BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE HOLDER FOR BIOPROSTHESIS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    Trumpf Medical

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761996199·Hospital Device

    ReLine

    FDA UDI
    Nuvasive, Inc.·00887517010582·RELINE-C Kerrison Reducer

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989050943·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 22

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776402600·9Fr Flex Biopsy Grasper 33cm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189756·AK3 Femoral Sizing/Alignment Guide

    SafeBreath Filter Mouthpiece

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIS VASO SHIELD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 5, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    THERMACHOICE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code MKN·August 2, 2010