Fresenius Kabi AG

FDA Filings

This page includes the latest FDA filings for Fresenius Kabi AG. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Fresenius Kabi AG
AMICUS Separator System2019-11-13
Fresenius Kabi AG
CATSmart2019-09-27
Fresenius Kabi AG
Automated Blood Cell Separators2019-07-26
Fresenius Kabi AG
Empty Containers For The Collection & Processing Of Blood/Blood Components2019-07-19
Fresenius Kabi AG
Empty Containers For The Collection & Processing Of Blood/Blood Components2018-12-21
Fresenius Kabi AG
CATSmart2018-12-10
Fresenius Kabi AG
Processing Systems For Frozen Blood2018-12-03
Fresenius Kabi AG
Automated Blood Cell Separators2018-08-14

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG2019-11-04
Multi-Sampling Connector
Fresenius Kabi AG2019-10-23
CompoSeal Slim
Fresenius Kabi AG2019-10-10
Vigilant Drug'Lib AGILIA US
Fresenius Kabi AG2019-07-23
Fenwal Transfer Pack Container 150 mL with Coupler
Fresenius Kabi AG2019-04-17
Fenwal Transfer Pack Container 600 mL with Male Luer Adapter
Fresenius Kabi AG2019-04-17
Fenwal Transfer Pack Container 300 mL with Coupler
Fresenius Kabi AG2019-04-15
Fenwal Transfer Pack Container 600 mL with Coupler
Fresenius Kabi AG2019-04-15
AMICUS Exchange Kit - Therapeutics
Fresenius Kabi AG2019-03-11
Waste Transfer Set
Fresenius Kabi AG2019-03-11
Fenwal Transfer Pack Container 600 mL with 8 coupl
Fresenius Kabi AG2019-03-08
Fenwal Quadruple Transfer Pack Container 150 mL wi
Fresenius Kabi AG2019-03-08
Aurora Xi Plasmapheresis System
Fresenius Kabi AG2019-01-14
Fenwal Transfer Pack Container 1000 mL with Couple
Fresenius Kabi AG2018-10-31
Volumat™ Line
Fresenius Kabi AG2018-09-28
Volumat™ Line
Fresenius Kabi AG2018-09-28
TPE Plasma Exchange Set
Fresenius Kabi AG2018-09-03
CompoMaster Net G5
Fresenius Kabi AG2018-09-03
CompoMat G5
Fresenius Kabi AG2018-09-03
CompoDock
Fresenius Kabi AG2018-09-03
COM.TEC
Fresenius Kabi AG2018-09-03
CATSmart
Fresenius Kabi AG2018-09-03
C.A.T.S
Fresenius Kabi AG2018-09-03
ATV-F140C Vacuum Lines Combi-pack
Fresenius Kabi AG2018-09-03
P1R Plasma Treatment Set
Fresenius Kabi AG2018-09-03
AT3 Autotransfusion Set
Fresenius Kabi AG2018-09-03
ATF 120 Fast start kit with AT3
Fresenius Kabi AG2018-09-03
ATF 40 Fast start kit with AT3
Fresenius Kabi AG2018-09-03
ATR CAP SET
Fresenius Kabi AG2018-09-03
ATV-180 Vacuum Line
Fresenius Kabi AG2018-09-03
ATV-70 Vacuum Line
Fresenius Kabi AG2018-09-03
ATF 120 Fast Start Kit
Fresenius Kabi AG2018-09-03
ATF 40 Fast Start Kit
Fresenius Kabi AG2018-09-03
ATS Suction Line
Fresenius Kabi AG2018-09-03
ATO Oxygenator line
Fresenius Kabi AG2018-09-03

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