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

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    C50

    FDA 510(k)
    FDA Class 2 ·Dental

    PERLA® TL Posterior Osteosynthesis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KGE·April 4, 2017

    RIATA ST OPTIM ACTIVE FIXATION

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

    RADIAL JAW 4 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·August 25, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 12, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 15, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 1, 2023

    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