6 results
·
29ms
·
Sources: EU EUDAMED, US FDA
HOLTER ST SYSTEM, MODEL NO. 5000-20
FDA 510(k)
FDA Class 2
·Cardiovascular
CK-1 ULTRAZYME PLUS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVOLUTION Revision CCK System
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 26, 2015