FDA applicant
Mediflex Intl.
FDA records 9 decisions for Mediflex Intl. (Fairfield, NJ) from 1984 to 1992: 9 510(k) clearances. Most are in product codes FIB (Protector, Transducer, Dialysis) 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 Mediflex Intl.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mediflex Intl. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mediflex Intl.’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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