60 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·October 8, 2008
Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.
FDA Recall
Terminated
·Innovacon Inc·Product code JHI·October 1, 2007
FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
FDA Recall
Terminated
·FHC, Inc.·Product code GZL·October 20, 2008
microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·March 30, 2010
STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·March 30, 2010
microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·March 30, 2010
Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·March 30, 2010
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
FDA Recall
Terminated
·FHC, Inc.·Product code GZL·December 28, 2009
FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
FDA Recall
Terminated
·FHC, Inc.·Product code GZL·October 20, 2008
FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
FDA Recall
Terminated
·FHC, Inc.·Product code GZL·October 20, 2008
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System, Product Number MT-DS-01
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
FDA Recall
Terminated
·FHC, Inc.·Product code GZL·June 17, 2020
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System, Product Number MT-DS
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018