510(k) Report

FDA applicant

Damae Medical

Paris, FR2 decisions2024–20250 recalls

FDA records 2 decisions for Damae Medical (Paris, FR) from 2024 to 2025: 2 510(k) clearances. All are in product code NQQ (System, Imaging, Optical Coherence Tomography…). Its devices cite 2 predicates, 1 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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Damae Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Damae Medical by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240610deepLiveDamae Medical · 20241cites it

What has FDA decided for it lately?

  • K252851deepLive (OSP12 + DMS)Damae Medical · 2025
  • K240610deepLiveDamae Medical · 2024

All 2 as Damae Medical →