BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756389488·BODY LIFT PACK

    ENSPIRE DEBRIDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OrthoPediatrics PediFoot Deformity Corrections System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 23, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013

    QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 2, 2014

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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