Shenzhen Browiner Tech 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 Radiography System (ManntiX B, ManntiX K)510(k)Dec 9, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 9, 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)510(k)Mar 28, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2024