BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    SATO FAMILY FIRST AID KIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CARDIOQ, MODEL 9051-7005

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BK-1426-00-01 STONYBROOK/HI-WALL PLATE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    8CM ANGLE ATTACHMENT, BLACK, MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 26, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 16, 2007

    ARIS TRANS OBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·November 14, 2012

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code QHT·April 13, 2021

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017