43 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Reliance Cervical IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
FDA 510(k)
FDA Class 2
·Radiology
ELECSYS IGE CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 19, 2025
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·January 26, 2026
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 2, 2025
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 16, 2025
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 21, 2025
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 24, 2026
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 10, 2025
DIREXION? HI-FLO? FATHOM?-16 SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 23, 2025
DIREXION TRANSEND-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 31, 2025
DIREXION? FATHOM?-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·July 8, 2025
DIREXION? HI-FLO? TRANSEND?-18 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 14, 2026
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 4, 2026
DIREXION? FATHOM?-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 9, 2026
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2026
DIREXION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·June 5, 2025
DIREXION? FATHOM?-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 9, 2026