FDA applicant
Medify Air, LLC
FDA records 1 decision for Medify Air, LLC (Boca Raton, FL) in 2023: 1 510(k) clearance. All are in product code FRF (Cleaner, Air, Medical Recirculating). 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 Medify Air, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2023high 1 (2023) · low 0 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Medify Air, LLC’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