26 datasets found
-
Federal
MedSun Reports
U.S. Department of Health & Human Services —
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the... -
Federal
Medical and Radiation Emitting Device Recalls
U.S. Department of Health & Human Services —
This database contains a list of classified medical device recalls since November 1, 2002 -
Federal
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
U.S. Department of Health & Human Services —
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved... -
Federal
Post-Approval Studies
U.S. Department of Health & Human Services —
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a... -
Federal
522 Postmarket Surveillance Studies
U.S. Department of Health & Human Services —
The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the... -
Federal
IVD Home Use Lab Tests (Over The Counter) Tests
U.S. Department of Health & Human Services —
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA
26 datasets found