FDA applicant

Nanovi A/S

Kgs. Lyngby, DK1 decision2022–20220 recalls

FDA records 1 decision for Nanovi A/S (Kgs. Lyngby, DK) in 2022: 1 De Novo grant. All are in product code QUV (Phase-Changing Fiducial Marker For Radiation…). 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, radiology panel, where it files most

How often FDA has decided Nanovi A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Nanovi A/S by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Nanovi A/S

Which product codes does it file in?

What has FDA decided for it lately?