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

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    Transducer Probe Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHAFT FOR REAMER

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489416156·

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981310080·Trial Rasp, 43mm x 30mm x 16mm, 15 Deg

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981304201·2-Hole No-Profile Interbody, 43mm x 30mm x 16mm...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247522·No-Profile Interbody, 43mm x 30mm x 16mm, 15 Deg

    SIGNA 7.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOPHYS BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 16, 2018

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·November 19, 2008

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 2, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2013

    MERIDIAN

    FDA Adverse Event
    Malfunction ·SEASPINE ORTHOPEDICS CORPORATION·Product code MAX·April 10, 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