FDA applicant
Neoventa Medical AB
FDA records 2 decisions for Neoventa Medical AB (Mölndal, SE) from 2005 to 2025: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HGP (Electrode, Circular (Spiral), Scalp And…) and HEO (Analyzer, Data, Obstetric). Its devices cite 1 predicate, 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 Neoventa Medical AB’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Neoventa Medical AB’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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