FDA applicant
Siemens Healthcare Diagnostic Products GmbH
FDA records 5 decisions for Siemens Healthcare Diagnostic Products GmbH (Marburg, DE) from 2016 to 2026: 5 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and DCN (System, Test, C-Reactive Protein). Its devices cite 5 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 Siemens Healthcare Diagnostic Products GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
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