Shenzhen Med-Link Electronics Tech Co., Ltd. FDA Approvals

0 new drug approvals and 6 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
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)510(k)Jan 8, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 8, 2026
Disposable Non-invasive EEG Sensor510(k)Jan 19, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 19, 2023
Med-link Disposable ECG Cable and Leadwires510(k)Jun 28, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 28, 2022
Med-link Pulse Oximeter510(k)May 20, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 20, 2022
Incontinence Probe510(k)Sep 17, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 17, 2021
Med-Link Temp-pulse Oximeter510(k)Mar 1, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 1, 2021