Certain Reworked Philips Trilogy Ventilators Recalled Due to Two Issues
Certain reworked Trilogy ventilators have two recent issues that may cause blockage or debris in the airpath.
Medical Devices
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Medical Device Updates
Non-Invasive Body Contouring Technologies
Talk with your health care provider about the benefits and risks of body contouring, also known as body sculpting.
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Le…
The FDA is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed.
Public Health Emergency Updates
Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation.
"Our center and the entire FDA stand ready to meet each challenge and opportunity in our continuing commitment to public health." - Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
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Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
(800) 638-2041
(301) 796-7100
Hours Available
Office of Communication and Education