BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    Profoject™ Disposable Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MPO Total Knee Systems MR Labeling

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSH·September 3, 2025

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·November 5, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·July 15, 2013

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSH·October 4, 2024

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSH·July 7, 2023

    PLATE BBL CHROMAGAR CANDIDA 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSI·September 13, 2021

    VISTASEAL DUAL APPLICATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code MZM·April 6, 2021

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014