XVIVO PERFUSION AB

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1212-2022Class IIXVIVO Organ Chamber REF 19020April 8, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K211333KIDNEY ASSIST-transportJanuary 20, 2022
K170826Perfadex PlusJune 22, 2018
K091989PERFADEX AND PERFADEX WITH THAMOctober 1, 2010