Ots Medical , Ltd. FDA Approvals

0 new drug approvals and 3 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
OTS 25-L (100-5)510(k)Jul 22, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 22, 2025
OTS 25-L (100-5)510(k)Jan 23, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 23, 2025
OTS 25 (100-1)510(k)Dec 7, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 7, 2023