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 |