Acurable Limited FDA Approvals

0 new drug approvals and 3 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
AcuPebble Ox (200)510(k)Mar 19, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 19, 2025
AcuPebble OX100510(k)Feb 3, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Feb 3, 2023
AcuPebble SA510(k)Jul 6, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2021