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

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    MENNEN BONE FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198666·AK3 Ultra Insert Trial Size 4, 11mm

    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Psoria-Shield AURORA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·November 27, 2024

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·February 4, 2026

    7.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·June 24, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 3, 2010

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 2012

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·March 13, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·September 5, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·February 11, 2025

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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