Ireland FDA 510(k) Overview
Leading Ireland FDA 510(k) manufacturers include Depuy Ireland UC, Cook Ireland, Ltd., Perfuze, Ltd. and 52 others.
Irish medical device manufacturers have submitted 167 FDA 510(k) notifications since 2018, achieving a 96.4% clearance rate across 55 manufacturers. Ireland is home to a significant cluster of multinational medtech companies, with particular activity in cardiovascular devices, in vitro diagnostics and Class II medical devices targeting the U.S. market.
Active in FDA 510(k) submissions since 2018. Many Ireland manufacturers work with FDA regulatory consultants to support U.S. market entry.