Enchant Tek 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
AllNEB510(k)Apr 29, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2025
AllPEP510(k)Feb 2, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2024