BEUDAMED
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    The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021819·OPTYC MBT BIC -7T 0A 018 UP

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISYS 1 (U.S),ACCESSORY, NON-STERILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 1, 2011

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

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

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025