BEUDAMED
    8 results · 23ms · 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.

    ACA BARBITURATES SCREEN/BENZODIAZEPIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Operating Room Light Handle Adapter

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

    DIRECT DIGITIZER, REGIUS MODEL 190

    FDA 510(k)
    FDA Class 2 ·Radiology

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·June 4, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 31, 2010

    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