FDA applicant
Siemens Medical Systems, Inc.
FDA records 25 decisions for Siemens Medical Systems, Inc. (Mavern, PA) from 2001 to 2014: 25 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 34 predicates, 4 of them its own earlier devices. 62 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2014
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Siemens Medical Systems, 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