BEUDAMED
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    CREED™ Cannulated Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMO-STREAM HEMODIALYSIS CATHETER SET

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

    MALLEABLE TIP ENDOSCOPIC APPLICATOR

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

    ISOFLEX S

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

    PENUMBRA SYSTEM SEPARATOR 032

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·August 18, 2011

    APEX KNEE SYSTEM

    FDA Adverse Event
    Injury ·OMNLIFE SCIENCE, INC·Product code JWH·July 10, 2013

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

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