BEUDAMED
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    M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010104311·4.0MM FULLY THREADED CANNULATED ...

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006781·Antrum Curette, 7mm x 11mm

    6203

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIVIX-S WIRELESS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 6, 2008

    USA ELITE SYSTEM SERIES ROLLER BALL ELECTRODE

    FDA Adverse Event
    Other ·GYRUS ACMI, INC·Product code GEI·August 10, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    POPULAR PLASTICS·Product code IKX·July 12, 2013

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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