BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    MPO Total Knee Systems MR Labeling

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Paxeon Femoral Head

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570200184·Paxeon Head, Ceramic Size 36mm S

    Signature Femoral Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215001964·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111526310·Ceramic Femoral Head, 36mm, S (-4.0 mm)

    SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIGNATURE Head - BIOLOX Delta

    FDA UDI
    AMPLITUDE SAS·03701089520799·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    ACRYSOF (R) IQ TORIC IOL CALCULATOR

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC.·Product code HQL·June 5, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023