| ONE PLUS IMPLANT SYSTEM (K133050) | Osseofuse, Inc. | 2014-09-19 |
| CLEAR GUIDE ONE (K141806) | Clear Guide Medical | 2014-09-19 |
| Extension Set with BD Q-Syte Luer Access Split Septum (K142527) | Acacia, Inc. | 2014-09-19 |
| SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS (K141998) | Pinghu Sama Medical Packing Co., Ltd. | 2014-09-19 |
| MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR (K133753) | Infobionic, Inc. | 2014-09-19 |
| APOLLO BALLOON DILATATION CATHETER (K133852) | Brosmed Medical | 2014-09-19 |
| EBM IDO VIEWER (K140399) | Ebm Technologies USA, LLC | 2014-09-18 |
| ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA (K141670) | Johnson & Johnson Vision Care, Inc. | 2014-09-18 |
| FIA Blood Glucose Monitoring System (G2) (K131173) | Hmd Biomedical, Inc. | 2014-09-18 |
| DENTAL IMAGING SOFTWARE (K141607) | Trophy | 2014-09-18 |
| MOBILEDIAGNOST WDR (K141895) | Sedecal., Sa. | 2014-09-18 |
| CORTEX ID SUITE (K141074) | Ge Medical Systems, LLC | 2014-09-18 |
| CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY (K141885) | Minxray, Inc. | 2014-09-18 |
| XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM (K141697) | Zimmer, Inc. | 2014-09-18 |
| IROOT FM (K130312) | Innovative Bioceramix, Inc. | 2014-09-18 |
| MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140613) | Ellipse Technologies, Inc. | 2014-09-18 |
| DISCOVERY IQ (K141477) | Ge Medical Systems, LLC | 2014-09-18 |
| RANDOX ALDOLASE CALIBRATION SERUM (K142181) | Randox Laboratories Limited | 2014-09-18 |
| EDWARDS ESHEATH INTRODUCER SET (K141696) | Edwards Lifesciences | 2014-09-18 |
| TRUE BA V BALLOON VALVULOPLASTY CATHETER (K141985) | C.R. Bard, Inc. | 2014-09-18 |
| MIVI 6F GUIDE CATHETER (K140557) | Mivi, LLC | 2014-09-18 |
| Veenstra Instruments VDC-506 Dose Calibrator (K142325) | Comecer Netherlands B.V. | 2014-09-18 |
| D-KAT Z-YPE (K142179) | Keeler, Ltd. | 2014-09-17 |
| AXIOM 2.8 (K141450) | Anthogyr Sas | 2014-09-17 |
| TRANSONIC HCM 103 SYSTEM (K134035) | Transonic Systems, Inc. | 2014-09-17 |
| TREKKER, TREKKER TRANSIT (K140416) | Convaid Products, Inc. | 2014-09-17 |
| Lung Density Analysis (K141069) | Imbio, LLC | 2014-09-17 |
| EMPRINT PROCEDURE PLANNING APPLICATION (K142048) | Covidien, LLC | 2014-09-17 |
| GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (K142336) | Arkray Factory, Inc. | 2014-09-17 |
| Arrow GPSCath Balloon Dialation Catheter (150 cm) (K142300) | Hotspur Technologies, Inc., | 2014-09-17 |
| ELECTRONIC PULSE STIMULATOR (K141260) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2014-09-17 |
| PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (K141638) | Propper Manufacturing Co., Inc. | 2014-09-17 |
| DA VINVI SURGICAL SYSTEM (K123329) | Intuitive Surgical, Inc. | 2014-09-17 |
| TRC-NW400 NON-MYDRIATIC RETINAL CAMERA (K141481) | Topcon Corporation | 2014-09-17 |
| YUSHENG (K141108) | Zibo Yusheng Plastic Products Co., Ltd. | 2014-09-16 |
| Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (K140496) | Beckman Coulter, Inc. | 2014-09-16 |
| TRANSONIC HCM 102 SYSTEM (K140017) | Transonic Systems, Inc. | 2014-09-16 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) (K140377) | Luminex Molecular Diagnostics, Inc. | 2014-09-16 |
| MOBIS II ST SPINAL IMPLANT (K141405) | Signus Medizintechnik GmbH | 2014-09-16 |
| GEM Flow COUPLER Device and System (K142309) | Synovis Life Technologies, Inc. | 2014-09-16 |
| STEREOS WORKSTATION (K141137) | Eos Imaging | 2014-09-15 |
| Sirius Femoral Stem, Size 30A (K142295) | Biomet, Inc. | 2014-09-15 |
| SOMATOM SCOPE/SOMATOM SCOPE POWER (K140912) | Siemens Medical Solutions USA, Inc. | 2014-09-15 |
| ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT (K141018) | Procter & Gamble Co. | 2014-09-15 |
| M-PM-DISC (PINK) (K140758) | Merz Dental GmbH | 2014-09-15 |
| GLUCOSTABILIZER INSULIN DOSING CALCULATOR (K141321) | Medical Decision Network | 2014-09-15 |
| KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES (K140362) | Katalyst Surgical, LLC | 2014-09-15 |
| POLYCRYL (K140039) | Aurolab | 2014-09-15 |
| ABPM7100 (K140928) | I.E.M. GmbH | 2014-09-15 |
| HARMONIC SCALLOP BLADE, GENERATOR G11 (K141122) | Ethicon Endo-Surgery, LLC | 2014-09-15 |
