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

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    Filters Regulation: Us FDA ×

    RX 90 ACETABULAR COMPONENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERFORMAX PEDIATRIC SE TOTAL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BLEASE FOCUS ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SPACELABS MEDICAL INC.·Product code BSZ·January 17, 2013

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·December 13, 2010

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015