BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    FEMORAL HEMI-HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·January 23, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    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