Brosmed Medical Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter510(k)Feb 27, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 27, 2025
Tri-Wedge PTA Scoring Balloon Dilatation Catheter510(k)Oct 22, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 22, 2024
POT PTCA Balloon Dilatation Catheter510(k)Apr 11, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 11, 2023
Tiche PTA Balloon Dilatation Catheter510(k)Jul 19, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 19, 2022
Artimes pro Balloon Dilatation Catheter510(k)Apr 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 14, 2021