510(k) Report

FDA applicant

Mri Devices Daum GmbH

Crofton,, MD1 decision2002–20020 recalls

FDA records 1 decision for Mri Devices Daum GmbH (Crofton,, MD) in 2002: 1 510(k) clearance. All are in product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…). 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 Mri Devices Daum GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mri Devices Daum GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mri Devices Daum GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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