FHC, Inc.
FHC, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2023, with 17 FDA device recalls on record.
Top product codes for FHC, Inc.
FDA recalls by FHC, Inc.
10 most recent of 17- 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.
- 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
- Z-2346-2018 — microTargeting" Drive System, Product Number MT-DS-01
- Z-2351-2018 — microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
- Z-2357-2018 — microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
- Z-2358-2018 — microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
- Z-2355-2018 — microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
- Z-2359-2018 — microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
- Z-2348-2018 — microTargeting" Drive System, Product Number 66-ZD-MD-01
- Z-2356-2018 — microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by FHC, Inc.
- K231141 — STarFix Designer Software C0265
- K200169 — VFS1 Bipolar Electrosurgical Generator
- K183123 — microTargeting Guideline 4000 5.0 System
- K121950 — MICROTARGETING XL STAR DRIVE SYSTEM
- K092192 — WAYPOINT STEREOTACTIC SYSTEM
- K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
- K071364 — MICROTARGETING GUIDELINE 4000
- K033173 — MICRO TARGETING ELECTRODE
- K011775 — MICRO TARGETING DRIVE SYSTEM
- K011992 — FHC MICROTARGETING DRIVE SYSTEM
- K003776 — MICROTARGETING DRIVE SYSTEM
- K991522 — MICROTARGETING ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.