Medical Device Manufacturer · NL , Best

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

8 submissions · 8 cleared · Since 2015

Recent clearances: Zenition 90, MR 5300 and MR 7700 R11 MR Systems, ClarifEye R1.0, ClarifEye Needle

Total

Cleared

Denied

Philips Medical Systems Nederlands B.V. has 8 FDA 510(k) cleared medical devices. Based in Best, NL.

Latest FDA clearance: May 2024. Active since 2015. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Philips Medical Systems Nederlands B.V. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Philips Medical Systems (Cleveland), Inc. and Regulatory Technology Services, LLC.

Philips Medical Systems Nederlands B.V. is one of 119 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Philips Medical Systems Nederlands B.V.

8 devices

1-8 of 8

MR 5300 and MR 7700 R11 MR Systems

K223442 · LNH

Radiology · 39d

Cleared Feb 23, 2021

ClarifEye R1.0, ClarifEye Needle

K201743 · OWB

Radiology · 243d

Cleared Sep 07, 2018

Philips Hemodynamic Application R1.0

K181311 · MWI

Cardiovascular · 113d

IntelliSpace Portal Platform

K162025 · LLZ

Radiology · 88d

Cleared Mar 22, 2016

Ingenia 1.5T and Ingenia 1.5T S R5.2

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: May 09, 2026

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

FDA 510(k) Regulatory Record - Philips Medical Systems Nederlands B.V.

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