BEUDAMED
    92 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 21, 2013

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·July 13, 2016

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 5, 2012

    Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·July 8, 2015

    DISP 9730951 STRL SPHERE, 5PK INSERT

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    BIT 9733516 2.9mm DRILL STERILE

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    PIN, 9733236, 150MM, STERILE, PERC REF

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    PACK 9731975 TUMOR RESECTION AXIEM CR

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·January 18, 2017

    KIT, 9731427, THORACIC TACTILE PROBES

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    DISP 9730950 STRL SPHERE, 1 PK INSERT

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    ENT PRGM 9734636 ADD FUSION NAV AxiEM

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014