FDA applicant
Cordis Corp.
FDA records 334 decisions for Cordis Corp. (Miami Lakes, FL) from 1976 to 2022: 328 510(k) clearances and 6 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 115 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 142 predicates, 85 of them its own earlier devices. 135 recalls are linked to its devices, 21 Class I.
FDA’s records also spell it “Cordis Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cordis Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Cordis 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 “Cordis”
FDA records each applicant name separately; these may or may not be the same firm.