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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 1 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Insertion Tube with Stylet	66-IT(DB1)-00515	FDA UDI	Class II	Active
WayPoint™ Sterilization Case	66-WP-SC-00337	FDA UDI	Class II	Active
microTargeting™ Stylet	66-ST-14P-00237	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	66-IT-IT1P-00703	FDA UDI	Class II	Active
WayPoint™ Burr Hole Entry Marker Tool	66-MP-EM-00720	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP5)-00510	FDA UDI	Class II	Active
STar™ Drive MA	FC8001-00827	FDA UDI	Class II	Active
33 cm Lead Insertion Tube Set	70-IT-1023-00849	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLP(SS)(BP8)-00659	FDA UDI	Class II	Active
microTargeting™ Electrode	5730R-00579	FDA UDI	Class II	Active
STar™ Drive M/E	FC8002-00828	FDA UDI	Class II	Active
microTargeting™ LeadLoc Depth Stop	66-AC-DC-00566	FDA UDI	Class II	Active
Nexprobe®	NP-1000-00872	FDA UDI	Class II	Active
WayPoint™ Fiducial Placement Template	66-DA-FT-02-00292	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-U4-00425	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWZP(AR)(DB1)-00450	FDA UDI	Class II	Active
microTargeting™ Electrode	34325Z-00793	FDA UDI	Class II	Active
microTargeting™ Single Electrode Carrier Set	66-AC-01-00513	FDA UDI	Class II	Active
STar™ Drive MA	70-ZD-MA-00216	FDA UDI	Class II	Active
Passive Headrest Accessories	PH-2510-00777	FDA UDI	Class II	Unknown
microTargeting™ Electrode	22635Z-00241	FDA UDI	Class II	Active
microTargeting™ Electrode Cable	FC1020-00903	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-02-00460	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(BP5)-00286	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(BP)(BP6)-00382	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPXN(SP)(AO9)-00335	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR35)-00485	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-DB12P-00327	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(AO)(A11)-00921	FDA UDI	Class II	Active
microTargeting™ Guideline 4000 LP+™ Channel Card	MT-LPP-APM-00556	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP8)-00511	FDA UDI	Class II	Active
microTargeting™ Single Procedure Kit	KTF1001-00757	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(NS)(SL2)-00446	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPLN(PA)(MP1)-00639	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	FC1012-00893	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR4)-00498	FDA UDI	Class II	Active
LeadLoc Depth Stop	66-AC-DCS-00520	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8006-00108	FDA UDI	Class II	Unknown
Guideline 4000™ 5.0	C0215-00674	FDA UDI	Class II	Active
microTargeting™ Electrode	44935Z-00256	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Accessory	66-ST-MO-00545	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(BP)(B10)-00456	FDA UDI	Class II	Active
WayPoint™ Locator Pins	66-WP-LP-00338	FDA UDI	Class II	Active
WayPoint™ Standoff Wrench	66-WP-SW-00603	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5735L-00580	FDA UDI	Class II	Active
microTargeting™ Stylet	66-ST-04-00243	FDA UDI	Class II	Active
WayPoint™ Combination Driver Bit	66-WP-CD-01-00320	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-08-00420	FDA UDI	Class II	Unknown
WayPoint™ Hex Wrench	66-WP-HW-00331	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	FC1011-00892	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