FDA applicant
Dehas Medical Systems GmbH
FDA records 2 decisions for Dehas Medical Systems GmbH (Luebeck, DE) from 2023 to 2024: 2 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 2 predicates, 0 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
How often FDA has decided Dehas Medical Systems GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Dehas Medical Systems GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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