| HPM-6000 (K160992) | BTL Industries, Inc. | 2016-10-21 |
| Distal Radius Plating System (K162635) | Miami Device Solutions, LLC | 2016-10-21 |
| M.U.S.T. Pedicle Screw System (K162061) | Medacta International S.A. | 2016-10-21 |
| NOSOGARD FILTERS (K153784) | Evoqua Water Technologies, LLC | 2016-10-21 |
| KARL STORZ NAV1 Electromagnetic Navigation System (K161555) | Karl Storz Endoscopy America, Inc. | 2016-10-21 |
| Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (K160187) | St Jude Medical | 2016-10-21 |
| MiniBox + (K161295) | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 |
| Rockwell Medical CitraPure Acid Concetrate (K160847) | Rockwell Medical | 2016-10-20 |
| COLORADO THERAPEUTICS XENOGRAFT IMPLANT (K160181) | Colorado Therapeutics, LLC | 2016-10-20 |
| Advanced Breast Template System (K161540) | Varian Medical Systems, Inc. | 2016-10-20 |
| IQM Integral Quality Monitor (also IQM) (K162629) | Irt Systems | 2016-10-20 |
| QuantumCam (K161674) | Ddd-Diagnostic A/S | 2016-10-20 |
| Fluent inflation device (K162272) | Vascular Solutions, Inc. | 2016-10-20 |
| Q13 SPIROLYSER® (K161676) | Fim Medical | 2016-10-20 |
| Green Smart (Model: PHT-35LHS) (K162660) | VATECH Co., Ltd. | 2016-10-20 |
| aoni Natural Rubber Latex Condom (K153016) | Guangzhou Daming United Rubber Products , Ltd. | 2016-10-20 |
| OPTIMUS CMF SYSTEM (K160363) | Osteonic Co., Ltd. | 2016-10-20 |
| HICP200 Patient/Monitor Interconnect Cable (K161010) | Innerspace Neuro Solutions, Inc. | 2016-10-20 |
| DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K161422) | Wrp Asia Pacific Sdn. Bhd. | 2016-10-20 |
| LiVac Retractor System (K162445) | Livac Pty, Ltd. | 2016-10-20 |
| Z-Clamp ISP System (K161016) | Zavation, LLC | 2016-10-19 |
| TENS Electrodes (K160081) | Cathay Manufacturing Corp. | 2016-10-19 |
| Pulsaderm Acne Device (K161941) | Nutra Luxe MD, LLC | 2016-10-19 |
| HDL-Cholesterol Gen.4 (K162593) | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| Advocate Insulin Pen Needles (K160199) | Diabetic Supply of Suncoast, Inc. | 2016-10-19 |
| Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) (K161473) | Medline Industries, Inc. | 2016-10-19 |
| Tyto Stethoscope (K160401) | Tyto Care , Ltd. | 2016-10-19 |
| ReNew V Handpiece Laparoscopic Instruments (K160706) | Microline Surgical, Inc. | 2016-10-19 |
| Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K162597) | Alcon Laboratories, Inc. | 2016-10-19 |
| ADAMANT ZIRCONIA DISC (K160203) | Adamant Co., Ltd. | 2016-10-19 |
| Avance Tubing, Avance Y-Connector, Avance ViewPad (K161797) | Molnlycke Health Care Us, LLC | 2016-10-19 |
| Klassic HD Hip System (K161073) | Total Joint Othopedics, Inc. | 2016-10-19 |
| Ultrasound System SONIMAGE HS1 (K162065) | Konica Minolta, Inc. | 2016-10-19 |
| NOBLUS™ Ultrasound Diagnostic System (K160559) | Hitachi Medical Corporation | 2016-10-18 |
| VITROS® Automation Solutions (K160495) | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 |
| Fujifilm Endoscope Models EC-600HL and EC-600LS (K162622) | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 |
| Premier Sealant (K161580) | Premier Dental Company Products | 2016-10-18 |
| Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (K162326) | Avinger, Inc. | 2016-10-18 |
| EasyMap MAP Catheter (K151139) | Medfact Engineering GmbH | 2016-10-18 |
| Neuromonitoring Kit (K161893) | SI-BONE, Inc. | 2016-10-18 |
| VersaOne Bladeless Trocar (K162584) | Covidien | 2016-10-18 |
| 16ch T/R Knee Coil (K162029) | Quality Electrodynamics, LLC | 2016-10-18 |
| IntelliSpace Portal Platform (K162025) | Philips Medical Systems Nederlands B.V. | 2016-10-18 |
| ENROUTE 0.014 Guidewire (K160643) | Lake Region Medical | 2016-10-18 |
| Rampart D Lumbar Interbody Fusion Device (K160074) | Spineology, Inc. | 2016-10-18 |
| Medtronic Temporary External Pacemaker 53401 (K162054) | Medtronic, Inc. | 2016-10-18 |
| NovoPen Echo (K162602) | Novo Nordisk, Inc. | 2016-10-18 |
| ClearLumen II Thrombectomy System (K161786) | Walk Vascular, LLC | 2016-10-18 |
| OSSTEM Implant System (K161604) | Osstem Implant Co., Ltd. | 2016-10-17 |
| bk2300 (K161960) | Bk Medical Aps | 2016-10-17 |
