Eurosets S.R.L 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
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)510(k)Sep 14, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 14, 2026
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)510(k)Dec 12, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 12, 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)510(k)Nov 24, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 24, 2025
AMG PMP Infant510(k)Dec 10, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 10, 2021
AMG PMP Pediatric510(k)Apr 1, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021