8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
INSTRUTAINER
FDA 510(k)
FDA Class 2
·General Hospital
FALL-SAFE VEST
FDA 510(k)
FDA Class 1
·General Hospital
MINIMUM ESSENTIAL MED. M0769 W/WO
FDA 510(k)
FDA Class 1
·Hematology
PRONTOSAN SOLUTION ROUND BOT."WEST" 350ML
FDA Adverse Event
Other
·B. BRAUN MEDICAL AG·Product code FRO·May 19, 2014
HUDSON ADULT HEATED WIRE CIRCUIT KIT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CBK·November 9, 2012
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·September 23, 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