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

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    UNIVERSAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PENTACAM SCHEIMPFLUG CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996

    PENUMBRA SYSTEM CANISTER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code BTA·March 15, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·May 6, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 13, 2012

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018