BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    CT PACE CATALOG NUMBER B7950A

    FDA 510(k)
    FDA Class 2 ·Radiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709693·GC Initial™ IQ/Effect Ingot C2-M, 4 pcs. X 5g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228725261·GC Initial™ IQ/Effect Ingot C2-M, 4 pcs. X 5g

    MICRUS COURIER ENZO MICROCATHETER 0.0190

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEST KIT FOR DETECTION OF HERPES SIMPLEX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·June 26, 2014

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 12, 2010

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·December 12, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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