Hjy Smart Medical Device 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
HJY VisualNext 3D Endoscopic Vision System510(k)May 21, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 21, 2025
HJY VisualNext Endoscopic Vision System510(k)Jul 28, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 28, 2023