BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    TRANSPARENT ADHESIVE DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IN-LINE ATS BLOOD RECOVERY BAG

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TECHNICON CHEM 1 PLASMA GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 20, 2015

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·December 10, 2010

    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

    FDA Recall
    Terminated ·Lansinoh Laboratories Inc·Product code IME·August 14, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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