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

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    CROUP TENT FRAME

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Insightra Freedom Ventral Hernia Repair System

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

    LOW FLOW OSV II HYDROCEPHALUS VALVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 22, 2012

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/ IKARIA·Product code MRN·August 23, 2010

    Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with stopcock and extension set, and specimen vials.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·May 6, 2020

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014