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

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    PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

    FDA 510(k)
    FDA Class 2 ·Neurology

    Inspire™ Esthetic Provisional Composite A2

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010757·Crown and Bridge Temporary Resin

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283518·DAVIS RETRACTOR DOUBLE ENDED 6"

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756379311·Foam Pad Surgical Positioning

    LIQUIBAND DUAL, MODEL LBD 001

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

    DAR-8000I

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    WAVEWRITER ALPHA? PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2025

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI·Product code MXC·January 13, 2014

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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