BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201

    FDA 510(k)
    FDA Class 2 ·Neurology

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983072·posteriors; shade C1; size XL; upper jaw

    DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EndoFLIP System

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

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·February 28, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 4, 2011

    QUANTUM? MAVERICK?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 6, 2014

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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