FDA.reportPublic FDA data

FHC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30022505463002250546FHC, INC.1N2026-01-011201 MAIN ST Bowdoin ME US 04287
30051612233005161223FHC, Inc1N2026-01-01180 Main St Greenville PA US 16125

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00873263003046WayPoint™ Surgical Kit - WayPoint Disposable Surgical Kit, sterile+1(800)326-2905fhcinc@fh-co.com
00873263003190WayPoint™ Implant Kit - WayPoint Disposable Implantation Kit, sterile+1(800)326-2905fhcinc@fh-co.com
00873263007693microTargeting™ Insertion Tube - Insertion Tube Set, 20mm above target, For use with Stereotactic Frame Contains: (1) Insertion Tube ID 1.6mm and Stylet (1) Spacer Tube+1(800)326-2905fhcinc@fh-co.com
00873263007785microTargeting™ Insertion Tube - microTargeting Insertion Tube with Stylet, nonsterile+1(800)326-2905fhcinc@fh-co.com
00873263007792microTargeting™ Insertion Tube - microTargeting™ Spacer Tube, nonsterile, for use with 66-IT(IT2)+1(800)326-2905fhcinc@fh-co.com
00873263009468microTargeting™ Platform - microTargeting™ Multi-Oblique Visualase Platform, 1x, nonsterile+1(800)326-2905fhcinc@fh-co.com
00873263009475microTargeting™ Measurement Probe - Measurement Probe (8mm Hub), 1x+1(800)326-2905fhcinc@fh-co.com
00873263009604microTargeting™ Measurement Probe - Measurement Probe (8mm Hub), 1x+1(800)326-2905fhcinc@fh-co.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
562171787376251K991522MICROTARGETING ELECTRODEGZL2000-08-04
562171480242670K990683AXON MP-1 MICROPOSITIONERHAW1999-11-03
562172062900221K970943GUIDELINE SYSTEMGZL1997-08-18
562171844245920K231141STarFix Designer Software C0265QRI2023-09-08
562171327305399K200169VFS1 Bipolar Electrosurgical GeneratorGEI2020-05-14
562171404441589K183123microTargeting Guideline 4000 5.0 SystemGZL2018-12-20
562171119213716K132611MICROTABLE SYSTEMHAW2014-03-06
562171367191877K121950MICROTARGETING XL STAR DRIVE SYSTEMHAW2012-07-26
562171007601530K092562MICROTARGETING STAR DRIVE SYSTEM, COMPONENTSHAW2009-09-18
2043141860479042K092192WAYPOINT STEREOTACTIC SYSTEMHAW2010-02-12
562171860479042K092192WAYPOINT STEREOTACTIC SYSTEMHAW2010-02-12
562171497850486K071364MICROTARGETING GUIDELINE 4000GZL2007-07-25
562171065038734K040334NAVIGUS PASSIVE PROBE, MODEL NP-1000HAW2004-10-04
562171809149394K033619NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000HAW2004-03-02
562171811512071K033173MICRO TARGETING ELECTRODEGZL2004-03-24
562171673888380K031885NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXXHBL2003-08-21
562171343207272K022100NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010HAW2002-09-25
562171113974889K012366NAVIGUS II TRAJECTORY GUIDEHAW2001-10-01
562171415019883K011992FHC MICROTARGETING DRIVE SYSTEMHAW2001-08-14
562171697281204K011775MICRO TARGETING DRIVE SYSTEMHAW2001-08-30
562171174014002K003776MICROTARGETING DRIVE SYSTEMHAW2001-02-23
562171294505183
562171562977110

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW132014-03-06
GZL52018-12-20
QRI12023-09-08
GEI12020-05-14
HBL12003-08-21

PMN#

GUDID#

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