| K180134 — Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC Jun 29, 2018 |
| K181410 — MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems, LLC Jun 29, 2018 |
| K173164 — Ecolab POU Water Filter | Ecolab, Inc. Jun 29, 2018 |
| K181068 — CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. Jun 29, 2018 |
| K180038 — NuVasive Pulse System | Nu Vasive, Incorporated Jun 29, 2018 |
| K172556 — TubeClear System | Actuated Medical, Inc. Jun 29, 2018 |
| K181232 — Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Largan Medical Co., Ltd. Jun 29, 2018 |
| K180389 — Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. Jun 29, 2018 |
| K180021 — Proton Positioing and Immobilization Devices | Medtec Inc Dba Civco Medical Solutions And Civco Radiotherap Jun 29, 2018 |
| K180481 — Servator B SALF Solution | S.A.L.F. Spa Jun 29, 2018 |
| K181203 — Juliet Ti | Spineart Jun 28, 2018 |
| K180993 — Beacon Advanced CO2 Laser System | Omniguide, Inc. Jun 28, 2018 |
| K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | ETHICON, Inc. Jun 28, 2018 |
| K181404 — Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. Jun 28, 2018 |
| K173116 — KJ ZIRCONIA Implant System | Kj Meditech Co., Ltd. Jun 28, 2018 |
| K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | ETHICON, Inc. Jun 28, 2018 |
| K180865 — ZMI Self-Adhesive Electrodes | Zmi Electronics , Ltd. Jun 28, 2018 |
| K172457 — Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited Jun 28, 2018 |
| K180583 — LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Richard Wolf Medical Instruments Corporation Jun 28, 2018 |
| K181121 — Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro | Home Well Trading, Ltd. Jun 28, 2018 |
| K181474 — ArtiClip LAA Exclusion System | AtriCure, Inc. Jun 28, 2018 |
| K180921 — Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. Jun 28, 2018 |
| K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | Zirkonzahn GmbH Jun 28, 2018 |
| K181144 — Angled Tip Ureteral Catheter | Cook Incorporated Jun 28, 2018 |
| K180729 — FaSet Fixation System | Huvexel Co. , Ltd. Jun 28, 2018 |
| K180454 — Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. Jun 27, 2018 |
| K180720 — Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel | Medibio USA, LLC Jun 27, 2018 |
| K181141 — OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery Jun 27, 2018 |
| K180364 — HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC Jun 27, 2018 |
| K180646 — Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Halyard Health Jun 27, 2018 |
| K181413 — uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. Jun 27, 2018 |
| K180895 — Alleye | Oculocare Medical AG Jun 27, 2018 |
| K180858 — CALLISTO eye | Carl Zeiss Meditec, AG Jun 27, 2018 |
| K181119 — Range (Denali and Mesa) Spinal Systems | K2M, Inc. Jun 26, 2018 |
| K173856 — Express 4 Sleep appliance/CPAP Sidekick appliance | Moses Appliances, LLC Jun 26, 2018 |
| K172846 — Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute Jun 26, 2018 |
| K180769 — SecurAcath | Interrad Medical, Inc. Jun 26, 2018 |
| K173725 — NeuMoDx GBS Assay | Neumodx Molecular, Inc. Jun 26, 2018 |
| K173361 — IV Administration Set | B.Braun Medical, Inc. Jun 26, 2018 |
| K173574 — DenSeeMammo | Statlife Jun 26, 2018 |
| K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. Jun 26, 2018 |
| K181230 — Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA | Largan Medical Co., Ltd. Jun 25, 2018 |
| K180701 — SafePath Suturing System | Safepath Medical, Inc. Jun 25, 2018 |
| K172788 — MONET Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation Jun 25, 2018 |
| K180995 — Vscan Extend | GE Medical Systems Ultrasound And Primary Care Diagnostics Jun 25, 2018 |
| K180690 — Navigation Instruments | Globus Medical, Inc. Jun 25, 2018 |
| K181465 — SpaceOAR System | Augmenix, Inc. Jun 25, 2018 |
| K180724 — SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC Jun 25, 2018 |
| K180674 — EVOL® ha-C Cervical Interbody Fusion System | Cutting Edge Spine, LLC Jun 25, 2018 |
| K180975 — QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. Jun 25, 2018 |