BEUDAMED
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    JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE

    iFUSE Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code FGE·September 26, 2012

    SPECTRUM INFUSION PUMP

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 14, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

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