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 9 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Multi-Oblique Tool Guide	66-MO-07-00810	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(SJ2)-00251	FDA UDI	Class II	Active
Star™ Drive M/E	FC8002-00149	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT(AR30)-00481	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	FC1011-00759	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-08P-00412	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWZN(BP)(BP8)-00439	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube with Stylet	66-IT(AR27)-00479	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(DB3)-00274	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-PH-00595	FDA UDI	Class II	Active
WayPoint™ Navigator	66-WP-NV(4.2)-00433	FDA UDI	Class II	Unknown
microTargeting Array Electrode Insertion Tube with Stylet	66-IT-AR42P-00614	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(BS)(OC2)-00409	FDA UDI	Class II	Active
microTargeting™ Lead Adapter	MT-LA-03-00805	FDA UDI	Class II	Active
microTargeting™ Stylet	66-ST-14P-00822	FDA UDI	Class I	Active
microTargeting™ Insertion Tube Set	MER-6000-00223	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube	FC8009-00765	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(OC2)-00487	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-4000-00370	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(NS)(SL2)-00464	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWBN(SP)(BW1)-00670	FDA UDI	Class II	Active
microTargeting™ Electrode	5735Z-00581	FDA UDI	Class II	Active
Guideline 4000™ 5.0 Accessory	C0233-00692	FDA UDI	Class II	Active
Insertion Tube	66-IT-40L-00851	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR37)-00495	FDA UDI	Class II	Active
STarFix™ Designer	C0267-00917	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MF-00626	FDA UDI	Class II	Unknown
STar™ Drive Electrode Carrier	FC8010-00834	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZP(BP)(BP5)-00454	FDA UDI	Class II	Active
Lower Lead Depth Stop	FC8014-00836	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDPZP(PA)(MP1)-00642	FDA UDI	Class II	Active
WayPoint™ Navigator	66-WP-NV(4.6)-00814	FDA UDI	Class II	Active
microTargeting™ Array Electrode	22335Z-00789	FDA UDI	Class II	Active
microTargeting™ WayPoint™ Inserter Kit	66-WP-ID-00333	FDA UDI	Class II	Unknown
STar™ Drive Frame Adapter Kit	70-FA-SF-01-00221	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBWBN(WH1)-00312	FDA UDI	Class II	Active
WayPoint™ Anchors	66-WP-AN-00313	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC1018-00894	FDA UDI	Class II	Active
STar™ Drive M/E	70-ZD-ME-00215	FDA UDI	Class II	Active
microTargeting™ Electrode	34385Z-00794	FDA UDI	Class II	Active
Nexframe	DB-2040-00780	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-MA-00408	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTSPBN(LX1)-00482	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-DB9P-00321	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-LX-00232	FDA UDI	Class II	Active
microTargeting™ Lead Insertion Tube with Stylet	66-IT-AR14P-00649	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	FC1010-00104	FDA UDI	Class II	Active
inomed Adapter	66-WP-IN-00838	FDA UDI	Class II	Active
microTargeting™ Electrode	MTSWBP(JN)(JN2)-00490	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-03P-00451	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