448 results
·
68ms
·
Sources: EU EUDAMED, US FDA
BERLIN HEART, INC.
FDA registration
BERLIN HEART, INC.·1 product·🇺🇸 United States
BERLIN HEART EXCOR PEDIATRIC VAD
FDA Adverse Event
Injury
·BERLIN HEART GMBH·Product code DSQ·September 27, 2018
EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·February 23, 2018
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·February 8, 2018
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·April 26, 2018
EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·November 8, 2018
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·December 21, 2018
EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·November 8, 2018
BERLIN HEART IKUS STATIONARY DRIVING UNIT
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·April 15, 2019
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·February 8, 2018
EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·June 19, 2018
BERLIN HEART EXCOR PEDIATRIC VAD
FDA Adverse Event
Death
·BERLIN HEART GMBH·Product code DSQ·June 3, 2019
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·November 28, 2018
EXCOR BLOOD PUMP PU VALVES 30ML IN/OUT Ø9MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·March 16, 2016
EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·May 21, 2018
EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·February 15, 2018
EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·June 11, 2018
EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·May 2, 2019
EXCOR BLOOD PUMP PU VALVES,30 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·June 3, 2019
EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·April 8, 2019