FDA applicant
Covidien Lp, Formerly Registered AS Tyco Healthcar
FDA records 4 decisions for Covidien Lp, Formerly Registered AS Tyco Healthcar (North Haven, CT) from 2007 to 2010: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 4 predicates, 0 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 Tyco Healthcar’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
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.