Philips Medizin Systeme Boeblingen GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Philips Medizin Systeme Boeblingen GmbH - FDA 510(k) Cleared Devices
Recent clearances: IntelliVue Multi-Measurement Module X3 (867030), IntelliVue Patient monitors MX400, MX450, MX500, MX550, Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
48
Total
48
Cleared
0
Denied
Philips Medizin Systeme Boeblingen GmbH has 48 FDA 510(k) cleared cardiovascular devices. Based in B?blingen, DE.
Latest FDA clearance: Feb 2026. Active since 2004.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Philips Medizin Systeme Boeblingen GmbH
48 devices
Cleared
Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
Cardiovascular
162d
Cleared
Oct 17, 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
Cardiovascular
186d
Cleared
Jul 02, 2024
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal...
Obstetrics & Gynecology
258d
Cleared
Dec 19, 2023
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850...
Cardiovascular
194d
Cleared
Nov 22, 2023
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement...
Cardiovascular
264d
Cleared
Aug 22, 2023
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450...
Cardiovascular
265d
Cleared
Oct 07, 2021
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850,...
Cardiovascular
195d
Cleared
Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
Cardiovascular
77d
Cleared
Sep 11, 2020
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
Cardiovascular
401d
Cleared
Nov 19, 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550,...
Cardiovascular
389d
Cleared
Oct 27, 2019
EarlyVue VS30
Cardiovascular
230d
Cleared
Apr 26, 2019
Philips IntelliVue XDS Software
Cardiovascular
214d
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