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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 2 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ STar™ Drive Insertion Tube Set	70-IT-AR-00217	FDA UDI	Class I	Active
microTargeting™ Insertion Tube Set	FC1036-00763	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-SB-00592	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier Hex Wrench	70-AC-HW-00555	FDA UDI	Class II	Active
microTargeting™ Electrode	FC1002-00747	FDA UDI	Class II	Active
microTargeting™ Electrode Cable	FC1020-00139	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(AR)(MP1)-00744	FDA UDI	Class II	Active
microTargeting™ Electrode	FC5000-00888	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-ES-00597	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR17)-00470	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPBN(PA)(DB2)-00315	FDA UDI	Class II	Active
microTargeting™ Array Electrode Carrier and Clamp	FC1021-00061-	FDA UDI	Class II	Active
WayPoint™ Navigator	66-WP-NV(4.4)-00613	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWZN(BP)(BP11)-00925	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC9002-00767	FDA UDI	Class II	Active
STarFix™ Designer	C0265-00860	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-KH1P-00296	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(AR)(MP7)-00923	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-GP-00618	FDA UDI	Class II	Active
microTargeting™ Array Electrode Carrier and Clamp	FC1021-00061	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	FC9002-00122	FDA UDI	Class II	Unknown
STar™ Drive MA System	ST-DS-MA-00441	FDA UDI	Class II	Active
WayPoint™ Standard Mounting Hub	66-MP-MH-00305	FDA UDI	Class II	Unknown
WayPoint™ Entry Offset Mounting Hub	66-MP-EH-00298	FDA UDI	Class II	Unknown
microTargeting™ Frame Adapter	66-FA-LX-01-00387	FDA UDI	Class II	Unknown
microTargeting™ Controller with Encoder	FC1007-00143	FDA UDI	Class II	Active
microTargeting™ Electrode	45335Z-00799	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube	FC4000-00753	FDA UDI	Class II	Active
microTargeting™ STar™ Array Insertion Tube Extractor	70-CN-ET-00236	FDA UDI	Class I	Active
microTargeting™ Electrode	FC2003-00884	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR39)-00497	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPBP(LS)(LS3)-00326	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(AR)(AR7)-00865	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBP(AO)(AO1)-00542	FDA UDI	Class II	Active
microTargeting™ Verfication Probe	66-IT-VP-00371	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(MD1)-00509	FDA UDI	Class II	Active
STar™ Drive Accesories Kit	70-AC-KT-MA-00282	FDA UDI	Class II	Active
STar™ Drive Positioner	70-DP-OS-00238	FDA UDI	Class II	Active
microTargeting™ WayPoint™ Inserter Kit	66-WP-ID-01-00336	FDA UDI	Class II	Active
microTargeting™ Lumen Cleaning Tool	66-CN-RT-00447	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(SJ1)-00253	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8004-00830	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MB-00413	FDA UDI	Class II	Unknown
STar™ Drive Frame Adapter	70-FA-BL-00235	FDA UDI	Class II	Active
STar™ Drive Lead Holder Screw	70-CN-DB-01-00260	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(JN11)-00262	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	FC1010-00738	FDA UDI	Class II	Active
microTargeting™ Electrode	34625Z-00249	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	KTF1002-00134	FDA UDI	Class I	Unknown
WayPoint™ Surgical Kit	66-WP-MR-00317	FDA UDI	Class II	Unknown

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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