BEUDAMED
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    Disposable Isolation Gown

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

    HCP DICOM NET

    FDA 510(k)
    FDA Class 2 ·Radiology

    VS3

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DURATA STS OPTIM ACTIVE FIXATION

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

    MAXI SKY 440

    FDA Adverse Event
    Malfunction ·BHM MEDICAL, INC.·Product code FNG·June 17, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 12, 2013

    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