BEUDAMED
    18 results · 17ms · Sources: EU EUDAMED, US FDA

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    TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S8 ESCAPE II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SOFTWARE(R) PLUS

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·9IBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SOFTWARE(R) PLUS

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·9IBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE

    BABY FX OXY W/HR & ART FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION·Product code DTZ·April 3, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code JOR·October 13, 2010

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012

    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