51 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ebony PTA 0.014 RX Peripheral Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
FDA 510(k)
FDA Class 2
·Hematology
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973257·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973301·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970041·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970065·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970058·
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970805·
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