FDA applicant
Meadox Medicals, Div. Boston Scientific Corp.
FDA records 54 decisions for Meadox Medicals, Div. Boston Scientific Corp. (Oakland, NJ) from 1976 to 1997: 53 510(k) clearances and 1 original PMA approval. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 22 predicates, 5 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Meadox Medicals, Div. Boston Scientific Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Meadox Medicals, Div. Boston Scientific Corp. since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Meadox Medicals, Div. Boston…’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 “Meadox”
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