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  1. Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

2022 Safety Communications

Device Name Date
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication 02/04/2022
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication 01/28/2022
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems - FDA Safety Communication 01/13/2022
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication 01/11/2022

 

 

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