BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    RANGE/MESA/DENALI SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925016200·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .6 M...

    PEEK Temporary Abutment

    FDA UDI
    BICON, LLC·00813110027870·4.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post

    SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIXPINE II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 5, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 3, 2014

    SPECTRANETICS LEAD LOCKING DEVICE

    FDA Adverse Event
    Death ·SPECTRANETICS CORPORATION·Product code DRB·May 31, 2013

    ALARIS SE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·June 15, 2011

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2015

    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

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013