Well Lead Medical 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
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact510(k)Mar 5, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 5, 2025
PVC Hydrophilic Urethral Catheter510(k)May 22, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 22, 2023
Wellead Ureteral Catheter510(k)Dec 16, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 16, 2022
Wei Nasal Jet Tube510(k)Jul 21, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 21, 2022
Wellead Endoscopic Seal510(k)Jan 14, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022
Well Lead All Silicone Foley Catheter with Temperature Sensor510(k)Apr 8, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Apr 8, 2021