24 results · 26ms · Sources: EU EUDAMED, US FDA

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NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)

FDA 510(k)
FDA Class 2 ·Cardiovascular

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025

NC QUANTUM APEX?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026

LARGE CANNULATED SCREWS

FDA UDI
Smith & Nephew, Inc.·03596010064134·CANNULATED HIP PIN 95MM

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)

FDA 510(k)
FDA Class 2 ·Cardiovascular

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024

UNKNOWN SAPPHIRE PUMP

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Injury ·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026

UNKNOWN SAPPHIRE PUMP

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

SAPPHIRE M.T INFUSION PUMP - GERMAN

FDA Adverse Event
Death ·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025

ISOFLEX OPTIM LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014