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Fresenius Kabi AG

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories7
Latest Approval2026-01-09
TypeNumberDevice NameCodeDate
510(k) K251139 KabiHelp® Uno; KabiHelp® Advance plus KPE 2026-01-09 View
510(k) K212445 freeflex+ Transfer Adapter LHI 2022-06-01 View
510(k) K210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo FRN 2022-03-01 View
510(k) K210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable FRN 2022-03-01 View
510(k) K210075 Vigilant Software Suite – Vigilant Master Med PHC 2022-03-01 View
510(k) K210089 CATSmart, Automated Blood Processing Autotransfusion System CAC 2021-02-11 View
510(k) K200530 AMICUS Separator System GKT 2020-09-11 View
510(k) K192150 AMICUS Separator System LKN 2019-11-13 View
510(k) K192368 CATSmart CAC 2019-09-27 View
510(k) K180831 CATSmart CAC 2018-12-10 View
510(k) K160735 CATSmart CAC 2016-09-16 View