Eurosets Srl

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One ADecember 12, 2025
K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)November 24, 2025
K202510AMG PMP InfantDecember 10, 2021
K202206AMG PMP PediatricApril 1, 2021
K141492ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)February 6, 2015
K102109ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MOFebruary 15, 2011