FDA applicant
Covidien
FDA records 227 decisions for Covidien (Boulder, CO) from 1991 to 2026: 224 510(k) clearances, 1 De Novo grant and 2 original PMA approvals. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GDW (Staple, Implantable). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 368 predicates, 134 of them its own earlier devices. 213 recalls are linked to its devices, 36 Class I.
FDA’s records also spell it “Covidien, LLC”, “Covidien LP”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Covidien’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Covidien’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 “Covidien”
FDA records each applicant name separately; these may or may not be the same firm.