7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIVERSAL TWO-PIECE MACHINES
FDA 510(k)
FDA Class 2
·Anesthesiology
PERFSCAPE
FDA 510(k)
FDA Class 2
·Radiology
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
FDA 510(k)
FDA Class 2
·Cardiovascular
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Malfunction
·DEPUY INTL., LTD. - 8010379·Product code KWA·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2010
ANKLE FUSION PLATE, LATERAL TTC
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·July 22, 2020