Suzhou Haowei 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
UniPearls® Embolic Microspheres510(k)Jul 31, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
UniPearls® Embolic Microspheres510(k)Nov 14, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 14, 2023