Israel FDA 510(k) Overview
Leading Israel FDA 510(k) manufacturers include Aidoc Medical , Ltd., CarboFix Orthopedics , Ltd., OSSIO , Ltd. and 264 others.
Israeli medical device manufacturers have submitted 636 FDA 510(k) notifications since 2018, achieving a 96.5% clearance rate across 263 manufacturers. Israel represents one of the most active medtech ecosystems relative to market size, with particular concentration in cardiovascular devices, neurology and advanced diagnostic imaging technologies.
Active in FDA 510(k) submissions since 2018. Many Israel manufacturers work with FDA regulatory consultants to support U.S. market entry.