DeviceClearance

K964073

Substantially Equivalent

BME BONE DRILL BITS

Applicant
Biomedical Ent., Inc.
Product code
GEY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Antonio, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GEY

product code GEY
Malfunction
7,488
Total
7,488

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.