49 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
FDA 510(k)
FDA Class 2
·Anesthesiology
Aurora Surgiscope System
FDA 510(k)
FDA Class 2
·Neurology
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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