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

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    Orthex External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Glidewell TuffSplint™ Appliance Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    Moda-flx Hemodialysis System and Cartridge

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    ALLOFIT-S IT ALLOCLASSIC SHELL, 52/II

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWB·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    PKG, 5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM, P/N 0250080586 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025