Biorep Technologies

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1538-2014Class IIJoseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool foMarch 19, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K210006MI DeTACHMarch 4, 2021