| NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142342) | Nacrous Plastic Co., Ltd. | 2014-12-18 |
| CPS Direct MediGuide Enabled outer catheter (K142239) | St Jude Medical | 2014-12-18 |
| OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM (K140978) | Osteomed | 2014-12-18 |
| Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (K143186) | Erbe USA, Inc. | 2014-12-18 |
| MULTIX FUSION VA30 & VA40 (K142049) | Siemens Medical Solutions USA, Inc. | 2014-12-18 |
| RAPID-I KIT (K140207) | Vitrolife Sweden AB | 2014-12-18 |
| DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) (K141727) | Liaoning Upcera Co., Ltd. | 2014-12-18 |
| StimPad OTC (K142686) | Aemed, Inc. | 2014-12-18 |
| Snap Insulin Pump System (K142619) | Asante Solutions, Inc. | 2014-12-18 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) (K142805) | Hartalega Sdb. Bhd. | 2014-12-18 |
| TRISTAR BONE GRAFT FIXATION SYSTEM (K141764) | Impladent , Ltd. | 2014-12-18 |
| MOERAE SURGICAL MARKING PEN (DEN130004) | Moerae Matrix, Inc. | 2014-12-18 |
| CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter (K142235) | St Jude Medical | 2014-12-18 |
| KIMGUARD ONE STEP STERILIZATION WRAP (K141712) | Halyard Health | 2014-12-18 |
| Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) (K142570) | Ever Light Plastic Products Co., Ltd. | 2014-12-18 |
| Quickie, Zippie (K142457) | Sunrise Medical (Us), LLC | 2014-12-18 |
| FASTFORWARD (K141420) | MedShape, Inc. | 2014-12-18 |
| AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS (K141214) | Teleflexmedical, Inc. | 2014-12-18 |
| Hermes Medical Imaging Suite v5.5 (K142631) | Hermes Medical Solutions AB | 2014-12-18 |
| MAS PLIF Fixation system (K142737) | Nu Vasive, Incorporated | 2014-12-18 |
| ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM (K141218) | Vadiswire Corporation | 2014-12-18 |
| SMART LABEL, PROPOFOL (K142333) | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 |
| CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 |
| UniWeb 8.0 (K142514) | Ebm Technologies Incorporated | 2014-12-18 |
| Threshold Pedicular Fixation System (K143403) | Spineology, Inc. | 2014-12-18 |
| ARTHREX SUTURETAK SUTURE ANCHORS (K140855) | Arthrex, Inc. | 2014-12-18 |
| SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (K142488) | Seaspine, Inc. | 2014-12-18 |
| Nitrile Powder Free Examination Glove (Blue) (K142588) | Hartalega Sdn Bhd | 2014-12-18 |
| RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (K143307) | Rayner Intraocular Lenses , Ltd. | 2014-12-18 |
| INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA (K142043) | Jensen Industries, Inc. | 2014-12-18 |
| VIBRANCE KEGEL DEVICE (VKD) (K141893) | Bioinfinity (M) Sdn. Bhd. | 2014-12-18 |
| BECTON DICKINSON INTELLIPORT SYSTEM (K141474) | Becton, Dickinson & CO | 2014-12-18 |
| RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU (K133047) | Biophor Diagnostics, Inc. | 2014-12-18 |
| VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws (K143050) | Smith & Nephew, Inc. | 2014-12-18 |
| Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (K142702) | Medivance, Inc. | 2014-12-18 |
| LT-300 Video Colposcope (K143119) | Lutech Industries, Inc. | 2014-12-18 |
| Echo Bi-Metric Microplasty Hip System (K143009) | Biomet, Inc. | 2014-12-18 |
| AMIGO REMOTE CATHETER SYSTEM (DEN140009) | Catheter Robotics, Inc. | 2014-12-18 |
| DISPOSABLE TRACHEAL TUBE (K140228) | Suzhou Weikang Medical Apparatus Co., Ltd. | 2014-12-18 |
| Powder Free Vinyl Patient Examination Gloves (K142571) | Ever Light Plastic Products Co., Ltd. | 2014-12-17 |
| DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT (K131643) | Reckitt Benckiser, LLC | 2014-12-17 |
| GM60A-32S, GM60A-40S (K142492) | Samsung Electronics Co., Ltd. | 2014-12-17 |
| STERIZONE CHEMICAL INDICATOR (K141698) | Tso3, Inc. | 2014-12-17 |
| GEN_3 (K141691) | Free Wheelchair Mission | 2014-12-17 |
| Radlink GPS (K142718) | Radlink, Inc. | 2014-12-17 |
| cobas MRSA/SA Test (K142721) | Roche Molecular Systems, Inc. | 2014-12-17 |
| VIDEO BRONCHOSCOPE SYSTEM (K141366) | Scholly Fiberoptic GmbH | 2014-12-17 |
| STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (K141580) | Tso3, Inc. | 2014-12-17 |
| CERAGEM AUTOMATIC THERMAL MASSAGER (K140592) | Ceragem International, Inc. | 2014-12-17 |
| HEPATIQ (K142891) | Hepatiq, LLC | 2014-12-17 |
