Fresenius Kabi AG

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
9
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251139KabiHelp® Uno; KabiHelp® Advance plusJanuary 9, 2026
K221121Volumat Polyethylene I.V. Administration SetJune 16, 2023
K220301Volumat LineJune 2, 2023
K212445freeflex+ Transfer AdapterJune 1, 2022
K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CablMarch 1, 2022
K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, AgiliMarch 1, 2022
K210075Vigilant Software Suite – Vigilant Master MedMarch 1, 2022
K210089CATSmart, Automated Blood Processing Autotransfusion SystemFebruary 11, 2021
K200530AMICUS Separator SystemSeptember 11, 2020
K192150AMICUS Separator SystemNovember 13, 2019
K192368CATSmartSeptember 27, 2019
K180831CATSmartDecember 10, 2018
K160735CATSmartSeptember 16, 2016
K121613AGILIA INFUSION SYSTEMMay 1, 2013