BEUDAMED
    206 results · 24ms · 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 FDA Recall ×

    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

    Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code HAW·May 2, 2008

    Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-003-150. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·June 5, 2008

    Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HAW·August 6, 2007

    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code HAW·July 23, 2013

    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code HAW·November 18, 2013

    BAG 9732315 MOUSE STERILE 15 PK

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

    The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code HAW·November 8, 2006

    Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. 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

    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

    FDA Recall
    Terminated ·Synaptive Medical, Inc.·Product code HAW·December 4, 2015

    ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HAW·February 14, 2014

    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·December 18, 2013

    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.

    FDA Recall
    Terminated ·Synaptive Medical Inc·Product code HAW·October 9, 2018

    Navitrack System - OS Knee Universal, Stereotaxic instrument

    FDA Recall
    Terminated ·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·October 28, 2008

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 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 ·MEDTECH SAS Parc Euromedecine Batiment·Product code HAW·May 8, 2018

    microTargeting" Drive System, Product Number MT-DS-01

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

    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 Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

    FDA Recall
    Terminated ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 10, 2019

    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·June 5, 2020

    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