MEDICAL DEVICES ---------------------------------------------------------------------------------------------------- Device Action Plan Device Action Plan - Six Month Report Medical Devices Regulated by CBER  

APPROVAL INFORMATION ---------------------------------------------------------------------------------------------------- Licensed Products and Establishments New Drug Applications Approved Since 1990 Substantially Equivalent 510(k) Device Information Device Approvals by Year Licensed / Approved HIV, HTLV and Hepatitis Tests  

APPROVAL DOCUMENTS ---------------------------------------------------------------------------------------------------- Licensed Products New Drug Applications Substantially Equivalent 510(k) Devices  

PREMARKET APPROVAL DEVICE INFORMATION ---------------------------------------------------------------------------------------------------- Premarket Approval Devices Applications Specific Premarket Approval Device Information