FDA applicant
Liebel-Flarsheim Company, LLC
FDA records 3 decisions for Liebel-Flarsheim Company, LLC (Cincinnati, OH) from 2012 to 2020: 3 510(k) clearances. Most are in product codes IZQ (Injector, Contrast Medium, Automatic) and PQH (Iodinated Contrast Media Transfer Tubing Set). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Liebel-Flarsheim”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Liebel-Flarsheim Company, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Liebel-Flarsheim Company, LLC’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) Report