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Fresenius Kabi AG

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

Total Devices11
Categories7
Latest FDA decision2026-01-09
TypeNumberDevice NameCodeDateActions
510(k) K251139 KabiHelp® Uno; KabiHelp® Advance plusKPE2026-01-09 View
510(k) K212445 freeflex+ Transfer AdapterLHI2022-06-01 View
510(k) K210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoFRN2022-03-01 View
510(k) K210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableFRN2022-03-01 View
510(k) K210075 Vigilant Software Suite – Vigilant Master MedPHC2022-03-01 View
510(k) K210089 CATSmart, Automated Blood Processing Autotransfusion SystemCAC2021-02-11 View
510(k) K200530 AMICUS Separator SystemGKT2020-09-11 View
510(k) K192150 AMICUS Separator SystemLKN2019-11-13 View
510(k) K192368 CATSmartCAC2019-09-27 View
510(k) K180831 CATSmartCAC2018-12-10 View
510(k) K160735 CATSmartCAC2016-09-16 View
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