United Kingdom FDA 510(k) Overview
Leading United Kingdom FDA 510(k) manufacturers include CooperVision, Inc., Unipath , Ltd., Oxoid , Ltd. and 192 others.
UK medical device manufacturers have submitted 734 FDA 510(k) notifications since 1978, with a 97.7% clearance rate across 195 manufacturers. The UK medtech sector reflects strong specialization in cardiovascular, orthopedic and in vitro diagnostic devices, with a well-established regulatory affairs ecosystem supporting FDA market entry.
Active in FDA 510(k) submissions since 1978. Many United Kingdom manufacturers work with FDA regulatory consultants to support U.S. market entry.