14 results
·
30ms
·
Sources: EU EUDAMED, US FDA
MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
FDA Adverse Event
Injury
·BRAEMAR MANUFACTURING, LLC·Product code DSI·June 27, 2019
ER920W EVENT RECORDER
FDA Adverse Event
Other
·BRAEMAR, INC.·Product code DRG·May 19, 2011
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Recall
Terminated
·BRAEMAR, INC.·Product code DRG·May 2, 2011
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Enforcement
Class II
·Terminated·BRAEMAR, INC.·July 10, 2013
LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
FDA Adverse Event
Injury
·BRAEMAR MANUFACTURING, LLC·Product code DSI·August 29, 2019
ER920W EVENT RECORDER
FDA Adverse Event
Malfunction
·BRAEMAR MANUFACTURING, INC.·Product code DRG·January 5, 2015
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Recall
Terminated
·BRAEMAR, INC.·Product code DRG·February 24, 2012
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Enforcement
Class II
·Terminated·BRAEMAR, INC.·July 10, 2013
MCOT PATCH
FDA Adverse Event
Injury
·BIO TELEMETRY, INC. / BRAEMAR MANUFACTURING, LLC·Product code DRX·September 23, 2020
Philips Medical Systems Nederland B.V.
Authorized representative
🇳🇱 Netherlands·21 Manufacturers·1029 Devices
Albert Heiss GmbH & Co. KG
Importer
🇩🇪 Germany·3 Manufacturers
Erbe Elektromedizin GmbH
Importer
🇩🇪 Germany·5 Manufacturers
International Associates Auditing & Certification Limited
Authorized representative
🇮🇪 Ireland·46 Manufacturers·161 Devices
W2O Medizintechnik AG
Importer
🇩🇪 Germany·14 Manufacturers