BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    Zoupure Nitrile Powder Free Examination glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LATEX EXAMINATION GLOVES (POWDERED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·November 3, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·August 23, 2011

    HEART START MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 25, 2013

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025