FHC, Inc.
Medical device manufacturer in Bowdoin, ME.
12510(k) clearances
0PMA approvals
26recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231141 | STarFix Designer Software C0265QRI · Traditional | 09/08/2023SE |
| K200169 | VFS1 Bipolar Electrosurgical GeneratorGEI · Traditional | 05/14/2020SE |
| K183123 | microTargeting Guideline 4000 5.0 SystemGZL · Special | 12/20/2018SE |
| K121950 | Microtargeting XL Star Drive SystemHAW · Special | 07/26/2012SE |
| K092192 | Waypoint Stereotactic SystemHAW · Traditional | 02/12/2010SE |
| K092562 | Microtargeting Star Drive System, ComponentsHAW · Special | 09/18/2009SE |
| K071364 | Microtargeting Guideline 4000GZL · Traditional | 07/25/2007SE |
| K033173 | Micro Targeting ElectrodeGZL · Traditional | 03/24/2004SE |
| K011775 | Micro Targeting Drive SystemHAW · Traditional | 08/30/2001SE |
| K011992 | FHC Microtargeting Drive SystemHAW · Special | 08/14/2001SE |
| K003776 | Microtargeting Drive SystemHAW · Traditional | 02/23/2001SE |
| K991522 | Microtargeting ElectrodeGZL · Traditional | 08/04/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0312-2025 Class I | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to…A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed… | 10/04/2024Open, Classified |
| Z-2540-2020 Class II | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and…An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of… | 06/17/2020Terminated |
| Z-2359-2018 Class II | 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… | 05/10/2018Terminated |
| Z-2358-2018 Class II | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2357-2018 Class II | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2356-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2355-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2354-2018 Class II | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DBThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2353-2018 Class II | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DBThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2352-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2351-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2350-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2349-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2348-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MD-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2347-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MDThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2346-2018 Class II | microTargeting" Drive System, Product Number MT-DS-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-2345-2018 Class II | microTargeting" Drive System, Product Number MT-DSThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | 05/10/2018Terminated |
| Z-0314-2011 | Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-0313-2011 | microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-0312-2011 | STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-0311-2011 | microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-1143-2010 | FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended…The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if… | 12/28/2009Terminated |
| Z-0499-2009 | FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc.…Mislabeled: May contain an electrode longer than labeled size | 10/20/2008Terminated |
| Z-0498-2009 | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by…Mislabeled: May contain an electrode longer than labeled size | 10/20/2008Terminated |
| Z-0497-2009 | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative…Mislabeled: May contain an electrode longer than labeled size | 10/20/2008Terminated |
| Z-0486-2009 | FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting…Measuring fixture is incorrectly graduated. | 10/08/2008Terminated |