BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Accu-Chek Safe-T-Pro Uno Lancing Device

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

    FDR D-EVO FLAT PANEL DETECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MARK 5 NUVO (M5C5)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·November 13, 2008

    SPACEMAKER BLUNT TIP TROCAR 10MM

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GCJ·August 25, 2011

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 18, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014