Piraeus Medical 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
93 NeuFlex Catheter510(k)May 23, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 23, 2025
87 NeuGlide Catheter510(k)Dec 6, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 6, 2024