BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA UDI
    Cardinal Health, Inc.·10884521051577·124 Cup

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978073255·BONE 890-609 PRESS PLUG 20MM

    FORZA

    FDA UDI
    Orthofix US LLC·18257200106165·9MM ARTICULATING TAMP

    AUDIOMETER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTOSOFT 30

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

    PYRAMESH® IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·October 17, 2010

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 13, 2014

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·November 21, 2012

    AUTOSOFT 30

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

    PYRAMESH IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012