FDA applicant
Embrace Medical, Ltd.
FDA records 1 decision for Embrace Medical, Ltd. (Tel-Aviv, IL) in 2023: 1 510(k) clearance. All are in product code DQX (Wire, Guide, Catheter). 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 Embrace Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2023high 1 (2023) · low 0 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Embrace 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