7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SENTEC LASER GUIDE LINE, MODEL SGL-05
FDA 510(k)
FDA Class 2
·Radiology
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stomach Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·March 19, 2015
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code BRZ·December 10, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 23, 2015