FDA applicant
Danumed Medizintechnik GmbH
FDA records 2 decisions for Danumed Medizintechnik GmbH (Regensburg, DE) in 2026: 2 510(k) clearances. Most are in product codes PIF (Gastrointestinal Tubes With Enteral Specific…) and KNT (Tubes, Gastrointestinal (And Accessories)). 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 Danumed Medizintechnik GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
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