T&R BIOFAB CO., 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
TnR Cranial Implant510(k)Jul 30, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2026
THERMOCLICK510(k)Dec 5, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 5, 2023