LEM Surgical AG 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
Dynamis Robotic Surgical System510(k)Jun 20, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 20, 2026
Dynamis Robotic Surgical System510(k)Apr 23, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 23, 2025