BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FIBERNET EMBOLIC PROTECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAXIM RPG PS FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

    FDA Adverse Event
    Other ·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010

    *

    FDA Adverse Event
    Malfunction ·UNK·Product code FTR·April 8, 2013

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 9, 2011

    FOGARTY EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·July 24, 2008

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·November 14, 2012

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018