6 results
·
25ms
·
Sources: EU EUDAMED, US FDA
KERAMAIL
FDA 510(k)
FDA Class 2
·Dental
ADVANTX AFM ANGIO SYSTEM S1808
FDA 510(k)
FDA Class 2
·Radiology
TOUCHLESS II INTERMITTENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 12, 2014
ACCU-CHEK TENDER INFUSION SET
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·December 1, 2010
GENERATOR PS100-100 PULSAR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY, LLC·Product code GEI·January 15, 2013