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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 8 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Insertion Tube with Stylet	66-IT(AR14)-00469	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(AO)(AO9)-00448	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT(FP3)-00664	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-15P-00821	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(MD2)-00493	FDA UDI	Class II	Active
microTargeting™ Drive Hex Wrench	66-CN-HX-00449	FDA UDI	Class II	Active
MacroStim Interface (MSI)	66-EL-MI-00422	FDA UDI	Class II	Active
microTargeting™ Directional Lead Holder	70-CN-DL-00701	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-MR3-00803	FDA UDI	Class II	Unknown
microTargeting™ Platform	MP-KIT-P-U3-00593	FDA UDI	Class II	Active
microTargeting™ Electrode	44375Z-00798	FDA UDI	Class II	Active
microTargeting™ Drive System	MT-DS-01-00350	FDA UDI	Class II	Active
microTargeting™ Electrode	45375Z-00800	FDA UDI	Class II	Active
WayPoint™ Standoff Wrench	66-WP-SW-00351	FDA UDI	Class II	Unknown
WayPoint™ Navigator	C0240-00783	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	66-FA-RD-02-00376	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDPZN(PA)(MP1)-00641	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR38)-00496	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP16)-00501	FDA UDI	Class II	Active
microTargeting™ Platform NeuroBlate® Adaptor Kit	66-WP-NB-00344	FDA UDI	Class II	Unknown
microTargeting™ STar™ Insertion Tube	70-IT-ARP-00227	FDA UDI	Class II	Active
Waypoint™ Navigator	C0244-00787	FDA UDI	Class II	Active
microTargeting™ Spacer, 11mm 1x	66-CN-BP11-00445	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB10)-00516	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (7mm)	FM-4007-00773	FDA UDI	Class II	Unknown
microTargeting™Spacer Tube	66-PT(BP10)-00662	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(SS)(BP8)-00660	FDA UDI	Class II	Active
microTargeting™ Electrode	34680-00125	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT(AO9)-00647	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube	70-IT(AR5)-00652	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	FC1009-00103	FDA UDI	Class II	Unknown
microTargeting™ Multi-Oblique Tool Guide	66-MO-04-00549	FDA UDI	Class II	Active
microTargeting™ Matrix Guide Bushings	66-AC-MB-00483	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(BP)(BP8)-00396	FDA UDI	Class II	Active
microTargeting™ Drive Accessories Kit	66-AC-KT-00491	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(AR)(MP3)-00452	FDA UDI	Class II	Unknown
microTargeting™ Verification Probe	66-IT-VP-03-00845	FDA UDI	Class II	Active
microTargeting™ Controller Storage Case	66-DA-SC-00438	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWLN(BP)(BP16)-00941	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(FP1)-00526	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZP(EP)(BP8)-00348	FDA UDI	Class II	Active
WayPoint™ Planner	66-WP-PL-00437	FDA UDI	Class II	Unknown
STar™ Drive Lead Adapter	70-CN-DB-00264	FDA UDI	Class II	Active
WayPoint™ Entry Offset Mounting Hub	66-MP-EH-00604	FDA UDI	Class II	Unknown
microTargeting™ Digital Display Unit (DDU)	66-EL-MS-01-00407	FDA UDI	Class II	Active
microTargeting™ Array Clamp	66-AC-SC-00458	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2001-00882	FDA UDI	Class II	Active
microTargeting™ Electrode	5035L-00576	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR29)-00866	FDA UDI	Class II	Active
microTargeting™ Stylet	66-IT(ST14)-00476	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