BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    TECA MODEL B9 ELECTROMYOGRAPH

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AVIATOR TRANSPORT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FIREFLY® Pedicle Screw Navigation Guide

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PATELLA CALIPER

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012

    THREE PEG PATELLA

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·July 28, 2010

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code LXH·January 24, 2024

    Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022