HealthData.Gov
This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to the level of CDRH regulation of a given…
Updated Oct 29, 2026
HealthData.Gov
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 releasable information submitted including…
Updated Oct 29, 2026
HealthData.Gov
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be…
Updated Oct 29, 2026