BEUDAMED
    8 results · 36ms · Sources: EU EUDAMED, US FDA

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    NIFA NON INVASIVE FLUTTER ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PREG-BETA ONE HOUR TUBE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMPULSE TBC ASSAY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NRG TRANSSEPTAL NEEDLE

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·December 29, 2020

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 12, 2014

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·November 2, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 23, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015