BEUDAMED
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    HMB32 Dialysis Solution

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM

    CAREFUSION NICOLET EDX

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855

    FDA 510(k)
    FDA Class 2 ·Neurology

    CERTAIN® TITANIUM HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 16, 2021

    CERTAIN¿ TITANIUM HEXED SCREW

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code NHA·August 9, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·July 8, 2013

    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.

    FDA Enforcement
    Class II ·Terminated·Myco Medical Supplies Inc·March 6, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 13, 2022

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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