| XTRAFIX EXTERNAL FIXATION SYSTEM (K113383) | Extraortho, Inc. | 2012-06-26 |
| THE HELENA V8 IMMUNODISPLACEMENT KIT (K111369) | Helena Laboratories Uk, Ltd. | 2012-06-26 |
| AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM (K120632) | STERIS Corporation | 2012-06-26 |
| GLIDER PTCA BALLOON CATHETER (K121681) | Trireme Medical, Inc. | 2012-06-26 |
| SURGIMESH XB - SKIRTED (K120025) | Aspide Medical | 2012-06-26 |
| I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (K120002) | Busse Hospital Disposables, Inc. | 2012-06-26 |
| SYS*STIM 240 (K113017) | Mettler Electronics Corp. | 2012-06-26 |
| NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U (K120336) | Hartalega Sdn Bhd | 2012-06-25 |
| IPS E.MAX PRESS MULTI (K120134) | Ivoclar Vivadent, AG | 2012-06-25 |
| AQUAMANTRYS3 BSC 9.1S (K121290) | Medtronic, Inc. | 2012-06-25 |
| PENTAX EPK-I5020 VIDEO PROCESSOR (K113873) | Pentax of America, Inc. | 2012-06-22 |
| CS 8100 CS 8100 ACCESS (K120975) | Trophy | 2012-06-22 |
| BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN (K121018) | Smith & Nephew, Inc. | 2012-06-22 |
| QUANTRA (K120472) | Hologic, Inc. | 2012-06-22 |
| EUROTROL GAS-ISE METABOLITES (K121468) | Eurotrol B.V. | 2012-06-22 |
| APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM (K121577) | Toshiba Medical Systems Corporation, Japan | 2012-06-22 |
| SHEATHES ULTRASOND GEL (K112827) | Sheathing Technologies, Inc. | 2012-06-22 |
| ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM (K121646) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2012-06-22 |
| XIA 4.5 SPINAL SYSTEM (K121342) | Stryker Corp. | 2012-06-22 |
| HERO GRAFT (K121532) | Hemosphere, Inc. | 2012-06-22 |
| CRYO-TOUCH III (K120415) | Myoscience, Inc. | 2012-06-22 |
| INSULIN PEN NEEDLE (K120690) | Tiger Medical Products, Ltd. | 2012-06-22 |
| ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (K112414) | Phadia US, Inc. | 2012-06-22 |
| KIMGUARD ONE-STEP STERILIZATION WRAP (K112805) | Kimberly-Clark Corp. | 2012-06-22 |
| SYNGO.MR NEUROLOGY (K121459) | Siemens Medical Solutions USA, Inc. | 2012-06-22 |
| TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER (K121222) | Abbott Vascular | 2012-06-22 |
| EMG RECORDING ELECTRODE ASSEMBLY (K120342) | Rhythmlink International, LLC | 2012-06-22 |
| ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM (K121699) | Siemens Medical Solutions USA, Inc. | 2012-06-22 |
| BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959) | Bio-Rad Laboratories | 2012-06-22 |
| CARBONAID C02 DIFFUSER (K112975) | Cardia Innovation AB | 2012-06-22 |
| ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) (K121028) | Etview , Ltd. | 2012-06-21 |
| AXERA ACCESS SYSTEM (K121521) | Arstasis, Inc. | 2012-06-21 |
| OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (K113566) | Life Technologies, Inc. | 2012-06-21 |
| PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP (K121032) | Hospira, Inc. | 2012-06-21 |
| EASYDEX (K120247) | Vineland Syrup, Inc. | 2012-06-21 |
| QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER (K112824) | Quality Life Technologies Co;Ltd | 2012-06-21 |
| BEAM BRUSH/BEAM APP (K121165) | Beam Technologies, LLC | 2012-06-21 |
| AIRTRAQ SP AIRTRAQ AVANT (K121378) | Prodol Meditec , Ltd. | 2012-06-21 |
| PROCOLL (K120339) | Innocoll Pharmaceuticals | 2012-06-21 |
| ZOLL PROPAQ XM (K121367) | ZOLL Medical Corporation | 2012-06-21 |
| VERSAVIT (K121675) | Synergetics, Inc. | 2012-06-21 |
| PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (K120245) | Playtex, Inc. | 2012-06-21 |
| WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031) | Alcon Research, Ltd. | 2012-06-21 |
| SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM (K120524) | Mui Scientific | 2012-06-21 |
| ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS (K113277) | Arrow International, Inc. | 2012-06-21 |
| GYRUS AMCI PK BUTTON ELECTRODE (K120567) | Gyrus Acmi, Inc. | 2012-06-20 |
| ASCEND SHOULDER SYSTEM (K121493) | Tornier, Inc. | 2012-06-20 |
| RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 (K121588) | Randox Laboratories, Ltd. | 2012-06-20 |
| E.G. SCAN II ESPHAGOSCOPE SYSTEM (K120702) | Intromedic Co., Ltd. | 2012-06-20 |
| BLUE MOUNTAIN CERVICAL PLATE (K112809) | Qualgenix, LLC | 2012-06-20 |
