Hua Yue Medical Technology 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
Assisted Reproduction Laser System (Model ILS-400M)510(k)Jun 17, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2026
Harioculture TL-16 Time-lapse Incubator510(k)May 22, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	May 22, 2025