9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
WESTERMAN-JENSEN BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131921·
EASYSTIM TN28_OTC
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO GEO STRUCTURE
FDA 510(k)
FDA Class 2
·Orthopedic
ADMIRAL XTREME PTA BALLOON CATHETER
FDA Adverse Event
Injury
·INVATEC SPA·Product code LIT·May 30, 2014
CAPIOX FX OXYGENATOR W/O RESERVOIR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 13, 2012
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·September 21, 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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018