Fhc Inc

FDA Filings

This page includes the latest FDA filings for Fhc Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3002250546
FEI Number3002250546
NameFHC, INC.
Owner & OperatorFHC, Inc.
Contact Address1201 Main St. --
Bowdoin ME 04287 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1201 MAIN ST
Bowdoin, ME 04287 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3005161223
FEI Number3005161223
NameFHC, Inc
Owner & OperatorFHC, Inc.
Contact Address1201 Main St. --
Bowdoin ME 04287 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address180 Main St
Greenville, PA 16125 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
FHC, INC.
microTargeting™ Electrode Sterilization Tray 67-00-12024-03-14
FHC, INC.
microTargeting™ Multi-Oblique Accessory 66-ST-MO2024-03-14
FHC, INC.
Passive Headrest PH-25002024-03-12
FHC, INC.
Passive Headrest Accessories PH-25102024-03-12
FHC, INC.
WayPoint™ Standoff Wrench 66-WP-SW2024-03-12
FHC, INC.
WayPoint™ Entry Offset Mounting Hub 66-MP-EH2024-03-12
FHC, INC.
WayPoint™ Target Offset Mounting Hub 66-MP-TH2024-03-12
FHC, INC.
WayPoint™ Standard Mounting Hub 66-MP-MH2024-03-12
FHC, INC.
WayPoint™ Burr Hole Entry Marker Tool 66-MP-EM2024-03-12
FHC, INC.
WayPoint™ Implantation Kit 66-WP-RU2024-03-12
FHC, INC.
microTargeting™ Drive DBS Adapter 66-CN-DB2024-03-12
FHC, INC.
WayPoint™ Sterilization Case 66-WP-SC2024-03-12
FHC, INC.
WayPoint™ Hex Wrench 66-WP-HW2024-03-12
FHC, INC.
STar™ Drive Lead Measurement Fixture 70-AC-MT-012024-03-12
FHC, INC.
STar™ Drive Positioner 70-DP-CS2024-03-12
FHC, INC.
STar™ Drive Positioner 70-DP-OS2024-03-12
FHC, INC.
STar™ Drive Frame Adapter 70-FA-BL2024-03-12
FHC, INC.
STar™ Drive Frame Adapter Kit 70-FA-SF-012024-03-12
FHC, INC.
microTargeting™ WayPoint™ Inserter Kit 66-WP-ID-032024-02-20
FHC, INC.
microTargeting™ Electrode Cable Adapter C02682023-11-24
FHC, INC.
microTargeting™ Platform Accessory MP-KIT-MF2023-10-17
FHC, INC.
STarFix™ Designer C02672023-10-16
FHC, INC.
STarFix™ Designer C02652023-09-26
FHC, INC.
microTargeting™ Electrode MTDWLP(SP)(MP4)2023-09-04
FHC, INC.
microTargeting™ Platform MP-KIT-A-ST2023-08-03
FHC, INC.
microTargeting™ Insertion Tube with Stylet 66-IT(AR23)2023-05-09
FHC, INC.
microTargeting™ Electrode MTDWLN(BP)(BP6)2023-03-20
FHC, INC.
microTargeting™ Insertion Tube with Stylet 66-IT(AR29)2022-10-10
FHC, INC.
microTargeting™ Electrode MTDWZP(AR)(AR7)2022-10-07
FHC, INC.
microTargeting™ Microtable™ Platform – Staged 66-MT-D32022-10-04
FHC, INC.
microTargeting™ Microtable™ Platform – Sequential 66-MT-D22022-10-04
FHC, INC.
microTargeting™ Electrode MTDWZN(AR)(AR7)2022-10-04
FHC, INC.
STar™ Drive Frame Adapter 70-FA-LX-NN2022-10-04
FHC, INC.
Guideline™ 4000 C02172022-09-27
FHC, INC.
microTargeting™ Multi-Oblique Tool Guide 66-MO-082022-08-19
FHC, INC.
microTargeting™ Insertion Tube 66-IT-ME1P2022-06-16
FHC, INC.
microTargeting™ Single Electrode Carrier Set 66-EL-EA-012022-06-16
FHC, INC.
Unibody™ Bone Fiducials (13mm) FM-40132022-05-26
FHC, INC.
Unibody™ Bone Fiducials (10mm) FM-40102022-05-26
FHC, INC.
Unibody™ Bone Fiducials (7mm) FM-40072022-05-26
FHC, INC.
LeadLoc Depth Stop 66-AC-DCM2022-05-10
FHC, INC.
LeadLoc Depth Stop 66-AC-DCS2022-05-03
FHC, INC.
Insertion Tube 66-IT-40L2022-04-06
FHC, INC.
33 cm Lead Insertion Tube Set 70-IT-10232021-12-22
FHC, INC.
Lower Lead Depth Stop 66-AC-LD2021-12-22
FHC, INC.
microTargeting™ NexFrame® Insertion Tube Kit 66-IT-4010S2021-12-15
FHC, INC.
microTargeting™ Insertion Tube with Stylet 66-IT-SG1P2021-11-05
FHC, INC.
microTargeting™ Platform C02842021-11-05
FHC, INC.
microTargeting™ Platform C02832021-11-05
FHC, INC.
microTargeting™ Verification Probe 66-IT-VP-032021-11-05
FHC, INC.
microTargeting™ Platform Accessory MP-KIT-A-PS2021-11-05
FHC, INC.
microTargeting™ Platform MP-KIT-P-SG2021-11-05
FHC, INC.
