BERLIN HEART GMBH

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1618-2023Class IEXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-0May 18, 2018