BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    FINGERTIP PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 4, 2022

    HEATLUX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VALO CORDLESS

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 19, 2016

    VICTORY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    DIMENSION XPAND PLUS WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHA·May 31, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 16, 2011

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    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