FDA applicant
Romidan, Ltd.
FDA records 1 decision for Romidan, Ltd. (Kiryat-Ono, IL) in 2010: 1 510(k) clearance. All are in product code LQY (Locator, Root Apex). 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 Romidan, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2010high 1 (2010) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Romidan, 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