8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HYSTEROSER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Arc Enterocuff
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTEX SYSTEM 6000
FDA 510(k)
FDA Class 2
·Radiology
ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 5, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 25, 2018
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·May 5, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 15, 2012
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025