BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    IB Lab LAMA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASO Speed Lacer II Ankle Stabilizer w/Stays

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236466·

    EMORY CARDIAC TOOLBOX 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 29, 2024

    SYMMETRY DR

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

    PROFEMUR(R) XM STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·August 25, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 12, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 22, 2024

    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