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Radiometer Medical ApS

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Seri recall (Z-1659-2025)Radiometer Medical ApS2025-04-23
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: recall (Z-2426-2024)Radiometer Medical ApS2024-07-24
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is inte recall (Z-1394-2023)Radiometer Medical ApS2023-04-17
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let recall (Z-1582-2018)Radiometer Medical ApS2018-03-14

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Every clearance here is in the API, with alerts when new ones post.