| K170392 — S.I.N. Implant System | S.I.N. Sistema DE Implante Nacional S.A. Dec 1, 2017 |
| K170553 — Altus Spine Interbody Fusion System | Altus Partners, LLC Dec 1, 2017 |
| K172666 — CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | Sutureease, Inc. Dec 1, 2017 |
| K172008 — ARIX Humerus System | Jeil Medical Corporation Dec 1, 2017 |
| K173148 — ACIF | Coligne AG Dec 1, 2017 |
| K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) | Beckman Coulter, Inc. Dec 1, 2017 |
| K173129 — PRECICE System | Nuvasive Specialized Orthopedics, Inc. Dec 1, 2017 |
| K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC Dec 1, 2017 |
| K172469 — TiLock Modular Spinal System | Genesys Spine Nov 30, 2017 |
| K173385 — Graft Delivery, DePuy Synthes | Micromedics, Inc. (D/B/A Nordson Medical) Nov 30, 2017 |
| K172225 — Atlantis Abutment for MIS Implant | Dentsply Sirona Nov 30, 2017 |
| K172769 — CryOmega Flexx | Cryoconcepts LP Nov 30, 2017 |
| K171571 — NexSite HD, Hemodialysis Step Tip Catheter (60cm) | Marvao Medical Devices, Ltd. Nov 30, 2017 |
| K173233 — ReliefBand 1.5 | Reliefband Technologies Nov 30, 2017 |
| K173522 — Solanas® Posterior Stabilization System | Alphatec Spine, Inc. Nov 30, 2017 |
| K172538 — Disposable Linear Stapler, Disposable Linear Cutter | Changzhou Kangdi Medical Stapler Co., Ltd. Nov 30, 2017 |
| K171578 — Infrared thermometer | Shenzhen Aeon Technology Co., Ltd. Nov 30, 2017 |
| K173099 — Fortis and Hana Anterior Cervical Plate System | Huvexel Co. , Ltd. Nov 30, 2017 |
| K171934 — Birmingham Hip (BH) Dual Mobility Insert | Smith & Nephew, Inc. Nov 30, 2017 |
| K172936 — Destiknee Total Knee System | Meril Healthcare Pvt. , Ltd. Nov 30, 2017 |
| K172925 — Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited Nov 30, 2017 |
| K172767 — Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | Zimmer, Inc. Nov 30, 2017 |
| K173399 — Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC Nov 30, 2017 |
| K172637 — HeRO Graft | Merit Medical Systems, Inc. Nov 30, 2017 |
| K170868 — FIXIT Threaded Anchor System | S.B.M Sas Science For Bio Materials Nov 30, 2017 |
| K162718 — Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited Nov 30, 2017 |
| K171350 — Collision Check | Radformation, Inc. Nov 29, 2017 |
| K170634 — Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 | Advanced Vehicle Concepts , Ltd. Nov 29, 2017 |
| K172491 — ICONN Square 2.5MM Suture Anchor | Iconn Orthopedics, LLC Nov 29, 2017 |
| K172020 — Arlington PLIF/TLIF Cage | Signature Orthopaedics Pty, Ltd. Nov 29, 2017 |
| K172019 — Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. Nov 29, 2017 |
| K170690 — M-Vizion Femoral Revision System | Medacta International S.A. Nov 29, 2017 |
| DEN170041 — GeneSTAT.MDx Coccidioides Assay | Dxna, LLC Nov 29, 2017 |
| K171803 — HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. Nov 29, 2017 |
| K172794 — Suction Irrigation Set | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Nov 29, 2017 |
| K170235 — Lucent® | Spinal Elements, Inc. Nov 29, 2017 |
| K172067 — One Mum Pumpset | Ardo Medical AG Nov 29, 2017 |
| K171466 — NobelDesign, DTX Studio Design | Nobel Biocare AB Nov 29, 2017 |
| K172689 — DESCRIBE PFD Patch | Merz North America, Inc. Nov 29, 2017 |
| K172771 — Epic Pro 940 | Biolase, Inc. Nov 29, 2017 |
| K171694 — s-Clean TiN Coating Abutments | Dentis Co., Ltd. Nov 29, 2017 |
| K173111 — LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. Nov 28, 2017 |
| K173290 — DuoFLEX Coil Suite | Mr Instruments, Inc. Nov 28, 2017 |
| K161652 — DIAZIR | Zxtgy (Beijing) Technology Co., Ltd. Nov 28, 2017 |
| K172642 — Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd Nov 28, 2017 |
| K170053 — Meridian PM | The Center For Craniofacial & Dental Sleep Medicine Nov 28, 2017 |
| K170916 — Portable Nebulizer | Microbase Technology Corporation Nov 28, 2017 |
| K170688 — PITStop® implant | In2Bones Sas Nov 28, 2017 |
| K173006 — Cefaly Dual | Cefaly Technology Nov 28, 2017 |
| K173377 — 3.0T 16ch Breast Coil | Neocoil, LLC Nov 28, 2017 |