| K170989 — Dymaxeon Spine System | Back 2 Basics Direct, LLC May 22, 2017 |
| K163394 — Hybrid3D | Hermes Medical Solutions AB May 22, 2017 |
| K170446 — LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. May 21, 2017 |
| K170874 — Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. May 19, 2017 |
| K163564 — SLIT LAMP SL-2000 | Nidek Co., Ltd. May 19, 2017 |
| K163261 — AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. May 19, 2017 |
| K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | Bio-Rad Laboratories May 19, 2017 |
| K170908 — PK AIM | Gyrus Acmi, Inc. May 19, 2017 |
| K170322 — Catalys Precision Laser System | Abbott Medical Optics, Inc. May 19, 2017 |
| K170752 — OEC Elite | Oec Medical Systems, Inc. May 19, 2017 |
| K162212 — DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. May 19, 2017 |
| K161807 — BEAMSCAN | Ptw-Freiburg Physikalisch Technische-Werksraetten May 19, 2017 |
| K171152 — Stryker Universal Neuro III System AXS Screw | Stryker May 19, 2017 |
| K170303 — E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. May 19, 2017 |
| K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | Sol-Millennium Medical, Inc. May 19, 2017 |
| K162542 — OsteoMed PINNACLE Driver | Osteomed May 19, 2017 |
| K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation May 19, 2017 |
| K160677 — MICRORUPTOR 6 | Meridian AG May 19, 2017 |
| K170018 — StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. May 19, 2017 |
| K163644 — Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation May 19, 2017 |
| K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group May 19, 2017 |
| K161813 — Frova Intubating Introducer | William Cook Europe Aps May 19, 2017 |
| K171135 — Lipogems System | Lipogems International Spa May 18, 2017 |
| K162716 — bibag | Fresenius Medical Care Renal Therapies Group, LLC May 18, 2017 |
| DEN170019 — Vitamin D 200M Assay for the Topaz System | Ab Sciex, LLC May 18, 2017 |
| K160509 — Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated May 18, 2017 |
| K160567 — Barone Jejunostomy Catheter Set | Cook Incorporated May 18, 2017 |
| K171165 — SmartByte Device | Scientific Intake May 18, 2017 |
| K161272 — Supreme and Response Electrophysiology Catheters | Surgical Instrument Service And Savings, Inc. May 18, 2017 |
| K171139 — LaparoLight Veress Needle | Buffalo Filter, LLC May 18, 2017 |
| K170639 — HEALIX ADVANCE Anchor with PERMATAPE Suture | Medos International SARL May 18, 2017 |
| K170804 — The Solstice OCT System | Life Spine, Inc. May 18, 2017 |
| K170078 — Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | Medisono, LLC May 17, 2017 |
| K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0 | The Tova Company May 17, 2017 |
| K161601 — Dynamika | Image Analysis Limited May 17, 2017 |
| K171138 — Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation May 17, 2017 |
| K162378 — FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. May 17, 2017 |
| K171355 — Surefire Precision Infusion System | Surefire Medical, Inc. May 17, 2017 |
| K163669 — Humeris Shoulder | Fx Solutions May 17, 2017 |
| K163094 — TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. May 17, 2017 |
| K170195 — QuantX | Quantitative Insights, Inc. May 17, 2017 |
| K170196 — A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. May 17, 2017 |
| K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems | Zimmer Dental, Inc. May 17, 2017 |
| K153748 — AirLife Misty Finity Nebulizer | Care Fusion May 17, 2017 |
| K170828 — Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. May 17, 2017 |
| K170680 — TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant May 16, 2017 |
| K170462 — KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. May 16, 2017 |
| K163181 — TRANSLACE Spinal Tethering System | Medtronic Sofamor Danek USA, Inc. May 16, 2017 |
| K171327 — Tyber Medical Wedge System | Tyber Medical, LLC May 16, 2017 |
| K163002 — Kangaroo Feeding Tube with IRIS Technology | Covidien (Dba Medtronic) May 16, 2017 |