Medical Device Manufacturer · NL , Best

Philips Medical Systems Nederland B.V. - FDA 510(k) Cleared Devices

106 submissions · 105 cleared · Since 2005

Recent clearances: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T, dS FootAnkle 16Ch 1.5T, Multimodality Simulation Workspace (MM Sim) (v1.0.0)

106

Total

105

Cleared

Denied

Philips Medical Systems Nederland B.V. has 105 FDA 510(k) cleared radiology devices. Based in Best, NL.

Latest FDA clearance: Jul 2026. Active since 2005.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Qsite, Philips Medical Systems (Cleveland), Inc. and Underwriters Laboratories, Inc.. 1 device has linked clinical trial registered on ClinicalTrials.gov.

Philips Medical Systems Nederland B.V. is one of 68 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.