Company ยท DE
Philips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 25 |
| HGM | System, Monitoring, Perinatal | 7 |
| DQA | Oximeter | 3 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DSJ | Alarm, Blood-Pressure | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2026 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Oct 17, 2025 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jul 2, 2024 | K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Dec 19, 2023 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX- Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Nov 22, 2023 | K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Aug 22, 2023 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 ( Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Oct 7, 2021 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Sep 30, 2021 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) Philips Medizin Systeme Boeblingen GmbH, DE | DXJ |
| Sep 11, 2020 | K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Nov 19, 2019 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliV Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Oct 27, 2019 | K190624 | EarlyVue VS30 Philips Medizin Systeme Boeblingen GmbH, DE | DSJ |
| Apr 26, 2019 | K182637 | Philips IntelliVue XDS Software Philips Medizin Systeme Boeblingen GmbH, DE | MSX |
| Nov 15, 2018 | K181831 | IntelliVue Multi-Measurement Module MMX Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Sep 10, 2018 | K173941 | IntelliSpace Perinatal Rev.K.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Sep 4, 2018 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jul 16, 2018 | K180534 | Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boeblingen GmbH, DE | DXJ |
| Dec 26, 2017 | K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH, DE | CCK |
| Oct 6, 2017 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extensio Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jan 27, 2017 | K161767 | Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boeblingen GmbH, DE | DXJ |
| Jul 1, 2016 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jul 17, 2015 | K151681 | IntelliVue Patient Monitor Philips Medizin Systeme Boeblingen GmbH, DE | DSI |
| Jun 25, 2015 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliV Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| May 13, 2015 | K150310 | IntelliVue Patient Monitor Philips Medizin Systeme Boeblingen GmbH, DE | DSI |
| Nov 26, 2013 | K131913 | INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC Philips Medizin Systeme Boeblingen GmbH, DE | DRG |
| Apr 12, 2013 | K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO Philips Medizin Systeme Boeblingen GmbH, DE | BZQ |
| Aug 29, 2012 | K122439 | INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jul 26, 2010 | K100420 | PHILIPS OBTRACEVUE MODEL SW REV. G.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Feb 17, 2010 | K092028 | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Oct 14, 2008 | K081793 | PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Aug 29, 2008 | K081937 | PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE Philips Medizin Systeme Boeblingen GmbH, DE | DQA |
| May 28, 2008 | K081203 | OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Nov 20, 2006 | K063315 | INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Sep 6, 2006 | K062392 | PHILIPS MP5 INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Aug 24, 2006 | K062137 | MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Aug 14, 2006 | K061610 | PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Feb 17, 2006 | K060221 | THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Jan 10, 2006 | K053522 | PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Dec 30, 2005 | K052795 | PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Nov 17, 2005 | K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. Philips Medizin Systeme Boeblingen GmbH, DE | DQA |
| Nov 2, 2005 | K052801 | INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Sep 14, 2005 | K051366 | PICONIBP OEM MODULE Philips Medizin Systeme Boeblingen GmbH, DE | DXN |
| Jul 1, 2005 | K051106 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH, DE | DXN |
| Apr 22, 2005 | K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Feb 11, 2005 | K050141 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Oct 15, 2004 | K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A Philips Medizin Systeme Boeblingen GmbH, DE | DQA |
| Jun 4, 2004 | K041235 | PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Apr 29, 2004 | K040917 | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B Philips Medizin Systeme Boeblingen GmbH, DE | CBQ |
| Mar 1, 2004 | K040304 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||