FDA 510(k) Medical Device Manufacturers - Ireland

Leading Ireland FDA 510(k) manufacturers include Depuy Ireland UC, Perfuze, Ltd., Abbott Ireland Diagnostics Division and 42 others.

Irish medical device manufacturers have submitted 143 FDA 510(k) notifications since 2019, achieving a 95.8% clearance rate across 45 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 2019. Many Ireland manufacturers work with FDA regulatory consultants to support U.S. market entry.