| VITALA CONTINENCE CONTROL DEVICE (K111365) | Convatec, Inc. | 2011-08-19 |
| LCCS INSULATED SPINAL NEEDLE (RF CANNULA) (K112231) | Lccs Products Limited | 2011-08-19 |
| UNIMAX VERESS NEEDLE (K111441) | Unimax Medical Systems, Inc. | 2011-08-19 |
| P200T (K111628) | Optos Plc. | 2011-08-19 |
| ELECTROTORQUE TLC (K103027) | Kaltenbach & Voigt GmbH | 2011-08-19 |
| EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS (K111432) | Wrightmedicaltechnologyinc | 2011-08-19 |
| BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR (K110879) | Biomet Sports Medicine | 2011-08-19 |
| NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (K111799) | Ascension Orthopedic | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
| E-CUBE (K111616) | Saeshin Precision Co., Ltd. | 2011-08-19 |
| SONAFINE WOUND DRESSING (K110172) | Stratus Pharmaceutical | 2011-08-19 |
| CAVIOS CAVITY LINER (K111668) | Neodental Chemical Products Co., Ltd. | 2011-08-19 |
| TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 (K111508) | Hologic, Inc. | 2011-08-19 |
| RSI 4200 (K102831) | Reimers Systems, Inc. | 2011-08-19 |
| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K112108) | Spineart | 2011-08-19 |
| MICROCATHETER (K112124) | Navilyst Medical, Inc. | 2011-08-19 |
| LIPOSONIX SYSTEM, MODEL 1 P00XXXX (K100874) | Medicis Technologies Corporation | 2011-08-19 |
| TRUEBEAM (K111106) | Varian Medical Systems, Inc. | 2011-08-18 |
| GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (K103673) | Techlab Inc., Corporate Research Center | 2011-08-18 |
| IMC BLOOD COLLECTION NEEDLE (K110656) | International Medsurg Connection | 2011-08-18 |
| AXIS-SHIELD ANTI-CCP (K110296) | Axis-Shield Diagnostics, Ltd. | 2011-08-18 |
| REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER (K110076) | Sterilmed, Inc. | 2011-08-18 |
| SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... (K111429) | Trek Diagnostic Systems, Ltd. | 2011-08-18 |
| MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... (K111807) | Medline Industries, Inc. | 2011-08-18 |
| ACE TRIMARK TRICAM DENTAL IMPLANT (K103790) | Ace Surgical Supply Company, Inc. | 2011-08-18 |
| AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM (K102394) | STERIS Corporation | 2011-08-18 |
| XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (K111167) | Velopex International, Inc. | 2011-08-18 |
| IMC INSULIN SYRINGE (K110882) | International Medsurg Connection | 2011-08-18 |
| SMR REVERSE SHOULDER SYSTEM (K110598) | Lima Corporate S.P.A. | 2011-08-18 |
| SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING (K103274) | Sentinelle Medical, Inc. | 2011-08-18 |
| CS 9300, CS 9300C (K103659) | Trophy | 2011-08-18 |
| SYNGO.CT VASCULAR ANALYSIS (K112020) | Siemens Medi Cal Solutions, Inc. | 2011-08-18 |
| ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736) | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |
| PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) (K111135) | K2m, Inc. | 2011-08-17 |
| FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (K111284) | Ostial Corporation | 2011-08-17 |
| NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602) | Nova Biomedical Corp. | 2011-08-17 |
| CROSSER RECANALIZATION SYSTEM (K112308) | C.R. Bard, Inc. | 2011-08-17 |
| GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX (K112281) | Trireme Medical, Inc. | 2011-08-17 |
| FIBERNET EMBOLIC PROTECTION DEVICE (K111987) | Lumen Biomedical, Inc. | 2011-08-17 |
| ZOLL E SERIES (K111594) | Zoll Medical Corporation, World Wide Headquarters | 2011-08-17 |
| REVOLVE ADDITIONAL IMPLANTS (K111449) | Globus Medical, Inc. | 2011-08-17 |
| REVERE CROSSTOP (K111479) | Globus Medical, Inc. | 2011-08-17 |
| VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (K111881) | Coloplast A/S | 2011-08-17 |
| PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K111083) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-08-17 |
| NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K111900) | Teleflexmedical, Inc. | 2011-08-17 |
| TRUMATCH PERSONALIZED SOLUTIONS (K110397) | DePuy Orthopaedics, Inc. | 2011-08-16 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) (K101973) | Omega Laboratories, Inc. | 2011-08-16 |
| ENDO HEAD (K111145) | Medacta International | 2011-08-16 |
| HAIRMAX DUAL 12 (K111714) | Lexington International, LLC | 2011-08-16 |
| CRANIAL REMOLDING ORTHOSIS (K111247) | Orthotic Care Services, Llp | 2011-08-15 |
| OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM (K111176) | Osteomed LP | 2011-08-15 |
| MEDILED MINI (K103735) | Medix I.C.S.A. | 2011-08-15 |
| ION HEALTH USB INSTA-SCAN THERMOMETER (K111974) | Taidoc Technology Corporation | 2011-08-15 |
| RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277) | Siemens Healthcare Diagnostics | 2011-08-15 |
| SENTRYSUITE PRODUCT LINE (K111053) | Carefusion Germany 234 GmbH | 2011-08-12 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K112103) | Boston Scientific Corp | 2011-08-12 |
| TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (K112034) | Carefusion 209, Inc. | 2011-08-12 |
| ISROBOT MONA LISA (K111347) | Biobot Surgical Pte., Ltd. | 2011-08-12 |
| ACCUSOM (K110486) | Novasom, Inc. | 2011-08-12 |
| NITRILE POWDER FREE EXAMINATION GLOVES (K110758) | Hartalega Sdn Bhd | 2011-08-12 |
| KIDS ROCK 3 CHAIR (K111739) | Pride Mobility Products Corp. | 2011-08-12 |
| EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (K103699) | Exactech, Inc. | 2011-08-12 |
| ZIRPRIME (K111383) | Noritake Co., Inc. | 2011-08-12 |
| NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 (K102120) | Hsiner Co., Ltd. | 2011-08-12 |
| SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) (K111300) | Pt Mahakarya Inti Buana | 2011-08-12 |
| NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS (K110580) | Straumann USA | 2011-08-12 |
| VITEK 2 AST-ST LINEZOLID (K111599) | bioMerieux, Inc. | 2011-08-12 |
| AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K102330) | STERIS Corporation | 2011-08-12 |
| NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER (K110627) | Marvao Medical Devices, Ltd. | 2011-08-12 |
| BRIVO XR385 (K103448) | Ge Medical Systems, LLC | 2011-08-12 |
| PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) (K110663) | Sofradim Production | 2011-08-11 |
| NIO COLOR 2MP (K111991) | Barco N.V. | 2011-08-11 |
| UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K110348) | Zimmer Spine | 2011-08-11 |
| WILDCAT CATHETER (K111338) | Avinger, Inc. | 2011-08-11 |
| ORIGIN ZIRCONIA (K110719) | B&D Dental Technologies | 2011-08-11 |
| EMBRYOSCOPE (K111715) | Unisense Fertilitech A/S | 2011-08-11 |
| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K111127) | Spineart | 2011-08-11 |
| PASCAL STREAMLINE 577 (WITH ACCESSORIES) (K111108) | Topcon Medical Laser Systems, Inc. | 2011-08-11 |
| DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES (K111282) | Starboard Medical, LLC | 2011-08-11 |
| INFILL GRAFT DELIVERY SYSTEM (K111632) | Pinnacle Spine Group, LLC | 2011-08-11 |
| LUCINA MODEL MELODI (K102516) | Genadyne Biotechnologies, Inc. | 2011-08-11 |
| EEVATM PETRI DISH (K103028) | Auxogyn, Inc. | 2011-08-11 |
| ANODIZED HEALING COLLAR (K111852) | Zimmer Dental, Inc. | 2011-08-11 |
| ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN (K110137) | HORIBA ABX SAS | 2011-08-10 |
| RADIOLOGICAL IMAGE PROCESSING SYSTEM (K102078) | VATECH Co., Ltd. | 2011-08-10 |
| RALCO (K110856) | Ralco S.R.L. | 2011-08-10 |
| EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K101533) | Tem Innovations GmbH | 2011-08-10 |
| C7 XR IMAGING SYSTEM (K111201) | Lightlab Imaging, Inc. | 2011-08-10 |
| LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K111158) | Innovative Gloves Co;, Ltd. | 2011-08-10 |
| I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) (K112180) | Infimed, Inc. | 2011-08-10 |
| BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER (K111963) | Bridgepoint Medical | 2011-08-10 |
| SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) (K103619) | Shandong Blue Sail Innovation Co., Ltd. | 2011-08-10 |
| SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437) | Synthes (USA) Products, LLC | 2011-08-10 |
| SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE (K111044) | ArthroCare Corporation | 2011-08-09 |
| BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 (K101307) | Andon Medical Co., Ltd. | 2011-08-09 |
| CRESCENT (R) SPINAL SYSTEM TITANIUM (K110543) | Medtronic Sofamor Danek USA, Inc. | 2011-08-09 |
| SAPPHIRE (K103657) | Orbusneich Medical, Inc. | 2011-08-09 |
| COLLACARE DENTAL (K110388) | Innocoll Pharmaceuticals, Ltd. | 2011-08-09 |
| OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (K110293) | Respironics New Jersey, Inc. | 2011-08-09 |
| METASURG SUBTALAR IMPLANT (K111265) | Metasurg | 2011-08-09 |