Eurosets S.R.L - FDA 510(k) Cleared Devices
Recent clearances: Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300), Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232), AMG PMP Infant
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eurosets S.R.L Cardiovascular ✕
6 devices
Cleared
Dec 12, 2025
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon...
Cardiovascular
269d
Cleared
Nov 24, 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
Cardiovascular
459d
Cleared
Dec 10, 2021
AMG PMP Infant
Cardiovascular
466d
Cleared
Apr 01, 2021
AMG PMP Pediatric
Cardiovascular
239d
Cleared
Feb 06, 2015
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
Cardiovascular
246d
Cleared
Feb 15, 2011
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS...
Cardiovascular
202d