| K173837 — RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation Jul 25, 2018 |
| K173947 — Lumbar Interbody Fusion System (OLLIF) | Advanced Research Medical, LLC Jul 25, 2018 |
| K180407 — Smartinhaler | Adherium (Nz), Ltd. Jul 25, 2018 |
| K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | Corinth Medtech, Inc. Jul 25, 2018 |
| K180632 — Exactech Equinoxe Small Reverse Shoulder System | Exactech, Inc. Jul 25, 2018 |
| K181670 — Alphenix, INFX-8000V/B, V8.0 | Canon Medical Systems Corporation Jul 25, 2018 |
| K181495 — Republic Spine Dark Star Spinal System | Republic Spine, LLC Jul 25, 2018 |
| K172095 — Autokeeper | Medexel Co.,Ltd Jul 24, 2018 |
| K172862 — Portable ECG Monitor (ECG3) | Andon Health Co, Ltd. Jul 24, 2018 |
| K180218 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid Jul 24, 2018 |
| K181178 — S-mini active Fixture | Neobiotech Co., Ltd. Jul 24, 2018 |
| K173929 — CipherOx CRI M1 | Flashback Technologies, Inc. Jul 24, 2018 |
| K181339 — Altus Spine Pedicle Screw System | Altus Partners, LLC Jul 24, 2018 |
| K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Neuro Kinetics, Inc. Jul 24, 2018 |
| K181686 — CELERITY 20 Steam Biological Indicator | STERIS Corporation Jul 24, 2018 |
| K181399 — FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. Jul 24, 2018 |
| K180544 — DePuy Synthes Static Staples | Synthes (USA) Products, LLC Jul 24, 2018 |
| K180115 — TWBM Pump | Taiwan Biomaterial Co., Ltd. Jul 24, 2018 |
| K181095 — RF-Relief | El Global Trade, Ltd. Jul 24, 2018 |
| K173943 — Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. Jul 24, 2018 |
| K180017 — MX40 Release C.01 | Philips Medical Systems Jul 24, 2018 |
| K181242 — Braun BNT400 No Touch + Forehead Thermometer | Kaz USA, Inc., A Helen Of Troy Company Jul 23, 2018 |
| K173444 — Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions, Inc. Jul 23, 2018 |
| K180518 — GME LinScan Lite 808 Laser System | Gme German Medical Engineering GmbH Jul 23, 2018 |
| K173645 — JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. Jul 23, 2018 |
| K181398 — DV-300 Aspirator | Ding Hwa Co., Ltd. Jul 23, 2018 |
| K180854 — Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. Jul 23, 2018 |
| K171888 — Non-contact infrared body thermometer | Hetaida Technology Co., Ltd. Jul 23, 2018 |
| K181083 — Stryker All-PEEK Knotless Anchor System | Stryker Jul 23, 2018 |
| K181629 — GC85A | Samsung Electronics Co., Ltd. Jul 20, 2018 |
| K181647 — Bandit guidewire | Vascular Solutions, Inc. Jul 20, 2018 |
| K173973 — TV-100 | Bio-Med Devices, Inc. Jul 20, 2018 |
| K181631 — GR40CW | Samsung Electronics Co., Ltd. Jul 20, 2018 |
| K173675 — AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec Limited Jul 20, 2018 |
| K173366 — NicoletOne | Natus Neurology Incorporated Jul 20, 2018 |
| K181636 — Aurora | Sodium Systems, LLC Jul 20, 2018 |
| K173188 — The Graft Natural Bone Substitute | Purgo Biologics, Inc. Jul 20, 2018 |
| K181626 — Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. Jul 20, 2018 |
| DEN170009 — Bonebridge | Med-El Elektromedizinische Geraete GmbH Jul 20, 2018 |
| K180864 — WATCHMAN TruSeal Access System | Boston Scientific Jul 20, 2018 |
| K181585 — JGH1 Core Deccompression Procedure Kit | AgNovos Healthcare USA, LLC Jul 20, 2018 |
| K180948 — TruDi NAV Suction Instruments | Acclarent, Inc. Jul 20, 2018 |
| K181017 — Free Testosterone AccuBind ELISA Test System | Monobind, Inc. Jul 20, 2018 |
| K180022 — Athena Cervical Plate System | Medyssey USA, Inc. Jul 20, 2018 |
| K181382 — GuardianTM Burr Hole Cover System | St Jude Medical Jul 20, 2018 |
| K180263 — EcoFit Vit E Acetabular System | Implantcast GmbH Jul 20, 2018 |
| K180629 — DentiqGuide | 3D Industrial Imaging Co., Ltd. Jul 19, 2018 |
| K181834 — Ultimax-i, DREX-UI80 (V1.60) | Canon Medical Systems Corporation Jul 19, 2018 |
| K170369 — Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. Jul 19, 2018 |
| K171566 — Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. Jul 19, 2018 |