BEUDAMED
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    ALIGN Radial Head System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111152078·SKLARLITE SPENCER STITCH 3 1/2

    Clear Guide SCENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOMEND

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    TEXIUM

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

    MAMMOMARK2 8 MR BIOSITE INDENT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·November 10, 2008

    16" EAGLE GRAVITY STAGE 3

    FDA Adverse Event
    STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·September 1, 2011

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

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