BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    HANSO ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450223741·

    MEDICON YASARGIL CLIP APPLYING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·March 23, 2010

    VERSA-DIAL 46X21X50 HUMERAL HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBF·October 7, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2014

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC.·Product code MIH·May 12, 2011

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·March 26, 2015

    THE ELECTRODE STORE

    FDA Adverse Event
    Malfunction ·THE ELECTRODE STORE·Product code GXZ·July 17, 2021

    QUADRA H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 18, 2026

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020