FDA 510(k) Medical Device Manufacturers - Ireland

Leading Ireland FDA 510(k) manufacturers include Depuy Ireland UC, Cook Ireland, Ltd., Depuy(Ireland) and 86 others.

Irish medical device manufacturers have submitted 295 FDA 510(k) notifications since 1993, achieving a 97.3% clearance rate across 89 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 1993. Many Ireland manufacturers work with FDA regulatory consultants to support U.S. market entry.