7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
IV START KIT
FDA 510(k)
FDA Class 2
·General Hospital
WILCOR-XR RP-L MEDICAL FILM
FDA 510(k)
FDA Class 1
·Radiology
RIFAMPIN DISC
FDA 510(k)
FDA Class 1
·Microbiology
AMNISURE
FDA Adverse Event
Death
·AMNISURE INTERNATIONAL LLC·Product code NQM·May 28, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 12, 2012
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 15, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015