510(k) K875277— ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.

Substantially Equivalent

Xomed, Inc.

Clearance details

Applicant: Xomed, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1987-12-24
Decision date: 1988-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

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.