Compumedics Limited FDA Approvals

0 new drug approvals and 4 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
Somfit D510(k)Aug 28, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Aug 28, 2025
Falcon HST510(k)Feb 20, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 20, 2025
Somfit510(k)Nov 30, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Nov 30, 2023
Okti510(k)Feb 9, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 9, 2023