BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Motive™ Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AS50 INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 17, 2008

    SYMPHONY

    FDA Adverse Event
    Injury ·SORIN CRM·Product code NVZ·August 12, 2011

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·July 16, 2013

    VASSALLO GT

    FDA Adverse Event
    Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025