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

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    Vivo 45 LS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 19, 2023

    SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IOS FASTSCAN SPRAY

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 27, 2013

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 14, 2011

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012