Medical devices [510(k)s] regulated by CBER
510(k)s with supporting documents
Premarket Approvals (PMAs) for devices approved by CBER
PMAs with supporting documents
Donor screening assays for infectious agents, including all HIV diagnostic assays
Page Last Updated: 01/05/2011
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.