Breas Medical AB 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
EveryWare510(k)May 20, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 20, 2025
Clearo510(k)May 16, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 16, 2025
Vivo 45 LS510(k)Jan 13, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 13, 2025
Vivo 1, Vivo 2510(k)Dec 13, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2024
Vivo 3510(k)Dec 13, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2024
Vivo 45 LS510(k)Jan 27, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 27, 2021