Medical Device Expiration Date Error

Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events.

Terminology that represents methods of evaluation used by the CDRH with respect to reporting Medical Device events.

Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events.

Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. …

Device and/or fragments of device are embedded in patient's vessel and/or plaque.

Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with…