BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    CAPSULE TENSION RING INSERTER, MODEL 7-810

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·October 2, 2024

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2014

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDD·June 3, 2013

    MEDTRONIC QUIK-COMBO

    FDA Adverse Event
    Malfunction ·MEDTRONIC PHYSIO-CONTROL·Product code MKJ·June 22, 2011

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

    AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024