DeviceClearance

K895372

Substantially Equivalent

X-RAY DETECTABLE GAUZE SPONGE

Applicant
Keilei Intl., Inc.
Product code
GDY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dover, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GDY

product code GDY
Malfunction
764
Total
764

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.