BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    AMR RESEARCH TONOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTO REFRACTOMETER NR-1000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·December 10, 2012

    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