| K182804 — Traditional Length GJ Feeding Device | Applied Medical Technology, Inc. Mar 1, 2019 |
| K183690 — Tenodesis Screw System | Paragon 28, Inc. Mar 1, 2019 |
| K183259 — Idys TLIF TiVac | Clariance, Sas Mar 1, 2019 |
| K181528 — Austin Miller Large External Fixation System | Austin Miller Trauma, LLC Feb 28, 2019 |
| K183099 — QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) Feb 28, 2019 |
| K183686 — FUJIFILM Endoscope Model EG-530N | Fujifilm Corporation Feb 28, 2019 |
| K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Feb 28, 2019 |
| K182250 — Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | AngioDynamics, Inc. Feb 28, 2019 |
| K180479 — ReDS System | Sensible Medical Innovations , Ltd. Feb 28, 2019 |
| K182629 — Digital Thermometer | Joytech Healthcare Co. , Ltd. Feb 28, 2019 |
| K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. Feb 28, 2019 |
| K182494 — FlowMet-R | Laser Associated Sciences, Inc. Feb 27, 2019 |
| K182003 — Lympha Press Optimal Plus | Mego Afek AC , Ltd. Feb 27, 2019 |
| K180682 — AeroPro Cordless Prophy System | Premier Dental Company Products Feb 27, 2019 |
| K182267 — PAT (Pain Alleviation Technologies) | Marchan Medical, LLC Feb 27, 2019 |
| K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation Feb 27, 2019 |
| K190155 — FibermarX Radiopaque Tissue Marker | Viscus Biologics, LLC Feb 27, 2019 |
| K183014 — uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. Feb 27, 2019 |
| K190087 — EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. Feb 27, 2019 |
| K182440 — Body System | A-1 Engineering Feb 26, 2019 |
| K183454 — Tyece OTC EMS System | Tyece , Ltd. Feb 26, 2019 |
| K182941 — HEALIX ADVANCE SP PEEK Anchor | Medos International SARL Feb 26, 2019 |
| K183211 — 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company Feb 26, 2019 |
| K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) | bioMerieux, Inc. Feb 26, 2019 |
| K183374 — GrayDuck Stent | Poll Medical, LLC Feb 26, 2019 |
| K182052 — Omni Instrument Tray | Hologic, Inc. Feb 26, 2019 |
| K181870 — Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use | Wuhan W.E.O Science & Technology Development Co., Ltd. Feb 26, 2019 |
| K190356 — ClariFix | Arrinex, Inc. Feb 26, 2019 |
| K182976 — SpringTMS | Eneura®, Inc. Feb 25, 2019 |
| K183179 — CAPERE Thrombectomy System | Vascular Medcure, Inc. Feb 25, 2019 |
| K183290 — Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Thrombolex, Inc. Feb 25, 2019 |
| K183698 — Zap-X Radiosurgery System | Zap Surgical Systems Feb 25, 2019 |
| K190071 — Perla® Posterior Cervico-Thoracic Fixation System | Spineart Feb 25, 2019 |
| K190151 — COBRA Fusion Ablation System | AtriCure, Inc. Feb 25, 2019 |
| K181551 — DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | Runbio Biotech Co.,Ltd Feb 22, 2019 |
| K183365 — Libertas Acetabular Hooded Liner | Maxx Orthopedics, Inc. Feb 22, 2019 |
| K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | Mauna Kea Technologies Feb 22, 2019 |
| K182542 — The EPAD 2 System | Safeop Surgical, Inc. Feb 22, 2019 |
| K183693 — Doctor Tecar | Mectronic Medicale S.R.L. Feb 22, 2019 |
| K183240 — Empower RF Catheter | Broncus Medical, Inc. Feb 22, 2019 |
| K182643 — IRIS 1.0 System | Intuitive Surgical Feb 22, 2019 |
| K182406 — Altus Spine Interbody Fusion System | Altus Partners, LLC Feb 22, 2019 |
| K182859 — Babyleo TN500 | Dragerwerk AG & CO Kgaa Feb 22, 2019 |
| K182488 — Reprocessed Response Diagnostic Electrophysiology Catheter | Innovative Health, LLC Feb 22, 2019 |
| K182825 — FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation Feb 22, 2019 |
| K183621 — EMMA 1.5T MRI System | Time Medical Limited Feb 22, 2019 |
| K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine Feb 22, 2019 |
| K181310 — HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. Feb 22, 2019 |
| K173418 — NobelParallel Conical Connection | Nobel Biocare AB Feb 21, 2019 |
| K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. Feb 21, 2019 |