XOMED AUDIANT BONE CONDUCTOR— 510(k) K881382

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K881382 for XOMED AUDIANT BONE CONDUCTOR, Substantially Equivalent on 1988-06-21. Applicant: Xomed, Inc..

Clearance details

Applicant: Xomed, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1988-04-01
Decision date: 1988-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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.