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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 6 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Electrode	FC1002-00880	FDA UDI	Class II	Active
microTargeting™ Stylet	66-ST-12-00825	FDA UDI	Class II	Active
microTargeting™ Platform	C0283-00846	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-14P-00385	FDA UDI	Class II	Active
STarFix™ Designer	C0265-01-00922	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWCN(AR)(AR2)-00392	FDA UDI	Class II	Active
microTargeting™ Insertion Tubes	66-IT(AR16)-00612	FDA UDI	Class II	Active
WayPoint™ Multi-Oblique Tool Guide	66-MO-05-00550	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-AR5P-00346	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP2)-00506	FDA UDI	Class II	Active
microTargeting™ Sterile Drape Sleeves	FC1004-00141	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	70-IT-7147LI-00231	FDA UDI	Class II	Active
Guideline 4000™ 5.0	C0217-00679	FDA UDI	Class II	Active
WayPoint™ Multi-Oblique Platform	66-DH-40-00543	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(DB1)-00276	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP22)-00586	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(AO)(AO1)-00372	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(NS)(SK2)-00462	FDA UDI	Class II	Active
microTargeting™ Platform Indexing Ring Screws	66-WP-RS-00334	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP19)-00567	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier	FC8008-00833	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	KTF1002-00891	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(BP)(BP6)-00868	FDA UDI	Class II	Active
VFS1 Generator Main Unit	C0840-00815	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	FC1009-00737	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(SP)(AR1)-00466	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(CH1)-00673	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-AR30P-00584	FDA UDI	Class II	Active
microTargeting™ Electrode	22630R-00239	FDA UDI	Class II	Active
microTargeting™ Controller	66-EL-MS-00419	FDA UDI	Class II	Active
microTargeting™ Electrodes	FC2004-00752	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-AO1P-00359	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(BP)(BP5)-00380	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZN(AO)(AO1)-00650	FDA UDI	Class II	Active
microTargeting™ Electrode	34680-00879	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPXP(BP)(BP7)-00341	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-AO11P-00867	FDA UDI	Class II	Active
microTargeting™ Electrode	44335Z-00797	FDA UDI	Class II	Active
microTargeting™ Insertion Tube and Stylet	66-IT-AR41P-00589	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-LG-00600	FDA UDI	Class II	Unknown
microTargeting™ Electrode	44975Z-00267	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-ED-00598	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-1028-00397	FDA UDI	Class II	Active
microTargeting™ Electrode	MER-5000T-00504	FDA UDI	Class II	Active
microTargeting™ Electrode	MTTWLN(ZK2)-00517	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-PH-00379	FDA UDI	Class II	Unknown
microTargeting™ Sterile Drape Sleeve	66-DA-SD-00436	FDA UDI	Class II	Active
microTargeting™ LP+ Electrode Cable	66-EL-LP-00258	FDA UDI	Class II	Active
microTargeting™ Depth Stop	FC8013-00633	FDA UDI	Class II	Unknown
Resident Expert Kinetic Testing Motion Detector	C0259-00811	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