11 results
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46ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASCOM US, INC.
FDA registration
ASCOM US, INC.·2 products·🇺🇸 United States
ASCOM MOBILE MONITORING GATEWAY (MMG)
FDA Adverse Event
Death
·ASCOM SWEDEN AB·Product code MSX·August 20, 2018
I62
FDA Adverse Event
Malfunction
·ASCOM (US) INC.·Product code IQA·November 27, 2020
TELLIGENCE
FDA Adverse Event
Malfunction
·ASCOM (US) INC.·Product code IQA·October 5, 2018
ASCOM ALARM
FDA Adverse Event
Death
·ASCOM US, INC.·Product code MSX·August 9, 2023
ASCOM ALARM SYSTEM
FDA Adverse Event
Injury
·ASCOM US, INC.·Product code MSX·February 17, 2026
ASCOM
FDA Adverse Event
Injury
·ASCOM US, INC.·Product code MSX·January 22, 2020
Ascom Telligence Nurse Call System
FDA Recall
Open, Classified
·Ascom (US) Inc.·Product code IQA·November 2, 2018
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
FDA Recall
Terminated
·Ascom US, INC.·Product code MSX·December 10, 2015
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
FDA Enforcement
Class II
·Terminated·Ascom US, INC.·May 18, 2016
Ascom Telligence Nurse Call System
FDA Enforcement
Class II
·Ongoing·Ascom (US) Inc.·November 28, 2018