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

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    TwinScan 808/755 Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECSYS IGE CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 24, 2016

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 11, 2014

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·August 4, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PKL·September 16, 2021

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018