DeviceClearance

K230569

Substantially Equivalent

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )

Applicant
Cardinalhealth
Product code
FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Waukegan, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

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.