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

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    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517204349·Archon Screw, 4.5x19mm Self-Tap Fixed

    PRISMAFLEX M150 SET

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

    HARRIER-SA™ Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·October 5, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 7, 2014

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 19, 2015

    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