K940684

Substantially Equivalent

SURGICAL INSTRUMENT, DISPOSABLE

Applicant
Her-Mar, Inc.
Product code
MDM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami Beach, FL, 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.