FDA applicant
Burditt & Calkins-Siemens-Elema
FDA records 10 decisions for Burditt & Calkins-Siemens-Elema (Mchenry, IL) from 1976 to 1984: 10 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and KRB (Probe, Thermodilution). 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 Burditt & Calkins-Siemens-Elema’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Burditt & Calkins-Siemens-Elema since 2007.
Recalls per year
No recall linked to its devices since 2007.
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