| Foresight Intracardiac Echocardiography (ICE) System (K151126) | Colibri Technologies, Inc. | 2015-12-18 |
| CUSA Excel+ (K150682) | Integra Lifesciences Corp. | 2015-12-18 |
| V8 Balloon Aortic Valvuloplasty Catheter (K152150) | Intervalve, Inc. | 2015-12-18 |
| Newa Skin Therapy System (DEN150005) | Endymed Medical, Ltd. | 2015-12-18 |
| Molteno3 Glaucoma Implant (K152996) | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 |
| WASTON Metallic Intramedullary Nail System (K151062) | Changzhou Waston Medical Appliance Co., Ltd. | 2015-12-17 |
| ARCHITECT 2nd Generation Testosterone (K152155) | Abbott Laboratories | 2015-12-17 |
| Klassic Knee System (K153310) | Total Joint Orthopedics, Inc. | 2015-12-17 |
| MoMe Software Platform (K152491) | Infobionic, Inc. | 2015-12-17 |
| Asahi REXEED-S Series Dialyzer (K153344) | Asahi Kasei Medical Co., Ltd. | 2015-12-17 |
| PRODIGY iConnect Blood Glucose Monitoring System (K142785) | Ok Biotech Co., Ltd. | 2015-12-17 |
| Next Science Wound Gel (K150792) | Next Science, LLC | 2015-12-17 |
| Freestyle Freedom Blood Glucose Monitoring Sytem (K152442) | Abbott Laboratories | 2015-12-17 |
| Bpump Blood Pressure Cuff (K151810) | Shenzhen Pump Medical System Co., Ltd. | 2015-12-17 |
| Renew NCP-5 External Counterpulsation System (K152115) | Stage 2 Innovations | 2015-12-17 |
| Laser Dock (K152636) | Patient Pocket, LLC | 2015-12-17 |
| PK AIM (K152219) | Gyrus Acmi, Inc. | 2015-12-17 |
| Sterisheet Sterilization Wrap (K152291) | Andersen Sterilizers, Inc. | 2015-12-17 |
| BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (K150815) | Becton, Dickinson and Company | 2015-12-17 |
| Intraluminal Applicator Set (K151022) | Varian Medical Systems, Inc. | 2015-12-17 |
| SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (K151329) | Sentec AG | 2015-12-17 |
| NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (K152857) | Neomed, Inc. | 2015-12-17 |
| Beacon Tissue Marker (SE) (K153189) | Scion Medical Technologies, LLC | 2015-12-17 |
| UV Lamps for Indoor Tanning Devices (K151370) | Light Sources, Inc. | 2015-12-17 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K152386) | Luminex Molecular Diagnostics, Inc. | 2015-12-17 |
| Vios Monitoring System (K150992) | Vios Medical, Inc. | 2015-12-16 |
| PulseFlowDF (K150806) | Pulseflow Technologies | 2015-12-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153450) | Microlife Intellectual Property GmbH | 2015-12-16 |
| ClearVue850 Diagnostic Ultrasound System (K153480) | Philips Health Care | 2015-12-16 |
| Counter OTC TENS Device, Model CSD-737Z (K151279) | Counter Scientific Development (Gz), Ltd. | 2015-12-16 |
| Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire (K151840) | Boston Scientific Corporation | 2015-12-16 |
| AquaShield system CO2, AquaShield system-PENTAX (K153362) | United States Endoscopy Group, Inc. | 2015-12-16 |
| Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (K150524) | Surgical Instrument Services and Savings, Inc. | 2015-12-16 |
| XM-01 Electronic Automatic Blood Pressure Monitor (K150908) | Sky Innovation Technology ( Shanghai) Limited | 2015-12-16 |
| Zenostar MT, Zenostar Color Liquids (K152118) | Wieland Dental + Technik GmbH & Co. KG | 2015-12-16 |
| Resolve 2.0 (K152322) | Denali Corporation | 2015-12-16 |
| Advanced Perfusion System 1 (K153376) | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| 8X-10-XXXX Camera System (K152513) | Santa Barbara Imaging Systems | 2015-12-15 |
| Latitude-C Cervical Interbody Spacer System (K151496) | Degen Medical | 2015-12-15 |
| Remedy® Shoulder Spacer (K152267) | Osteoremedies, LLC | 2015-12-15 |
| Monitor B40 (K151063) | Ge Medical Systems China Co., Ltd. | 2015-12-15 |
| AccuLIF TL and PL Cage (K152651) | Stryker Corporation | 2015-12-15 |
| Balloon controller PB-30 (K153483) | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 |
| Alevicyn SG Antipruritic Gel (K152945) | Oculus Innovative Sciences | 2015-12-15 |
| ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (K150854) | Phadia AB | 2015-12-14 |
| Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm (K152202) | Tni Manufacturing, Inc. | 2015-12-14 |
| OneTouch Ultra Plus Flex Blood Glucose Monitoring System (K151611) | Lifescan Europe | 2015-12-14 |
| Econsole1 (K152172) | DRTECH Corporation | 2015-12-14 |
| V-STEADY, V-FAST (K150408) | G21, S.R.L. | 2015-12-14 |
