FDA applicant
Nox Medical Ehf
FDA records 8 decisions for Nox Medical Ehf (Reykjavik, IS) from 2008 to 2026: 8 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and OLZ (Automatic Event Detection Software For…). Its devices cite 14 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Nox Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nox Medical Ehf’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Nox Medical Ehf’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report