26 datasets found
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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
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
Radiation Emitting Product Corrective Actions and Recalls
U.S. Department of Health & Human Services —
This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and... -
Federal
Clinical Laboratory Improvement Amendments
U.S. Department of Health & Human Services —
This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease... -
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
X-Ray Assembler Data
U.S. Department of Health & Human Services —
Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database...
26 datasets found