Huvitz 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
Applanation Tonometer HT-5000510(k)Oct 23, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Oct 23, 2023
Fundus Camera510(k)Feb 2, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 2, 2021