Austria FDA 510(k) Overview
Leading Austria FDA 510(k) manufacturers include W&H Dentalwerk Buermoos GmbH, G.Tec Medical Engineering GmbH, Med-El Elektromedizinische Geraete GmbH and 40 others.
Austrian medical device manufacturers have submitted 99 FDA 510(k) notifications since 1993, achieving a 97% clearance rate across 43 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 1993. Many Austria manufacturers work with FDA regulatory consultants to support U.S. market entry.
Search Austria devices in FDA 510(k) database