FDA 510(k) Medical Device Manufacturers - Netherlands

Leading Netherlands FDA 510(k) manufacturers include Philips Medical Systems Nederland B.V., Cavex Holland BV, Pie Medical Imaging BV and 65 others.

Dutch medical device manufacturers have submitted 297 FDA 510(k) notifications since 1998, with a 99.3% clearance rate across 68 manufacturers. The Netherlands medtech sector is active in imaging systems, radiation therapy devices, clinical diagnostics and software-based medical devices, supported by a well-developed regulatory affairs ecosystem.

Active in FDA 510(k) submissions since 1998. Many Netherlands manufacturers work with FDA regulatory consultants to support U.S. market entry.