Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list XVIVO Perfusion with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 23, 2026: Perfadex Plus.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 23, 2026 | Perfadex PlusK261644 · KDN | 510(k) clearances |
| Apr 8, 2022 | XVIVO Organ Chamber REF 19020Class II · The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. | Device recalls |
| Jan 20, 2022 | KIDNEY ASSIST-transportK211333 · KDN | 510(k) clearances |
| Jun 22, 2018 | Perfadex PlusK170826 · KDN | 510(k) clearances |
| Oct 1, 2010 | PERFADEX AND PERFADEX WITH THAMK091989 · KDN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
