22 results
·
39ms
·
Sources: EU EUDAMED, US FDA
FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·October 17, 2024
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENSITE VERISMO SEGMENTATION TOOL V.2.0
FDA 510(k)
FDA Class 2
·Radiology
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 21, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 2, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 27, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 10, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 6, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 25, 2025
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 13, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·June 13, 2011
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 28, 2025
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 2, 2026