BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    XN-L CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENZYME IMMUNOASSAY, VANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VENUS FREEZE SYSTEM

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

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·June 10, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 6, 2011

    MTOME ST HOLSTER/CABLES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·September 11, 2008

    ROOT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·September 20, 2018

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code SFI·April 15, 2026

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012