FDA applicant
Covidien, Formerly US Surgical A Divison of Tyco H
FDA records 13 decisions for Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, CT) from 2010 to 2013: 13 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 38 predicates, 9 of them its own earlier devices. 81 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Covidien, Formerly US Surgical A Divison of Tyco H’s devices, and how often a recall has named them.
FDA decisions per year
5in 2013
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like Covidien, Formerly US Surgical A…’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.