CardioTek BV

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1283-2022Class IICardioTek EP-TRACER Software V2.x.April 25, 2022
Z-2657-2017Class IICardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measuremeApril 13, 2017