FDA applicant
Medefield Pty., Ltd.
FDA records 6 decisions for Medefield Pty., Ltd. (Mchenry, IL) in 1980: 6 510(k) clearances. All are in product code KTA (Medium, Contrast, Radiologic). 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 Medefield Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medefield Pty., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
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