ClearanceBrief
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

Company510(k)sRecalls
Data Critical Corp.90
Datex-Ohmeda90
GE Healthcare54
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.70
Visicu, Inc.52
Philips Medical Systems60
Current Health50
Draeger Medical Systems, Inc.50
Earlysense, Ltd.40
Mindray DS USA, Inc. dba Mindray North America04
Decided510(k)Device and applicantCode
Oct 7, 2026K260075eClinics
Ceiba Healthcare US, Inc.
MSX
Sep 12, 2026K261287Digistat Care
Ascom Ums Srl Unipersonale, IT
MSX
Aug 13, 2026K260211Dashboard (P007000)
Hill-Rom, Inc.
MSX
Jul 26, 2026K261367Corsano CardioWatch 287-2 System
Corsano Health B.V., NL
MSX
Mar 30, 2026K253654IntelliVue Measurement Rack 6000 (867317)
Philips Medizin Systeme Böblingen GmbH, DE
MSX
Sep 30, 2025K243270TigerConnect Alarm Management
Tigerconnect
MSX
Jul 31, 2025K242728BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
Jun 5, 2025K242750Central Station
Nihon Kohden Digital Health Solutions, LLC
MSX
Jan 8, 2025K242842ANNE View, Central Hub
Sibel Health, Inc.
MSX
Nov 14, 2024K241397Hinscope
Hinlab Sas, FR
MSX
Jul 12, 2024K233834Infinity Gateway Suite
Draeger Medical Systems, Inc.
MSX
May 9, 2024K233418Biofourmis Everion+ (G2)
Biofourmis Singapore Pte., Ltd., SG
MSX
Mar 22, 2024K232548Corsano CardioWatch 287-2 System
Corsano Health B.V., NL
MSX
Aug 24, 2023K231506Current Health System
Current Health , Ltd., GB
MSX
Jul 31, 2023K223567CNS-2101 Central Monitor
Nihon Kohden Corporation, JP
MSX
Feb 23, 2023K213863Everion+ System
Biofourmis Singapore Pte., Ltd., SG
MSX
Nov 1, 2022K222550Current Health System
Current Health , Ltd., GB
MSX
Jun 7, 2022K203579Infinity Gateway Suite
Draeger Medical Systems, Inc.
MSX
Jun 3, 2022K211046eCareManager 4.5
Visicu, Inc.
MSX
Jun 1, 2022K220058BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
Feb 11, 2022K212622Zyter RPM
Zyter, Inc.
MSX
Dec 9, 2021K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)
Airstrip Technologies, Inc.
MSX
Sep 10, 2021K210160AlertWatch:AC
Alertwatch, Inc.
MSX
Sep 3, 2021K210133Current Health Monitoring System Gen 2 (G2)
Current Health, GB
MSX
Oct 30, 2020K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Technologies, Inc., TW
MSX
Oct 30, 2020K193421Smart Alarm Interface
Boxview, LLC
MSX
Jun 5, 2020K192952Spire Health Remote Patient Monitoring System
Spire, Inc. D/B/A Spire Health
MSX
May 21, 2020K193391BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
May 11, 2020K193043Critical Alert CommonPath Enterprise
Critical Alert
MSX
Jul 12, 2019K191272Wearable Device, Wearable Package
Current Health , Ltd., GB
MSX
Apr 26, 2019K182637Philips IntelliVue XDS Software
Philips Medizin Systeme Boeblingen GmbH, DE
MSX
Mar 27, 2019K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Current Health , Ltd., GB
MSX
Mar 13, 2019K183238BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
Nov 23, 2018K180430Digistat Smart Central
Ascom Ums Srl Unipersonale, IT
MSX
Nov 14, 2018K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Snap40, Ltd., GB
MSX
Apr 3, 2018K180566Unite Connect for Clinical Systems
Ascom Sweden AB, SE
MSX
Mar 14, 2018K173203Athena GTX Device Management Suite (ADMS) Software
Athena Gtx
MSX
Aug 3, 2017K171322eCareManager 4.1
Visicu, Inc.
MSX
Apr 20, 2017K162607BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
Sep 30, 2016K153156eCareManager 4.0.1
Visicu, Inc.
MSX
Sep 19, 2016K160862AirStrip RPM
Airstrip Technologies, Inc.
MSX
Jun 24, 2016K161164CareEvent inclusive of the CareEvent Mobile Application accessory
Philips Medical Systems
MSX
Dec 21, 2015K151672Cerner CareAware Event Management
Cerner Corporation
MSX
Aug 31, 2015K151006EarlySense Central Display Station (CDS)
Earlysense, Ltd., IL
MSX
Jul 6, 2015K150632Hypervisor IX Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MSX
Jan 30, 2015K140852VECTRAPLEX CMS
Vectracor, Inc.
MSX
Jan 15, 2015K142935CareEvent
Philips Medical Systems
MSX
Dec 12, 2014K141756INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
Draeger Medical Systems, Inc.
MSX
Dec 3, 2014K143057M3290B Philips IntelliVue Information Center iX
Philips Medical Systems
MSX
Jul 1, 2014K132036HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
MSX

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