| K192464 — Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. Aug 25, 2020 |
| K201772 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. Aug 25, 2020 |
| K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. Aug 25, 2020 |
| K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Kitazato Corporation Aug 25, 2020 |
| K192809 — Dental Handpiece | Micro-Nx Co., Ltd. Aug 25, 2020 |
| K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | Orthosensor, Inc. Aug 25, 2020 |
| K201979 — Cervical Plate System | Eminent Spine, LLC Aug 25, 2020 |
| K192380 — ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. Aug 24, 2020 |
| K202054 — Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC Aug 24, 2020 |
| K200695 — MATRx plus | Zephyr Sleep Technologies Aug 24, 2020 |
| K193364 — Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose Aug 24, 2020 |
| K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Diasorin Molecular, LLC Aug 22, 2020 |
| K201693 — DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Aug 21, 2020 |
| K193260 — U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. Aug 21, 2020 |
| K202116 — EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. Aug 21, 2020 |
| K200957 — Brainsway Deep TMS System | Brainsway , Ltd. Aug 21, 2020 |
| K201749 — Arthrex SwiveLock Anchor | Arthrex, Inc. Aug 21, 2020 |
| K202036 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. Aug 21, 2020 |
| K201513 — Quantra QPlus System | Hemosonics, LLC Aug 21, 2020 |
| K193201 — BTL-785F | Btl Aug 21, 2020 |
| K201056 — NeuroBlate System | Monteris Medical, Inc. Aug 21, 2020 |
| K200216 — 4K UHD Camera System | Scivita Medical Technology Co., Ltd. Aug 21, 2020 |
| K193578 — Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. Aug 20, 2020 |
| K200093 — Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | Anhui Lntco Medical Products Co., Ltd. Aug 20, 2020 |
| K202130 — FUJIFILM Video Laparoscope | Fujifilm Corporation Aug 20, 2020 |
| K200939 — Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Aug 20, 2020 |
| K201636 — Hercules Suture Anchor System | In2Bones USA, LLC Aug 20, 2020 |
| K200586 — Straumann TLX Implant System | Institut Straumann AG Aug 20, 2020 |
| K192291 — TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. Aug 20, 2020 |
| K193318 — Distinct® Early Detection Pregnancy Test | ACON Laboratories, Inc. Aug 20, 2020 |
| K192275 — invisa-RED ELITE | IR Technology, LLC Aug 19, 2020 |
| K202050 — Cranial 4Pi Immobilization | Brainlab AG Aug 19, 2020 |
| K193476 — VariLymph 12 pro | Slk Medical GmbH Aug 19, 2020 |
| K193537 — Omnichroma Flow | Tokuyama Dental Corporation Aug 19, 2020 |
| K193595 — Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | Penumbra, Inc. Aug 19, 2020 |
| K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service And Savings Inc.(Dba Medline Ren Aug 19, 2020 |
| K201362 — CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | Medtronic Aug 19, 2020 |
| K200597 — Straumann BLX Gold Abutments | Straumann USA, LLC (On Behalf Of Institut Straumann Ag) Aug 19, 2020 |
| K201360 — Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co. , Ltd. Aug 19, 2020 |
| K200033 — HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO Aug 19, 2020 |
| K201137 — Asept Surgical Face Mask | Pfm Medical, Inc. Aug 19, 2020 |
| K201995 — CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. Aug 19, 2020 |
| K200191 — Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona Aug 19, 2020 |
| K201334 — Keystone Dental XL Dental Implant System | Keystone Dental, Inc. Aug 18, 2020 |
| K202012 — Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products, Inc. Aug 18, 2020 |
| K192723 — Coloring Liquid | Aidite (Qinhuangdao) Technology Co., Ltd. Aug 18, 2020 |
| K191591 — BB Base 3D printing resin for denture base | Enlighten Materials Co., Ltd. Aug 18, 2020 |
| K190600 — ORION Spinal System | Orion Biotech, Inc. Aug 18, 2020 |
| K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation Aug 17, 2020 |
| K201177 — RadGil2 | R3 X-Ray L.L.C Aug 17, 2020 |