Fresenius Kabi AG - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
Fresenius Kabi AG has 12 FDA 510(k) cleared medical devices. Based in Lake Zurich, US.
Latest FDA clearance: Jan 2026. Active since 2013. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Fresenius Kabi AG Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Fresenius Kabi AG
12 devices
Cleared
Jan 09, 2026
KabiHelp® Uno
General Hospital
270d
Cleared
Jun 01, 2022
freeflex+ Transfer Adapter
General Hospital
300d
Cleared
Mar 01, 2022
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines...
General Hospital
413d
Cleared
Mar 01, 2022
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link,...
General Hospital
413d
Cleared
Mar 01, 2022
Vigilant Software Suite – Vigilant Master Med
General Hospital
413d
Cleared
Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
Cardiovascular
29d
Cleared
Sep 11, 2020
AMICUS Separator System
Gastroenterology & Urology
193d
Cleared
Nov 13, 2019
AMICUS Separator System
Gastroenterology & Urology
96d
Cleared
Sep 27, 2019
CATSmart
Cardiovascular
28d
Cleared
Dec 10, 2018
CATSmart
Cardiovascular
255d
Cleared
Sep 16, 2016
CATSmart
Anesthesiology
183d
Cleared
May 01, 2013
AGILIA INFUSION SYSTEM
General Hospital
334d