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

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    SKIN MARKER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ABUSCREEN FP FOR METHAMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2014

    VICTORY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·January 9, 2013

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024