XVIVO PERFUSION AB

FDA Regulatory Profile

XVIVO PERFUSION AB appears in FDA public data with 1 recall, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1212-2022, Class II) was initiated on April 8, 2022. Its most recent 510(k) clearance was granted on January 20, 2022.

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