Company · SE

Xvivo Perfusion AB

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (1 in 12 months)

1recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
KDN	System, Perfusion, Kidney	4
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	1

Decided	510(k)	Device and applicant	Code
Jul 23, 2026	K261644	Perfadex Plus Xvivo Perfusion AB, SE	KDN
Jan 20, 2022	K211333	KIDNEY ASSIST-transport Xvivo Perfusion AB, SE	KDN
Jun 22, 2018	K170826	Perfadex Plus Xvivo Perfusion AB, SE	KDN
Oct 1, 2010	K091989	PERFADEX AND PERFADEX WITH THAM Xvivo Perfusion AB, SE	KDN

Date	Firm and product	Code	Linked 510(k)
Apr 8, 2022	XVIVO PERFUSION AB XVIVO Organ Chamber REF 19020 Terminated	PHO	None listed