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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 12 of 15

Device	Model / Reference	Registries	Class	Status
STar™ Drive XL Frame Adapter	70-FA-RD-XL-00225	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(BS)(FM2)-00534	FDA UDI	Class II	Active
microTargeting™ Depth Stop	66-AC-DS(1.8)-00634	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	FC1036-00896	FDA UDI	Class II	Active
microTargeting™ Electrode	22670-00745	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWZN(AO)(AO9)-00426	FDA UDI	Class II	Active
STar™ Drive Positioner	70-DP-CS-00245	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR23)-00874	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT-AO6P-00736	FDA UDI	Class II	Active
microTargeting™ Electrode	34685L-00252	FDA UDI	Class II	Active
microTargeting™ Guideline 4000 LP+™ Cart	MT-LPP-CART-00281	FDA UDI	Class II	Active
microTargeting™ Electrodes	FC5000-00755	FDA UDI	Class II	Active
33 cm Lead Insertion Tube Set	FC1023-00820	FDA UDI	Class II	Active
Nexframe Screws	SR-10-00873	FDA UDI	Class II	Active
microTargeting™ Platform	MP-KIT-P-EP-00417	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	FC1011-00130	FDA UDI	Class II	Unknown
microTargeting™ Electrode	34620R-00571	FDA UDI	Class II	Active
microTargeting™ STar™ Insertion Tube Set	FC9003-00123	FDA UDI	Class II	Unknown
microTargeting™ Insertion Tube Set	66-IT-09P-00405	FDA UDI	Class II	Active
Resident Expert Software Module	C0258-00808	FDA UDI	Class II	Unknown
Ablation Platform Mounting Hardware	C0257-00733	FDA UDI	Class II	Active
microTargeting™ Guideline 4000 LP+™ Breakout Box	MT-LPP-BOX-00279	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR20)-00471	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBPBN(AZ1)-00291	FDA UDI	Class II	Active
microTargeting ™ Lead Adapter	MT-LA-02-00608	FDA UDI	Class II	Active
microTargeting™ Frame Adapter	66-FA-BL-00393	FDA UDI	Class II	Unknown
microTargeting™ Electrode	5035Z-00577	FDA UDI	Class II	Active
microTargeting™ Guideline 4000™ 5.0 Remote Control	C0222-00684	FDA UDI	Class II	Active
Passive Headrest	PH-2500-00776	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWAN(AR)(AR1)-00360	FDA UDI	Class II	Unknown
microTargeting™ Electrode	MTDWLP(SP)(MP4)-00915	FDA UDI	Class II	Active
OsteoMed™ Power Driver	68-OM-SD-00365	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(BP18)-00503	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(CG7)-00512	FDA UDI	Class II	Active
STar™ Drive Frame Adapter	70-FA-RD-01-00224	FDA UDI	Class II	Unknown
microTargeting™ Array Electrode	25375Z-00792	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWLN(BP)(BP7)-00743	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AR21)-00474	FDA UDI	Class II	Active
WayPoint™ Anchors	66-WP-AN2-00624	FDA UDI	Class II	Active
microTargeting™ Cord Kit	66-EL-CK-CH-00265	FDA UDI	Class II	Unknown
microTargeting™ Spacer Tube	66-PT(IT1)-00698	FDA UDI	Class II	Active
microTargeting™ Electrode	22675L-00244	FDA UDI	Class II	Active
microTargeting™ Electrode	MTBPLN(KB1)-00657	FDA UDI	Class II	Active
STar™ Drive SteriSuite Case	67-00-7-00299	FDA UDI	Class II	Active
microTargeting™ Insertion Tube with Stylet	66-IT(AO10)-00648	FDA UDI	Class II	Active
microTargeting™ Electrode	MTDWXN(BS)(OC3)-00536	FDA UDI	Class II	Active
microTargeting™ Electrode Cable Adapter	C0268-00918	FDA UDI	Class II	Active
microTargeting™ Insertion Tube Set	66-IT-03-00457	FDA UDI	Class II	Active
microTargeting™ Microtable™ Platform – Single	66-MT-D1-00643	FDA UDI	Class II	Unknown
Frame Adapter for Leibinger RM™	66-FA-RM-00616	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