50 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
FDA 510(k)
FDA Class 2
·Hematology
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
FDA 510(k)
FDA Class 2
·Radiology
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 23, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·May 8, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 25, 2026
DXTEND GLENOSPHERE ECC D38MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·March 6, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·January 27, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code KRG·August 8, 2014
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 27, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 13, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 30, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 22, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 22, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 20, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 30, 2026
HEART LUNG MACHINE
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·August 13, 2025
HEART LUNG MACHINE
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·August 13, 2025
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·December 1, 2025
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·December 22, 2025