FDA applicant
Siemens Medical Solutions USA, Inc.
FDA records 791 decisions for Siemens Medical Solutions USA, Inc. (Iselin, NJ) from 1980 to 2026: 788 510(k) clearances and 3 original PMA approvals. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 1,124 predicates, 742 of them its own earlier devices. 838 recalls are linked to its devices, 14 Class I.
FDA’s records also spell it “Siemens Medical Solutions U.S.A.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Medical Solutions USA, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
15in 2025
2026 so far, outlined.
Recalls per year
8in 2026
Class I Class II/III not classified
Planning a device like Siemens Medical Solutions USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report