BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.

    FDA Enforcement
    Class II ·Terminated·Argo Medical Technologies Ltd·May 19, 2021

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Enforcement
    Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024

    Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.

    FDA Enforcement
    Class II ·Terminated·S.A.E. AFIKIM·November 6, 2013