BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Strados Remote Electronic Stethoscope Platform (RESP)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMAGER II ANGIOGRAPHIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    ION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 3, 2014

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·August 23, 2011

    M2A 38MM MODULAR HEAD -6MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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