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Sign in to claim this brandFHC, 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/
- —
- —
- [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 15 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Waypoint Stereotactic System | K092192 | FDA 510(k) | Class II | Active |
| Microtargeting Guideline 4000 | K071364 | FDA 510(k) | Class II | Active |
| VFS1 Bipolar Electrosurgical Generator | K200169 | FDA 510(k) | Class II | Active |
| Fhc Microtargeting Drive System | K011992 | FDA 510(k) | Class II | Active |
| Micro Targeting Electrode | K033173 | FDA 510(k)FDA UDI | Class II | Active |
| Visualase™ Neuro Accessories and Tools | 9736545 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736541 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736543 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736537 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736544 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736540 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736539 | EUDAMEDFDA UDI | Class I | Active |
| Visualase™ Neuro Accessories and Tools | 9736536 | EUDAMEDFDA UDI | Class IIa | Active |
| Visualase™ Neuro Accessories and Tools | 9736538 | EUDAMEDFDA UDI | Class IIa | 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 |