FDA applicant
Virility Medical, Ltd.
FDA records 3 decisions for Virility Medical, Ltd. (Hod-Hasharon, IL) from 2021 to 2026: 2 510(k) clearances and 1 De Novo grant. All are in product code QRC (Non-Implanted Electrical Stimulation Device…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Virility Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Virility Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Virility Medical, 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