510(k) K905800— X-T AIR DRILL

Substantially Equivalent

Xomed-Treace, Inc.

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1990-12-28
Decision date: 1991-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.