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

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    Lucitone Digital Print Denture™ System

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTISTRAND, MODEL 1032S

    FDA 510(k)
    FDA Class 2 ·Radiology

    Biomet Microfixation OmniMax MMF System

    FDA 510(k)
    FDA Class 2 ·Dental

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code FSA·November 11, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 12, 2011

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 23, 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