6 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Concentriq Dx
FDA 510(k)
FDA Class 2
·Pathology
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
FDA 510(k)
FDA Class 2
·Microbiology
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTL·October 28, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 26, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013