BEUDAMED
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    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BICON, LLC

    FDA registration
    BICON, LLC·18 products·🇺🇸 United States

    NEUROEPG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

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

    NOVOPEN ECHO

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S - DEVICE MANUFACTURING AND SOURCI·Product code FMF·October 31, 2014

    TENDRIL ST

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

    POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·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