APPROVALS ---------------------------------------------------------------------------------------------------- Biological Approvals Establishment/Product File Licensing Actions Recalls Withdrawals Safety Issues Product Approval Information - New Drug Applications  

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