BEUDAMED
    249 results · 21ms · Sources: EU EUDAMED, US FDA

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    Lucy Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO: POCKETVIEW ECG SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TIO2MESH TM

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

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2023

    STRYKER NAV3I(TM) PLATFORM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·October 30, 2014

    FLEXIMA¿ BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·August 16, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 9, 2013

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code PPM·November 22, 2021

    VITROS Chemistry Products COCM Reagent

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIO·October 4, 2013

    enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 28, 2011

    VITROS XT 3400 Chemistry System, Catalog No. 6844458

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS XT 7600 Integrated System, Catalog No. 6844461

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·March 20, 2019

    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023

    VITROS Immunodiagnostic Products Troponin I ES Calibrators

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023