42 results · 22ms · Sources: EU EUDAMED, 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