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Total Product Life Cycle (TPLC)
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including... -
FDA Recognized Consensus Standards
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center... -
MAUDE (Manufacturer and User Facility Device Experience)
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991,... -
X-Ray Assembler Data
Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the...