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FHC, Inc.

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accur recall (Z-0312-2025)FHC, Inc.2024-11-08
microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS- recall (Z-0311-2011)FHC, Inc.2010-11-03
STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS De recall (Z-0312-2011)FHC, Inc.2010-11-03
microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a recall (Z-0313-2011)FHC, Inc.2010-11-03
Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives Pr recall (Z-0314-2011)FHC, Inc.2010-11-03
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to recall (Z-1143-2010)FHC, Inc.2010-03-16
FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Driv recall (Z-0486-2009)FHC, Inc.2008-12-22
FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative record recall (Z-0497-2009)FHC, Inc.2008-12-18
FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by M recall (Z-0498-2009)FHC, Inc.2008-12-18
FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minne recall (Z-0499-2009)FHC, Inc.2008-12-18
FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: recall (Z-0179-06)FHC, Inc.2005-11-23
Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System wit recall (Z-0180-06)FHC, Inc.2005-11-23
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with th recall (Z-0895-05)FHC, Inc.2005-06-16

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Every clearance here is in the API, with alerts when new ones post.