BEUDAMED
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    STERILE ISOLATION GOWN

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

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517346964·PRECEPT NIT K-Wire, Bevel Tip

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209114399·KIT, ROO K9 HANDLER M-FAK - BASIC - ODG

    ACUMED

    FDA UDI
    Acumed LLC·10806378046261·SL ProShot Assembly

    GORE INFINIT MESH

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

    MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2024

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 8, 2024

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·May 8, 2014

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    SPHERXII MAS DEFORMITY SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE, INC.·Product code NKB·July 31, 2013

    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 17, 2020

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    ACCOLADE SR SL MRI (Model L310)

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