BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

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

    ARTICUL/EZE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295128939·ARTICUL/EZE TRIAL BALL GROOVED 26mm DIA +10

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2024

    UroNav (Version 2.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    PLYAXL OPN SCRWDRVR- MODULAR TI MOD

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code HXX·December 5, 2008

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 29, 2013

    NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT

    FDA Adverse Event
    Injury ·MISONIX, INC.·Product code LFL·December 3, 2025

    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