BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    BIOMICROSCOPY CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MOLECULAR ADSORBENT RECIRCULATING(MARS)

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

    EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014

    TBD

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·October 31, 2012

    PLATINUM 10 CONCENTRATOR 9153642104

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 2, 2015

    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·January 22, 2020

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    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