| Hoffman LRF System (K161753) | Stryker GmbH | 2016-11-15 |
| Digital Diagnostic Mobile X-ray System (K162278) | Samsung Electronics Co., Ltd. | 2016-11-15 |
| Optima XR240amx (K162990) | Ge Medical Systems, LLC | 2016-11-15 |
| VLP Wrist Fracture System (K161665) | Smith & Nephew, Inc. | 2016-11-15 |
| Charisma (K160049) | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | 2016-11-15 |
| StatStrip Xpress Glucose Hospital Meter System (K161856) | Nova Biomedical Corporation | 2016-11-15 |
| Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742) | Tornier, Inc. | 2016-11-15 |
| IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (K161831) | Immunodiagnostic Systems , Ltd. | 2016-11-15 |
| Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) (K153409) | Protect U Guard, LLC | 2016-11-15 |
| eUnity (K161515) | Client Outlook, Inc. | 2016-11-15 |
| CushionCast Moldable Cushions (K162265) | Izi Medical Products, LLC | 2016-11-15 |
| AccuCath Intravascular Catheter (K162894) | C.R. Bard, Inc. | 2016-11-15 |
| X-MIND trium (K160166) | De Gotzen S.R.L. | 2016-11-15 |
| Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (K161494) | Siemens Healthcare Diagnostics, Inc. | 2016-11-15 |
| FasTouch Fixation System (K162252) | Via Surgical , Ltd. | 2016-11-14 |
| Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K162457) | Rocket Medical Plc | 2016-11-14 |
| ThermoPro (K161862) | Zimmer Medizinsysteme GmbH | 2016-11-14 |
| PathLoc-SI Joint Fusion System (K153656) | L&K BIOMED Co., Ltd. | 2016-11-14 |
| Vital Sync Informatics Manager & Virtual Patient Monitoring Platform (K160718) | Covidien | 2016-11-14 |
| Ligasure Blunt Tip, Sealer/Divider, Nano-coated (K162941) | Covidien | 2016-11-14 |
| i-CAT FLX V series / KaVo 3D eXam+ V series (K162085) | Imaging Sciences International | 2016-11-10 |
| FORTEZZA Spinal Stabilization System (K162576) | Osso Surgical | 2016-11-10 |
| JAS Pulse(TM) Ultrasonic Therapy (K161628) | Bonutti Research, Inc. | 2016-11-10 |
| Calprest NG (K160447) | Eurospital S.P.A. | 2016-11-10 |
| Sunmed Control Syringes (K160190) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-11-10 |
| Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL (K161623) | B.Braun Medical, Inc. | 2016-11-10 |
| iCodeConnect (K160127) | 3B Medical, Inc. | 2016-11-10 |
| rainbow Shine (K160079) | Genoss Co., Ltd. | 2016-11-10 |
| Solitaire 2 Revascularization Device (K162539) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-11-10 |
| FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (K161738) | Taidoc Technology Corporation | 2016-11-10 |
| XBraid TT Suture Tape (K162310) | Stryker | 2016-11-10 |
| IPS CaseDesigner (K161634) | Nobel Biocare AB | 2016-11-10 |
| DePuy Synthes MAXFRAME Multi-Axial Correction System (K161417) | Synthes USA, LLC | 2016-11-10 |
| ESU-1 Electrosurgical Generator (K162656) | Tva Medical, Inc. | 2016-11-10 |
| Magma Spark (K162781) | Formatk Systems , Ltd. | 2016-11-09 |
| LUCAS 3 Chest Compression System (K161768) | Jolife AB | 2016-11-09 |
| Tritanium® PL Cage (K162262) | Stryker | 2016-11-09 |
| EXPRT Revision Hip System (K161610) | Encore Medical L.P. | 2016-11-09 |
| Raycast High Precision Lung Board Solution (K162862) | Orfit Industries NV | 2016-11-09 |
| Insulia Diabetes Management Companion (K161433) | Voluntis Sa. | 2016-11-09 |
| HYPNOSPAD (K152660) | Somnics, Inc. | 2016-11-09 |
| Vivo 60 (K160481) | Breas Medical AB | 2016-11-09 |
| Virtu C Spinal Implant System (K161649) | Met 1 Technologies, LLC | 2016-11-09 |
| SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive (K161011) | Adhezion Biomedical, LLC | 2016-11-08 |
| YO Home Sperm Test (K161493) | Medical Electronic Systems , Ltd. | 2016-11-08 |
| Amendia Interbody Fusion Devices (K160924) | Amendia, Inc. | 2016-11-08 |
| Cadwell AmpliScan (K161027) | Cadwell Industries, Inc. | 2016-11-08 |
| Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (K161438) | Genesys Spine | 2016-11-08 |
| dS Small Extremity 16CH 1.5T Coil (K162863) | Invivo Therapeutics Corporation | 2016-11-07 |
| P1145 Dental Restorative (K162257) | Kerr Corporation | 2016-11-07 |
| Renovo Life Small Bone IM Nail System (K161254) | Renovo Life, LLC | 2016-11-07 |
