| K190461 — Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | Philips Medical Systems Nederland B.V. Jun 4, 2019 |
| K183533 — Unity Total Knee System | Corin U.S.A. Limited Jun 4, 2019 |
| K190573 — KOWA DR-1a | Kowa Company , Ltd. Jun 4, 2019 |
| K190337 — ReWalk Restore | Re Walk Robotics , Ltd. Jun 3, 2019 |
| K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. Jun 3, 2019 |
| K191185 — Solanas® Posterior OCT Fixation System | Alphatec Spine Jun 3, 2019 |
| K182625 — Diapex Plus | DiaDent Group International Jun 3, 2019 |
| K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Bionime Corporation Jun 2, 2019 |
| K190572 — Erchonia FX-635 | Erchonia Corporation Jun 1, 2019 |
| K190246 — NeuroShield | Monarch Bioimplants GmbH May 31, 2019 |
| K182443 — Pristine Hemodialysis Catheter | Pristine Access Technologies , Ltd. May 31, 2019 |
| K182725 — Apis | Sweetbio, Inc. May 31, 2019 |
| K190565 — Cervical Plate | Eisertech, LLC May 31, 2019 |
| K190546 — NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC May 31, 2019 |
| K190240 — Tiger Sharps Containers | International Marketing Specialists, Inc. May 31, 2019 |
| K182678 — Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer, Inc. May 31, 2019 |
| K190194 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax Medical, A Division Of Pentax Of America, Inc. May 31, 2019 |
| K190766 — PALACOS fast R+G | Heraeus Medical GmbH May 31, 2019 |
| K190831 — E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. May 31, 2019 |
| K190757 — MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. May 31, 2019 |
| K190543 — Cannulated Hemi Implant | Vilex IN Tennessee, Inc. May 31, 2019 |
| K190310 — U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC May 31, 2019 |
| K190896 — BriefCase | Aidoc Medical , Ltd. May 31, 2019 |
| K191067 — Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. May 30, 2019 |
| K182660 — GaltTWS | Galt Medical Corp. May 30, 2019 |
| K190628 — FlexSeal Introducer Sheath with Hydrophilic Coating | Freudenberg Medical Mis, Inc. May 30, 2019 |
| K191145 — MasterLoc Extension | Medacta International S.A. May 30, 2019 |
| K191188 — ASHK100G | Lg Electronics May 30, 2019 |
| K182308 — Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. May 30, 2019 |
| K173158 — Air Relax | Maxstar Industrial Co., Ltd. May 30, 2019 |
| K190623 — Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic May 30, 2019 |
| K182611 — Qangio XA 3D | Medis Medical Imaging Systems BV May 30, 2019 |
| K190160 — neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. May 30, 2019 |
| K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | Emcyte Corporation May 30, 2019 |
| K183337 — LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch-Pharmazeutische Fabrik GmbH May 29, 2019 |
| K191124 — Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A May 29, 2019 |
| K191122 — 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products May 29, 2019 |
| K182403 — Peel-Away Introducer | Cook Incorporated May 29, 2019 |
| K190534 — Manual Wheelchair SIVFH2A102 | Jiangsu Horizon Medical Science & Technology Co., Ltd. May 29, 2019 |
| K191157 — uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. May 29, 2019 |
| K190510 — GuttaSil | Meta Biomed Co., Ltd. May 29, 2019 |
| K190914 — MTS Doxycycline 0.016 - 256 µg/mL | Liofilchem S.R.L. May 29, 2019 |
| K183336 — Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. May 29, 2019 |
| K182910 — Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. May 29, 2019 |
| K190877 — Juliet® Ti LL Lumbar Interbody Device | Spineart May 29, 2019 |
| K181630 — Revolution External Plating System | New Standard Device Dba Metalogix May 29, 2019 |
| K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited May 29, 2019 |
| K183084 — Fuji Cervical Plate System | Altus Partners, LLC May 29, 2019 |
| K183645 — Silver High Performance Dressing | Advanced Medical Solutions, Ltd. May 29, 2019 |
| K182716 — Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. May 29, 2019 |