FDA applicant
Brh Medical, Ltd.
FDA records 1 decision for Brh Medical, Ltd. (Jerusalem, IL) in 2017: 1 510(k) clearance. All are in product code IMI (Ultrasonic Diathermy For Use In Applying…). Its devices cite 2 predicates, 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 Brh Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2017high 1 (2017) · low 0 (2018)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Brh 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