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

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    Vent-Os Sinus Dilation family

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HEALTHTRACKER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 10, 2013

    KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPT

    FDA Adverse Event
    Malfunction ·MERIT CABLES, INC·Product code MLN·September 8, 2008

    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 4, 2018

    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