FHC, Inc.
Bowdoin, ME, US
FHC, INC. appears in FDA device records in Bowdoin, ME. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for FHC, Inc. between 2007 and 2023. The busiest year on record is 2007, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231141 | STarFix Designer Software C0265 | QRI | Substantially Equivalent | |
| K200169 | VFS1 Bipolar Electrosurgical Generator | GEI | Substantially Equivalent | |
| K183123 | microTargeting Guideline 4000 5.0 System | GZL | Substantially Equivalent | |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | HAW | Substantially Equivalent | |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | HAW | Substantially Equivalent | |
| K071364 | MICROTARGETING GUIDELINE 4000 | GZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002250546 | 3002250546 | FHC, INC. | 1201 MAIN ST, Bowdoin, ME 04287 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GZLElectrode, Depth
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- HAOInstrument, Surgical, Non-Powered
- HAWNeurological Stereotaxic Instrument
- GAHStylet, Surgical, General & Plastic Surgery
- QRISurgical Planning Software For Neurological Stereotaxic Instruments
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0312-2025 | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures. | 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. | Class I | Open, Classified | |
| Z-2540-2020 | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740 | 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. | Class II | Terminated | |
| Z-2359-2018 | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), | 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. | Class II | Terminated | |
| Z-2358-2018 | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 | 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. | Class II | Terminated | |
| Z-2357-2018 | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 | 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. | Class II | Terminated | |
| Z-2356-2018 | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 | 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. | Class II | Terminated | |
| Z-2355-2018 | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 | 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. | Class II | Terminated | |
| Z-2354-2018 | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB | 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. | Class II | Terminated | |
| Z-2353-2018 | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB | 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. | Class II | Terminated | |
| Z-2352-2018 | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME | 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. | Class II | Terminated | |
| Z-2351-2018 | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA | 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. | Class II | Terminated | |
| Z-2350-2018 | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME | 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. | Class II | Terminated | |
| Z-2349-2018 | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA | 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. | Class II | Terminated | |
| Z-2348-2018 | microTargeting" Drive System, Product Number 66-ZD-MD-01 | 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. | Class II | Terminated | |
| Z-2347-2018 | microTargeting" Drive System, Product Number 66-ZD-MD | 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. | Class II | Terminated | |
| Z-2346-2018 | microTargeting" Drive System, Product Number MT-DS-01 | 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. | Class II | Terminated | |
| Z-2345-2018 | microTargeting" Drive System, Product Number MT-DS | 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. | Class II | Terminated | |
| Z-0314-2011 | Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system. | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | Terminated | ||
| Z-0313-2011 | microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system. | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | Terminated | ||
| Z-0312-2011 | STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system. | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | Terminated | ||
| Z-0311-2011 | microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system. | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | Terminated | ||
| Z-1143-2010 | FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures. | 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. | Terminated | ||
| Z-0499-2009 | FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. | Mislabeled: May contain an electrode longer than labeled size | Terminated | ||
| Z-0498-2009 | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. | Mislabeled: May contain an electrode longer than labeled size | Terminated | ||
| Z-0497-2009 | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. | Mislabeled: May contain an electrode longer than labeled size | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets FHC, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain