510(k) Report

FDA applicant

Neuromod Devices Limited

Dublin 8, IE1 decision2023–20230 recalls

FDA records 1 decision for Neuromod Devices Limited (Dublin 8, IE) in 2023: 1 De Novo grant. All are in product code QVN (Combined Acoustic And Electrical External…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Neuromod Devices Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Neuromod Devices Limited by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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