Medical Device Manufacturer · NL , Best

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

103 submissions · 102 cleared · Since 2005
103
Total
102
Cleared
1
Denied
FDA 510(k) Regulatory Record - Philips Medical Systems Nederland B.V. Cardiovascular ✕
4 devices
1-4 of 4
Cleared Oct 24, 2025
LumiGuide Equipment R2.1
K252645 · DQK
Cardiovascular · 64d
Cleared Mar 14, 2024
LumiGuide Wire
K233853 · DQK
Cardiovascular · 100d
Cleared Jun 08, 2023
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
K223918 · DQK
Cardiovascular · 161d
Cleared Oct 24, 2018
KODEX EPD System
K180940 · DQK
Cardiovascular · 197d
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