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Eurosets S.R.L

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261438 HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)DTZ2026-09-14 View
510(k) K250821 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)DTZ2025-12-12 View
510(k) K242503 Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ2025-11-24 View
510(k) K202510 AMG PMP InfantDTZ2021-12-10 View
510(k) K202206 AMG PMP PediatricDTZ2021-04-01 View
510(k) K102109 ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012DTZ2011-02-15 View
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