BEUDAMED
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    U-MID PREFILLED NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763494321·MIS Cannulated Screw, Ø10.5 x 85mm, Ø6.0mm Rod

    XN CAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 11, 2025

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013

    OLYMPUS ENDOSCOPES

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KOG·July 13, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025