11 results
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68ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARDIAC INSIGHT, INC.
FDA registration
CARDIAC INSIGHT, INC.·3 products·🇺🇸 United States
Cardea SOLO
FDA UDI
CARDIAC INSIGHT, INC.·10857553006112·Cardea SOLO Wearable Sensor (M300)
Cardea 20/20 ECG
FDA UDI
CARDIAC INSIGHT, INC.·00857553006016·Cardea 20/20 ECG is a portable ECG recorder des...
Cardea SOLO
FDA UDI
CARDIAC INSIGHT, INC.·00857553006139·Cardea SOLO PC Software - ECG analysis software...
Stealth System S300
FDA UDI
CARDIAC INSIGHT, INC.·00857553006092·StealthView Software & Smart Cable - ECG analys...
Stealth System S300
FDA UDI
CARDIAC INSIGHT, INC.·20857553006072·Stealth System Wearable Sensor (M300).
CardeaScreen
FDA UDI
CARDIAC INSIGHT, INC.·00857553006009·CardeaScreen is a portable ECG recorder designe...
Cardea SOLO
FDA UDI
CARDIAC INSIGHT, INC.·10857553006129·Cardea SOLO Analysis Package - ECG analysis sof...
CARDEA SOLO
FDA Adverse Event
Injury
·CARDIAC INSIGHT, INC.·Product code DSH·December 14, 2023
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·August 29, 2022
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·January 21, 2025