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

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    Range (Denali and Mesa) Spinal Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493929535·AVANOS* Universal Block Trays

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651929539·

    TRABECULAR METAL (TM) FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    PROLENE BLU 75CM M0.7

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAW·July 10, 2019

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013

    PKG SPI2 HI RES PIP DVI

    FDA Adverse Event
    Malfunction ·STRYKER COMMUNICATIONS·Product code GCJ·July 8, 2011

    VALIANT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 17, 2014

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 5, 2019

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018