10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EMIT ST URINE ETHYL ALCOHOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776001438·Malleable Swivel aluminum
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209134434·
ProSeal Injector Plus (Model no. 421050)
FDA 510(k)
FDA Class 2
·General Hospital
MICRODERM, MODEL/VERSION 3.5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWER LOC
FDA Adverse Event
Malfunction
·BARD·Product code FPA·May 23, 2014
MYNX CADENCE VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·June 20, 2012
UTERINE ARTERY EMBOLIZATION
FDA Adverse Event
Injury
·Product code NAJ·September 14, 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