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  4. Where can I find a list of devices approved/cleared by CBER?
  1. FDA Basics for Industry

Where can I find a list of devices approved/cleared by CBER?

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

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