BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    BACTEC PEDS PLUS/F

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ROADRUNNER ELECTRIC SCOOTER-3 WHEELED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DDV LIGATOR

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    EVOLUTION® MP? CS INSERT SIZE 3+ 17MM RIGHT

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code HRY·December 11, 2024

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code MSS·January 16, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·December 14, 2010

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012

    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012