7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EEG NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 11, 2015
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 3, 2014
LINOX SD 60/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG.·Product code LWS·December 13, 2010
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 29, 2013