BEUDAMED
    760 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.

    FDA Recall
    Terminated ·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010

    PATIENT TRACKER 9733534XOM ENT 1PK

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014

    INST 9731132 KIT CR REF FRAME DRIVER 5PK

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014

    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 17, 2015

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HAW·August 21, 2015

    Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

    FDA Recall
    Open, Classified ·Globus Medical, Inc.·Product code HAW·December 11, 2023

    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

    FDA Recall
    Terminated ·Elekta Inc·Product code HAW·March 30, 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 Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 9, 2021

    ROSA Surgical Device 2.5.8

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HAW·February 10, 2013

    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HAW·February 5, 2013

    ROSA Surgical Device 2.5.8

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HAW·April 8, 2016

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code HBW·January 24, 2024

    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

    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·May 10, 2017

    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

    FDA Recall
    Terminated ·Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446·Product code LRZ·November 5, 2015