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 14 of 15

Device	Model / Reference	Registries	Class	Status
microTargeting™ Insertion Tube with Stylet	66-IT(DB4)-00524	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube	FC8009-00119	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	66-IT-AR-00355	FDA UDI	Class II	Active
microTargeting™ Spacer Tube	66-PT(FP1)-00266	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-BI-00416	FDA UDI	Class II	Unknown
microTargeting™ Array Electrode Insertion Tube Set	66-IT-1018-00403	FDA UDI	Class II	Active
microTargeting™ Array Electrode	22675Z-00246	FDA UDI	Class II	Active
Cable Management System	66-AC-CM-00340	FDA UDI	Class II	Active
microTargeting™ Protective Tube	66-PT(FP2)-00666	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT-1019-00399	FDA UDI	Class II	Active
Nexdrive™	MI-2000-00772	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-U4-00594	FDA UDI	Class II	Active
STar™ Drive Electrode Carrier	70-AC-AR-00284	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC7140LI-00764	FDA UDI	Class II	Active
Waypoint™ Navigator	C0243-00786	FDA UDI	Class II	Active
Unibody™ Bone Fiducials (10mm)	FM-4010-00876	FDA UDI	Class II	Active
Guideline 4000 5.0™ LF Interface	C0220-00678	FDA UDI	Class II	Active
microTargeting™ Sterilization Case	67-00-6-00353	FDA UDI	Class II	Active
OsteoMed™ Manual Driver Handle	66-WP-DH-00323	FDA UDI	Class II	Active
microTargeting™ Verfication Probe	66-IT-VP-01-00364	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-ME-00625	FDA UDI	Class II	Active
Star™ Drive M/E	FC8002-00637	FDA UDI	Class II	Unknown
microTargeting™ STar™ Drive Depth Stop	66-AC-DL-00695	FDA UDI	Class II	Active
MicroTargeting™ Sterilization Basket	C0256-00732	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-07P-00421	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(DB8)-00528	FDA UDI	Class II	Active
microTargeting™ Accessories Kit	FC1017-00019	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-EO-00596	FDA UDI	Class II	Active
microTargeting™ Controller Handheld Remote Control	66-EL-RM-00395	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	66-IT(FP2)-00663	FDA UDI	Class II	Active
microTargeting™ Differential Electrode	MTDWLN(AR)(DU1)-00707	FDA UDI	Class II	Active
microTargeting™ Insertion Tubes	66-IT(AR8)-00611	FDA UDI	Class II	Active
microTargeting™ Platform Accessory	MP-KIT-A-SG-00599	FDA UDI	Class II	Unknown
microTargeting™ Array Electrode Insertion Tube	66-IT-NX1P-00288	FDA UDI	Class II	Active
microTargeting™ Electrode Cable	66-EL-EC-00155	FDA UDI	Class II	Active
microTargeting™ Insertion Tube	FC1019-00895	FDA UDI	Class II	Active
WayPoint™ Target Offset Mounting Hub	66-MP-TH-00310	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	66-IT-FPP-00301	FDA UDI	Class II	Active
Guideline 4000 5.0™ microTargeting™ Interface Card	C0218-00680	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(OC1)-00489	FDA UDI	Class II	Active
microTargeting™ Array Electrode	22375Z-00790	FDA UDI	Class II	Active
microTargeting™ Verification Probe	66-IT-VP-02-00361	FDA UDI	Class II	Active
Visualase™ Neuro Accessories and Tools	9736542	EUDAMEDFDA UDI	Class I	Active
Microtargeting Electrode	K991522	FDA 510(k)	Class II	Active
Microtargeting Xl Star Drive System	K121950	FDA 510(k)	Class II	Active
Microtargeting Star Drive System, Components	K092562	FDA 510(k)	Class II	Active
Microtargeting Drive System	K003776	FDA 510(k)	Class II	Active
Micro Targeting Drive System	K011775	FDA 510(k)	Class II	Active
microTargeting Guideline 4000 5.0 System	K183123	FDA 510(k)	Class II	Active
STarFix Designer Software C0265	K231141	FDA 510(k)	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