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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 5 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Insertion Tube with Stylet	66-IT(AR36)-00494	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(AR)(DB1)-00742	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-LX-NV-00930	FDA UDI	Class II	Active
microTargeting™ Protective Tube	66-PT(FP4)-00668	FDA UDI	Class II	Active
microTargeting™ Controller with Motor	FC1008-00150	FDA UDI	Class II	Unknown
microTargeting™ Electrode	34685Z-00254	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPBP(AO)(AO1)-00322	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBWAN(JJ2)-00308	FDA UDI	Class II	Active
WayPoint™ Implantation Kit	66-WP-RU-00708	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-LE-00294	FDA UDI	Class II	Active
microTargeting™ Electrode Lead Cable	C0231-00691	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZP(AO)(AO1)-00651	FDA UDI	Class II	Active
microTargeting™ Electrode	FC1003-00136	FDA UDI	Class II	Unknown
WayPoint™ Implant Kit	66-WP-IKS-00319	FDA UDI	Class II	Active
microTargeting™ WayPoint™ Inserter Kit	66-WP-ID-03-00919	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPXP(AO)(AO9)-00339	FDA UDI	Class II	Active
microTargeting™ Platform	C0284-00847	FDA UDI	Class II	Active
microTargeting™ Drive Measurement Fixture	66-AC-MT-00467	FDA UDI	Class II	Active
microTargeting™ Line Cord	66-EL-LC-USA-00269	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB2)-00522	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-DV1P-00306	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(MP9)-00255	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2003-00751	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-LX-NN-00854	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-SB-00423	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTBPBN(EN2)-00297	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC8009-00898	FDA UDI	Class II	Active
microTargeting™ Array Electrode Insertion Tube Set	FC1012-00131	FDA UDI	Class II	Unknown
microTargeting™ Electrode	FC1003-00748	FDA UDI	Class II	Active
STar™ Drive Accessories Kit	70-AC-KT-ME-00278	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-NB-00812	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP17)-00502	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	66-FA-LX-00391	FDA UDI	Class II	Active
microTargeting™ Drive System	MT-DS-00352	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(BP7)-00280	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-08-00861	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(DB7)-00268	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-MR1-00428	FDA UDI	Class II	Active
microTargeting™ Electrode	FC1002-00135	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	66-IT-14S-00620	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-05-00442	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-21-00552	FDA UDI	Class II	Active
WayPoint™ Combination Driver Bit	66-WP-CD-00318	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-ME1P-00858	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(AR)(DB1)-00435	FDA UDI	Class II	Active
WayPoint™ Target Offset Mounting Hub	66-MP-TH-00724	FDA UDI	Class II	Active
microTargeting™ Electrode	34680-00746	FDA UDI	Class II	Active
Nexdrive™	MI-2000-00871	FDA UDI	Class II	Active
WayPoint™ Navigator	C0239-00782	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	FC1011-00152	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