FDA applicant
Ibex Medical Analytics, Ltd.
FDA records 1 decision for Ibex Medical Analytics, Ltd. (Tel Aviv, IL) in 2025: 1 510(k) clearance. All are in product code QPN (Software Algorithm Device To Assist Users In…). Its devices cite 1 predicate, 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 Ibex Medical Analytics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Ibex Medical Analytics, 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