FDA applicant
Medical Precision BV
FDA records 2 decisions for Medical Precision BV (Zwolle, NL) from 2021 to 2023: 1 510(k) clearance and 1 De Novo grant. All are in product code QRN (Radiation Therapy Marking Device). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Medical Precision BV’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Medical Precision 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