BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNK

    FDA Adverse Event
    Injury ·UNK·Product code FTR·March 13, 2000

    MODULAR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

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

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·April 26, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 26, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 10, 2011

    DURAMER SLR BIPOLAR ACETABULAR SHELL LINER

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWB·March 28, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014