BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    SERIM DISINTEK OPA TEST STRIP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SQA, SPERM QUALITY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 8, 2021

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 18, 2025

    2520274-2013-02248

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 29, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 9, 2011

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH W/VAMP PLUS SYSTEM

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

    LGC TIBIAL FIT TRAY CEM SZ 4F / 5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 24, 2024

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    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