FDA applicant
Bluewind Medical, Ltd.
FDA records 4 decisions for Bluewind Medical, Ltd. (Herzliya, IL) from 2023 to 2026: 3 510(k) clearances and 1 De Novo grant. All are in product code QXM (Implanted Tibial Electrical Urinary Continence…). Its devices cite 3 predicates, 3 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 Bluewind Medical, 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 2023.
Planning a device like Bluewind 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