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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 3 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Electrode	MTDPXN(EP)(BP8)-00570	FDA UDI	Class II	Active
microTargeting™ WayPoint Anchors	66-WP-AN5-00316	FDA UDI	Class II	Active
microTargeting™ Microtable™ Platform – Staged	66-MT-D3-00645	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTSWBN(LX1)-00488	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLP(BP)(BP16)-00942	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBPBN(DT1)-00671	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-EP-00591	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBWAP(JJ2)-00309	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AO6)-00468	FDA UDI	Class II	Active
microTargeting™ Platform Adapter Kit	66-FA-SF-00295	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT(IT1)-00697	FDA UDI	Class II	Active
NEXDRIVE™ w/DIG	MI-1000-00870	FDA UDI	Class II	Active
microTargeting™ Electrode Lead Cable	C0232-00781	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-BI-00590	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(BP)(BP11)-00924	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP20)-00568	FDA UDI	Class II	Active
microTargeting™ Electrode	22670-00124	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5700R-00578	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-AR21P-00583	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	66-FA-RD-01-00378	FDA UDI	Class II	Unknown
Guideline 4000 5.0™ 3m Interface Cable	C0221-00681	FDA UDI	Class II	Active
Lower Lead Depth Stop	FC8014-00819	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	66-IT(FP4)-00665	FDA UDI	Class II	Active
microTargeting™ Platfrom Accessory	MP-KIT-A-MS-00374	FDA UDI	Class II	Active
microTargeting™ USB to Serial Adapter	MT-LPP-CONV-00285	FDA UDI	Class II	Active
microTargeting™ Cleaning Brushes	66-CN-BR-00455	FDA UDI	Class II	Active
microTargeting™ Electrode	MTSPLN(RD1)-00486	FDA UDI	Class II	Active
STar™ Drive MA	FC8001-00148	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	FC1036-00114	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT(ES5)-00531	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-BP8P-00332	FDA UDI	Class II	Active
Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System	MT-LA-01-00610	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC9002-00900	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-AR6P-00342	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-06-00630	FDA UDI	Class II	Active
microTargeting™ Controller	66-EL-MS-04-00541	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(AR)(AR7)-00863	FDA UDI	Class II	Active
microTargeting™Array Electrode Insertion Tube Set	FC1012-00153	FDA UDI	Class II	Unknown
microTargeting™ Electrode	22670R-00242	FDA UDI	Class II	Active
microTargeting™ Electrode	MTTWLP(ZK2)-00519	FDA UDI	Class II	Active
STar™ Drive Insertion Tube Set	70-IT-04-00218	FDA UDI	Class I	Active
WayPoint™ Anchors	66-WP-AN1-00623	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(BP)(BP7)-00406	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-MP-00367	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(SJ3)-00247	FDA UDI	Class II	Active
microTargeting™ Electrode	34680R-00250	FDA UDI	Class II	Active
microTargeting™ Electrode	35385Z-00796	FDA UDI	Class II	Active
Nexframe Screws	SR-10-00804	FDA UDI	Class II	Active
microTargeting™ Electrode	44935L-00573	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPBN(PS)(PS1)-00632	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