FDA applicant
Boston Scientific, Target
FDA records 19 decisions for Boston Scientific, Target (Fremont, CA) from 1999 to 2003: 19 510(k) clearances. Most are in product codes HCG (Device, Neurovascular Embolization) and DQY (Catheter, Percutaneous). Its devices cite 36 predicates, 8 of them its own earlier devices. 31 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, Target’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Boston Scientific, Target since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Boston Scientific, Target’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.