28 results
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73ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
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HIPOINT 88
FDA Adverse Event
Death
·ROUTE 92 MEDICAL, INC.·Product code QJP·November 11, 2025
HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)
FDA Adverse Event
Death
·ROUTE 92 MEDICAL, INC.·Product code QJP·September 27, 2023
FULL LENGTH 070 REPERFUSION SYSTEM (FREECLIMB 70 REPERFUSION SYSTEM)
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code NRY·September 27, 2023
HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code QJP·January 12, 2024
088 ACCESS SYSTEM (HIPOINT 88)
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code QJP·February 24, 2023
HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code QJP·December 5, 2023
HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code QJP·January 12, 2024
FREECLIMB 70 REPERFUSION SYSTEM
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code NRY·March 20, 2024
FREECLIMB 70 REPERFUSION SYSTEM
FDA Adverse Event
Death
·ROUTE 92 MEDICAL, INC.·Product code NRY·February 7, 2024
FREECLIMB 70 REPERFUSION SYSTEM
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code NRY·November 11, 2024
FREECLIMB 70 REPERFUSION SYSTEM
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code NRY·November 11, 2024
070 ACCESS SYSTEM (HIPOINT 70)
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code QJP·November 8, 2024
FREECLIMB 54 REPERFUSION SYSTEM
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code NRY·April 16, 2025
BASE CAMP SHEATH SYSTEM
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code DQY·April 16, 2025
HIPOINT 88
FDA Adverse Event
Malfunction
·ROUTE 92 MEDICAL, INC.·Product code QJP·April 26, 2025
FREECLIMB 70 REPERFUSION SYSTEM
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code NRY·February 19, 2025
088 ACCESS SYSTEM
FDA Adverse Event
Death
·ROUTE 92 MEDICAL, INC.·Product code QJP·December 15, 2022
HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)
FDA Adverse Event
Death
·ROUTE 92 MEDICAL, INC.·Product code QJP·December 5, 2023
FREECLIMB 70 REPERFUSION CATHETER WITH TENZING 7
FDA Adverse Event
Injury
·ROUTE 92 MEDICAL, INC.·Product code NRY·February 24, 2026
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·January 6, 2026