Mako Surgical Corp. FDA Approvals

0 new drug approvals and 7 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
Mako Total Knee Application510(k)Feb 25, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Feb 25, 2026
Mako Total Knee Application (3.0); Hybrid Tip Pointer510(k)Apr 25, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 25, 2025
Mako Total Hip Application 5.0510(k)Mar 5, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 5, 2025
Mako Shoulder Application (1.0)510(k)Nov 7, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2024
Mako Total Knee Application510(k)Jun 11, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 11, 2024
Restoris Multi-Compartmental Knee System510(k)Jun 2, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2022
Mako Total Knee Application510(k)Apr 15, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 15, 2022