47 results
·
26ms
·
Sources: EU EUDAMED, US FDA
COMMUNI-CALL
FDA 510(k)
FDA Class 2
·Physical Medicine
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
FDA 510(k)
FDA Class 2
·Cardiovascular
KMD-MARK1 TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·March 14, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·August 29, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·August 28, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·April 30, 2025
LUX-DX INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·December 20, 2024
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·December 31, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·May 14, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·August 13, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·October 20, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·March 2, 2026
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·May 28, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·December 24, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·October 6, 2025
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·November 11, 2025
LUX-DX INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·November 22, 2024
LUX-DX? INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·September 26, 2025
LUX-DX INSERTABLE CARDIAC MONITOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MXD·February 6, 2025