| Materialise TKA Guide System (K162273) | Materialise NV | 2016-11-07 |
| MCP Bone Putty (K160446) | Biostructures, LLC | 2016-11-07 |
| MicrO2 OSA Device with Micro-Recorder (K161624) | Microdental, Inc. | 2016-11-07 |
| Irix-C Cervical Integrated Fusion System (K162944) | X-Spine Systems, Inc. | 2016-11-07 |
| UltraShape System (K161952) | Syneron Medical, Ltd. | 2016-11-07 |
| Powder Free Nitrile Examination Gloves (Blue) (K162113) | Nam Viet Glove Joint Stock Company | 2016-11-07 |
| SPEEDTRAP Graft Preparation System (K161638) | Medos International SARL | 2016-11-07 |
| Avance Foam Dressing Kit - XL (K161935) | Molnlycke Health Care Us, LLC | 2016-11-04 |
| Pinpoint GT Introducer Needle (K162769) | C.R. Bard, Inc. | 2016-11-04 |
| I View and Imagen Sensor (K162619) | Trident S.R.L | 2016-11-04 |
| LipiFlow Thermal Pulsation System (K161357) | Tearscience, Inc. | 2016-11-04 |
| D-SPECT Scanner, D-SPECT L Scanner (K161740) | Spectrum Dynamics Medical, Ltd. | 2016-11-04 |
| Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 (K162350) | Boston Scientific Corporation | 2016-11-04 |
| VSTAAR AdjusteR (K160278) | Spinal Acoustics, LLC | 2016-11-04 |
| ABL90 FLEX PLUS (K160153) | Radiometer Medical Aps | 2016-11-04 |
| Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646) | Diazyme Laboratories | 2016-11-04 |
| Inclusive Abutments (K160979) | Prismatik Dentalcraft, Inc. | 2016-11-04 |
| Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source (K162573) | Source Production and Equipment Co., Inc. | 2016-11-04 |
| Trex_HD (K162595) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-11-04 |
| SuniIQ Digital Radiography System (K162585) | Suni Medical Imaging, Inc. | 2016-11-04 |
| SwiftNINJA Microcatheter (K161921) | Merit Medical Systems, Inc. | 2016-11-04 |
| Barrier Supreme Sterilization Wrapper (K162162) | Standard Textile Co., Inc. | 2016-11-04 |
| CardioInsight Cardiac Mapping System (K162440) | Cardioinsight Technologies, Inc. | 2016-11-04 |
| Lipogems System (K161636) | Lipogems International Spa | 2016-11-04 |
| AOS Small Fragment Plating System (K161913) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2016-11-04 |
| PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (K160361) | Primed Medical Products, Inc. | 2016-11-04 |
| LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer (K161703) | Aap Implantate AG | 2016-11-04 |
| Puritan Fecal Opti-Swab Collection and Transport System (K162284) | Puritan Medical Products, LLC | 2016-11-04 |
| Vitrea CT Dual Energy Image View (K161157) | Vital Images, Inc. | 2016-11-03 |
| Intermittent Pneumatic Compression system (K160180) | Daesung Maref Co., Ltd. | 2016-11-03 |
| CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System (K162136) | L&K BIOMED Co., Ltd. | 2016-11-03 |
| Vonflex S (K152615) | Vericom Co., Ltd. | 2016-11-03 |
| Avance Gauze Dressing Kits (K161948) | Molnlycke Health Care Us, LLC | 2016-11-03 |
| MicrUs (K161968) | Telemed | 2016-11-03 |
| MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (K161779) | Medsource International, LLC | 2016-11-03 |
| Nanova Interference Screw (K161174) | Nanova Biomaterials, Inc. | 2016-11-03 |
| CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (K160921) | Cs Medical, LLC | 2016-11-03 |
| MatrixRIB Fixation System (K161590) | Synthes (USA) Products, LLC | 2016-11-03 |
| CastleLoc Spinal Fixation System (K162801) | L&K BIOMED Co., Ltd. | 2016-11-03 |
| Nunchaku (K161373) | Fci (France Chirurgie Instrumentation) | 2016-11-03 |
| Electronic Sphygmomanometer (K160349) | Guangdong Biolight Meditech Co., Ltd. | 2016-11-03 |
| PleurX Peritoneal Catheter System (K160437) | Care Fusion | 2016-11-03 |
| Persona Partial Knee System (K161592) | Biomet, Inc. | 2016-11-03 |
| Greiner Holdex (K160532) | Greiner Bio-One Na, Inc. | 2016-11-03 |
| FONA Pan/Ceph (K161131) | Fona S.R.L | 2016-11-03 |
| Senographe Pristina (K162268) | GE Healthcare | 2016-11-03 |
| Boosting Catheter (K160561) | Qxmedical, LLC | 2016-11-02 |
| joimax Electrosurgical Instruments (K161378) | Joimax GmbH | 2016-11-02 |
| Lucid Q-PTP / HWA 55 (K161670) | Bison Medical Co, Ltd. | 2016-11-02 |