ClearanceBrief
Panels › Cardiovascular › Product code MHX · Class 2

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Regulation 870.1025

16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
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Top companies in MHX

Company510(k)sRecalls
GE Healthcare1052
Philips North America046
Ge Medical Systems Information Technologies348
Philips Medical Systems327
Spacelabs Healthcare433
Draeger Medical Systems, Inc.259
GE Healthcare Finland Oy1510
Philips Medizin Systeme Boeblingen GmbH250
Shenzhen Mindray Bio-Medical Electronics Co.230
Philips Electronics North America Corporation022
Decided510(k)Device and applicantCode
Oct 14, 2026K260676Radius VSM and Accessories
Masimo Corporation
MHX
Sep 1, 2026K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSig
GE Healthcare Finland Oy, FI
MHX
Aug 28, 2026K260343Carescape Canvas 1000; Carescape Canvas Smart Display
GE Healthcare Finland Oy, FI
MHX
Aug 20, 2026K260579Infinity® Acute Care System (IACS) – VG8.1
Draeger Medical Systems, Inc.
MHX
Aug 6, 2026K251508Telemetry Monitor (iT30, iT50)
Edan Instruments, Inc., CN
MHX
Jul 24, 2026K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Ge Medical Systems Information Technologies, Inc.
MHX
Jun 4, 2026K254209Radius VSM and Accessories
Masimo Corporation
MHX
May 29, 2026K252840M12 Telemetry System
Global Instrumentation, LLC
MHX
May 20, 2026K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 1
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Apr 24, 2026K250349Vista CMS
Shanghai Draeger Medical Instrument Co., Ltd., CN
MHX
Apr 16, 2026K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Apr 10, 2026K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S No
Shanghai Draeger Medical Instrument Co., Ltd., CN
MHX
Feb 6, 2026K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Jan 9, 2026K252589Corvair Monza
AliveCor, Inc.
MHX
Dec 17, 2025K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15);
Shenzhen Comen Medical Instruments Co.,Ltd, CN
MHX
Nov 10, 2025K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 8
Philips Medizin Systeme Böblingen GmbH, DE
MHX
Oct 17, 2025K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Sep 2, 2025K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
Philips Medizin Systeme Böblingen GmbH, DE
MHX
Jul 29, 2025K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Edan Instruments, Inc., CN
MHX
Jul 9, 2025K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Ge Medical Systems Information Technologies, Inc.
MHX
May 29, 2025K250757Radius VSM and Accessories
Masimo Corporation
MHX
May 5, 2025K242962Telemetry Monitor 5500 Release 4.0 (867232)
Philips Medizin Systeme Böblingen GmbH, DE
MHX
Aug 1, 2024K240312Infinity CentralStation Wide
Draeger Medical Systems, Inc.
MHX
Jun 28, 2024K240320Patient Monitor (RespArray)
Edan Instruments, Inc., CN
MHX
Jun 7, 2024K231010Corvair
AliveCor, Inc.
MHX
Apr 19, 2024K232962Patient Monitor (iX10, iX12, iX15)
Edan Instruments, Inc., CN
MHX
Feb 5, 2024K232694Central Monitoring System (MFM-CMS)
Edan Instruments, Inc., CN
MHX
Dec 19, 2023K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Nov 22, 2023K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Oct 17, 2023K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+
Draeger Medical Systems, Inc.
MHX
Aug 22, 2023K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Jul 6, 2023K221056ARGUS PB-3000
Schiller AG, CH
MHX
Jun 1, 2023K223498Radius VSM and Accessories
Masimo Corporation
MHX
Apr 6, 2023K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
GE Healthcare Finland Oy, FI
MHX
Feb 3, 2023K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
Philips Medizin Systeme Böblingen GmbH, DE
MHX
Dec 29, 2022K211619Multi-Parameter Patient Monitor
Shenzhen Comen Medical Instruments Co.,Ltd, CN
MHX
Dec 21, 2022K222586Mural Clinical Viewer
Ge Medical Systems Information Technologies, Inc.
MHX
Dec 20, 2022K221904EK12 V2 Algorithm
Ge Medical Systems Information Technologies, Inc.
MHX
Aug 11, 2022K220308Patient Monitor: RespArray
Edan Instruments, Inc., CN
MHX
Aug 10, 2022K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
Caf Medical Solutions, Inc.
MHX
Aug 1, 2022K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
Caf Medical Solutions, Inc.
MHX
Jul 29, 2022K220989Next Generation NetKonnect
Nihon Kohden Digital Health Solutions, Inc.
MHX
Jul 12, 2022K213799N Series Patient Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Apr 13, 2022K213363CARESCAPE B450, E-musb
GE Healthcare Finland Oy, FI
MHX
Apr 13, 2022K213336Carescape B850, E-musb
GE Healthcare Finland Oy, FI
MHX
Apr 13, 2022K213181CARESCAPE B650, E-musb
GE Healthcare Finland Oy, FI
MHX
Apr 12, 2022K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP,
Ge Medical Systems Information Technologies, Inc.
MHX
Apr 1, 2022K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Ge Medical Systems Information Technologies, Inc.
MHX
Mar 4, 2022K211900Patient Information Center iX
Philips Medizin Systeme Böblingen GmbH, DE
MHX
Feb 1, 2022K203088Infinity Acute Care System (IACS) Monitoring System
Draeger Medical Systems, Inc.
MHX

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