BEUDAMED
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    Distal Elbow Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Sensi-Disc™ Ceftizoxime - 30 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902316238·BD BBL™ Sensi-Disc™ Ceftizoxime - 30 µg

    MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES

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

    SMARTDOP XT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·November 13, 2008

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·July 12, 2013

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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