FDA applicant

Aventamed Dac

Bishopstown, IE2 decisions2024–20250 recalls

FDA records 2 decisions for Aventamed Dac (Bishopstown, IE) from 2024 to 2025: 2 510(k) clearances. All are in product code ETD (Tube, Tympanostomy). Its devices cite 3 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2025

2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

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Aventamed Dac

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?