BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Ceragem Automatic Thermal Massager (CGM MB-2401)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192497·Mod Tibia Starter Drill guide

    Remington Medical Inc. Tuohy Epidural Needles

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·August 30, 2017

    VANGUARD DCM CR TIBIAL BEARING 12MM X 79/83MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 15, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 6, 2014

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·July 26, 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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013