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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 7 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Procedure Kit	KT-PPK-S-00366	FDA UDI	Class II	Active
microTargeting™ STar™ Electrode Carrier	FC8010-00085	FDA UDI	Class II	Unknown
microTargeting™ Drive DBS Adapter	66-CN-DB-00453	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2003-00128	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	66-IT(DB14)-00214	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-ED-00180	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWZP(SS)(BP8)-00661	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (7mm)	FM-4007-00875	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-05P-00432	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(CV2)-00655	FDA UDI	Class II	Active
microTargeting™ Protective Tube	66-PT(FP3)-00667	FDA UDI	Class II	Active
Lower Lead Depth Stop	66-AC-LD-00850	FDA UDI	Class II	Active
microTargeting Insertion Tube	66-IT-AR4P-00349	FDA UDI	Class II	Active
microTargeting™ Microtable™ Platform – Sequential	66-MT-D2-00644	FDA UDI	Class II	Unknown
STar™ Drive Frame Adapter	FC8003-00829	FDA UDI	Class II	Active
LeadLoc Depth Stop	66-AC-DCM-00530	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZN(BP)(BP7)-00343	FDA UDI	Class II	Active
microTargeting™Array Electrode Insertion Tube Set	FC1012-00760	FDA UDI	Class II	Active
microTargeting™ STar™ Inerstion Tube Set	70-IT-3007-00234	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-ZD-00219	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	FC4001-00754	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	KT-FPK-S20-00508	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2004-00885	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBWLP(ZK1)-00669	FDA UDI	Class II	Active
WayPoint™ Surgical Kit	66-WP-SKS-00304	FDA UDI	Class II	Active
microTargeting™ Electrode	5005L-00273	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(LS)(LS3)-00386	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC1018-00761	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBP(SB)(SB2)-00390	FDA UDI	Class II	Active
microTargeting™ Array Electrode	25335Z-00791	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(BS)(OC5)-00646	FDA UDI	Class II	Active
WayPoint™ Depth Stop	66-DS-MO-00565	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(BP)(BP8)-00582	FDA UDI	Class II	Active
MicroTargeting™ RPD Adapter	C0255-00731	FDA UDI	Class II	Active
WayPoint™ Indexing Ring	66-MP-IR-00303	FDA UDI	Class II	Active
Lead Adapter Cable	MT-LA-04-00823	FDA UDI	Class II	Active
microTargeting™ Guideline 4000™ 5.0 Ethernet Cable	C0234-00734	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-SG-00539	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT-AR27P-00540	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(AR)(AR1)-00394	FDA UDI	Class II	Unknown
microTargeting™ Electrode	44930R-00572	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (13mm)	FM-4013-00775	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWBN(BP)(BP7)-00384	FDA UDI	Class II	Active
STar™ Drive MA	FC8001-00635	FDA UDI	Class II	Unknown
microTargeting™ Platform	MP-KIT-P-EO-00418	FDA UDI	Class II	Unknown
microTargeting™ Platform	MP-KIT-P-SG-00843	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-13P-00569	FDA UDI	Class II	Active
microTargeting™ Power Assist with Display Assembly	66-DA-ME-00440	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8003-00105	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT(BP21)-00585	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