BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    NEUTRAL BUFFERED FORMALIN 10%

    FDA 510(k)
    FDA Class 1 ·Pathology

    Tryptik Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 23, 2014

    LUMAX 540 VR-T

    FDA Adverse Event
    Death ·BIOTRONIK SE & CO. KG·Product code MRM·November 5, 2012

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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