Accuro Medical Products, LLC | 2011-01-24 |
| DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE (K103157) | Angstrom Mfg., Inc. | 2011-01-24 |
| RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE (K102336) | Boston Scientific Corporation | 2011-01-24 |
| VIZION DR (K102123) | Viztek, Inc. | 2011-01-24 |
| VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V (K101604) | Vascular Solutions, Inc. | 2011-01-24 |
| SORBACT (K100591) | Abigo Medical AB | 2011-01-24 |
| APTUS ULNA PLATES (K103332) | Medartis AG | 2011-01-24 |
| COMPACT PIEZO P2K, POWERCARE (K102218) | Mectron S.P.A. | 2011-01-24 |
| LIPOCONTROL (K090754) | Osyris Medical | 2011-01-21 |
| FETCH 2 ASPIRATION CATHETER MODEL 109400-001 (K101354) | Medrad Interventional/Possis | 2011-01-21 |
| REALEYE MODEL VCPS (K100625) | Navotek Medical, Ltd. | 2011-01-21 |
| 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (K103243) | Synthes (Usa) | 2011-01-21 |
| DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION (K100957) | Pacific Consolidated Industries, LLC | 2011-01-21 |
| GRANDIO SO FLOW (K103580) | Voco GmbH | 2011-01-21 |
| EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM (K102870) | Exactech, Inc. | 2011-01-21 |
| MAGO 4S (K093101) | Diamedix Corp. | 2011-01-21 |
| HAMILTON-C2 (K102775) | Hamilton Medical AG | 2011-01-21 |
| HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT (K101894) | Bioremedi Therapeutic Systems, Inc. | 2011-01-21 |
| LIAISON XL ANALYZER MODEL 10050 (K103529) | DiaSorin, Inc. | 2011-01-21 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) (K103746) | Biosense Webster, Inc. | 2011-01-21 |
| LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE (K110131) | 3M Espe Dental Products | 2011-01-21 |
| TAPERLOC COMPLETE, SIZE 5 AND 6 (K103755) | Biomet Manufacturing Corp | 2011-01-21 |
| LOW ADHERENT AFM AG DRESSINGS (K103141) | Milliken Healthcare Products, LLC | 2011-01-21 |
| ENDOSERTER (K090626) | Ocular Systems, Inc. | 2011-01-21 |
| INFA WARMER I (K102227) | Atom Medical Corporation | 2011-01-21 |
| MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (K101147) | Alma Lasers, Inc. | 2011-01-21 |
| TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K102154) | The Lagado Corp. | 2011-01-21 |
| MOBIUS ULTRASOUND IMAGING SYSTEM (K102153) | Mobisante, Inc. | 2011-01-20 |
| QUANTA SYSTEM DUOLITE (K103539) | Quanta System Spa | 2011-01-20 |
| EMERALD SPINAL SYSTEM (K101446) | Mazor Surgical Technologies , Ltd. | 2011-01-20 |
| TERASON T3200 ULTRASOUND SYSTEM (K110020) | Teratech Corp. | 2011-01-20 |
| PCP/PC STETHOSCOPE (K102893) | Rnk Products, Inc. | 2011-01-20 |
| DMC COMPOSITE 2 (K103351) | Kerr Corporation | 2011-01-20 |
| SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE (K103762) | Sorin Group Deutschland GmbH | 2011-01-20 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |
| CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS (K102203) | Chemtron Biotech, Inc. | 2011-01-20 |
| STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (K103468) | Sorin Group Deutschland GmbH | 2011-01-20 |
| MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE (K103017) | Mederi Therapeutics, Inc. | 2011-01-20 |
| COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE (K103715) | Mirador Biomedical, Inc. | 2011-01-20 |
| ELECYSYS SHBG (K102814) | Roche Diagnostics | 2011-01-20 |
| LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS (K100610) | Lutronic Corporation | 2011-01-20 |
| MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (K100585) | Gaymar Industries, Inc. | 2011-01-20 |
| ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (K102743) | Ortho Solutions Limited | 2011-01-20 |
| VASCOPRESS SEQUENTIAL DVT PUMP (K102940) | Compression Therapy Concepts | 2011-01-20 |
| STERILE SALINE SOLUTION (K102165) | Cachet Pharmaceuticals Pvt. , Ltd. | 2011-01-19 |
| R3 XLPE ANTEVERTED LINERS (K102370) | Smith & Nephew, Inc. | 2011-01-19 |
| SP-FIX SPINOUS PROCESS FIXATION PLATE (K102195) | Globus Medical, Inc. | 2011-01-19 |
| ALBOGRAFT VASCULAR PROSTHESIS (K103080) | LeMaitre Vascular, Inc. | 2011-01-19 |
| WBR XPRESS PET (K103710) | Ultraspect , Ltd. | 2011-01-19 |
| IO-FLEX CATHETER (K102594) | Baxano, Inc. | 2011-01-19 |
| CPS DIRECT SL II SLITTABLE OUTER CATHETER (K103250) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-01-19 |
| ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM (K103533) | Advanced Orthopaedic Solutions, Inc. | 2011-01-19 |
| NEXGEN PERIPHERAL GUIDE CATHETER (K102979) | Nexgen Medical Systems, Inc. | 2011-01-18 |
| VEPER SYSTEM, EXPEDIUM SYSTEM (K103133) | Depuy Spine, Inc. | 2011-01-18 |
| ALIF SPINAL TRUSS INTERBODY FUSION DEVICE (K083894) | 4-Web Spine, LLC | 2011-01-18 |
| IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 (K093627) | Shanghai Apolo Medical Technologies Co., Ltd. | 2011-01-18 |
| CARDIO MED (K103334) | Cardio Medical Products, Inc. | 2011-01-18 |
| RVT CTO DEVICE (K101599) | Revascular Therapeutics, Inc. | 2011-01-18 |
| STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (K103469) | Sorin Group Deutschland GmbH | 2011-01-18 |
| G-PROX EZ ENDOSCOPIC GRASPER (K103688) | Usgi Medical | 2011-01-14 |
| E1 AVANTAGE HEAD (K101336) | Biomet Manufacturing Corp | 2011-01-14 |
| ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES (K103501) | Alma Lasers, Inc. | 2011-01-14 |
| SOUNDBITE HEARING SYSTEM BY SONITUS (K100649) | Sonitus Medical, Inc. | 2011-01-14 |
| CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER (K102589) | Codman & Shurtleff, Inc. | 2011-01-14 |
| ORTHOFLEX ROD (K102601) | Ortho-Pro, LLC | 2011-01-14 |
| GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT (K103088) | Given Imaging , Ltd. | 2011-01-14 |
| HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX (K102885) | Stryker Corp. | 2011-01-14 |
| NORFOLK MEDICAL NORPORT FAMILY OF PORTS (K102385) | Norfolk Medical Products, Inc. | 2011-01-14 |