FDA applicant
Ganshorn Medizin Electronic GmbH
FDA records 2 decisions for Ganshorn Medizin Electronic GmbH (Niederlauer, DE) from 2016 to 2024: 2 510(k) clearances. Most are in product codes JEH (Plethysmograph, Volume) and BZG (Spirometer, Diagnostic). 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 Ganshorn Medizin Electronic 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 2016.
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