Shenzhen HugeMed Medical Technical Development Co., Ltd. FDA Approvals

0 new drug approvals and 8 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
Suction Pump (SU-90)510(k)May 14, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 14, 2026
Single-use Ureteral Access Sheath510(k)Jul 8, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 8, 2025
Biliary Pancreaticobiliary Scope System510(k)Jan 21, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 21, 2025
Ureterorenoscope System510(k)May 10, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 10, 2024
Rhinolaryngoscope system510(k)Apr 26, 2024Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Apr 26, 2024
Choledochoscope System510(k)Mar 6, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2024
Cystoscope System510(k)Nov 13, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023
Bronchoscope System510(k)Apr 11, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Apr 11, 2023