| ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT (K112456) | Teleflexmedical, Inc. | 2011-10-04 |
| OEC(R) 9800, OEC(R) 9800 PLUS (K111551) | Ge Oec Medical Systems, Inc. | 2011-10-04 |
| CARDIOMED (K103651) | Cardio Medical Products, Inc. | 2011-10-04 |
| SHAKER DIGITAL THERMOMETER (K112703) | Measure Technology Co. , Ltd. | 2011-10-04 |
| DIGITAL CLINICAL THERMOMETER MODEL V901US (K112116) | Amperor-Electronic(Sz) Co., Ltd. | 2011-10-04 |
| FLAATZ 560 (K111583) | Drtech Corp. | 2011-10-04 |
| VENOTRAIN CURAFLOW (K111662) | Bauerfeind AG | 2011-10-04 |
| APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM (K110870) | Toshiba America Medical Systems, In.C | 2011-10-04 |
| PROSTHETIC SYSTEM (K110308) | Osstem Implant Co., Ltd. | 2011-10-03 |
| PINNACLE PRECISION ACCESS SYSTEM (K111606) | Terumo Medical Corp. | 2011-10-03 |
| PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF (K111169) | Kwang Myung Daicom, Inc. | 2011-10-03 |
| SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871) | Piave Spazzolificio S.P.A. | 2011-10-03 |
| STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM (K111357) | Straumann USA | 2011-10-03 |
| REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER (K111735) | Encore Medical L.P. | 2011-10-03 |
| ETWO SKIN TREATMENT SYSTEM (K110672) | Syneron, Ltd. | 2011-10-03 |
| MOBICATH TRANSSEPTAL NEEDLE (K111644) | Great Batch Medical | 2011-10-03 |
| CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE (K103675) | Chienmax Vietnam Co., Ltd. | 2011-10-03 |
| EXCELLAGEN (K110318) | Tissue Repair Company | 2011-10-03 |
| ARMADA 35/35LL PTA CATHETER (K111899) | Abbott Vascular | 2011-10-03 |
| VITEK 2 STREPTOCOCCUS LEVOFLOXACIN (K112228) | bioMerieux, Inc. | 2011-10-03 |
| HTS EXTREMITY COIL, HTS SURFACE COIL (K112293) | Time Medical Systems, Inc. | 2011-09-30 |
| NEUROVISION NERVE LOCATOR MONITOR (K110140) | Neurovision Medical Products, Inc. | 2011-09-30 |
| FREERIDER MODEL LUGGIE MODEL 168-4IT (K110165) | Freerider Luggie Scooters, Inc. | 2011-09-30 |
| LDR SPINE ROI-A INTERBODY FUSION SYSTEM (K110327) | Ldr Spine USA | 2011-09-30 |
| DESARA MESH (K112609) | Caldera Medical, Inc. | 2011-09-30 |
| PHILIPS INTELLIVUE TCG10 (K110474) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-09-30 |
| APEX (K111676) | Elekta Limited | 2011-09-30 |
| DYNAMIC ECG SYSTEM MODEL TLC5000 (K101273) | Contec Medical System Co., Ltd. | 2011-09-30 |
| WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE (K111865) | Fujifilm Medical System U.S.A., Inc. | 2011-09-30 |
| BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (K111366) | Becton, Dickinson and Company (BD) | 2011-09-30 |
| 3DI INCLUDING CSCORE (K112530) | Shina Systems , Ltd. | 2011-09-30 |
| ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE (K112738) | Andon Medical Co., Ltd. | 2011-09-30 |
| SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK (K111412) | Steerable Technologix | 2011-09-30 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K112320) | Health & Life Co., Ltd. | 2011-09-30 |
| RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 (K110904) | Randox Laboratories, Ltd. | 2011-09-30 |
| RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K102673) | Phadia US, Inc. | 2011-09-30 |
| IMAGELINK (K112096) | Computer Programs and Systems, Inc. | 2011-09-30 |
| RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (K110846) | Randox Laboratories Limited | 2011-09-30 |
| SURGIMAP (TM) SPINE (K111019) | Nemaris, Inc. | 2011-09-30 |
| DISCOVERY MR750W 3.0T (K103327) | Ge Healthcare Japan Corporation | 2011-09-30 |
| RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM (K112442) | Biolitec Medical Devices, Inc. | 2011-09-30 |
| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (K111570) | Thayer Medical Corporation | 2011-09-29 |
| PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES (K111878) | Cardinal Health, Inc. | 2011-09-29 |
| TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE (K112136) | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-09-29 |
| EMG SYSTEM (K111687) | Myotronics-Noromed, Inc. | 2011-09-29 |
| CHARTIS CATHETER MODEL CHR-CA-12.0 (K111522) | Pulmonx, Inc. | 2011-09-29 |
| BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION (K112434) | Bd Medical Surgical | 2011-09-29 |
| CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K111916) | Conformis, Inc. | 2011-09-29 |