| ABLE-X (K120783) | Im-Able, Ltd. | 2012-06-20 |
| DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S (K120048) | Drfp , Ltd. | 2012-06-20 |
| CONE-TROL HEMOGLOBIN A1C CONTROL SET (K121534) | Cone Bioproducts | 2012-06-20 |
| TI-MAX X450 (K112024) | Nakanishi, Inc. | 2012-06-20 |
| ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES (K120418) | Olympus Winter & Ibe GmbH | 2012-06-20 |
| X4 (K120447) | Advanced Brain Monitoring, Inc. | 2012-06-20 |
| MICROMANIPULATOR SET (K120877) | Narishige Co., Ltd. | 2012-06-20 |
| ENDOGATER AVANTAGE CO2 INSUFFLATOR (K113310) | Byrne Medical, Inc. | 2012-06-20 |
| QFIX RADIOTHERAPY CHAIR (K120916) | Wfr/Aquaplast Corp. | 2012-06-20 |
| CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403) | Teleflex, Inc. | 2012-06-20 |
| BODYFIX SYSTEM (K121530) | Medical Intelligence Medizintechnik GmbH | 2012-06-20 |
| SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML (K113033) | Nephron Pharmaceuticals Corp. | 2012-06-19 |
| SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (K112030) | Synthes USA, LLC | 2012-06-19 |
| I-ROOT 100 (K112508) | S-Denti Co., Ltd. | 2012-06-19 |
| HEALITE II SYSTEM (K113668) | Lutronic Corporation | 2012-06-19 |
| OP SPINE SYSTEM (K121250) | OrthoPediatrics Corp. | 2012-06-19 |
| LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; (K121024) | Encore Medical L.P. | 2012-06-19 |
| TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT (K120286) | Church & Dwight Co., Inc. | 2012-06-19 |
| MICROEEG SYSTEM (K112817) | Bio-Signal Group Corporation | 2012-06-19 |
| BEAUTICEM SA (K120159) | Shofu Dental Corporation | 2012-06-18 |
| CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL (K120910) | GE Medical Systems SCS | 2012-06-18 |
| MATRIXBRUSH ENDOMETRIAL SAMPLER (K112763) | Post Oak Innovations, Inc. | 2012-06-18 |
| CMI IMPLANT IS II ACTIVE (K120503) | Neobiotech Co., Ltd. | 2012-06-18 |
| CIRRUS PHOTO (K112184) | Carl Zeiss Meditec, Inc. | 2012-06-18 |
| SYNTHES VA LCP ANKLE TRAUMA SYSTEM (K120854) | Synthes USA | 2012-06-18 |
| ALPHA ORTHOPAEDICS AT2 SYSTEM (K120527) | Alpha Orthopaedics, Inc. | 2012-06-18 |
| POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (K121130) | Biomet Spine | 2012-06-15 |
| MEDYSSY LT CAGE SYSTEM (K121246) | Medyssey Co, Ltd. | 2012-06-15 |
| BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS (K120823) | Fresenius Medical Care North America, Design Cente | 2012-06-15 |
| GREENLIGHT MOXY FIBER OPTIC (K120870) | American Medical Systems | 2012-06-15 |
| AUDIT MICROLQ SPINAL FLUID CONTROL (K112742) | Aalto Scientific, Ltd. | 2012-06-15 |
| READY VIEW (K113456) | Ge Healthcare (Ge Medical Systems Scs) | 2012-06-15 |
| DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM (K113613) | Shantou Institute of Ultrasonic Instuments | 2012-06-15 |
| INFINITI(R) VISION SYSTEM (K120912) | Alcon Manufacturing, Ltd. | 2012-06-15 |
| FORA COMFORTSCAN EAR THERMOMETER (K121118) | Foracare, Inc. | 2012-06-15 |
| TM-400 DEVICE (K120203) | Zimmer Trabecular Metal Technology, Inc. | 2012-06-15 |
| 1.5T 16CH FLEX SPEEDER LARGE (K121362) | Neocoil, LLC | 2012-06-15 |
| DURAGEN SECURE DURAL REGNERATION MATRIX (K120600) | Integra Life Sciences | 2012-06-15 |
| ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET (K121533) | Tosoh Bioscience, Inc. | 2012-06-15 |
| IVENT101 (K112754) | Versamed Medical Systems , Ltd. | 2012-06-15 |
| SIGNATURE PLANNER,SIGNATURE GUIDES (K111863) | Materialise NV | 2012-06-15 |
| EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) | Depuy Spine, Inc. | 2012-06-14 |
| ULTRASONIC SURGERY MACHINE (K113152) | Dmetec.Co., Ltd. | 2012-06-14 |
| CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE (K121451) | Medtronic, Inc. | 2012-06-14 |
| FUSION FLAT PANEL (K113449) | Icrco, Inc. | 2012-06-14 |
| REVERE 4.5 STABILIZATION SYSTEM (K113395) | Globus Medical, Inc. | 2012-06-14 |
| SUREFIRE HI-FLOW MICROCATHETER (K121677) | Surefire Medical, Inc. | 2012-06-14 |
| SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K120648) | Fujifilm Medical System U.S.A., Inc. | 2012-06-14 |
| FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR (K121470) | Andon Health Co, Ltd. | 2012-06-14 |
| OBIX PERINATAL DATA SYSTEM 7.0 (K121208) | Clinical Computer Systems, Inc. | 2012-06-14 |