FDA Import Refusal 101-8366633-8/231/1 — Edwards Lifesciences

Edwards Lifesciences — FEI 3003242659

The FDA refused shipment 101-8366633-8/231/1 from Edwards Lifesciences (Dominican Republic) on October 23, 2025. The refused product falls under Devices — TRANSDUCER, PRESSURE, CATHETER TIP. Cited charge: 237 This firm has 5 or more other import refusals on record.