BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    IGI-SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MDU5 PLUS STERILE BAG

    FDA 510(k)
    FDA Class 2 ·Radiology

    EPIC VR

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

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·August 25, 2011

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 12, 2013

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    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