BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    Tablo Hemodialysis System, Tablo Cartridge

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

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705742·Hayden Mallet 7-1/2" (18.8cm), 7.5oz. (213 gram...

    BONGROS HA

    FDA 510(k)
    FDA Class 2 ·Dental

    UROSTATION 3D PROSTATE SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code ETN·November 7, 2013

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 8, 2011

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 26, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 24, 2008

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 8, 2022

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 28, 2022

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018