BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Operio

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HYPEROX 101

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    GENERATOR MODEL UNKNOWN

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·January 5, 2011

    BIOGLUE SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code MUQ·July 23, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017