7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
OXYMATIC-24
FDA 510(k)
FDA Class 2
·Anesthesiology
ENTERNAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 19, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 22, 2012
UNK COONRAD/MORREY HUMERAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDC·October 19, 2010
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025