FDA applicant
Covidien, LLC, Formerly Registered AS Tyco Healthca
FDA records 2 decisions for Covidien, LLC, Formerly Registered AS Tyco Healthca (North Haven, CT) in 2010: 2 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and NIE (Catheter, Hemodialysis, Triple Lumen…). Its devices cite 6 predicates, 0 of them its own earlier devices. 26 recalls are linked to its devices, 25 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Covidien, LLC, Formerly Registered AS Tyco Healthca’s devices, and how often a recall has named them.
FDA decisions per year
2in 2010
2026 so far, outlined.
Recalls per year
25in 2023
Class I Class II/III not classified
Planning a device like Covidien, LLC, Formerly Registered AS…’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.