Philips Medizin Systeme Boeblingen GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
48
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVFebruary 6, 2026
K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550October 17, 2025
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)July 2, 2024
K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-SDecember 19, 2023
K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)November 22, 2023
K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue PatAugust 22, 2023
K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMOctober 7, 2021
K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)September 30, 2021
K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550September 11, 2020
K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MXNovember 19, 2019
K190624EarlyVue VS30October 27, 2019
K182637Philips IntelliVue XDS SoftwareApril 26, 2019
K181831IntelliVue Multi-Measurement Module MMXNovember 15, 2018
K173941IntelliSpace Perinatal Rev.K.00September 10, 2018
K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream ExtSeptember 4, 2018
K180534Philips IntelliVue GuardianSoftwareJuly 16, 2018
K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionDecember 26, 2017
K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, October 6, 2017
K161767Philips IntelliVue GuardianSoftwareJanuary 27, 2017
K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue PatieJuly 1, 2016