K930457

Substantially Equivalent

MEDIMAC BANDAGE

Applicant
Enquay Pharmaceutical
Product code
KGX
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boca Raton, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KGX

product code KGX
Injury
1,590
Malfunction
1,357
Other
3
Total
2,950

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.