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FDA 510(k) Applications Submitted by Fresenius Kabi AG
FDA 510(k) Number
Submission Date
Device Name
Applicant
K192150
08/09/2019
AMICUS Separator System
Fresenius Kabi AG
K160735
03/17/2016
CATSmart
FRESENIUS KABI AG
K180831
03/30/2018
CATSmart
Fresenius Kabi AG
K121613
06/01/2012
AGILIA INFUSION SYSTEM
FRESENIUS KABI AG
K210089
01/13/2021
CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG
K210073
01/12/2021
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG
K210074
01/12/2021
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Fresenius Kabi AG
K210075
01/12/2021
Vigilant Software Suite û Vigilant Master Med
Fresenius Kabi AG
K212445
08/05/2021
freeflex+ Transfer Adapter
Fresenius Kabi AG
K200530
03/02/2020
AMICUS Separator System
Fresenius Kabi AG
K192368
08/30/2019
CATSmart
Fresenius Kabi AG
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