FDA applicant
Monargue Intl.
FDA records 1 decision for Monargue Intl. (Chatsworth, CA) in 1985: 1 510(k) clearance. All are in product code LRA (Hearing Aid, Tactile). 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 Monargue Intl.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Monargue Intl. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Monargue Intl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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