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

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    Yikang Endotracheal Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VISORB QUICK

    FDA Adverse Event
    Malfunction ·CP MEDICAL·Product code GAM·June 21, 2019

    GE DATEX-OHMEDA AISYS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LUMANOSITY CELEBRITY, MODEL 204

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·October 29, 1999

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC.·Product code KGX·May 25, 2021

    BECKMAN-COULTER

    FDA Adverse Event
    Malfunction ·BECKMAN-COULTER·Product code GKZ·October 6, 2008

    6000CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·December 10, 2019

    EXOGEN Ultrasound Coupling Gel

    FDA Enforcement
    Class II ·Terminated·Bioventus, LLC·January 20, 2021

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 9, 2018

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·July 31, 2019

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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