BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    ROTAPRO Rotational Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATHASSIST LIGHT FIBER

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

    G4 SLEEVED NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC SURGICAL TISSUE VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·July 8, 2022

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 3, 2014

    HI-TORQUE ADVANCE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·August 23, 2011

    APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·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