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Philips Medizin Systeme Boeblingen GmbH FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)510(k)Feb 6, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 6, 2026
IntelliVue Patient monitors MX400, MX450, MX500, MX550510(k)Oct 17, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 17, 2025
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)510(k)Jul 2, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jul 2, 2024
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)510(k)Dec 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 19, 2023
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)510(k)Nov 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2023
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)510(k)Aug 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 22, 2023
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4510(k)Oct 7, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 7, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)510(k)Sep 30, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 30, 2021

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