10 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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 Enforcement
Class II
·Terminated·MEDTECH SAS·June 13, 2018
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 Enforcement
Class I
·Terminated·MEDTECH SAS·November 13, 2019
ROSA One 3.1 Brain Application
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
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
ROSA One 3.1 Brain Application
FDA Recall
Terminated
·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020
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
ROSA Brain 3.0 Application-Brain
FDA Recall
Terminated
·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020
MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HAW·February 27, 2017
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code OLO·February 27, 2017