28 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE Lunar DXA Bone Densitometers with enCORE version 17
FDA 510(k)
FDA Class 2
·Radiology
S 100 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GE VOLUSON E8 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 4, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·January 30, 2013
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021
TALENT STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 10, 2012
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
X SERIES
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 31, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014
CONTOUR NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 13, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 28, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 28, 2014