FDA applicant
Vitatron Medical BV
FDA records 19 decisions for Vitatron Medical BV (Mchenry, IL) from 1976 to 1986: 19 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and KRG (Programmer, Pacemaker). 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 Vitatron Medical BV’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Vitatron Medical BV since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vitatron Medical BV’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