DeviceClearance

K023486

Substantially Equivalent

OSSTAPLE, MAXILLOFACIAL

Applicant
Biomedical Enterprises, Inc.
Product code
JEY
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Antonio, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY
Injury
1,542
Malfunction
2,292
Total
3,834

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.