42 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
FDA 510(k)
FDA Class 2
·Cardiovascular
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033336526·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033336533·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033336519·
ANALYST PANELS + ANALYTICAL TEST ROTOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNTHES CERVIFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 3, 2014
KYPHOPAK TRAY
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code HRX·May 24, 2021
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code HRX·November 6, 2019
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code HRX·April 5, 2021
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code HRX·July 11, 2019
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code HRX·August 31, 2019
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code HRX·March 7, 2018
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·March 19, 2013
VERSACARE BED
FDA Adverse Event
Death
·HILL-ROM INC.·Product code FNL·March 4, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 15, 2014
KYPHON XPANDER II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code HRX·May 17, 2018
1030489-2019-01511
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019
KYPHON XPANDER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code HRX·March 23, 2021
KYPHON XPANDER¿ II INFLATABLE BONE TAMP
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code HRX·August 26, 2025