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  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Other Medical Device EUAs

This page lists EUAs not described in any of the other pages in the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices Section.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA Issued Device Type Letter of Authorization Fact Sheets Other Documents Assigned Product Code
05/11/2020 LVEF Screen Eko Devices, Inc, ELEFT QLL
05/26/2020 Predictive Screening CLEW Medical Ltd. QLM
05/29/2020 Right Ventricular Assist Catheter Abiomed, Inc., Impella RP System QOC
04/18/2020 Face Mask (non-Surgical) Face Mask (non-Surgical)   QKR
08/03/2020 Left Ventricular Support System Abiomed, Inc., Impella LV Systems QOC
09/24/2020 Predictive Screening COVIage QLM
11/21/2020 Extracorporeal Membrane Oxygenation Terumo Cardiovascular CAPIOX Emergency Bypass System QOD
03/19/2021 Symptom Screening Tool Tiger Tech Solutions, Inc., Tiger Tech COVID Plus Monitor QOA

 

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