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

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    EliA SmDP Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    PROWICK

    FDA 510(k)
    FDA Unclassified ·Unknown

    AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376668475·12mm CORE, NANOTEC BAN 18 x 30 mm 7°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376668284·12mm CORE, NANOTEC KBN 18 x 30 mm 7°

    INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 28, 2025

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 3, 2008

    MITEK VAPR HANDPIECE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GEI·July 28, 2011

    SCREWDRIVER BLADE, CANNULATED

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code LXH·June 21, 2013

    ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 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