Drägerwerk AG Co. Kgaa FDA Approvals

0 new drug approvals and 5 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
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)510(k)May 21, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 21, 2026
Babyleo TN500510(k)Feb 13, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 13, 2026
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)510(k)Dec 1, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 1, 2025
Atlan510(k)Jul 23, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 23, 2023
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus510(k)Dec 7, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 7, 2022