56 results
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12ms
·
Sources: EU EUDAMED, US FDA
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
FDA Recall
Terminated
·Cook Inc.·Product code DYB·December 21, 2018
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Recall
Terminated
·Hologic, Inc·Product code NSU·August 4, 2020
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only.
FDA Recall
Terminated
·Medline Industries Inc·Product code JJX·January 15, 2021
Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT
FDA Recall
Terminated
·Covidien LLC·Product code FSY·April 16, 2015
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