| Infinix, INFX-8000V, V6.35 (K162614) | Toshibamedical Systems Corporation | 2016-10-17 |
| Fingertip Pulse Oximeter MD300CG11/MD300CG51 (K160268) | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-14 |
| MedDream (K162011) | Softneta Uab | 2016-10-14 |
| FREND Testosterone Test System (K153577) | Nanoentek USA, Inc. | 2016-10-14 |
| NovaPACS (K160371) | Novarad Corporation | 2016-10-14 |
| D-10 Hemoglobin A1c Program (K161687) | Bio-Rad Laboratories, Inc. | 2016-10-14 |
| ANYVIEW-500R Fluoroscopic Mobile X-Ray System (K160279) | Ecotron Co., Ltd. | 2016-10-14 |
| Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device (K161886) | Guangdong Transtek Medical Electronics Co., Ltd. | 2016-10-14 |
| iNSitu Total Hip System (K161184) | Theken Companies, LLC | 2016-10-14 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |
| BSD3543 Digital Flat Panel X-ray Detector (K162487) | Bontech, Inc. | 2016-10-14 |
| R2P SlenGuide (K161546) | Ashitaka Factory of Terumo Corporation | 2016-10-14 |
| VascuCel (K162579) | Admedus Regen Pty, Ltd. | 2016-10-14 |
| MyLabSix CrystaLine (K162290) | Esaote, S.p.A. | 2016-10-14 |
| BracePaste Adhesive (K160782) | American Orthodontics | 2016-10-14 |
| Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (K161569) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2016-10-14 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K161882) | Integra LifeSciences Corporation | 2016-10-14 |
| Olive Plus (K161981) | Ama Network, Inc. | 2016-10-14 |
| Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K161714) | Immunalysis Corporation | 2016-10-14 |
| ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip (K161912) | Asahi Intecc Co., Ltd. | 2016-10-14 |
| IH Implant System (K153521) | Sewonmedix, Inc. | 2016-10-14 |
| Overwatch Spine System (K161842) | Amendia, Inc. | 2016-10-13 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K160562) | Hartalega Snd. Bhd. | 2016-10-13 |
| Bioflux Software (K162571) | Biotricity, Inc. | 2016-10-13 |
| VT·One, VT·One 60days (K161410) | Carilex Medical, Inc. | 2016-10-13 |
| Sunmed Haemostatic Valves (K153685) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-10-13 |
| AIR OPTIX COLORS (K162596) | Alcon Laboratories, Inc. | 2016-10-13 |
| ADVIA Centaur HAV IgM Assay (K161964) | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| OTC TENS Device, Model PTS-IV (K161537) | Counter Scientific Development (Gz), Ltd. | 2016-10-13 |
| XCage™ Interbody Fusion System (K160076) | Ouroboros Medical, Inc. | 2016-10-13 |
| Ulna Plating System (K162424) | Biomet, Inc. | 2016-10-12 |
| Toricolors (hioxifilcon D) Soft Contact Lenses (K161931) | Polydev , Ltd. | 2016-10-12 |
| ClearPetra Suction-Evacuation Sheath (K161110) | Well Lead Medical Co., Ltd. | 2016-10-12 |
| FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (K161815) | Genesee Biomedical, Inc. | 2016-10-12 |
| Navien Intracranial Support Catheter (K161152) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-10-12 |
| Spetzler Malis Dual Illuminating Bipolar Forceps (K160103) | Synergetics | 2016-10-12 |
| Stryker OrthoMap Precision Knee system (K162341) | Stryker Leibinger GmbH & Co KG | 2016-10-12 |
| FTRD System Set (K153550) | Ovesco Endoscopy AG | 2016-10-12 |
| Express SD Biliary Monorail Premounted Stent System (K162404) | Boston Scientific Corporation | 2016-10-12 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K162550) | Medtronic, Inc. | 2016-10-12 |
| HammerTech Fixation System (K161449) | Fusion Orthopedics, LLC | 2016-10-11 |
| IcePearl 2.1 CX L, IceForce 2.1 CX L (K162599) | Galil Medical , Ltd. | 2016-10-11 |
| EnSite Velocity Surface Electrode Kit (K160186) | St Jude Medical | 2016-10-07 |
| Pyrenees Cervical Plate System (K162664) | K2m, Inc. | 2016-10-07 |
| Sterilization Tray (K160912) | STERIS Corporation | 2016-10-07 |
| CAVUX™ Cervical Cage (K161642) | Providence Medical Technology, Inc. | 2016-10-07 |
| Pantera Pro (K160985) | Biotronik, Inc. | 2016-10-07 |
| PK Morcellator (K161038) | Gyrus Acmi, Inc. | 2016-10-07 |
| SpiroScout (K160116) | Ganshorn Medizin Electronic GmbH | 2016-10-07 |
| Straumann Sterile Healing Solution (K161677) | Institut Straumann AG | 2016-10-07 |