Fusion Robotics, LLC 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
Remi Robotic Navigation System510(k)Mar 13, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 13, 2023
Remi Robotic Navigation System510(k)Oct 28, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Oct 28, 2022