This database includes:
- a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
- De Novo
- Medical Device Reports (MAUDE)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Registration & Listing
- Total Product Life Cycle
- X-Ray Assembler
Need information about classifying your device?