| K173004 — SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. May 8, 2018 |
| K180922 — Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa May 8, 2018 |
| K171690 — Trident Extremity Fixation System | Trident Orthopedics May 8, 2018 |
| K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube | Smiths Medical Asd, Inc. May 8, 2018 |
| K172484 — A-CIFT SoloFuse | Spinefrontier, Inc. May 8, 2018 |
| K180386 — Meron Plus QM | Voco GmbH May 8, 2018 |
| K173510 — BioStamp nPoint | Mc10, Inc. May 8, 2018 |
| K173901 — MyoSure MANUAL Tissue Removal Device | Hologic, Inc. May 8, 2018 |
| K173831 — Glidesheath Slender | Terumo Medical Corporation May 8, 2018 |
| K172661 — Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG May 8, 2018 |
| K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | Hill-Rom, Inc. May 7, 2018 |
| K180034 — Weinmann Tracheostomy Exchange Set | Cook Incorporated May 7, 2018 |
| K180031 — Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC May 7, 2018 |
| K180296 — Afinion HbA1c Dx | Alere Technologies AS May 7, 2018 |
| DEN170015 — Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. May 7, 2018 |
| K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation May 4, 2018 |
| K180641 — Invenia ABUS Viewer | GE Healthcare May 4, 2018 |
| K172614 — Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | Caldera Medical, Inc. May 4, 2018 |
| K172100 — URIS OMNI System | Truabutment, Inc. May 4, 2018 |
| K162021 — 3.0 Dynamic TiBase | Talladium Espana, SL May 4, 2018 |
| K173684 — g.Estim PRO | G.Tec Medical Engineering GmbH May 4, 2018 |
| K180437 — Hexanium® TLIF | Spinevision, S.A.S. May 4, 2018 |
| K180740 — VitriGuard | Origio A/S May 4, 2018 |
| K173711 — Wallaby Avenir Coil System | Wallaby Medical, Inc. May 4, 2018 |
| K172271 — Trackit T4 EEG Amplifier | Lifelines , Ltd. May 4, 2018 |
| K173874 — StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC May 4, 2018 |
| K172568 — Cervage | Precifit Medical, Ltd. May 4, 2018 |
| K180623 — Ulthera System | Ulthera, Inc. May 4, 2018 |
| K180157 — QT ECG | QT Medical, Inc. May 4, 2018 |
| K173892 — NuVasive® XLX Interbody System | Nu Vasive, Incorporated May 4, 2018 |
| K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System | Cutting Edge Spine, LLC May 4, 2018 |
| K180317 — EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System | Microport Orthopedics, Inc. May 4, 2018 |
| K173913 — MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC May 4, 2018 |
| K180313 — Apollo TMS Therapy System | Mag & More GmbH May 4, 2018 |
| K171007 — Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. May 3, 2018 |
| K172137 — PIEZOTOME CUBE | Satelec - Acteon Group May 3, 2018 |
| K180162 — VivaScope System | Caliber Imaging & Diagnostics, Inc. May 3, 2018 |
| K181001 — Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC May 3, 2018 |
| K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | PAJUNK GmbH Medizintechnologie May 3, 2018 |
| K180071 — STYLO Interbody Fusion Device | Legend Spine Technologies May 3, 2018 |
| K180214 — Repris Bladder Injection System | Uro-1, Inc. May 3, 2018 |
| K172980 — Micropuncture Pedal Access Set | Cook Incorporated May 3, 2018 |
| K180019 — CAAS Workstation | Pie Medical Imaging BV May 3, 2018 |
| K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. May 3, 2018 |
| K171577 — Smartcord, Smartcord X | Eastdent Co., Ltd. May 3, 2018 |
| K173540 — Brainsway Deep (DTMS) System | Brainsway , Ltd. May 3, 2018 |
| K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. May 2, 2018 |
| K173946 — ADAPT for Gamma3 | Stryker GmbH May 2, 2018 |
| K173807 — Accu O2 Oxygen Analyzer | Precision Medical, Inc. May 2, 2018 |
| K173861 — Drug Relief | Dyansys, Inc. May 2, 2018 |