BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Maxcon Sharps Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SLIM E30 II CO2 LASER

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

    XYLOS VESSEL GUARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 7, 2024

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·June 20, 2013

    COULTER LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

    EQUALIZER BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DQY·September 29, 2008

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    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 COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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