BEUDAMED
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    ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517203830·Archon Screw, 4.0x18mm Self-Drill Var

    CANNULAE, PLASTIC DISPOSABLE NASAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 16, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 16, 2013

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·June 12, 2007

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·October 5, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 3, 2014

    ACCOLADE SR SL MRI (Model L310)

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