FDA applicant
Tyco Healthcare Group LP
FDA records 6 decisions for Tyco Healthcare Group LP (Mansfield, MA) from 2001 to 2008: 6 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and GDW (Staple, Implantable). Its devices cite 9 predicates, 0 of them its own earlier devices. 33 recalls are linked to its devices.
FDA’s records also spell it “Tyco Healthcare Group”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tyco Healthcare Group LP’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
5in 2019
Class I Class II/III not classified
Planning a device like Tyco Healthcare Group LP’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 “Tyco”
FDA records each applicant name separately; these may or may not be the same firm.