7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BLEEDING TIME DEVICE DISPOSABLE
FDA 510(k)
FDA Class 2
·Hematology
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQUILION PRIME, V5.00
FDA 510(k)
FDA Class 2
·Radiology
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·May 23, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 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