| LUMINESSE PORCELAIN SYSTEM (K140848) | Talladium, Inc. | 2014-12-17 |
| STERIZONE STERILIZER (K141163) | Tso3, Inc. | 2014-12-17 |
| MANIPULATOR; MANIPULATOR PRO (K142164) | Gynetech Pty. , Ltd. | 2014-12-17 |
| InFill Graft Delivery System (K143488) | Pinnacle Spine Group, LLC | 2014-12-17 |
| HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536) | Lake Region Medical | 2014-12-17 |
| GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM (K140284) | Given Imaging , Ltd. | 2014-12-17 |
| The OnControl Bone Marrow Biopsy System by Vidacare (K142377) | Vidacare, LLC | 2014-12-17 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| PRELUDE PLASTIC JACKETED GUIDE WIRE (K142051) | Merit Medical Systems, Inc. | 2014-12-17 |
| ACCU-CHEK AVIVA EXPERT SYSTEM (K142089) | Roche Diagnostics Corporation | 2014-12-17 |
| RTHawk, HeartVista Workstation with RTHawk (K142997) | Heartvista, Inc. | 2014-12-17 |
| SOFIA (R) STREP A+ FIA (K141775) | Quidel Corporation | 2014-12-16 |
| A1c iGear System (K142789) | Sakae Corporation | 2014-12-16 |
| Elecsys Estradiol III Calcheck (K143284) | Roche Diagnostics | 2014-12-16 |
| StitchKit (K142639) | Origami Surgical, LLC | 2014-12-16 |
| ArthroPlan Digital Templating Software (K142944) | Arthromeda, Inc. | 2014-12-16 |
| ImmersiveTouch3 and MicrovisTouch (K140860) | Immersivetouch | 2014-12-16 |
| EXA (K142919) | Viztek, LLC | 2014-12-16 |
| Sensor Medical Family of Vitrectomy Lenses and Products (K142715) | Sensor Medical Technology, LLC | 2014-12-16 |
| Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens (K143052) | Yung Sheng Optical Co., Ltd. | 2014-12-16 |
| AIA-PACK C-Peptide Control Set (K143296) | Tosoh Bioscience, Inc. | 2014-12-16 |
| MERIT HYDROPHILIC GUIDEWIRE (K141295) | Merit Medical Systems, Inc. | 2014-12-16 |
| FORT DEFIANCE AUTOMATED STEAM STERILIZER (K141009) | Fort Defiance Industries, Inc. | 2014-12-16 |
| Phlebo Press DVT 603 (K142772) | Mego Afek AC , Ltd. | 2014-12-16 |
| Mini and Micro Fragments Reconstruction System-NEOFIX (K142419) | Neoortho Productos Orthopedicos S/A | 2014-12-16 |
| RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS (K142108) | Brainlab AG | 2014-12-16 |
| BBS REVOLUTION (K142329) | Dbmedx, Inc. | 2014-12-15 |
| Stabilynx PEEK Suture Anchor (K142643) | D3 Dc, LLC /Stabilynx, Inc. | 2014-12-15 |
| WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER (K140667) | Well Lead Medical Co., Ltd. | 2014-12-15 |
| NEXTGEN ALTIUS OCT SYSTEM (K140734) | Ebi, LLC | 2014-12-15 |
| INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K141513) | Summit Medical, Inc. | 2014-12-15 |
| ProxiFuse Hammer Toe Device (K142490) | Cartiva, Inc. | 2014-12-15 |
| PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (DEN140010) | Wallac OY | 2014-12-15 |
| The Panthera Anti-Snoring Device (K143244) | Panthera Dental, Inc. | 2014-12-15 |
| PLAC TEST FOR LP-PLA2 ACTIVITY (K141575) | Diadexus, Inc. | 2014-12-15 |
| ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (K140593) | Cook, Inc. | 2014-12-15 |
| ENDO-CORD (K141330) | Enroxtech, Inc. | 2014-12-15 |
| Intact Advance and Intact Excision XL, Intact BLES (K142477) | Intact Medical Corporation | 2014-12-15 |
| BruxZir Anterior (K143330) | Prismatik Dentalcraft, Inc. | 2014-12-15 |
| TELESENSE (K142180) | Scottcare Corporation | 2014-12-12 |
| ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141303) | Zhida Glove Co., Ltd. | 2014-12-12 |
| SUMMED INFLATION DEVICE KIT (K133795) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014-12-12 |
| TRAUSIM DENTAL IMPLANT SYSTEM (K140202) | Jiangsu Trausim Medical Instrument | 2014-12-12 |
| THERASNORE (K140663) | Distar, LLC | 2014-12-12 |
| IPACS MEDICAL IMAGE MANAGEMENT SYSTEM (K140797) | Visbion Limited | 2014-12-12 |
| YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141304) | Yongxin Healthcare Co., Ltd. | 2014-12-12 |
| CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES (K142081) | Osprey Medical, Inc. | 2014-12-12 |
| 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe (K142620) | Excelsior Medical Corporation | 2014-12-12 |
| LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM (K140680) | Alpine Biomed Aps | 2014-12-12 |
| VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL (K140350) | Preventive Technologies, Inc. | 2014-12-12 |