BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TEMPERATURE SENSING FOLEY CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SIMPLIFLOS DENTAL FLOSSER

    FDA 510(k)
    FDA Class 1 ·Dental

    M2A 38MMX48MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 16, 2014

    ASR FEMORAL IMPLANT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·December 14, 2012

    DEXTRUS 4136

    FDA Adverse Event
    Death ·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024