BEUDAMED
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    BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040114575·Maxi-Temp HP Mixing Tips

    NEUROSIGN LARYNGEAL ELECTRODES

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

    MODIFICATION TO KIDNEY DIALYZER

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

    BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 22, 2018

    HS III PROXIMAL SEAL SYTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 4, 2013

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 31, 2014

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 27, 2011

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026