7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
GLUCOSE-HK TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MARK IV FLOATATION THERAPY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELITE MPX
FDA Adverse Event
Injury
·Product code GEX·June 20, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 28, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 30, 2010
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020