FDA applicant
Medicsense USA
FDA records 1 decision for Medicsense USA (Somerset, MA) in 2006: 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 Medicsense USA’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medicsense USA since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medicsense USA’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