K240077

Substantially Equivalent

Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)

Applicant: Covidien
Product code: FLL
Advisory panel: General Hospital
Date received: 2024-01-10
Decision date: 2024-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.