| D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (K112525) | Parexel International | 2011-09-29 |
| SCEPTER C OCCLUSION BALLOON CATHETER (K110741) | MicroVention, Inc. | 2011-09-29 |
| 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT (K112584) | Intuitive Surgical, Inc. | 2011-09-29 |
| TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET (K111351) | Us Infusion Dba Truecare Biomedix | 2011-09-29 |
| PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (K111832) | Heraeus Kulzer, LLC | 2011-09-29 |
| EQUIMATRIX (K111816) | Luitpold Pharmaceuticals, Inc. | 2011-09-29 |
| MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM (K111350) | Medicam, Inc. | 2011-09-29 |
| X12 STERILE REFLECTIVE MARKER SPHERE (K111443) | Pinsco Inc. Dba B & L Engineering | 2011-09-29 |
| HYDROCOIL EMBOLIC SYSTEM (HES) (K112226) | MicroVention, Inc. | 2011-09-29 |
| NEODYNE DRESSING (K112131) | Neodyne Biosciences, Inc. | 2011-09-29 |
| AGILLS PF DELIVERY SYSTEM (K111943) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-09-29 |
| MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE (K110606) | M.V.S.R.L. | 2011-09-29 |
| ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS (K112556) | Howmedica Osteonics Corp. | 2011-09-28 |
| LITE-MED LM-9200 ELMA (K103217) | Lite-Med, Inc. | 2011-09-28 |
| AURIGA XL (K111475) | Starmedtec GmbH | 2011-09-28 |
| PIONEER CROSSFUSE II IBF/VBR SYSTEM (K112496) | Pioneer Surgical Technology, Inc. | 2011-09-28 |
| PALINDROME H, SI, HSI CHRONIC CATHETER (K112477) | Covidien | 2011-09-28 |
| SPINEFRONTIER LUMBAR IBF SYSTEM (K111553) | Spinefrontier, Inc. | 2011-09-28 |
| AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (K111697) | Abbott Medical Optics, Inc. | 2011-09-27 |
| CD HORIZON(R) SPINAL SYSTEM (K112555) | Medtronic Sofamor Danek USA, Inc. | 2011-09-27 |
| NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516) | Liposcience, Inc. | 2011-09-27 |
| SONIX ULTRASOUND SCANNER (K112726) | Ultrasonix Medical Corporation | 2011-09-27 |
| ISOAMP HSV ASSAY (K111951) | Biohelix Corporation | 2011-09-27 |
| HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER (K110673) | Hitachi Medical Systems America, Inc. | 2011-09-27 |
| COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION (K103396) | I-Sens, Inc. | 2011-09-27 |
| RADIAL ARTERY COMPRESSION TOURNIQUET (K111837) | Lepu Medical Technology (Beijing) Co., Ltd. | 2011-09-27 |
| EXETER HIP STEM (K110290) | Howmedica Osteonics Corp. | 2011-09-27 |
| VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN (K112129) | bioMerieux, Inc. | 2011-09-27 |
| LOGIQ P3 (K112371) | GE Healthcare | 2011-09-27 |
| META-LOCK SUTURE ANCHOR SYSTEM (K110800) | Tarsus Medical, Inc. | 2011-09-27 |
| HAIRMAX LASERCOMB (K112524) | Lexington International, LLC | 2011-09-26 |
| SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS (K111809) | Biomaterials Korea, Inc. | 2011-09-26 |
| INQU PASTE MIX (K111838) | Isto Technologies, Inc. | 2011-09-26 |
| ASTRA TECH IMPLANT SYSTEM (K111287) | Astra Tech AB | 2011-09-26 |
| 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR (K111496) | Totoku Electric Co., Ltd. | 2011-09-26 |
| SURGICASE ORTHOGNATHIC SOFTWARE WIZARD (K111641) | Materialise NV | 2011-09-26 |
| THE ESPINER SAC OR E SAC (K111845) | Espiner Medical Limited | 2011-09-26 |
| KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE (K110462) | Kepler Medtec | 2011-09-26 |
| SELECTRA ACCESSORY KIT (K111839) | Biotronik, Inc. | 2011-09-26 |
| TEPHAFLEX MESH (K111946) | Tepha, Inc. | 2011-09-26 |
| SELECTRA SLITTER TOOL (K112482) | Biotronik, Inc. | 2011-09-26 |
| PASS LP SPINAL SYSTEM (K110497) | Medicrea International | 2011-09-26 |
| SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE (K111880) | Spineology, Inc. | 2011-09-26 |
| CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE (K111614) | Ge Healthcare Integrated IT Solutions | 2011-09-26 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K112232) | Stryker Sustainability Solutions | 2011-09-26 |
| CS 7600 (K111649) | Carestream Health, Inc. | 2011-09-23 |
| KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (K103150) | Kimberly-Clark | 2011-09-23 |
| MAMMODIAGNOST DR (K110572) | Philips Medical Systems | 2011-09-23 |
| PLANMED NUANCE EXCEL (K111361) | Planmeca USA, Inc. | 2011-09-23 |
| ULTRASEAL XT HYDRO (K112517) | Ultradent Products, Inc. | 2011-09-23 |
| MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS (K111888) | Masimo Corporation | 2011-09-23 |