Is this your brand? Sign in to claim ownership.

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 11 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Electrode	35325Z-00795	FDA UDI	Class II	Active
microTargeting™ Depth Stop	66-AC-DS(1.8)-00514	FDA UDI	Class II	Unknown
microTargeting Array Electrode Insertion Tube with Stylet	66-IT-AR43P-00615	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2002-00750	FDA UDI	Class II	Active
MicroTargeting™ RPD Adapter	C0254-00730	FDA UDI	Class II	Active
microTargeting™ Electrode Insertion Tube Set	66-IT-01P-00463	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-LX-01-00229	FDA UDI	Class II	Unknown
microTargeting™ Electrode Sterilization Tray	FC1001-00140	EUDAMEDFDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	KTF1002-00758	FDA UDI	Class II	Active
Nexframe	DB-2040-00869	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR40)-00499	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MG-00627	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLP(BP)(BP6)-00398	FDA UDI	Class II	Active
VFS1 Footpedal	C0841-00816	FDA UDI	Class II	Active
microTargeting™ Electrode Insertion Tube Set	66-IT-01-00473	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-DV1-00311	FDA UDI	Class II	Active
microTargeting™ Single Procedure Kit	KTF1001-00133	FDA UDI	Class II	Unknown
STar™ Drive Frame Adapter	70-FA-RM-00222	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(SS)(BP8)-00658	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-U3-00424	FDA UDI	Class II	Unknown
Microtargeting ™ STar Drive Adapter	70-FA-RR-00929	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPBP(BP)(BP7)-00325	FDA UDI	Class II	Active
microTargeting™ Electrode Cable	66-EL-EC-01-00257	FDA UDI	Class II	Active
microTargeting™ Single Electrode Carrier Set	66-EL-EA-01-00859	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-RD-00226	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MH-00628	FDA UDI	Class II	Active
microTargeting™ Multi-Oblique Tool Guide	66-MO-02-00547	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	FC4001-00887	FDA UDI	Class II	Active
microTargeting™ Insertion Tubes 1x	66-IT(AR22)-00477	FDA UDI	Class II	Active
WayPoint™ Standard Mounting Hub	66-MP-MH-00722	FDA UDI	Class II	Active
WayPoint™ Depth Stop	66-DS-MO-00544	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	FC7140LI-00118	FDA UDI	Class II	Unknown
microTargeting™ Drive	66-ZD-MD-00357	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube Set	FC9003-00768	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPXN(BP)(BP7)-00330	FDA UDI	Class II	Active
microTargeting™ NexFrame® Insertion Tube Kit	66-IT-4015S-00368	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(AR)(AR2)-00375	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR24)-00478	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-14-00389	FDA UDI	Class II	Active
microTargeting™ Electrode	FC2002-00883	FDA UDI	Class II	Active
STar™ Drive Lead Measurement Fixture	70-AC-MT-00272	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(AR)(AR1)-00431	FDA UDI	Class II	Unknown
microTargeting™ Multi-Oblique Tool Guide	66-MO-20-00551	FDA UDI	Class II	Active
microTargeting™ Differential Electrode	MTDWZN(AR)(DU1)-00706	FDA UDI	Class II	Active
microTargeting™ Drive	66-ZD-MD-01-00356	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	FC8005-00107	FDA UDI	Class II	Unknown
WayPoint™ Pilot Drill	66-WP-PD-00347	FDA UDI	Class II	Active
microTargeting™ Electrode and Insertion Tube Kit	FC4001-00116	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube	66-IT-DB11P-00328	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(DB5)-00270	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Termobit Prod Srl RO

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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