| K201446 — HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC Oct 1, 2020 |
| K200067 — MectaScope System | Medacta International S.A. Oct 1, 2020 |
| K201359 — ECG Cables and Leadwires | Xinkang Medical Instrument Co. , Ltd. Oct 1, 2020 |
| K202564 — DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH Sep 30, 2020 |
| K202376 — EverLift Submucosal Lifting Agent | Gi Supply, Inc. Sep 30, 2020 |
| K200475 — IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. Sep 30, 2020 |
| K192051 — THINQ | Corticometrics, LLC Sep 30, 2020 |
| K201928 — e-Ortho Shoulder Software | FH Industrie Sep 30, 2020 |
| K201188 — Clear Guide SCENERGY | Clear Guide Medical Sep 30, 2020 |
| K202542 — Allura Vaginal Stent | Pmt Corporation Sep 30, 2020 |
| K192077 — Tua Face Fitness / Tua Trend Face | Vupiesse S.R.L Sep 30, 2020 |
| K202566 — Wiygul Catheter | Big Blue Biotech, Inc. Sep 30, 2020 |
| K193131 — BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | Becton, Dickinson And Company Sep 29, 2020 |
| K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | Philips Medical Systems Sep 29, 2020 |
| K201819 — Cadwell Apollo System | Cadwell Industries, Inc. Sep 29, 2020 |
| K202546 — LVivo Seamless | Dia Imaging Analysis, Ltd. Sep 29, 2020 |
| K193401 — Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH Sep 29, 2020 |
| K201790 — Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. Sep 29, 2020 |
| K201895 — Cefaly Dual | Cefaly Technology Sep 29, 2020 |
| K202685 — Eon Aligner | Eon Dental Jordan, LLC Sep 28, 2020 |
| K201682 — RIST Radial Access Catheter | Rist Neurovascular, Inc. Sep 28, 2020 |
| K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | Volcano Corporation Sep 28, 2020 |
| K192717 — da Vinci SP Surgical System | Intuitive Surgical, Inc. Sep 28, 2020 |
| K201221 — Electrosurgical Generator | New Deantronics Taiwan , Ltd. Sep 28, 2020 |
| K200557 — Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | Jiangsu Shenli Medical Production Co., Ltd. Sep 28, 2020 |
| K201795 — Transcend | Ultradent Product, Inc. Sep 28, 2020 |
| K193299 — VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) | bioMerieux, Inc. Sep 28, 2020 |
| K201814 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit | Becton, Dickinson And Company Sep 28, 2020 |
| K182906 — Portable Mesh Nebulizer | Feellife Health, Inc. Sep 27, 2020 |
| K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | Guangzhou Wondfo Biotech Co., Ltd. Sep 25, 2020 |
| K201103 — Xeleris V Processing and Review Systems | GE Healthcare Sep 25, 2020 |
| K193546 — Distal Centralizers | Biomet, Inc. Sep 25, 2020 |
| K202522 — Synchro SELECT Guidewire | Stryker Neurovascular Sep 25, 2020 |
| K201787 — Light Cure Dental Adhesive | Rizhao Huge Biomaterials Company, Ltd. Sep 25, 2020 |
| K193583 — Restrata® | Acera Surgical, Inc. Sep 25, 2020 |
| K200076 — Breezing Med | Tf Health Co. Sep 25, 2020 |
| K191982 — Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) | Shenzhen Kentro Medical Electronics Co., Ltd. Sep 25, 2020 |
| K202039 — Honorst Implant System | Medimecca Co., Ltd. Sep 25, 2020 |
| K201439 — Ventilator, Non-continuous (Respirator) | Respironics, Inc. Sep 25, 2020 |
| K201273 — ImageSPECTRUM | Canon, Inc. Sep 25, 2020 |
| K201756 — Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent | Stryker Sustainability Solutions Sep 25, 2020 |
| K201820 — NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | Nu Vasive, Incorporated Sep 25, 2020 |
| K202277 — Surgical Face Mask | Jiangxi 3L Medical Products Group Co., Ltd. Sep 25, 2020 |
| K202446 — BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson And Company Sep 25, 2020 |
| K200051 — PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. Sep 25, 2020 |
| K201770 — Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation Sep 24, 2020 |
| K200569 — RayStation | RaySearch Laboratories AB (PUBL) Sep 24, 2020 |
| DEN200002 — Tangible Boost | Tangible Science, Inc. Sep 24, 2020 |
| K201684 — A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation Sep 24, 2020 |
| K202484 — Cordera Hip System | Conformis, Inc. Sep 24, 2020 |