7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DIDECO-SHILEY UNIVERSAL Y
FDA 510(k)
FDA Class 2
·Anesthesiology
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
FDA 510(k)
FDA Class 2
·Hematology
CORDIA IC
FDA 510(k)
FDA Class 2
·Immunology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 23, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 3, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 9, 2010
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009