Fresenius Kabi AG FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
KabiHelp® Uno; KabiHelp® Advance plus510(k)Jan 9, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 9, 2026
freeflex+ Transfer Adapter510(k)Jun 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 1, 2022
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo510(k)Mar 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022
Vigilant Software Suite Vigilant Master Med510(k)Mar 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable510(k)Mar 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022
CATSmart, Automated Blood Processing Autotransfusion System510(k)Feb 11, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Feb 11, 2021