K143161

Substantially Equivalent

Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)

Applicant: Covidien
Product code: GEI
Advisory panel: General, Plastic Surgery
Date received: 2014-11-03
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, US

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.