DeviceClearance

K984162

Substantially Equivalent

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE

Applicant
Nobelpharma USA, Inc.
Product code
MAH
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westmont, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MAH

product code MAH
Injury
4,155
Total
4,155

Source: openFDA MAUDE database, through . 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.