| OTC12D AUTO RADIOGRAPHIC SYSTEM (K152767) | Del Medical, Inc. | 2015-12-14 |
| Cardinal Health Trochanteric IM Nail System (K150769) | Cardinalhealth | 2015-12-14 |
| Endoskeleton(r) TCS System (K153122) | Titan Spine, LLC | 2015-12-14 |
| QuickRay HD Intraoral Sensor (K151926) | Denterprise International, Inc. | 2015-12-14 |
| ViSi Mobile Monitoring System (K152341) | Sotera Wireless, Inc. | 2015-12-14 |
| AbStats Gateway (K150782) | Gi Logic, Inc. | 2015-12-14 |
| Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (K152554) | C.R. Bard, Inc. | 2015-12-14 |
| ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS (K150877) | Instrumentation Laboratory CO | 2015-12-13 |
| LC Bead LUMI (K152157) | Biocompatibles UK , Ltd. | 2015-12-11 |
| MicroSpot Handpiece (K152153) | Asclepion Laser Technologies GmbH | 2015-12-11 |
| VINTAGE Art LF (K152451) | Shofu Dental Corporation | 2015-12-11 |
| FIREFLY Pedicle Screw Navigation Guide (K143222) | Mighty Oak Medical, Inc. | 2015-12-11 |
| Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System (K152987) | Xenco Medical, LLC | 2015-12-11 |
| BD FlowSmart Set, MiniMed Pro-Set (K153257) | Becton, Dickinson and Company | 2015-12-11 |
| DR 600 (K152639) | Agfa Healthcare N.V. | 2015-12-11 |
| Liquichek Cardiac Markers Plus Control LT (K150300) | Bio-Rad Laboratories | 2015-12-11 |
| AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (K153088) | Boston Scientific Corporation | 2015-12-11 |
| Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (K151767) | Siemens Healthcare Diagnostics, Inc. | 2015-12-11 |
| MotoBand¿ CP Implant System (K152306) | Crossroads Extremity Systems, LLC | 2015-12-11 |
| ORTHOLOC® 3Di Foot Plating Reconstruction System (K152974) | Wrightmedicaltechnologyinc | 2015-12-11 |
| SpeedLock Knotless Fixation System (K153313) | ArthroCare Corporation | 2015-12-11 |
| GORE SYNECOR Biomaterial (K152609) | W. L. Gore & Associates, Inc. | 2015-12-11 |
| Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm (K153461) | Maquet Critical Care AB | 2015-12-11 |
| Panther StereoSeed (K143514) | Prowess, Inc. | 2015-12-11 |
| VariLift-L Interbody Fusion Device (K151900) | Wenzel Spine, Inc. | 2015-12-11 |
| iViewDose R1.0 (K153011) | Elekta Limited | 2015-12-11 |
| Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein (K151114) | St. Marys Rubbers Pvt, Ltd. | 2015-12-11 |
| Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (K151381) | Covidien | 2015-12-11 |
| Spinal Inner Fixation System (K143013) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| AccuCath Intravascular Catheter (K153298) | C.R. Bard, Inc. | 2015-12-10 |
| OneQ-SL Implant System (K142313) | Dentis Co., Ltd. | 2015-12-10 |
| ALP VasQcare Take Home System (K151158) | Currie Medical Specialties, Inc. | 2015-12-10 |
| BRX PRO Bruxism Guard (K151933) | 12th Man Technologies, Inc. | 2015-12-10 |
| AOS Small Fragment Plating System (K152732) | Avanced Orthopaedic Solutions, Inc. (Aos) | 2015-12-10 |
| Regenomer® Syringe, Regenomer® Plug, Regenomer® Block (K150079) | Nibec Co., Ltd. | 2015-12-10 |
| Fuse Gastroscopy System (K152182) | Endochoice, Inc. | 2015-12-10 |
| BEAUTIFIL II Enamel (K151699) | Shofu Dental Corporation | 2015-12-10 |
| Twin Peaks Lumbar Interbody Fusion System (K152355) | Spineway | 2015-12-10 |
| PAPAYA 3D Plus (K150354) | Genoray Co., Ltd. | 2015-12-10 |
| Biomet Microfixation OmniMax MMF System (K152326) | Biomet Microfixation | 2015-12-10 |
| 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708) | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 |
| Checkme Pro Health Monitor (K150869) | Viatom Technology Co., Ltd. | 2015-12-10 |
| Sterile Repositionable Hemostasis Clipping Device (K152001) | Micro-Tech (Nanjing) Co., Ltd. | 2015-12-10 |
| D-100 HbA1c, D-100 HbA1c Calibrator Pack (K151321) | Bio-Rad Laboratories, Inc. | 2015-12-09 |
| PENTRA XLR (K151133) | HORIBA ABX SAS | 2015-12-09 |
| Touch Ultrasound (K152467) | Carestream Health, Inc. | 2015-12-09 |
| Biodesign Enterocutaneous Fistula Plug (K150668) | Cook Biotech Incorprated | 2015-12-09 |
| MIVI Mi-AXUS Guide Catheter (K151396) | Mivi Neuroscience, Inc. | 2015-12-09 |
| ProParaFlu+ Assay (K153223) | Hologic, Inc. | 2015-12-09 |
| da Vinci Xi Hasson Cone (K153126) | Intuitive Surgical, Inc. | 2015-12-09 |
| One Coat 7 Universal (K152243) | Coltene/Whaledent AG | 2015-12-09 |