FDA applicant
Olympus Life & Material Science Europa GmbH (Irish
FDA records 3 decisions for Olympus Life & Material Science Europa GmbH (Irish (Co. Clare, IE) in 2007: 3 510(k) clearances. Most are in product codes CEC (Radioimmunoassay, Free Thyroxine) and GHH (Fibrin Split Products). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Life & Material Science Europa GmbH (Irish’s devices, and how often a recall has named them.
FDA decisions per year
3in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Olympus Life & Material Science Europa…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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