Braincare Desenvolvimento E Inovação Tecnológica S.A. FDA Approvals

0 new drug approvals and 2 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
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)510(k)Jul 18, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2024
B4C System510(k)Oct 8, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 8, 2021