BEUDAMED
    14 results · 31ms · Sources: EU EUDAMED, US FDA

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    LEADS, IMPLANTABLE CARDIAC PACEMAKERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111296291·JACKSON TUBE IMPRV #8 STL

    T2 FLEXIBLE NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bluetooth blood pressure monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·ACUMED LLC·Product code HWC·January 11, 2021

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 2, 2018

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·April 30, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·January 24, 2008

    SELECTSECURE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·August 20, 2018

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 29, 2018

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 22, 2018

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 29, 2018

    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