FDA applicant
Bellco Srl (Now Part of Medtronic, Inc)
FDA records 1 decision for Bellco Srl (Now Part of Medtronic, Inc) (Mirandola, IT) in 2020: 1 De Novo grant. All are in product code QIR (Pediatric Hemodialysis System). 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 Bellco Srl (Now Part of Medtronic, Inc)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Bellco Srl (Now Part of Medtronic, 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) ReportOther applicant names beginning “Bellco”
FDA records each applicant name separately; these may or may not be the same firm.