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

DateFirm and productCodeLinked 510(k)
Apr 15, 2025Baxter Healthcare Corporation
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11)
Open, Classified
MHXK171621
Apr 14, 2025Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor (CVSM):
Open, Classified
MHXK171621
Feb 5, 2025Philips North America Llc
IntelliVue Patient Monitor MX550. Model Number: 866066
Open, Classified
MHXK082583
Feb 5, 2025Philips North America Llc
IntelliVue Patient Monitor MX500. Model Number: 866064
Open, Classified
MHXK082583
Feb 5, 2025Philips North America Llc
IntelliVue Patient Monitor MX450. Model Number: 866062
Open, Classified
MHXK082583
Feb 5, 2025Philips North America Llc
IntelliVue Patient Monitor MX400. Model Number: 866060
Open, Classified
MHXK082583
Feb 5, 2025Philips North America Llc
IntelliBridge EC10 Module. Model Number: 865115
Open, Classified
MHXK082583
Jan 30, 2025Draeger Medical Systems, Inc.
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical
Open, Classified
MHXK151860
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Open, Classified
MHXK141156
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Open, Classified
MHXK141156
Dec 17, 2024Philips North America Llc
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Open, Classified
MHXNone listed
Oct 4, 2024Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3)
Open, Classified
MHXK130849
K131872
Sep 30, 2024Philips North America Llc
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Open, Classified
MHXK153702
Sep 25, 2024Philips North America
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Open, Classified
MHXK130849
K131872
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified
MHXK130849
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified
MHXK130849
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to gen
Open, Classified
MHXK130849
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified
MHXK130849
Jun 25, 2024Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Open, Classified
MHXK203088
Jun 21, 2024GE Healthcare Finland Oy
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2
Open, Classified
MHXK191149
K213181
Jun 21, 2024GE Healthcare Finland Oy
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01
Open, Classified
MHXK191149
K213181
Jun 21, 2024GE Healthcare Finland Oy
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 55
Open, Classified
MHXK191323
K213336
Jun 21, 2024GE Healthcare Finland Oy
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Open, Classified
MHXK223531
Jun 21, 2024GE Healthcare Finland Oy
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-0105
Open, Classified
MHXK223531
Jun 6, 2024Nihon Kohden America Inc
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs
Open, Classified
MHXNone listed
May 15, 2024Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Open, Classified
MHXK153702
Apr 25, 2024Philips North America Llc
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Elec
Open, Classified
MHXK153702
Mar 27, 2024Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Open, Classified
MHXK153702
Jan 13, 2024Philips North America
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Open, Classified
MHXK153702
K161164
Jan 13, 2024Philips North America
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Open, Classified
MHXK153702
K161164
Sep 29, 2023GE Medical Systems China Co., Ltd.
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Open, Classified
MHXK223531
Sep 21, 2023Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Open, Classified
MHXK201746
Sep 19, 2023Philips North America Llc
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 8
Open, Classified
MHXK153702
Apr 27, 2023Draeger Medical Systems, Inc.
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity pat
Open, Classified
MHXK200859
Apr 27, 2023Draeger Medical Systems, Inc.
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Open, Classified
MHXK151860
Apr 1, 2023Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital
Open, Classified
MHXK201746
Dec 19, 2022GE Medical Systems, LLC
B125M Patient Monitor, REF 6160000-005-XXXXXXX
Open, Classified
MHXK213490
Dec 19, 2022GE Medical Systems, LLC
B125M Patient Monitor, REF 6160000-004-XXXXXX
Open, Classified
MHXK213490
Dec 19, 2022GE Medical Systems, LLC
B105M Patient Monitor, REF 6160000-003
Open, Classified
MHXK213490
Dec 19, 2022GE Medical Systems, LLC
B125P Patient Monitor (with E-module slot option), REF 6160000-002
Open, Classified
MHXK213490
Dec 19, 2022GE Medical Systems, LLC
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
Open, Classified
MHXK213490
May 31, 2022Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
Open, Classified
MHXK141156
Mar 4, 2022Draegar Medical Systems, Inc.
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Open, Classified
MHXK130711
Jul 23, 2021GE Healthcare, LLC
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Open, Classified
MHXK071073
May 25, 2021Remote Diagnostic Technologies Ltd.
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a t
Open, Classified
MHXK201746
Mar 23, 2021Philips North America, LLC
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare envir
Terminated
MHXK123900
Feb 10, 2021Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient
Open, Classified
MHXK093788
K113798
Aug 4, 2020GE Healthcare, LLC
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple
Terminated
MHXK200494
Jun 30, 2020Philips North America, LLC
IntelliVue MX700 patient monitor, model no. 865241
Terminated
MHXK150310
Jun 30, 2020Philips North America, LLC
IntelliVue MX800 patient monitor, model no. 865240
Terminated
MHXK150310

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