BEUDAMED
    22 results · 55ms · Sources: EU EUDAMED, US FDA

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    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·November 28, 2023

    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·November 28, 2023

    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 11, 2021

    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·August 22, 2024

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code ONO·October 14, 2022

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023

    RadiaLux Lighted Retractor (Pink), REF: 50-101-1

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code GAD·December 8, 2022

    Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·December 4, 2024

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    AxiEM" Non-Invasive Patient Tracker

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·December 15, 2022

    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    Mazor X Surgical System Positioner Type II, REF: ASM0214-02

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·December 5, 2019

    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 9, 2021

    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·March 26, 2024

    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Littleton·Product code OWB·April 26, 2024

    Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Boxborough·Product code OWB·May 19, 2026

    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Littleton·Product code OWB·July 25, 2023