FDA applicant
Boston Scientific Corp
FDA records 809 decisions for Boston Scientific Corp (Maple Grove, MN) from 1981 to 2026: 732 510(k) clearances, 2 De Novo grants and 75 original PMA approvals. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 783 predicates, 488 of them its own earlier devices. 888 recalls are linked to its devices, 103 Class I.
FDA’s records also spell it “Boston Scientific Corporation”, “Boston Scientific”, “Boston Scientific Limited”, “Boston Scientific Corporation -”, “Boston Scientific, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Boston Scientific Corp’s devices, and how often a recall has named them.
FDA decisions per year
16in 2025
2026 so far, outlined.
Recalls per year
72in 2026
Class I Class II/III not classified
Planning a device like Boston Scientific Corp’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 “Boston”
FDA records each applicant name separately; these may or may not be the same firm.