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Panels › Cardiovascular › Product code MSX · Class 2

System, Network And Communication, Physiological Monitors

Regulation 870.2300

5510(k)s in 12 months (121 all time)
3recalls in 12 months (23 all time)
22recalls that name a 510(k)
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Top companies in MSX

DateFirm and productCodeLinked 510(k)
Oct 7, 2026Mindray DS USA, Inc.
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Open, Classified
MSXK242728
Oct 7, 2026Mindray DS USA, Inc.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Open, Classified
MSXK242728
Dec 12, 2025Mindray DS USA, Inc. dba Mindray North America
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version:
Open, Classified
MSXK220058
Mar 27, 2024Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Open, Classified
MSXK161164
Jan 3, 2022Philips North America Llc
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use
Terminated
MSXNone listed
May 27, 2021Mindray DS USA, Inc. dba Mindray North America
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with
Terminated
MSXK193391
Feb 22, 2021Mindray DS USA, Inc. dba Mindray North America
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 0
Open, Classified
MSXK193391
Jan 25, 2018Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Mod
Terminated
MSXK141156
Sep 28, 2017Philips Electronics North America Corporation
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Terminated
MSXK031187
K040404 +4
Jul 14, 2017Mindray DS USA, Inc. dba Mindray North America
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Terminated
MSXK150632
Jan 4, 2016Vidco, Inc.
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is
Terminated
MSXK972880
Dec 10, 2015Ascom US, INC.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Terminated
MSXK111215
Dec 10, 2015Visicu, Inc.
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either di
Terminated
MSXK001972
K012171
Feb 11, 2013Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgra
Terminated
MSXK080192
Jan 3, 2013Mindray DS USA, Inc. d.b.a. Mindray North America
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network dev
Terminated
MSXK080192
Apr 27, 2012Visicu, Inc.
Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinica
Terminated
MSXK001972
K012171
Aug 12, 2010Ge Healthcare, Llc
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers i
Terminated
MSXK052972
Sep 4, 2009GE Medical Systems, LLC
Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monito
Terminated
MSXK070421
Apr 6, 2009GE Healthcare
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finl
Terminated
MSXK052972
Nov 5, 2008GE Healthcare
GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB05 software. GE Healthcare 8200 West Tower Avenue, Milwaukee, WI 53223 Mobile
Terminated
MSXK061994
Jun 24, 2008GE Healthcare
S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.
Terminated
MSXK052972
Jul 20, 2004Datascope Corp
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
Terminated
MSXK993531
Jul 20, 2004General Electric Medical Systems Information Technology
PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
Terminated
MSXK020524

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