BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    GEL FLOTATION CUSHION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SUNTANNING DEVICE (SEPAR. FROM K812225)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NYLUS PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TITAN NB INFRA ZERO ANG 18CM

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·July 17, 2018

    DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES BALSTHAL·Product code KTT·May 15, 2014

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 31, 2012

    PYXIS ANESTHESIA SYSTEM (PAS)

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code BRY·August 19, 2010

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020

    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