Mint Medical GmbH

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2068-2026Class IIMint Lesion; Software Versions: 3.4.0 up to 3.9.5.;January 7, 2026
Z-0709-2025Class IImint Lesion, Software Versions: 3.9.0 through 3.9.5.November 15, 2024
Z-0710-2025Class IImint Lesion, Software Versions: 3.10.0 and 3.10.1.November 15, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K142647mint LesionApril 13, 2015