Augmedics, Ltd. FDA Approvals

0 new drug approvals and 6 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
xvision Spine system510(k)Jul 31, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
xvision Spine system510(k)Oct 3, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 3, 2025
xvision Spine system510(k)Mar 13, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Mar 13, 2025
xvision Spine System510(k)Oct 16, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 16, 2024
xvision Spine System510(k)Nov 17, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2022
xvision Spine system (XVS)510(k)Jul 19, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 19, 2021