BEUDAMED
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    BSM 21 BLOOD SAFETY MODULE

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

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575386451·Rotational Knee Joint Prosthesis,with anti-luxa...

    CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER

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

    Quantitative Electrocardiographic Detector (QED 2000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRI TS BASEPLATE SIZE 3

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·June 5, 2014

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·November 12, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·September 29, 2010

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024