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

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    GLUCOSE (HK) REAGENT (PROCEDURE NO.16)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS

    FDA 510(k)
    FDA Class 1 ·Dental

    AP01 AND AP02

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

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013

    ADJ PIN COLELT 2.0-3.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·December 28, 2010

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·July 21, 2014

    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