BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    C-DAK ARTIFICIAL KIDNEY

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

    EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

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

    PROBE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    HEARTMATE II LVAS, EUROPE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·May 6, 2014

    ASR XL TAP SLV ADAP 12/14+5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 13, 2012

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2015

    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·September 21, 2016

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018