BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Talon DistalFix Antegrade/Retrograde Femoral Nail

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Resection Guide Base

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040659·

    Alteon

    FDA UDI
    Exactech, Inc.·10885862517630·ALTEON MONO REVSTM TRIAL SIZE 15X295

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 26, 2020

    X2ABS DUAL CHANNEL FITNESS BELT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARDIOSOFT PC ECG, USB VERSION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code NDL·February 22, 2026

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 7, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 2, 2014

    NAVIGATOR 10MM X 26MM X 0DEG. SPACER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MAX·June 23, 2011

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 8, 2021

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    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