BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Dental High-speed Handpiece and Accessories

    FDA 510(k)
    FDA Class 1 ·Dental

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.3ML 0.30MM X 8MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 8, 2023

    Electrocardiograph

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMECATH DUAL LUMEN HEMODIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PRECISION? MONTAGE? MRI

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

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·March 8, 2023

    SCRDRIVERSHAFT T25 F/URS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

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    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·July 14, 2008

    TRIAL SPACER AND IMPLANT HOLDER FOR EVOLUTION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·July 16, 2024

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    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