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

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    INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHASIX-HIGH FREQUENCY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    GAINOR MEDICAL SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 18, 2014

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 19, 2010

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ILJ·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024