BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SwishPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106173·4.1mmD x 16mmL, 4.8mmD Platform

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113881·PS-R Insert, Size 1 x 16mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123137·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 150mm

    IRON 5 X CONC REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WIENER LAB. BILIRUBINA DIRECT AA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 14, 2012

    SwishPlus Implant Intended for use in support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·March 28, 2018

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024