Oxehealth Limited 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
Vital Signs510(k)Feb 2, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 2, 2026
Vital Signs510(k)Aug 27, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 27, 2025
Oxevision Sleep Device510(k)Apr 3, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 3, 2024
Oxehealth Vital Signs510(k)Apr 29, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 29, 2022
Vital Signs510(k)Jul 20, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 20, 2021
Oxehealth Vital Signs510(k)Mar 26, 2021Cardiovascular	Cardiovascular	510(k)Unknown (Direct)	Mar 26, 2021