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

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    430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111068775·SKLHN METZ LAHEY SCISS CVD 8"

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100400·MELLINGER PHACO SPECULUM

    IDEAL IQ SOFTWARE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 8, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 8, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    FMsealer Open Shears. Model FM3001

    FDA Enforcement
    Class II ·Terminated·Domain Surgical, Inc.·December 7, 2016

    ProScreen 10 Panel Cup, Item No. PSCup-10M

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015