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

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    I ESTRIOL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989050806·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 8

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189817·AK3 T-Handle IM Rod

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197536103·Markham-Meyerding Laminectomy Retractor 24x65m...

    Carescape One

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDA RESTORE, MODEL PTSCS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS LLC·Product code OYC·May 28, 2019

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code GZB·May 5, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTE·October 15, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 26, 2007

    BD ALARIS¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021

    UNSPECIFIED BD INFUSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021