FDA applicant
Levita Magnetics International Corp
FDA records 8 decisions for Levita Magnetics International Corp (San Mateo, CA) from 2016 to 2025: 7 510(k) clearances and 1 De Novo grant. All are in product code PNL (Magnetic Surgical System). Its devices cite 9 predicates, 8 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 Levita Magnetics International Corp’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Levita Magnetics International Corp’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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