| K201530 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | Hartalega NGC Sdn. Bhd. Aug 5, 2020 |
| K190580 — NADIA SI Fusion System | Ilion Medical, Inc. Aug 5, 2020 |
| K201715 — Smart Toe II, X Fuse | Stryker GmbH Aug 5, 2020 |
| K201240 — Mariner Cap System | SeaSpine Orthopedics Corporation Aug 5, 2020 |
| K191955 — Enhanced External Counter Pulsation Device Plus Omay-A | Omay(Guangzhou)Med Technologies Co., Ltd. Aug 5, 2020 |
| K201531 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega Sdn Bhd Aug 5, 2020 |
| K201952 — CrossGlide ETS Plus | Crossbay Medical Aug 5, 2020 |
| K200351 — PlasmaFlight | Manamed, Inc. Aug 5, 2020 |
| K201168 — ECG Monitor App | Samsung Electronics Co., Ltd. Aug 4, 2020 |
| K193210 — HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. Aug 4, 2020 |
| K193545 — Corin Optimized Positioning System (OPS) Femoral | Corin USA Aug 4, 2020 |
| K201958 — ETD Family of Electrotherapy Devices | Therasigma, LLC Aug 4, 2020 |
| K201850 — Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. Aug 4, 2020 |
| K201500 — Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | Life Spine, Inc. Aug 4, 2020 |
| K193666 — Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff | Medline Industries, Inc. Aug 4, 2020 |
| K201704 — CoFix System | Paradigm Spine GmbH Aug 4, 2020 |
| K191670 — CureOs TCP | Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic Aug 4, 2020 |
| K201217 — HemoCue Hb 301 System | Hemocue AB Aug 4, 2020 |
| K192712 — Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | Medtronic, Inc. Aug 3, 2020 |
| K192991 — Vesco Medical Extension Feeding Set | Vesco Medical, LLC Aug 3, 2020 |
| K200649 — Arm-Type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. Aug 3, 2020 |
| K193355 — Electrodes Handpieces for Mygen V-1000 RF System | RF Medical Co., Ltd. Aug 3, 2020 |
| K200667 — EyeArt | Eyenuk, Inc. Aug 3, 2020 |
| K200954 — Glaucoma Module | Topcon Healthcare Solutions, Inc. Aug 3, 2020 |
| K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | Neotract, Inc. Jul 31, 2020 |
| K200791 — Navigation Enabled Intruments | Medos International SARL Jul 31, 2020 |
| K200803 — BEAR and BEAR mini | Foreo, Inc. Jul 31, 2020 |
| K200039 — P pro Crown & Bridge | Deltamed GmbH Jul 31, 2020 |
| K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | Diatron Group Jul 31, 2020 |
| K200584 — xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. Jul 31, 2020 |
| K193237 — Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. Jul 31, 2020 |
| K190790 — Flex Fit | Dk Mungyo Corporation Jul 31, 2020 |
| K201087 — CORBEL Spacers | Globus Medical, Inc. Jul 31, 2020 |
| K192499 — Cyber Blade | SIDAM S.R.L. Jul 31, 2020 |
| K201898 — Clear Guide SCENERGY | Clear Guide Medical Jul 31, 2020 |
| K192294 — I Do | I DO Biotech Co., Ltd. Jul 31, 2020 |
| K201833 — BiPad Hand Activated, Disposable Bipolar Electrocautery Cords | Bipad Surgical, Inc. Jul 31, 2020 |
| K201597 — Liver Incytes, Model 1005 | Sonic Incytes Jul 31, 2020 |
| K201951 — Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. Jul 31, 2020 |
| K201511 — Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions Jul 31, 2020 |
| K201069 — VibrantVue Scleral Saline | Dry Eye Innovations, LLC Jul 31, 2020 |
| K191101 — Kendall NPWT Incision Management Dressing Kit | Cardinalhealth Jul 31, 2020 |
| K201648 — Sterispine PS | Safe Orthopaedics Jul 30, 2020 |
| K200832 — Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. Jul 30, 2020 |
| K201543 — MAGEC® System | Nuvasive Specialized Orthopedics, Inc. Jul 30, 2020 |
| K200142 — SpeediCath Soft | Coloplast Jul 30, 2020 |
| K193417 — FractureDetect (FX) | Imagen Technologies, Inc. Jul 30, 2020 |
| K201002 — Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. Jul 30, 2020 |
| DEN200015 — cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. Jul 30, 2020 |
| K200082 — BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. Jul 30, 2020 |