FHC, Inc.

FDA Regulatory Profile

Summary

Total Recalls
17 (1 Class I)
510(k) Clearances
12
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0312-2025Class ImicroTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guidOctober 4, 2024
Z-2540-2020Class IIFHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate eJune 17, 2020
Z-2346-2018Class IImicroTargeting" Drive System, Product Number MT-DS-01May 10, 2018
Z-2348-2018Class IImicroTargeting" Drive System, Product Number 66-ZD-MD-01May 10, 2018
Z-2356-2018Class IImicroTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601May 10, 2018
Z-2351-2018Class IImicroTargeting" STar" Drive System (Manual), Product Number 70-ZD-MAMay 10, 2018
Z-2358-2018Class IImicroTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002May 10, 2018
Z-2355-2018Class IImicroTargeting" Drive System Distributed by Medtronic, Product Number FC1006May 10, 2018
Z-2359-2018Class IImicrotargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),May 10, 2018
Z-2347-2018Class IImicroTargeting" Drive System, Product Number 66-ZD-MDMay 10, 2018
Z-2354-2018Class IImicroTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DBMay 10, 2018
Z-2349-2018Class IImicroTargeting" STar" Drive System (Manual), Product Number ST-DS-MAMay 10, 2018
Z-2352-2018Class IImicroTargeting" STar" Drive System (Motorized), Product Number 70-ZD-MEMay 10, 2018
Z-2353-2018Class IImicroTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DBMay 10, 2018
Z-2350-2018Class IImicroTargeting" STar" Drive System (Motorized), Product Number ST-DS-MEMay 10, 2018
Z-2345-2018Class IImicroTargeting" Drive System, Product Number MT-DSMay 10, 2018
Z-2357-2018Class IImicroTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001May 10, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K231141STarFix Designer Software C0265September 8, 2023
K200169VFS1 Bipolar Electrosurgical GeneratorMay 14, 2020
K183123microTargeting Guideline 4000 5.0 SystemDecember 20, 2018
K121950MICROTARGETING XL STAR DRIVE SYSTEMJuly 26, 2012
K092192WAYPOINT STEREOTACTIC SYSTEMFebruary 12, 2010
K092562MICROTARGETING STAR DRIVE SYSTEM, COMPONENTSSeptember 18, 2009
K071364MICROTARGETING GUIDELINE 4000July 25, 2007
K033173MICRO TARGETING ELECTRODEMarch 24, 2004
K011775MICRO TARGETING DRIVE SYSTEMAugust 30, 2001
K011992FHC MICROTARGETING DRIVE SYSTEMAugust 14, 2001
K003776MICROTARGETING DRIVE SYSTEMFebruary 23, 2001
K991522MICROTARGETING ELECTRODEAugust 4, 2000