FDA applicant
Mallinckrodt Inc., Liebel-Flarsheim Business
FDA records 8 decisions for Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, OH) from 1997 to 2009: 8 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and IZQ (Injector, Contrast Medium, Automatic). Its devices cite 9 predicates, 4 of them its own earlier devices. 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mallinckrodt Inc., Liebel-Flarsheim Business’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
5in 2012
Class I Class II/III not classified
Planning a device like Mallinckrodt Inc., Liebel-Flarsheim…’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 “Mallinckrodt”
FDA records each applicant name separately; these may or may not be the same firm.