ENDOTRONIX

FDA Regulatory Profile

ENDOTRONIX appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0542-2020, Class II) was initiated on September 25, 2019.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0542-2020Class IImyCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure manSeptember 25, 2019