BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    HemosIL Liquid Anti-Xa

    FDA 510(k)
    FDA Class 2 ·Hematology

    KSEA SPINOSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    ATLAS PLUS HF CRT-D

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

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

    COULTER® AC*T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 12, 2013

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

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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018