8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085259·
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
FDA 510(k)
FDA Unclassified
·Unknown
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 10, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 2, 2011
IN TOUCH EU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013
NA
FDA Adverse Event
Injury
·FOOTPRINT MEDICAL, INC.·Product code LJS·September 24, 2025