Monteris Medical FDA Approvals

0 new drug approvals and 5 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
NeuroBlate System510(k)Sep 3, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 3, 2026
NeuroBlate System510(k)Apr 23, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 23, 2026
Monteris Medical NeuroBlate System510(k)Jun 4, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 4, 2024
NeuroBlate System510(k)Dec 8, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
NeuroBlate Fusion-S Software V3.17510(k)Mar 15, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 15, 2023