7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LYSING REAGENT
FDA 510(k)
FDA Class 1
·Hematology
One-Fil
FDA 510(k)
FDA Class 2
·Dental
GE LOGIQ 7, MODEL 2354858
FDA 510(k)
FDA Class 2
·Radiology
PLUM A + DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 7, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code NEP·November 14, 2012
BOSTON SCIENTIFIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC, CORP. HEADQUARTERS·Product code KNY·September 7, 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