K855132

Substantially Equivalent

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Applicant
Dynarex Corp.
Product code
MDM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brewster, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM
Injury
247
Malfunction
1,516
Total
1,763

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.