Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Fresenius SELabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Fresenius Kabi with 14 510(k) clearances, 4 drug applications and 1 warning letter. The most recent is a 510(k) clearance dated Jan 9, 2026: KabiHelp® Uno; KabiHelp® Advance 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.
| Jan 9, 2026 | KabiHelp® Uno; KabiHelp® Advance plusK251139 · KPE | 510(k) clearances |
| Jan 4, 2024 | Warning letter: CAPA, MDR reporting, 510(k) requiredCDRH | Warning letters |
| Jun 16, 2023 | Volumat Polyethylene I.V. Administration SetK221121 · FPA | 510(k) clearances |
| Jun 2, 2023 | Volumat LineK220301 · FPA | 510(k) clearances |
| Jun 1, 2022 | freeflex+ Transfer AdapterK212445 · LHI | 510(k) clearances |
| Mar 1, 2022 | Vigilant Software Suite – Vigilant Master MedK210075 · PHC | 510(k) clearances |
| Mar 1, 2022 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoK210073 · FRN | 510(k) clearances |
| Mar 1, 2022 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableK210074 · FRN | 510(k) clearances |
| Feb 11, 2021 | CATSmart, Automated Blood Processing Autotransfusion SystemK210089 · CAC | 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
