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

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    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DTE

    FDA UDI
    Guilin Woodpecker Medical Instrument Co., Ltd.·06944843657769·Dental X-Ray Device

    Bernafon

    FDA UDI
    Bernafon AG·05711584115275·CO7 MNR, 2.4G NFM MAC CAPTO 7 GPL

    LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: INJECTABLE MIMIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS·Product code FMI·March 16, 2016

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    OVERJET CARIES ASSIST

    FDA Adverse Event
    Malfunction ·OVERJET·Product code MYN·February 18, 2025

    125° RADIOLUCENT TARGETING ARM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·July 12, 2024

    125° RADIOLUCENT TARGETING ARM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·January 2, 2026

    IMPACTOR PAD

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·January 2, 2026

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 24, 2008

    PUMP IN STYLE BREAST PUMP

    FDA Adverse Event
    Injury ·MEDELA, INC.·Product code HGX·August 11, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024