BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    APEX(TM) PROSTATIC BALLOON DILATION CATHETER

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

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 15, 2025

    TOCO LITE, MODEL TD-01

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IVAS 20MM (10 GAUGE) BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·January 9, 2013

    XPRT

    FDA Adverse Event
    Malfunction ·GAYMAR INDUSTRIES, INC.·Product code FNM·November 24, 2010

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 3, 2014

    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