Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 20 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Fresenius SE and its 20 subsidiaries with 356 drug applications, 139 510(k) clearances, 90 drug recalls, 63 device recalls, 6 warning letters and 5 complete response letters. The most recent is a 510(k) clearance dated Oct 19, 2026: multiFiltratePRO System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Fresenius SE and its 20 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
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
