| K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO Sep 8, 2017 |
| K170041 — XableCath Support Catheter | Xablecath, Inc. Sep 7, 2017 |
| K172489 — Reliance Cervical IBF System | Reliance Medical Systems, LLC Sep 7, 2017 |
| K162171 — S4 Screw System | Subchondral Solutions Sep 7, 2017 |
| K170855 — T-Rex Standalone ALIF | Siats, LLC Sep 7, 2017 |
| K171126 — Implantium II | Dentium Co., Ltd. Sep 7, 2017 |
| K172433 — NICO BrainPath | Nico Corporation Sep 7, 2017 |
| K170381 — Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | Medtronic Advanced Energy Sep 7, 2017 |
| K170442 — Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation Sep 7, 2017 |
| K171730 — FuckWater | Non-Friction Products, Inc. Sep 7, 2017 |
| K170981 — NeuroQuant | Cortechs Labs, Inc. Sep 7, 2017 |
| K161586 — The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | Shenzhen Homed Medical Device Co., Ltd. Sep 6, 2017 |
| K172375 — MicroSTAAR Injector System Cartridges | STAAR Surgical Company Sep 6, 2017 |
| K171496 — Tritanium C Anterior Cervical Cage | Stryker Spine Sep 6, 2017 |
| K163538 — QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Inova Diagnostics, Inc. Sep 6, 2017 |
| K172394 — Steerable Guide Catheter | Abbott Vascular Sep 6, 2017 |
| K171027 — Dentis Dental Implant System | Dentis Co., Ltd. Sep 6, 2017 |
| K163510 — Poseidon Ultrasound System | Butterfly Network, Inc. Sep 6, 2017 |
| K172372 — QuadraSphere Microspheres | Biosphere Medical, S.A. Sep 6, 2017 |
| K171178 — Central Monitoring System | Edan Instruments, Inc. Sep 6, 2017 |
| K171035 — Katalyst Mark 1 Muscle Stimulation System | Katalyst, Inc. Sep 6, 2017 |
| K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. Sep 5, 2017 |
| K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. Sep 5, 2017 |
| K163464 — Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | Bmc Medical., Ltd. Sep 5, 2017 |
| K172048 — FluidSmart | Thermedx, LLC Sep 5, 2017 |
| K163338 — OMNIBotics Knee System | Omnllife Science, Inc. Sep 1, 2017 |
| K171323 — BIOPHOTAS CELLUMA3 | Biophotas, Inc. Sep 1, 2017 |
| K170547 — Arthrex Mesh Plate System | Arthrex, Inc. Sep 1, 2017 |
| K171558 — ExsoMed ITN Cannulated Screw System | Exsomed Holdings Company, LLC Sep 1, 2017 |
| K171583 — RhythmView Workstation | Abbott Electrophysiology Sep 1, 2017 |
| K170181 — Prizma | G-Medical Innovations , Ltd. Sep 1, 2017 |
| K170970 — Epilaser | Epilady 2000, LLC Sep 1, 2017 |
| K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000) | Cair Lgl Sep 1, 2017 |
| K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging , Ltd. Sep 1, 2017 |
| K163302 — Senographe Pristina | GE Healthcare Sep 1, 2017 |
| K163439 — NaviENT | Claronav, Inc. Sep 1, 2017 |
| K171507 — CustomizedBone Service | Fin-Ceramica Faenza S.P.A. Sep 1, 2017 |
| K171358 — Emprint SX Ablation Platform and Accessories | Coviden, LLC Sep 1, 2017 |
| K163448 — GrindCare System | Sunstar Suisse S.A. Sep 1, 2017 |
| K171704 — CAPRI Corpectomy Cage System | K2M Aug 31, 2017 |
| K163337 — Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer | Midmark Corporation Aug 31, 2017 |
| K172098 — Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. Aug 31, 2017 |
| K162613 — Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products Aug 31, 2017 |
| K162533 — Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. Aug 31, 2017 |
| K170599 — SureFlo EVD Catheter | Arkis Biosciences, Inc. Aug 31, 2017 |
| K171010 — Latitude EV Total Elbow Arthroplasty | Tornier, Inc. Aug 31, 2017 |
| K171642 — Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. Aug 31, 2017 |
| K163402 — NLZ Motor System | Nakanishi, Inc. Aug 31, 2017 |
| K163423 — Orthopantomograph OP300 | Palodex Group OY Aug 31, 2017 |
| K170031 — Internal Octa Implant System | Ebi, Inc. Aug 31, 2017 |