Draegerwerk AG & CO Kgaa 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
Evita (V800); Evita (V600)510(k)May 7, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 7, 2026
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)510(k)Apr 4, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 4, 2025
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)510(k)Jun 14, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2023
Babylog VN800, Babylog VN600510(k)May 16, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 16, 2023
Evita V800, Evita V600510(k)May 16, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 16, 2023
CO2 Mainstream Sensor510(k)Apr 5, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 5, 2023