BEUDAMED
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    32HQ713D

    FDA 510(k)
    FDA Class 2 ·Radiology

    T3 Platform software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013

    Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.

    FDA Recall
    Terminated ·St. Jude Medical Inc·Product code OCL·December 9, 2008

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026