7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PREPACELL-STERILE-BONE MARROW ASPIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SleepStageML
FDA 510(k)
FDA Class 2
·Neurology
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
FDA 510(k)
FDA Class 2
·Physical Medicine
LINX REFLUS MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL INC.·Product code LEI·May 21, 2014
OVATIO
FDA Adverse Event
Malfunction
·SORIN CRM·Product code MRM·October 26, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 8, 2010
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