Brazil FDA 510(k) Overview
Leading Brazil FDA 510(k) manufacturers include Jjgc Industria E Comercio DE Materiais Dentarios S.A., S.I.N. ? Sistema DE Implante Nacional S.A., GM Dos Reis Industria e Comercio Ltda. and 61 others.
Brazilian medical device manufacturers have submitted 182 FDA 510(k) notifications since 1990, with a 99.5% clearance rate across 64 manufacturers. Brazil's FDA-active medtech sector reflects the country's growing investment in U.S. market access, with activity in dental devices, cardiovascular equipment and diagnostic technologies.
Active in FDA 510(k) submissions since 1990. Many Brazil manufacturers work with FDA regulatory consultants to support U.S. market entry.
Search Brazil devices in FDA 510(k) database