BEUDAMED
    4 results · 13ms · Sources: EU EUDAMED, US FDA

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    ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Enforcement
    Class I ·Terminated·BERLIN HEART GMBH·May 31, 2023

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Recall
    Terminated ·BERLIN HEART GMBH Wiesenweg 10 Berlin Germany·Product code DSQ·May 18, 2018

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020