BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHILIPS GYROVIEW-HR IMAGING WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIROTHERM HUMIDIFIER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LAPRO-CLIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GCJ·June 4, 2025

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 10, 2014

    ABC HANDPIECE LAPAROSCOPIC

    FDA Adverse Event
    Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019

    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·September 8, 2015

    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·October 10, 2019