BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    ROEKO SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983037·posteriors; shade A4; size M; lower jaw

    UNILITH 3 MODELS 7580/7583/7680/7683

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Monaco RTP System

    FDA 510(k)
    FDA Class 2 ·Radiology

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024218185·

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·February 28, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 7, 2011

    SYSTEM 6 NON STERILE BATTERY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·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