FDA applicant
Bard Medsystems Div.
FDA records 1 decision for Bard Medsystems Div. (North Reading, MA) in 1993: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bard Medsystems Div.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bard Medsystems Div. since 2007.
Recalls per year
2in 2011
Class I Class II/III not classified
Planning a device like Bard Medsystems Div.’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 “Bard”
FDA records each applicant name separately; these may or may not be the same firm.