Mazor Robotics , Ltd. 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
Mazor X System / Mazor X Stealth Edition510(k)Sep 11, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 11, 2025
Mazor X System (Mazor X Stealth Edition)510(k)Apr 7, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 7, 2023