BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EpiWatch Monitoring System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    GRAFTSAVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    TENDRIL ST

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 11, 2014

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 27, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·July 23, 2013

    PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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