BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    SURGICAL DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690126560·Modular Knee Stem Pilot 19mm x 150mm

    CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·January 25, 2021

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code MXC·January 13, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 31, 2013

    RHEUMATOID FACTOR TEST SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC.·Product code DHR·June 25, 2011

    COBAS® SARS-COV-2 ¿ 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·April 27, 2022

    COVEREDGE? 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 23, 2025

    COBAS® SARS-COV-2 - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·February 15, 2022

    COBAS® SARS-COV-2 - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·January 6, 2022

    COBAS® SARS-COV-2 - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·January 6, 2022

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012