BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOAM RING PORT PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERAMAGE UP

    FDA 510(k)
    FDA Class 2 ·Dental

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    UNKNOWN DEPUY GMV SMARTSET CEMENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NDN·December 7, 2012

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010

    REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    FDA Recall
    Terminated ·Allergan PLC·Product code LPN·December 29, 2020

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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