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

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    ODI HD Dental Sensor

    FDA 510(k)
    FDA Class 2 ·Dental

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120390·2-LEVEL PLATE ASSEMBLY, 34MM

    SPECTRA SYSTEM DENTAL IMPLANTS 2008

    FDA 510(k)
    FDA Class 2 ·Dental

    HM-LAMP II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013

    PROMUS ELEMENT ¿ LONG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 4, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 21, 2014

    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 21, 2014

    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