6 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BILIRUBIN STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANGIOSCULPT PTA SCORING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Prase MIS Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
HT COMMAND
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 18, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 25, 2010
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·December 20, 2012