50 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CARTO ENT System
FDA 510(k)
FDA Class 2
·Neurology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103814·2.8 mm X 230 mm Smooth Guide Wire
OsteoMed
FDA UDI
OSTEOMED LLC·00842528109991·2.8mm x 230mm Smooth Guide Wire, Sterile, 2 Pk
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
FDA 510(k)
FDA Class 1
·Dental
SYSTEMS INTEGRATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
DIREXION HI-FLO FATHOM-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 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