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

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    MULTICHEM ENZYMATIC CHOLESTEROL SYS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES

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

    MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    AMS INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code JCW·November 9, 2012

    ENDOPATH XCEL BLUNT TIP TROCAR

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

    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