15 results · 21ms · Sources: EU EUDAMED, US FDA

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Waterlase Express

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

THERMODILUTION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 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

SAPPHIRE M.T INFUSION PUMP - FRENCH

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

ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 14, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

LONG GAMMA NAIL, RIGHT 11X340 MM X135

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·September 15, 2008

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017