BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    BLUE 400; BLUE 400 S

    FDA 510(k)
    FDA Class 2 ·Neurology

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000878702·INSERTER 9240215 M4 PLATE

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074125251·INSERTER 9240215 M4 PLATE

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526781726·LUMBAMED FACET 3 POINT SILVER V

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776413811·Cone Ring Curette, size 2, 6mm, angled, 9"

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199694·Modular Knee Stem Pilot 21mm x 150mm

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184089·Integra® Jarit® Cone Ring Curette, Angled 35°, ...

    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM

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

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 20, 2002

    LINEAR?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 19, 2026

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 22, 2013

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 7, 2020

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 26, 2012

    SYRINGE 20ML LL S/C 48

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·March 5, 2024

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 1, 2020

    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.

    FDA Enforcement
    Class II ·Ongoing·NuVasive Specialized Orthopedics, Inc.·November 27, 2024

    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