BEUDAMED
    66 results · 12ms · Sources: EU EUDAMED, US FDA

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    The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FHN·July 19, 2011

    Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FHN·June 17, 2009

    Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00522612 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FHN·June 17, 2009

    Four Shooter Saeed Multi-Band Ligator

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FHN·January 15, 2004

    Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

    FDA Recall
    Terminated ·Cook Endoscopy·Product code FHN·September 3, 2010

    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