| K172357 — Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | Ever Growth (Vietnam) Co. , Ltd. Dec 29, 2017 |
| K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. Dec 29, 2017 |
| K173664 — Medtronic O-arm O2 Imaging System | Medtronic, Inc. Dec 29, 2017 |
| K173102 — Reliance Cervical IBF System | Reliance Medical Systems, LLC Dec 29, 2017 |
| K173403 — GEM Premier 5000 | Instrumentation Laboratory CO Dec 29, 2017 |
| K170165 — Osteo-P Bone Graft Substitute | Molecular Matrix, Inc. Dec 29, 2017 |
| K172474 — Celerity 20 HP Biological Indicator | STERIS Corporation Dec 29, 2017 |
| K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | Ansell Healthcare Products, LLC Dec 29, 2017 |
| K171108 — AUTOBAHN Nailing System | Globus Medical, Inc. Dec 29, 2017 |
| K173087 — UroLift System (UL400 and UL500) | Neotract, Inc. Dec 28, 2017 |
| K173652 — Piccolo Composite Nailing System | CarboFix Orthopedics , Ltd. Dec 28, 2017 |
| K171269 — X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) Dec 28, 2017 |
| K171061 — MRSASelect II | Bio-Rad Dec 28, 2017 |
| DEN160037 — dermaPACE System | Sanuwave, Inc. Dec 28, 2017 |
| K163328 — Planmed Clarity | Planmed OY Dec 28, 2017 |
| K172505 — MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | Mis Implants Technologies , Ltd. Dec 28, 2017 |
| K173420 — Radiomics App v1.0 | Microsoft Corp. Dec 27, 2017 |
| K170104 — COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. Dec 27, 2017 |
| K172848 — MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems Dec 27, 2017 |
| K171037 — PoreStar Patient Specific Implant | Anatomics Pty, Ltd. Dec 27, 2017 |
| K172904 — IntelliVue Capnography Extension, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH Dec 26, 2017 |
| K170138 — NEURONAUTE | Bioserenity Dec 26, 2017 |
| K172645 — iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. Dec 26, 2017 |
| K173008 — SCS 17-01 | Anika Therapeutics, Inc. Dec 26, 2017 |
| K171049 — Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare Dec 26, 2017 |
| K173073 — AltiVate Anatomic to Reverse Conversion Module | Encore Medical L.P. Dec 26, 2017 |
| K170960 — CoaguChek Vantus System | Roche Diagnostics Dec 25, 2017 |
| K171581 — Neuro Omega System | Alpha Omega Engineering , Ltd. Dec 22, 2017 |
| K172706 — GammaPod - Model A | Xcision Medical Systems, LLC Dec 22, 2017 |
| K172688 — Align Radial Head System | Skeletal Dynamics, LLC Dec 22, 2017 |
| K172383 — Arthrosurface Bone Screws | Arthrosurface, Inc. Dec 22, 2017 |
| K172388 — VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF Dec 22, 2017 |
| K172785 — CONQUEST FN | Smith & Nephew Dec 22, 2017 |
| K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | True Diagnostics, Inc. Dec 22, 2017 |
| K171584 — B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. Dec 22, 2017 |
| K173492 — MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation Dec 22, 2017 |
| K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Inova Diagnostics, Inc. Dec 22, 2017 |
| K172507 — SOZO | ImpediMed Limited Dec 22, 2017 |
| DEN160014 — remOVE System | Ovesco Endoscopy AG Dec 22, 2017 |
| K172978 — SurgeoBite | Surgovations, LLC Dec 22, 2017 |
| K171102 — Ives MR Conditional Cup Electrode | Ives Egg Solutions Dec 21, 2017 |
| K173287 — Elite HV Radial | Galt Medical Corp. Dec 21, 2017 |
| K170028 — FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | Dako Denmark A/S Dec 21, 2017 |
| K172893 — SafeSept Needle Free Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC Dec 21, 2017 |
| K171848 — FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers | Globus Medical, Inc. Dec 21, 2017 |
| K172330 — Blustone Synergy Silica System | Blustone Synergy Dec 21, 2017 |
| K172448 — Riptide Aspiration System | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Dec 21, 2017 |
| K173250 — Solana GBS Assay | Quidel Corporation Dec 21, 2017 |
| K171877 — SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. Dec 21, 2017 |
| K172922 — MMPC-4127F1 | Barco N.V. Dec 21, 2017 |