| K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB Jun 25, 2018 |
| DEN170004 — Ellipsys Vascular Access System | Avenu Medical, Inc. Jun 22, 2018 |
| K170826 — Perfadex Plus | Xvivo Perfusion AB Jun 22, 2018 |
| K180824 — VaPro 2 Intermittent Catheter | Hollister Incorporated Jun 22, 2018 |
| DEN160006 — everlinQ endoAVF System | Tva Medical, Inc. Jun 22, 2018 |
| K173066 — OSSEODUO Shaver and Drill System | Bien-Air Surgery SA Jun 22, 2018 |
| K180815 — MIM - SPECTRA Quant | Mim Software, Inc. Jun 22, 2018 |
| K180493 — A3 Total Knee System | Beijing AK Medical Co., Ltd. Jun 22, 2018 |
| K180282 — MIS Internal Hex Dental Implant System | Mis Implants Technologies , Ltd. Jun 22, 2018 |
| K151721 — FIJI SUN FLUORESCENT TANNING UNIT | Kdb Inc. (Dba) Sperti Sunlamp Jun 22, 2018 |
| K181051 — IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | Shape Memory Medical Jun 22, 2018 |
| K173414 — Advance Biliary Balloon Catheter | Cook Incorporated Jun 22, 2018 |
| K180577 — BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories Jun 22, 2018 |
| K172586 — Vios Monitoring System Model 2050 | Vios Medical, Inc. Jun 22, 2018 |
| K180594 — Knotless SutureTak Anchors | Arthrex, Inc. Jun 22, 2018 |
| K172779 — AIROS 8 Sequential Compression Device | Airos Medical, Inc. Jun 22, 2018 |
| K180152 — gel-e Flex | Gel-E, Inc. Jun 22, 2018 |
| K180785 — iSLEEVE Introducer Set | Boston Scientific Corporation Jun 22, 2018 |
| K173595 — Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. Jun 22, 2018 |
| K180581 — UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH Jun 22, 2018 |
| K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | SEKISUI Diagnostics, LLC Jun 22, 2018 |
| K180166 — Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. Jun 22, 2018 |
| K180331 — Wireless Pain Relieve Device | Shenzhen Dongdixin Technology Co., Ltd. Jun 22, 2018 |
| K181492 — Elecsys CA 15-3 II | Roche Diagnostics Jun 22, 2018 |
| K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | Terumo Cardiovascular Systems Corporation Jun 22, 2018 |
| K172770 — AIROS 6 Sequential Compression Device | Airos Medical, Inc. Jun 22, 2018 |
| K180791 — Straumann BLX Surgical Cassette | Institut Straumann AG Jun 21, 2018 |
| K173348 — 0.9% Sodium Chloride Injection, USP | Medline Industries, Inc. Jun 21, 2018 |
| K172975 — DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. Jun 21, 2018 |
| K173028 — BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte. , Ltd. Jun 21, 2018 |
| K173717 — Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation Jun 21, 2018 |
| K170886 — HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co., Ltd. Jun 21, 2018 |
| K172483 — Kopac Sterile Needle | Poonglim Pharmatech, Inc. Jun 21, 2018 |
| K181085 — LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Covidien Jun 21, 2018 |
| K180809 — Eclipse II | Carestream Health, Inc. Jun 21, 2018 |
| K181437 — Pure Vu System | Motus GI Medical Technologies , Ltd. Jun 21, 2018 |
| K180008 — Penumbra System | Penumbra, Inc. Jun 20, 2018 |
| K180885 — HairMax Laser | Lexington International, LLC Jun 20, 2018 |
| K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) | bioMerieux, Inc. Jun 20, 2018 |
| K180911 — Visura Technologies TEECAD System | Visura Technologies, LLC Jun 20, 2018 |
| K172536 — Atlas Percussion Adjusting Instrument | Spinalight, Inc. Jun 20, 2018 |
| K173147 — SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. Jun 20, 2018 |
| K181364 — Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A Jun 20, 2018 |
| K180377 — Fracture and Correction System | In2Bones USA, LLC Jun 20, 2018 |
| K180743 — Balanced Knee Revision System - Offset Junction Box | Ortho Development Corporation Jun 20, 2018 |
| K181348 — Cartiva SCI Disposable Instrumentation Set | Cartiva, Inc. Jun 20, 2018 |
| K181358 — Televere Digital Dental Imaging System | Televere Systems, Inc. Jun 20, 2018 |
| K181389 — Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien Jun 19, 2018 |
| K173905 — Surgic Pro, Surgic Pro+ | Nakanishi, Inc. Jun 19, 2018 |
| K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Bionime Corporation Jun 19, 2018 |