BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Solanas® Posterior OCT Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776178710·Hern Ovum Fcp Lrg

    ARTERIAL LINE SET 2.5F, 22G, 5CM

    FDA Adverse Event
    Injury ·COOK MEDICAL·Product code DQY·December 26, 2017

    70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 26, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011

    SUBDURAL ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016