FDA applicant
Boston Scientific Scimed, Inc.
FDA records 40 decisions for Boston Scientific Scimed, Inc. (Plymouth, MN) from 1994 to 2005: 35 510(k) clearances and 5 original PMA approvals. Most are in product codes JCT (Prosthesis, Tracheal, Expandable) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 49 predicates, 26 of them its own earlier devices. 62 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Boston Scientific Scimed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Boston Scientific Scimed, Inc. since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Boston Scientific Scimed, 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 “Boston”
FDA records each applicant name separately; these may or may not be the same firm.