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FHC, INC.

United States·US-MF-000012111

Last updated September 17, 2026

Information

Country: United States
Address: 1201, Main St, Bowdoin, United States
Website: www.fh-co.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)326-2905
PRRC Contact: Kelly Moeykens
EUDAMED SRN: US-MF-000012111
FDA FEI Number: 3002250546
DUNS Number: 108179458

Catalogue (714)

Page 4 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Insertion Tube Set	66-IT-11P-00801	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(CV1)-00654	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR32)-00484	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-CV2P-00926	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-SG1P-00842	FDA UDI	Class II	Active
microTargeting™ DBS Measurement Fixture	66-AC-MT-01-00287	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR3)-00480	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(AR)(AR2)-00404	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (7mm)	FM-4007-00855	FDA UDI	Class II	Active
33 cm Lead Insertion Tube Set	FC1023-00905	FDA UDI	Class II	Active
Guideline 4000 5.0™ microTargeting™ Controller Card	C0223-00683	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP3)-00507	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier	70-AC-01-00290	FDA UDI	Class II	Active
microTargeting™ Guideline 4000™ 5.0 High Performance External Speaker	C0237-00735	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB7)-00527	FDA UDI	Class II	Active
microTargeting™ Electrode Sterilization Tray	67-00-1-00261	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5005Z-00277	FDA UDI	Class II	Active
Microtargeting ™ STar Drive Adapter	C0305-00802	FDA UDI	Class II	Active
STar™ Drive Insertion Tube Extractor	FC8011-00120	FDA UDI	Class I	Active
microTargeting™ Frame Adapter	66-FA-RD-03-00373	FDA UDI	Class II	Unknown
Unibody™ Bone Fiducials (13mm)	FM-4013-00857	FDA UDI	Class II	Active
Electrode Depth Stop Adapter	66-AC-DS-00518	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube	FC4000-00115	FDA UDI	Class II	Unknown
microTargeting™ STar™ Insertion Tube	FC9001-00766	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (10mm)	FM-4010-00774	FDA UDI	Class II	Unknown
Resident Expert Software Module	C0258-00818	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBP(LS)(LS3)-00388	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-MR3-00807	FDA UDI	Class II	Active
microTargeting™ Controller with Motor	FC1008-00144	FDA UDI	Class II	Unknown
WayPoint™ Navigator	C0241-00784	FDA UDI	Class II	Active
microTargeting™ Controller with Motor	FC1008-00826	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(AR)(MP7)-00920	FDA UDI	Class II	Active
STar™ Drive XL Frame Adapter	70-FA-LX-XL-00228	FDA UDI	Class II	Active
Waypoint™ Navigator	C0242-00785	FDA UDI	Class II	Active
microTargeting™ Electrode	22635L-00240	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBWLN(ZK1)-00656	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Accessory	66-DS-IT-00553	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB3)-00523	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZP(NS)(SL2)-00358	FDA UDI	Class II	Active
microTargeting™ Electrode	MTSPAN(RD1)-00475	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(BP)(BP8)-00459	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5000R-00574	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-CN-I2-00461	FDA UDI	Class II	Active
microTargeting™ Electrode	5705L-00283	FDA UDI	Class II	Active
microTargeting™ Electrode Carrier	66-AC-EC-00505	FDA UDI	Class II	Active
Guideline 4000™ 5.0	C0224-00685	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2001-00126	FDA UDI	Class II	Unknown
microTargeting™ NexFrame™ Drive Adapter	66-DM-02-00429	FDA UDI	Class II	Active
microTargeting™ Stylet	66-ST-12P-00824	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBPBP(DT1)-00672	FDA UDI	Class II	Active

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FDA Recalls (29)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 4, 2024	Z-0312-2025	—	open, classified	A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Jun 17, 2020	Z-2540-2020	—	terminated	An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
May 10, 2018	Z-2350-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2349-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2348-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2352-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2354-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2355-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2345-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2358-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2351-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2346-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2359-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2357-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2347-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2353-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
May 10, 2018	Z-2356-2018	—	terminated	The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
Mar 30, 2010	Z-0311-2011	—	terminated	Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
Mar 30, 2010	Z-0312-2011	—	terminated	Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
Mar 30, 2010	Z-0313-2011	—	terminated	Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
Mar 30, 2010	Z-0314-2011	—	terminated	Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
Dec 28, 2009	Z-1143-2010	—	terminated	The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location.
Oct 20, 2008	Z-0497-2009	—	terminated	Mislabeled: May contain an electrode longer than labeled size
Oct 20, 2008	Z-0498-2009	—	terminated	Mislabeled: May contain an electrode longer than labeled size
Oct 20, 2008	Z-0499-2009	—	terminated	Mislabeled: May contain an electrode longer than labeled size
Oct 8, 2008	Z-0486-2009	—	terminated	Measuring fixture is incorrectly graduated.
Oct 31, 2005	Z-0180-06	—	terminated	Power Assist microTargeting System may advance beyond intended target
Oct 31, 2005	Z-0179-06	—	terminated	Power Assist microTargeting System may advance beyond intended target
Mar 14, 2005	Z-0895-05	—	terminated	Potential for non-sterile pin to contaminate sterile field