7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BARRIER SURGICAL HOOD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
U&U Enteral Syringe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
DUROM ACETABULAR COMPONENT 56/50 CODE P
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 7, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2012
BIPOLAR LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 14, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025