FDA applicant
Siemens Healthcare Diagnostics Products GmbH
FDA records 28 decisions for Siemens Healthcare Diagnostics Products GmbH (Marburg, DE) from 2002 to 2026: 23 510(k) clearances, 1 De Novo grant and 4 original PMA approvals. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and DFH (Kappa, Antigen, Antiserum, Control). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Siemens Healthcare Diagnostics Products, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Healthcare Diagnostics Products GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
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