BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALCOHOL CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209120376·KIT, TRAUMA MANAGEMENT - CUSTOM

    TruSPECT Processing Station

    FDA 510(k)
    FDA Class 2 ·Radiology

    CUTTERBOND ZINC PHOSPHATE CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·April 3, 2014

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·December 3, 2012

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·October 5, 2010

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022