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

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    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEXA BONE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    CAPSUREFIX MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    JAGTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 21, 2008

    PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·March 23, 2018

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023