BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE

    FDA 510(k)
    FDA Class 1 ·Dental

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080945·Tap 4.0mm (for 4.5mm Screw)

    Electronic Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·September 21, 2009

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·December 14, 2009

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·January 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 2, 2010

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    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

    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