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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 10 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Platform Tool Guide	66-WP-TG18MM-00362	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZP(EP)(BP7)-00345	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC7140LI-00897	FDA UDI	Class II	Active
microTargeting™ Drive System	FC1006-00147	FDA UDI	Class II	Active
microTargeting™ Electrode	FC1003-00881	FDA UDI	Class II	Active
Guideline 4000 5.0™ Interface	C0219-00677	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBPBN(KB1)-00302	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-ES-00181	FDA UDI	Class II	Unknown
microTargeting™ Stylet	66-ST-17-00711	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC1018-00112	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5030R-00575	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-PS-00844	FDA UDI	Class II	Active
WayPoint™ Pilot Drill	66-WP-P2-00622	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-A-ST-00852	FDA UDI	Class I	Active
microTargeting™ Electrode	MTBPXN(EN3)-00307	FDA UDI	Class II	Active
microTargeting™ Insertion Tube set	66-IT-13-00813	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-LG-00537	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWBN(AO)(A10)-00363	FDA UDI	Class II	Active
microTargeting™ Electrode	44975L-00263	FDA UDI	Class II	Active
Guideline 4000™ 5.0	C0216-00675	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier	70-AC-05-00696	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube	FC9001-00121	FDA UDI	Class II	Unknown
microTargeting™ Depth Stop	FC8013-00835	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC9001-00899	FDA UDI	Class II	Active
microTargeting™ Guideline 4000 LP+™	MT-LPP-00271	FDA UDI	Class II	Active
microTargeting™ Controller Power Assist System	66-DS-PA-00427	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-07-00430	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MJ-00629	FDA UDI	Class II	Active
Guideline™ 4000	C0217-00864	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8005-00831	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8004-00106	FDA UDI	Class II	Unknown
Unibody™ Bone Fiducials (10mm)	FM-4010-00856	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPLP(PA)(MP1)-00640	FDA UDI	Class II	Active
WayPoint™ Implantation Kit	66-WP-RU-00533	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5705Z-00289	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLP(BS)(FM2)-00538	FDA UDI	Class II	Active
microTargeting™ Electrode	44970R-00259	FDA UDI	Class II	Active
microTargeting™ Electrode	34625L-00248	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube Set	70-IT-7107-00233	FDA UDI	Class II	Active
microTargeting™ Electrode Sterilization Tray	FC1001-00653	FDA UDI	Class II	Unknown
Array Electrode Insertion Tube with Stylet	66-IT-7100-00609	FDA UDI	Class II	Active
microTargeting™ Platform NeuroBlate® Adaptor Kit	66-WP-NB-00601	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWLP(SP)(AR1)-00402	FDA UDI	Class II	Active
STar™ Drive Insertion Tube Extractor	FC8011-00902	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(SP)(JV1)-00411	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	FC7100-00756	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(BS)(OC4)-00557	FDA UDI	Class II	Active
microTargeting™ Guideline 5 Accessory	C0225-00686	FDA UDI	Class II	Active
WayPoint™ Simultaneous Bilateral Kit	66-WP-BKS-00324	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTSWLP(JN)(JN1)-00492	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