NOBELPHARMA BONE ANCHORED HEARING AID— 510(k) K955713

Substantially Equivalent

Nobelpharma USA, Inc.

FDA 510(k) clearance K955713 for NOBELPHARMA BONE ANCHORED HEARING AID, Substantially Equivalent on 1996-08-09. Applicant: Nobelpharma USA, Inc..

Clearance details

Applicant: Nobelpharma USA, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1995-12-18
Decision date: 1996-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, 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.