FDA applicant
Mac Lee Medical Products
FDA records 14 decisions for Mac Lee Medical Products (Topeka, KS) from 1979 to 1988: 14 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FPA (Set, Administration, Intravascular). 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 Mac Lee Medical Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mac Lee Medical Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mac Lee Medical Products’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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