| K180876 — DTRAX Spinal System | Providence Medical Technology, Inc. May 18, 2018 |
| K180886 — Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | Liofilchem S.R.L. May 18, 2018 |
| K180051 — XSTAT 30, 1-Pack | Revmedx, Inc. May 18, 2018 |
| K180908 — Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. May 18, 2018 |
| K180259 — Sterile Hypodermic Needle for Single Use | Jiangsu Shenli Medical Production Co., Ltd. May 18, 2018 |
| K180771 — Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. May 18, 2018 |
| K172430 — ArgenIS Titanium Abutments | Argen Corporation May 18, 2018 |
| K180217 — VESTEX Apparel | Vestagen Protective Technologies, Inc. May 18, 2018 |
| K172813 — Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. May 18, 2018 |
| K180524 — EEG-Now | Encephalodynamics, Inc. May 18, 2018 |
| K180663 — LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | Livermoretech, Inc. May 18, 2018 |
| K173294 — Magnesium | Abbott Laboratories May 18, 2018 |
| K173431 — Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. May 18, 2018 |
| K180460 — Theradome LH40 | Theradome, Inc. May 18, 2018 |
| K173108 — Smoklean | Sejong Medical Co., Ltd. May 18, 2018 |
| K180375 — The IQoolTM Warm System | Braincool AB May 18, 2018 |
| K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | Medical Components, Inc. (Dba MedComp) May 17, 2018 |
| K172480 — icotec Interbody Cage System | Icotec AG May 17, 2018 |
| K173360 — Athena 190 | Medical Rehab Products, LLC May 17, 2018 |
| K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation May 17, 2018 |
| K173832 — InTice-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. May 17, 2018 |
| K172894 — Infrared Thermometer | Shenzhen Jiacom Technology CO ., Ltd. May 17, 2018 |
| K172592 — CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. May 17, 2018 |
| DEN170086 — TrueTear Intranasal Tear Neurostimulator | Allergan May 17, 2018 |
| K180466 — FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. May 17, 2018 |
| K180742 — EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical May 17, 2018 |
| K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. May 17, 2018 |
| K172524 — Zimmer Persona Personalized Knee System | Zimmer, Inc. May 17, 2018 |
| K173931 — MindMotion(TM) GO | Mindmaze SA May 17, 2018 |
| K181111 — Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. May 17, 2018 |
| K181023 — Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter | Meril Life Sciences Private Limited May 17, 2018 |
| K180906 — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. May 16, 2018 |
| K180239 — Additive Orthopaedics Patient Specific 3D Printed Bone Segments | Additive Orthopaedics, LLC May 16, 2018 |
| K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co, Ltd. May 16, 2018 |
| K180527 — IS3 | Hiossen, Inc. May 16, 2018 |
| K180519 — HARRIER-SA Lumbar Interbody System | Choicespine, LP May 16, 2018 |
| K180901 — Low Dose CT Lung Cancer Screening Option | Hitachi Healthcare Americas May 16, 2018 |
| K172675 — Varian Cervical Sleeves | Varian Medical Systems, Inc. May 16, 2018 |
| K173940 — Astroid Planning App | .Decimal, LLC May 15, 2018 |
| K180476 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn. Bhd. May 15, 2018 |
| K180687 — Reliance Lumber IBF System | Reliance Medical Systems May 15, 2018 |
| K180624 — Guided Growth Plate System Plus | Orthofix Srl May 15, 2018 |
| K180986 — XableCath Support Catheter Product Family | Xablecath, Inc. May 15, 2018 |
| K181003 — VIVIX-S 1717V | Vieworks Co., Ltd. May 15, 2018 |
| K180513 — CustomizedBone Service | Fin-Ceramica Faenza S.P.A. May 15, 2018 |
| K180883 — 5D Viewer | Samsung Medison Co., Ltd. May 15, 2018 |
| K171449 — Metacem | Meta Biomed Co., Ltd. May 15, 2018 |
| K180445 — reVive Light Therapy LED Ultrasonic Wrinkle System | Led Technologies, Inc. May 15, 2018 |
| K181153 — ICEfx Cryoablation System | Galil Medical, Inc. May 15, 2018 |
| K180412 — Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | Penumbra, Inc. May 15, 2018 |