FDA applicant
Medcon, Ltd.
FDA records 4 decisions for Medcon, Ltd. (Efrat, IL) from 1997 to 2006: 4 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and IZI (System, X-Ray, Angiographic). Its devices cite 5 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medcon, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medcon, Ltd. since 2007.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Medcon, Ltd.’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