XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.— 510(k) K872168

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K872168 for XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO., Substantially Equivalent on 1987-06-30. Applicant: Xomed, Inc..

Clearance details

Applicant: Xomed, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1987-06-08
Decision date: 1987-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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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.