| Flower Upper Extremity Plating Set (K142306) | Flower Orthopedics Corporation | 2014-09-15 |
| WHISPERJECT AUTOINJECTOR (K141384) | Scandinavian Health Limited | 2014-09-12 |
| DX-D IMAGING PACKAGE (K141602) | Agfa Healthcare N.V. | 2014-09-12 |
| Pilot Ultra Diode Laser (K142226) | CAO Group, Inc. | 2014-09-12 |
| ZVPLASTY (K141419) | Zavation, LLC | 2014-09-12 |
| ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX (K140367) | Harbor Medtech, Inc. | 2014-09-12 |
| C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES (K142134) | Conmed Corporation, Largo | 2014-09-12 |
| CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM (K141949) | Aap Implantate AG | 2014-09-12 |
| Pilot Pro Diode Laser (K142223) | CAO Group, Inc. | 2014-09-12 |
| LARIAT sulture Delivery Device (K142241) | Sentreheart, Inc. | 2014-09-12 |
| INTRA. OX HANDHELD TISSUE OXIMETER (K133983) | Vioptix, Inc. | 2014-09-12 |
| Pilot Elite Diode Laser (K142225) | CAO Group, Inc. | 2014-09-12 |
| MYLABSEVEN, MYLABALPHA (K142008) | Esaote, S.p.A. | 2014-09-12 |
| MYLABGAMMA (K142077) | Esaote, S.p.A. | 2014-09-12 |
| ARTIMES BALLOON DILATATION CATHETER (K141025) | Brosmed Medical | 2014-09-12 |
| MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE (K140608) | Merit Medical Systems, Inc. | 2014-09-12 |
| ORTHODONTIC ACRYLIC (NOT FINALIZED) (K141439) | Bisco, Inc. | 2014-09-12 |
| PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS (K141235) | Microport Orthopedics, Inc. | 2014-09-12 |
| NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE (K140050) | Hartalega Sdn Bhd | 2014-09-12 |
| BIOGRAPH TRUE PET/CT FAMILY SOFTWARE (K141971) | Siemens Medical Solutions USA, Inc. | 2014-09-12 |
| SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV (K141033) | Argentum Medical, LLC | 2014-09-12 |
| RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (K140991) | Ranfac, Corp. | 2014-09-11 |
| OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K141079) | Optimedica Corporation | 2014-09-11 |
| ELITE + LASER SYSTEM (K141425) | Cynosure, Inc. | 2014-09-11 |
| TABLO CARTRIDGE (K140841) | Home Dialysis Plus | 2014-09-11 |
| CRANE ACRYLIC HERBST APPLIANCE (K140429) | Crane Dental Laboratory, Inc. | 2014-09-11 |
| IASSIST KNEE SYSTEM (K141601) | Zimmer Cas | 2014-09-11 |
| MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO (K134019) | Nxstage Medical, Inc. | 2014-09-11 |
| CONTACT LENS CASE (K140488) | Maca Plastics, Inc. | 2014-09-10 |
| TRIDENT FUSION IMPLANT (K141937) | Vilex IN Tennessee, Inc. | 2014-09-10 |
| NOVAGUARD S A SAFETY SYSTEM (K141464) | West Pharmaceutical Services | 2014-09-10 |
| BTL-9000; BTL-9000 RADIOFREQUENCY MODULE (K134040) | Btl Industries, Ltd. | 2014-09-10 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130742) | Dahoon Plastic Co., Ltd. | 2014-09-10 |
| Direxion Torqueable Microcatheter (K142259) | Boston Scientific Corp | 2014-09-10 |
| KEGEL SMART, KEGELSMART PEARL (K140780) | Regulatory Insight, Inc. | 2014-09-10 |
| Apollo Suture Anchor System and Titan Screws (K142230) | Valeris Medical | 2014-09-10 |
| TABLO CONSOLE (K140866) | Home Dialysis Plus | 2014-09-10 |
| TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS (K140390) | Biomet Manufacturing Corp | 2014-09-10 |
| EyeSuite Imaging (K142423) | Haag-Streit AG | 2014-09-10 |
| GLOBE-TROTTER GT5400 (K141565) | Draeger Medical Systems, Inc. | 2014-09-10 |
| VIA SPINOUS PROCESS FIXATION SYSTEM (K142213) | Spineology, Inc. | 2014-09-10 |
| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS (K141835) | Spineart | 2014-09-10 |
| RENAISSANCE X SYSTEM (K140167) | Mazor Robotics , Ltd. | 2014-09-10 |
| SURGICAL DRAPE (K140195) | Griffith-Lucas, LLC | 2014-09-10 |
| ITRAC CERVICAL TRACTION SYSTEM (K131983) | Pivotal Health Solutions | 2014-09-10 |
| SC2000 and ACUSON X300 Diagnostic Ultrasound Systems (K142395) | Siemens Medical Solutions USA, Inc. | 2014-09-09 |
| SPACELABS HEALTHCARE TELEMETRY RECEIVER (K141156) | Spacelabs Healthcare | 2014-09-09 |
| POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131340) | Made Plastic Co., Ltd. | 2014-09-09 |
| NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) (K141244) | North American Science Assoc., Inc. | 2014-09-09 |
| FRIMAP ADAPTER CONNECTOR (MAC) (K142182) | Topera, Inc. | 2014-09-09 |