| K201854 — CAPOGEN Laser Cap | Nature, Inc.Redible, Inc. Sep 1, 2020 |
| K201135 — Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. Sep 1, 2020 |
| K193589 — TrueTear Intranasal Tear Neurostimulator | Allergan Aug 31, 2020 |
| K201052 — KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. Aug 31, 2020 |
| K202251 — Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | Penumbra, Inc. Aug 31, 2020 |
| K201831 — CONFIDENCE Spinal Cement System | Depuy Spine, Inc. Aug 31, 2020 |
| K201405 — LabPro Data Management System | Beckman Coulter, Inc. Aug 30, 2020 |
| K201432 — Masimo O3 Regional Oximeter System | Masimo Corporation Aug 29, 2020 |
| DEN190042 — Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation Aug 28, 2020 |
| K193005 — DIMI RRT System | Dialco Medical, Inc. Aug 28, 2020 |
| K192671 — Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. Aug 28, 2020 |
| K202224 — SpaceOAR System | Boston Scientific Corporation Aug 28, 2020 |
| K200926 — OrthoGold 100 | Tissue Regeneration Technologies, LLC Aug 28, 2020 |
| K200369 — OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH Aug 28, 2020 |
| K202099 — AOS Galileo Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. Aug 28, 2020 |
| K200958 — MODULIF-A Anterior Lumbar Interbody Fusion System | Spinal Stability, LLC Aug 28, 2020 |
| K191041 — Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. Aug 28, 2020 |
| K201199 — Jada System | Alydia Health Aug 28, 2020 |
| K201476 — DreaMed Advisor Pro | DreaMed Diabetes, Ltd. Aug 28, 2020 |
| K201166 — Temno Elite Biopsy System | Merit Medical Systems, Inc. Aug 28, 2020 |
| K191938 — FitRelief TENS&EMS Wireless Device | Heat IN A Click, LLC Aug 28, 2020 |
| K200859 — Infinity M300 | Draeger Medical Systems, Inc. Aug 28, 2020 |
| K202108 — External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. Aug 28, 2020 |
| K192953 — APTOS Threads Polypropylene Surgical Sutures | Aptos, LLC Aug 27, 2020 |
| K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company Aug 27, 2020 |
| K190864 — Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Aug 27, 2020 |
| K201162 — Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. Aug 27, 2020 |
| K201830 — ANSER Clavicle Pin | BAAT Medical Products B.V. Aug 27, 2020 |
| K200973 — Synapse 3D Cardiac Tools | Fujifilm Corporaton Aug 27, 2020 |
| K201981 — Magicore System | Innobiosurg Co., Ltd. Aug 27, 2020 |
| K201115 — Next Generation Balloon Dilation System | Acclarent, Inc. Aug 27, 2020 |
| K201807 — ANCORIS | Miegmbh Aug 27, 2020 |
| K192062 — Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST Aug 27, 2020 |
| K192863 — MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation Aug 26, 2020 |
| K201549 — Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. Aug 26, 2020 |
| K193653 — Hydrophilic Coating Guide Wire | Suzhou Hengrui Disheng Medical Co., Ltd. Aug 26, 2020 |
| K201856 — Provicol QM Aesthetic | Voco GmbH Aug 26, 2020 |
| K202064 — Admiral ACP System | SeaSpine Orthopedics Corporation Aug 26, 2020 |
| K202072 — MindsEye Expandable Port | Minnetronix Neuro, Inc. Aug 26, 2020 |
| K200714 — AVIEW | Coreline Soft Co., Ltd. Aug 26, 2020 |
| K200796 — Emprint Ablation System with Thermosphere Technology | Covidien, LLC Aug 26, 2020 |
| K200373 — Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med Spa Aug 26, 2020 |
| K201020 — BriefCase | Aidoc Medical , Ltd. Aug 26, 2020 |
| K201472 — VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH Aug 26, 2020 |
| K201267 — Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek Aug 26, 2020 |
| K200923 — Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. Aug 26, 2020 |
| K201805 — VersaOne Reusable Positioning Trocar System | Covidien Aug 26, 2020 |
| K193177 — CER-S | Cardiocalm Aug 26, 2020 |
| K191640 — TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. Aug 26, 2020 |
| K201141 — FIRMM | Nous Imaging, Inc. Aug 26, 2020 |