226 results
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11ms
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Sources: EU EUDAMED, US FDA
Endocoupler 18 MM F.L, Autoclavable Catalog Number: 7207905, 7207905S
FDA Recall
Terminated
·Smith And Nephew, Inc. Endoscopy Division·Product code FXM·February 19, 2004
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA Recall
Terminated
·bioMerieux·Product code LJC·August 6, 2003
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code FFK·May 24, 2017
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FRN·January 26, 2017
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
FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·October 31, 2005
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·March 14, 2005
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
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
Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·October 31, 2005
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
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
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 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
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
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 System, Product Number 66-ZD-MD-01
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018