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

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    Radiation Planning Assistant (RPA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021142·FPS 2.7mm x 28mm Locking Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694075428·FPS 2.7 x 28mm Locking Screw Sterile Qty 5

    AUDIOTRAVELLER, MODEL AA222

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Action Trackchair Hawk

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 4, 2024

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 2, 2024

    12X150MM KII SHIELDED BLADED ACCESS SYS THREADED

    FDA Adverse Event
    APPLIED MEDICAL·Product code GCJ·July 8, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018