FDA applicant
M. Imonti and Associates Inc.,
FDA records 6 decisions for M. Imonti and Associates Inc., (San Juan Capistrano, CA) from 1991 to 1995: 6 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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 M. Imonti and Associates Inc.,’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for M. Imonti and Associates Inc., since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like M. Imonti and Associates Inc.,’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