BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    VERO CELLS

    FDA 510(k)
    FDA Class 1 ·Hematology

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094183411·Eye Shield Metal

    OPTION A02 MODEL 15202A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Single Use Hemoclips

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

    EARLYVUE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQA·December 16, 2020

    EARLYVUE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQA·August 25, 2020

    EARLYVUE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQA·August 25, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 15, 2012

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015