Guangdong Youkey Medical 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
Digital Ultrasonic Diagnostic Imaging System (Model: F6)510(k)Mar 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
Pocket Ultrasound System510(k)Feb 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 18, 2022