Austria FDA 510(k) Overview
Leading Austria FDA 510(k) manufacturers include W&H Dentalwerk Buermoos GmbH, Med-El Elektromedizinische Geraete GmbH, Med-El Elektromedizinische Ger?te GmbH and 28 others.
Austrian medical device manufacturers have submitted 76 FDA 510(k) notifications since 1998, achieving a 97.4% clearance rate across 31 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 1998. Many Austria manufacturers work with FDA regulatory consultants to support U.S. market entry.