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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 13 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Single Electrode Insertion Tube Set	66-IT-4015N-00621	FDA UDI	Class II	Active
microTargeting™ WayPoint™ Inserter Kit	66-WP-ID-02-00532	FDA UDI	Class II	Active
microTargeting™ Drive Sterilization Case	67-00-4B-00354	FDA UDI	Class II	Unknown
STar™ Drive M/E System	ST-DS-ME-00443	FDA UDI	Class II	Active
WayPoint™ Entry Offset Mounting Hub	66-MP-EH-00726	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-03-00548	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC1019-00113	FDA UDI	Class II	Unknown
STar™ Drive Frame Adapter	FC8006-00832	FDA UDI	Class II	Active
microTargeting™ Electrode	22670-00878	FDA UDI	Class II	Active
microTargeting™ Position Display Encoder	66-DA-EN-02-00444	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2002-00127	FDA UDI	Class II	Unknown
Nexprobe®	NP-1000-00770	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(SP)(AR5)-00472	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	66-FA-RD-00383	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLP(BP)(BP8)-00400	FDA UDI	Class II	Active
WayPoint™ Fiducial Placement Template	66-DA-FT-03-00839	FDA UDI	Class II	Unknown
microTargeting™ Electrodes	FC5000-00117	FDA UDI	Class II	Unknown
microTargeting™ Array Electrode Carrier Set	66-AC-AR-00525	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB9)-00529	FDA UDI	Class II	Active
microTargeting™ Electrodes	FC2004-00129	FDA UDI	Class II	Unknown
microTargeting™ Single Electrode Insertion Tube Set	66-IT-4015-00369	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB12)-00521	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MC-00414	FDA UDI	Class II	Active
STar™ Drive Platform Adapter Kit	70-FA-SF-00220	FDA UDI	Class II	Unknown
microTargeting™ Electrode	FC2001-00749	FDA UDI	Class II	Active
microTargeting™ NexFrame® Insertion Tube Kit	66-IT-4010S-00848	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube	70-IT-AR5P-00230	FDA UDI	Class II	Active
STar™ Drive Lead Measurement Fixture	70-AC-MT-01-00275	FDA UDI	Class II	Active
Guideline 4000 5.0™ Motor & Encoder	C0235-00682	FDA UDI	Class II	Active
microTargeting™ Drive Array Clamp	66-AC-NC-00465	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC9003-00901	FDA UDI	Class II	Active
microTargeting™ Drive Mount and Guide	66-DM-01-00434	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier	FC8008-00083	FDA UDI	Class II	Unknown
WayPoint™ Standard Mounting Hub	66-MP-MH-00605	FDA UDI	Class II	Unknown
microTargeting™ Sterile Drape Sleeves	FC1004-00904	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP11)-00500	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR31)-00817	FDA UDI	Class II	Active
WayPoint™ Standoff Wrench	66-WP-SW-00728	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (13mm)	FM-4013-00877	FDA UDI	Class II	Active
WayPoint™ Burr Hole Entry Marker Tool	66-MP-EM-00300	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	66-IT-09-00410	FDA UDI	Class II	Active
WayPoint™ Navigator	66-WP-NV(4.5)-00699	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-3000-00381	FDA UDI	Class II	Active
microTargeting™ Electrode Lead Cable	C0230-00690	FDA UDI	Class II	Active
microTargeting™ Electrode Cable	FC1020-00151	FDA UDI	Class II	Active
microTargeting™ Single Procedure Kit	KTF1001-00890	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	FC7100-00132	FDA UDI	Class II	Unknown
microTargeting™ Platform Accessory	MP-KIT-MD-00415	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-01-00546	FDA UDI	Class II	Active
NEXDRIVE™ w/DIG	MI-1000-00771	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