Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA product code MHX · 403 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1025
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1987-09-21 – 2026-09-01
MHX
2026-09-01
MHX
2026-08-28
Carescape Canvas 1000; Carescape Canvas Smart Display
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MHX
2026-08-20
Infinity® Acute Care System (IACS) – VG8.1
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MHX
2026-08-06
Telemetry Monitor (iT30, iT50)
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MHX
2026-07-24
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
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MHX
2026-06-04
Radius VSM and Accessories
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MHX
2026-05-29
M12 Telemetry System
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MHX
2026-05-20
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
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MHX
2026-04-24
Vista CMS
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MHX
2026-04-16
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
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MHX
2026-04-10
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
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MHX
2026-02-06
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
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MHX
2026-01-09
Corvair Monza
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MHX
2025-12-17
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
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MHX
2025-11-10
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
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MHX
2025-10-17
IntelliVue Patient monitors MX400, MX450, MX500, MX550
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MHX
2025-09-02
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
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MHX
2025-07-29
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
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MHX
2025-07-09
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
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MHX
2025-05-29
Radius VSM and Accessories
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MHX
2025-05-05
Telemetry Monitor 5500 Release 4.0 (867232)
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MHX
2024-08-01
Infinity CentralStation Wide
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MHX
2024-06-28
Patient Monitor (RespArray)
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MHX
2024-06-07
Corvair
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MHX
2024-04-19
Patient Monitor (iX10, iX12, iX15)
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MHX
2024-02-05
Central Monitoring System (MFM-CMS)
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MHX
2023-12-19
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
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MHX
2023-11-22
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
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MHX
2023-10-17
Infinity CentralStation Wide, Infinity M300, Infinity M300+
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MHX
2023-08-22
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
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MHX
2023-07-06
ARGUS PB-3000
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MHX
2023-06-01
Radius VSM and Accessories
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MHX
2023-04-06
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
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MHX
2023-02-03
IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
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MHX
2022-12-29
Multi-Parameter Patient Monitor
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MHX
2022-12-21
Mural Clinical Viewer
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MHX
2022-12-20
EK12 V2 Algorithm
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MHX
2022-08-11
Patient Monitor: RespArray
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MHX
2022-08-10
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
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MHX
2022-08-01
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
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MHX
2022-07-29
Next Generation NetKonnect
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MHX
2022-07-12
N Series Patient Monitors
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MHX
2022-04-13
CARESCAPE B450, E-musb
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MHX
2022-04-13
Carescape B850, E-musb
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MHX
2022-04-13
CARESCAPE B650, E-musb
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MHX
2022-04-12
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
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MHX
2022-04-01
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
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MHX
2022-03-04
Patient Information Center iX
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MHX
2022-02-01
Infinity Acute Care System (IACS) Monitoring System
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MHX
2021-12-09
Infinity Acute Care System (IACS) Monitoring Solution
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MHX
2021-10-07
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
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MHX
2021-07-16
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
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MHX
2021-01-23
Patient Monitor
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MHX
2021-01-07
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
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MHX
2020-11-04
Monitor B125, Monitor B105
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MHX
2020-09-18
Tempus Pro Patient Monitor
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MHX
2020-09-11
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
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MHX
2020-08-28
Infinity M300
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MHX
2020-06-08
ePM Series Patient monitors
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MHX
2020-05-07
Patient Monitor
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MHX
2020-04-02
Patient Monitor
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MHX
2020-03-29
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
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MHX
2020-01-29
Carescape B850
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MHX
2020-01-24
CARESCAPE B450
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MHX
2020-01-21
CARESCAPE B650
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MHX
2019-12-20
Carescape One
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MHX
2019-12-19
ZOLL Arrhythmia Management Sysyem
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MHX
2019-12-13
C50 and C80 Multi-parameter Patient Monitor
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MHX
2019-11-19
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
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MHX
2019-10-31
ePM Series Patient monitors
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MHX
2019-08-06
M3290B Patient Information Center iX
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MHX
2019-07-10
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
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MHX
2018-12-21
North-vision Multi-parameter Patient Monitor
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MHX
2018-12-10
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
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MHX
2018-11-30
ZOLL Propaq M
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MHX
2018-11-15
IntelliVue Multi-Measurement Module MMX
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MHX
2018-09-04
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
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MHX
2018-09-04
Surveyor Patient Monitor
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MHX
2018-08-16
Multi-parameter Patient Monitor, models C30
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MHX
2018-07-24
MX40 Release C.01
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MHX
2018-06-19
ViSi Mobile Monitoring System
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MHX
2018-05-11
µCor Heart Failure and Arrhythmia Management System
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MHX
2018-01-10
Tempus Pro Patient Monitor
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MHX
2017-12-08
CMS-2000 Central Monitoring System
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MHX
2017-11-15
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
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MHX
2017-11-09
MX40 Release B.07
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MHX
2017-11-01
Monitor B125, Monitor B105
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MHX
2017-10-06
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
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MHX
2017-08-23
Passport Series Patient Monitors(Passport 12m, Passport 17m)
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MHX
2017-07-07
M3290B Philips IntelliVue Information Center iX
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MHX
2017-07-06
Tempus Pro Patient Monitor
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MHX
2017-06-30
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
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MHX
2017-06-06
EK12 Algorithm
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MHX
2017-05-24
Central Monitoring System
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MHX
2017-04-04
Nihon Kohden Vital Sign Telemeter
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MHX
2017-02-03
Telemetry Transmitter
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MHX
2017-01-11
Mortara Surveyor Patient Monitor
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MHX
2016-12-22
Patient Monitor
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MHX
2016-09-02
Nihon Kohden Vital Sign Telemeter
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MHX
2016-08-04
Surveyor S4 Mobile Monitor
View details →No matching devices.
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