Disa Medinotec 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
OutFlo Aortic Valve Dilatation Balloon Catheter510(k)Mar 11, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 11, 2025
Trachealator510(k)Nov 24, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Nov 24, 2021