22 results · 25ms · Sources: EU EUDAMED, US FDA

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Thoraguard System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

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

NC QUANTUM APEX

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

SAPPHIRE M.T INFUSION PUMP - FRENCH

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

BD PHOENIX¿ AST BROTH, 4.5 ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·December 28, 2022

NC QUANTUM APEX

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

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

SAPPHIRE M.T INFUSION PUMP - GERMAN

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

SAPPHIRE M.T INFUSION PUMP - FRENCH

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

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013

RIGIDFIX CROSS PIN KIT

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MAI·July 27, 2011

CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·September 29, 2008

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