DeviceClearance

K161948

Substantially Equivalent

Avance Gauze Dressing Kits

Applicant
Molnlycke Health Care Us, LLC
Product code
OMP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP
Death
31
Injury
1,707
Malfunction
4,047
Other
1
Total
5,786

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.