FHC, Inc.

Serial numbers: 01689 through 01708 and 01756 through 01758.

Neurological Devices

2

No

Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.

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.

Lot number: 866051

Neurological Devices

2

No

Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.

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.

Lot numbers 47647 and 475611.

Neurological Devices

2

No

Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.

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.

Not coded.

Neurological Devices

2

No

Nationwide Distribution including states of CO, FL, NC and NM.

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.

Not serialized . Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

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.