Datex Ohmeda, Inc. FDA Approvals

0 new drug approvals and 7 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
Novii+ Wireless Patch System510(k)Aug 10, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Aug 10, 2026
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)510(k)Jul 28, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 28, 2026
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)510(k)Oct 22, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 22, 2025
Carestation 750/750c510(k)Mar 28, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2023
Giraffe Omnibed Carestation CS1510(k)Mar 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 2, 2022
Giraffe Incubator Carestation CS1510(k)Mar 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 2, 2022
CARESCAPE R860510(k)Nov 4, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Nov 4, 2021