Bonebridge— 510(k) DEN170009

Unknown

Med-El Elektromedizinische Geraete GmbH

FDA 510(k) clearance DEN170009 for Bonebridge, Unknown on 2018-07-20. Applicant: Med-El Elektromedizinische Geraete GmbH.

Clearance details

Applicant: Med-El Elektromedizinische Geraete GmbH
Product code: Code PFO
Advisory panel: Ear, Nose, Throat
Date received: 2017-02-13
Decision date: 2018-07-20
Decision: Unknown
Clearance type: Direct
Location: Innsbruck, AT

View on FDA.gov ↗

Adverse events under product code PFO

product code PFO

Injury: 2,752
Total: 2,752

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.