BEUDAMED
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    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 Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·February 5, 2025

    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 Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·October 16, 2024

    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 Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·November 15, 2023

    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 Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·May 15, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·January 17, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·January 17, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·January 18, 2023

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

    FDA Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·June 14, 2023

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

    FDA Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·June 14, 2023

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·December 18, 2019

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·December 18, 2019

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·December 18, 2019

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·June 17, 2020

    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 Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·December 29, 2021

    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 Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·December 29, 2021

    AxiEM" Non-Invasive Patient Tracker

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·February 8, 2023

    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 Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·November 23, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·June 24, 2026

    O-arm O2 Imaging System. Mobile X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·July 16, 2025

    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 Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Littleton·June 12, 2024