BEUDAMED
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    iPhysio® System

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102763·DODICK-KAMMANN CHOPPER ANGLED 1.5MM

    GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Unclassified ·Unknown

    MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REFLEXION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DRF·October 31, 2008

    SITTER SELECT ALARM

    FDA Adverse Event
    Injury ·J. T. POSEY COMPANY·Product code KMI·August 26, 2011

    HUBER PLUS

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC.·Product code FPA·July 8, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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