Austria FDA 510(k) Overview
Leading Austria FDA 510(k) manufacturers include Med-El Elektromedizinische Geraete GmbH, Med-El Elektromedizinische Ger?te GmbH, W&H Dentalwerk Buermoos GmbH and 27 others.
Austrian medical device manufacturers have submitted 59 FDA 510(k) notifications since 2018, achieving a 96.6% clearance rate across 30 manufacturers. Austria's medtech sector reflects the country's precision manufacturing tradition, with activity in surgical instruments, diagnostic devices and specialty medical equipment.
Active in FDA 510(k) submissions since 2018. Many Austria manufacturers work with FDA regulatory consultants to support U.S. market entry.