22 results · 38ms · Sources: EU EUDAMED, US FDA

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Sapphire Infusion Pump

FDA 510(k)
FDA Class 2 ·General Hospital

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

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

CELL-DYN RUBY SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

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

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

CELL-DYN DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

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

UNKNOWN TRIDENT CERAMIC ACETABULAR SYSTEM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 7, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·September 15, 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