| PMT TRUSCAN SURFACE ELECTRODE (K122376) | Pmt Corp. | 2012-12-19 |
| CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 (K122954) | Foundry Newcoxi, Inc. | 2012-12-19 |
| OVS1 VIDEO SYSTEM (K123359) | Olive Medical Corp. | 2012-12-19 |
| BASIXCONPAK ANALOG INFLATION SYRINGE (K122321) | Merit Medical Ireland, Ltd. | 2012-12-19 |
| BIO-SEAL LUNG BIOPSY TRACT SYSTEM (DEN090007) | Angiotech | 2012-12-19 |
| KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (K120985) | Kimberly-Clark Corp. | 2012-12-19 |
| MOBICATH TRANSSEPTAL NEEDLE (K122832) | Great Batch Medical | 2012-12-19 |
| CERTUS 140 2.45GHZ ABLATION SYSTEM (K122217) | Neuwave Medical, Inc. | 2012-12-19 |
| NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR (K121369) | Ibramed Equipamentos Medicos | 2012-12-19 |
| IND ONE STEP OCCULT BLOOD (FOB) TEST (K113506) | Ind Diagnostics, Inc. | 2012-12-19 |
| LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM (K123564) | GE Healthcare | 2012-12-18 |
| EVOLUTION 3E VENTILATOR (K113743) | Event Medical, Inc. | 2012-12-18 |
| AESCULAP NOVOSYN ABSORBABLE SUTURE (K122734) | Aesculap, Inc. | 2012-12-18 |
| IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER (K123318) | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-12-18 |
| UPSYLON Y MESH (K122794) | Boston Scientific Corp | 2012-12-18 |
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (K123561) | Bsn Medical, Inc. | 2012-12-18 |
| DR. SCHOLL'S COMPRESSION SOCKS (K123398) | Renfro Corporation | 2012-12-18 |
| NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (K122968) | Coloplast Corp. | 2012-12-18 |
| ORICARE L2700 (K122875) | Oricare, Inc. | 2012-12-18 |
| NUTRISAFE 2 FEEDING TUBE (K121105) | Vygon Corp. | 2012-12-18 |
| TRAUS SIP10 (K123695) | Saeshin Precision Co., Ltd. | 2012-12-18 |
| HERMES MEDICAL IMAGING SUITE V5.2 (K121278) | Hermes Medical Solutions AB | 2012-12-18 |
| VERTEX RECONSTRUCTION SYSTEM (K123568) | Medtronic Sofamor Danek USA, Inc. | 2012-12-18 |
| ALPHA CRYPTOCOCCAL ANTIGEN EIA (K120946) | Immuno-Mycologics, Inc. | 2012-12-17 |
| SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (K122211) | Synthes Spine | 2012-12-17 |
| VERTIFLEX SPINOUS PROCESS FIXATION PLATE (K122509) | Vertiflex, Inc. | 2012-12-17 |
| LACRIFAST (K120886) | Hiroyasu Higuchi | 2012-12-17 |
| COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM (K120955) | Aesculap Implant Systems, LLC | 2012-12-17 |
| CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215) | Ventana Medical Systems, Inc. | 2012-12-17 |
| PERCUNAV (K121498) | Philips Health Care | 2012-12-14 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM (K123010) | ACON Laboratories, Inc. | 2012-12-14 |
| APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM (K113018) | BEIJING SYNTECH LASER CO., LTD. | 2012-12-14 |
| COUGHASSIST T70 DEVICE (K121955) | Respironics, Inc. | 2012-12-14 |
| MOLECULAR ADSORBENT RECIRCULATING(MARS) (K113313) | Gambro Renal Products, Inc. | 2012-12-14 |
| MAXLOCK EXTREME SYSTEM MODEL MXL (K123203) | Orthohelix Surgical Designs, Inc. | 2012-12-14 |
| OXTI INFLATION DEVICE (K122152) | Oxti Corporation | 2012-12-14 |
| VIDEO SYSTEM CENTER (K122831) | Olympus Medical Systems Corp. | 2012-12-14 |
| GLIADIN IGA AND GLIADIN LGA (K113377) | Grifols USA, LLC | 2012-12-14 |
| NDX ABUTMENTS (K121117) | National Dentex Corp | 2012-12-14 |
| GYRUS ACMI BICOAG HEMOSTASIS PROBE (K123319) | Olympus Surgical Technologies America | 2012-12-14 |
| OCELOT PIXL CATHETER (K123532) | Avinger, Inc. | 2012-12-14 |
| CONELOG IMPLANT SYSTEM (K113779) | Altatec GmbH | 2012-12-14 |
| ASCENDX VCF REDUCTION SYSTEM (K100404) | Aoi Medical, Inc. | 2012-12-14 |
| SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) (K122937) | Cook, Inc. | 2012-12-14 |
| EMPOWER CLEAR (K122753) | American Orthodontics | 2012-12-14 |
| UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K123531) | LeMaitre Vascular, Inc. | 2012-12-14 |
| ANODYNE ANTERIOR CERVICAL PLATE SYSTEM (K121514) | Corelink, LLC | 2012-12-14 |
| AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 (K122827) | Medtronic, Inc. | 2012-12-14 |
| CATHETER CONNECTIONS DUALCAP SOLO (K123065) | Catheter Connections, Inc. | 2012-12-14 |
| BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623) | Respironics, Inc. | 2012-12-14 |
| MEDILAS H LASER FIBERS (K123385) | Dornier Medtech America, Inc. | 2012-12-14 |
| CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (K122840) | Mick Radio-Nuclear Instruments, Inc. | 2012-12-14 |
| EMVERA DIOLUX (K123257) | Emvera Technologies, Inc. | 2012-12-14 |
| VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (K122613) | Toshiba America Medical Systems, In.C | 2012-12-13 |
| ENAMIC (K122269) | Vita Zahnfabrik H.Rauter GmbH & Co. | 2012-12-13 |
| GORE FLOW REVERSAL SYSTEM MODEL GFRS073 (K123156) | W. L. Gore & Associates, Inc. | 2012-12-13 |
| ORTHODONTIC CERAMIC BRACKETS (K123094) | Tomy, Inc. | 2012-12-13 |
| DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM (K123503) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-12-13 |
| DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) (K123492) | Philips Medical Systems | 2012-12-13 |
| MEDLINX SURGICAL MESH (K120844) | Medlinx Acala Pte, Ltd. | 2012-12-13 |
| AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE (K123448) | Medtronic, Inc. | 2012-12-13 |
| CELLTRACKS AUTOPREP SYSTEM (K122821) | Veridex, LLC | 2012-12-13 |
| ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936) | Microgenics Corporation | 2012-12-13 |
| FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H (K122535) | Fujifilm Medical System U.S.A., Inc. | 2012-12-13 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K122958) | Oscor, Inc. | 2012-12-13 |
| PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM (K122459) | Boston Scientific Corporation | 2012-12-13 |
| SIGNAL GEAR URETHRAL CATHETER ELECTRODE (K113771) | Neurovision Medical Products, Inc. | 2012-12-13 |
| MILAGRO INTERFERENCE SCREWS (K122869) | Depuy Mitek, A Johnson & Johnson Company | 2012-12-13 |
| PRESTO 1000 SYSTEM (K123565) | Physiosonics, Inc. | 2012-12-13 |
| HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, (K121218) | Andrew Technologies, LLC | 2012-12-13 |
| DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K121853) | Defibtech, LLC | 2012-12-13 |
| CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) (K121398) | Guidepath Medical, Inc. | 2012-12-13 |
| ZOLL SUREPOWER SINGLE BAY CHARGER (K122839) | ZOLL Medical Corporation | 2012-12-13 |
| AMPLIVUE C. DIFFICILE ASSAY (K123355) | Quidel Corporation | 2012-12-13 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K122960) | Oscor, Inc. | 2012-12-13 |
| VEX-S 100W INTRAORAL X-RAY SYSTEM (K123493) | VATECH Co., Ltd. | 2012-12-13 |
| TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS (K122855) | Straumann USA | 2012-12-12 |
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230) | Impac Medical Systems, Inc. | 2012-12-12 |
| ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K122213) | Soflex Limited | 2012-12-12 |
| HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER (K122000) | Changzhou Holymed Products Co., Ltd. | 2012-12-12 |
| CRYOTOP (K112695) | Kitazato Biopharma Co;Ltd | 2012-12-12 |
| S4 SPINAL SYSTEM (K123352) | Aesculap Implant Systems, Inc. | 2012-12-12 |
| ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (K121842) | Axis-Shield Diagnostics, Ltd. | 2012-12-12 |
| STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE (K122555) | Steritec Products Mfg Co, Inc. | 2012-12-12 |
| SURGICAL GOWN, SMS (K121152) | Jiangsu Guangda Medical Material, Co., Ltd. | 2012-12-12 |
| LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (K121508) | Fotona D.D. | 2012-12-12 |
| VSP SYSTEM (K120956) | Medical Modeling, Inc. | 2012-12-12 |
| LENSX LASER SYSTEM (K123120) | Alcon Lensx, Inc. | 2012-12-12 |
| VASU-PICC (K122423) | Medical Components, Inc. | 2012-12-12 |
| MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (K122571) | Seaspine, Inc. | 2012-12-12 |
| NAVIGATOR HD URETERAL ACCESS SHEATH SET (K122649) | Boston Scientific Corp | 2012-12-12 |
| EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N (K123317) | Olympus Medical Systems Corporation | 2012-12-11 |
| DA01 BLOOD GLUCOSE MONITORING SYSTEM (K120866) | Delbio Incorporation | 2012-12-11 |
| ULTRASONIC SURGERY (K121620) | Dmetec.Co., Ltd. | 2012-12-11 |
| NP-CAST ABUTMENT SYSTEM (K121843) | Osstem Implant Co., Ltd. | 2012-12-11 |
| CARDIOSCOPE (K121266) | Pulsecor Limited | 2012-12-11 |
| NIXALL TM WOUND AND SKIN CARE (K113693) | Seriously Clean, Ltd. | 2012-12-11 |
| PBP TOTAL HIP SYSTEM (K122158) | Pipeline Biomedical Products, LLC | 2012-12-11 |
| L.A.M. IMP WOUND GEL (K123113) | Glycobiosciences, Inc. | 2012-12-11 |