FDA applicant
Boston Scientific/Medi-Tech
FDA records 5 decisions for Boston Scientific/Medi-Tech (Natick,, MA) from 2001 to 2002: 5 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and MSD (Catheter, Hemodialysis, Implanted). 6 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/Medi-Tech’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Boston Scientific/Medi-Tech since 2007.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Boston Scientific/Medi-Tech’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.