BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    Data-Cyte Extend 0.8%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137341442·Reagent Red Blood Cells panel used for identifi...

    SOL-CARE SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Neurosign V4 Intraoperative Nerve Monitor

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

    HEMOSPHERE FORESIGHT MODULE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 19, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019