WIDEXLINK IN CLEAR SERIES HEARING AIDS— 510(k) DEN100025

Name: FDA 510(k) clearance DEN100025
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Unknown

Office Research IN Clinical Amplifiction

FDA 510(k) clearance DEN100025 for WIDEXLINK IN CLEAR SERIES HEARING AIDS, Unknown on 2011-03-31. Applicant: Office Research IN Clinical Amplifiction. Device class: 2.

Clearance details

Applicant: Office Research IN Clinical Amplifiction
Product code: Code OSM
Device class: Class 2
Regulation: 21 CFR 874.3305
Advisory panel: Ear, Nose, Throat
Date received: 2010-10-13
Decision date: 2011-03-31
Decision: Unknown
Clearance type: Post-NSE
Location: Lisle, IL, US

View on FDA.gov ↗

Adverse events under product code OSM

product code OSM

Injury: 195
Total: 195

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.