FDA applicant
Covidien Lp, Formerly Registered AS United States
FDA records 8 decisions for Covidien Lp, Formerly Registered AS United States (North Haven, CT) from 2002 to 2009: 7 510(k) clearances and 1 original PMA approval. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and OCW (Endoscopic Tissue Approximation Device). Its devices cite 15 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Covidien Lp, Formerly Registered AS United States’s devices, and how often a recall has named them.
FDA decisions per year
4in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Covidien Lp, 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.