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    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·September 11, 2019

    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code CAZ·April 21, 2026

    Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Recall
    Terminated ·Integra Limited·Product code GWM·September 10, 2013

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566.

    FDA Recall
    Terminated ·Cook, Inc.·Product code JOH·April 21, 2010

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.

    FDA Recall
    Terminated ·Cook, Inc.·Product code JOH·April 21, 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