Lower Lead Depth Stop FC80142021-08-09
FHC, INC.
microTargeting™ Depth Stop FC80132021-08-09
FHC, INC.
STar™ Drive Electrode Carrier FC80102021-08-09
FHC, INC.
STar™ Drive Electrode Carrier FC80082021-08-09
FHC, INC.
microTargeting™ Controller with Motor FC10082021-08-09
FHC, INC.
microTargeting™ STar™ Electrode Carrier FC80102021-07-29
FHC, INC.
WayPoint™ Fiducial Placement Template 66-DA-FT-032021-06-30
FHC, INC.
inomed Adapter 66-WP-IN2021-06-30
FHC, INC.
WayPoint™ Fiducial Placement Template 66-DA-FT-022021-06-21
FHC, INC.
STar™ Drive Electrode Carrier 70-AC-012021-06-15
FHC, INC.
microTargeting™ Platform Accessory MP-KIT-ME2021-06-08
FHC, INC.
WayPoint™ Depth Stop 66-DS-MO2021-06-08
FHC, INC.
microTargeting™ Multi-Oblique Accessory 66-DS-IT2021-06-08
FHC, INC.
WayPoint™ Locator Pins 66-WP-LP2021-06-08
FHC, INC.
microTargeting™ Stylet 66-ST-12P2021-03-15
FHC, INC.
microTargeting™ Stylet 66-ST-122021-03-15
FHC, INC.
Lead Adapter Cable MT-LA-042021-03-01
FHC, INC.
microTargeting™ Stylet 66-ST-14P2021-02-23
FHC, INC.
microTargeting™ Sterile Drape Sleeves FC10042021-02-05
FHC, INC.
33 cm Lead Insertion Tube Set FC10232020-12-18
FHC, INC.
Lower Lead Depth Stop FC80142020-12-18
FHC, INC.
microTargeting™ Insertion Tube with Stylet 66-IT-15P2020-11-10
FHC, INC.
Unibody™ Bone Fiducials (13mm) FM-40132020-11-10
FHC, INC.
Unibody™ Bone Fiducials (10mm) FM-40102020-11-10
FHC, INC.
Unibody™ Bone Fiducials (7mm) FM-40072020-11-10
FHC, INC.
NEXDRIVE™ MI-20002020-11-10
FHC, INC.
NEXDRIVE™ w/DIG MI-10002020-11-10
FHC, INC.
microTargeting™ Multi-Oblique Tool Guide 66-MO-072020-10-14
FHC, INC.
microTargeting™ Insertion Tube with Stylet 66-IT(AR31)2020-09-18
FHC, INC.
Resident Expert Software Module C02582020-08-18
FHC, INC.
VFS1 Footpedal C08412020-08-05
FHC, INC.
VFS1 Generator Main Unit C08402020-08-05
FHC, INC.
WayPoint™ Navigator 66-WP-NV(4.6)2020-08-03
FHC, INC.
Resident Expert Kinetic Testing Motion Detector C02592020-06-29
FHC, INC.
microTargeting™ Platform MP-KIT-P-NB2020-06-08
FHC, Inc.
VFS1 Bipolar Electrosurgical Generator2020-05-14
FHC, INC.
Resident Expert Software Module C02582020-04-06
FHC, INC.
Waypoint™ Navigator C02442020-03-30
FHC, INC.
Waypoint™ Navigator C02432020-03-30
FHC, INC.
Waypoint™ Navigator C02422020-03-30
FHC, INC.
WayPoint™ Navigator C02412020-03-30
FHC, INC.
WayPoint™ Navigator C02392020-03-30
FHC, INC.
WayPoint™ Navigator 66-WP-NV(4.5)2020-03-30
FHC, INC.
Ablation Platform Mounting Hardware C02572020-03-25
FHC, INC.
MicroTargeting™ Sterilization Basket C02562020-03-09
FHC, INC.
MicroTargeting™ RPD Adapter C02552020-03-09
FHC, INC.
MicroTargeting™ RPD Adapter C02542020-03-09
FHC, INC.
microTargeting™ Frame Adapter 66-FA-RD-032020-02-24
FHC, INC.
microTargeting™ Frame Adapter 66-FA-RD-022020-02-24
FHC, INC.
microTargeting(TM) Guideline 4000(TM) 5.0 System2018-12-31
FHC, Inc.
MicroTargeting Guideline 4000 5.0 System2018-12-20
FHC, INC.
microTargeting Microtable Platform2018-01-17
FHC, INC.
DP Stylet 5x 204mm2015-03-06
FHC, INC.
microTargeting XL STar Drive System2012-12-13
FHC, INC.
MICROTARGETING XL STAR DRIVE SYSTEM2012-07-26
FHC, Inc [FHC, Inc.]
WayPoint Stereotactic System2010-02-26
FHC, INC.
WayPoint Stereotactic System2010-02-26
FHC, INC.
WAYPOINT STEREOTACTIC SYSTEM2010-02-12
FHC, INC.
microTargeting STar Drive System2009-10-14
FHC, INC.
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS2009-09-18
FHC, INC.
microTargeting Electrode 1(electrode type)2(material with insulation)3(impedance)4(sterility)(x)(y)variations2007-11-06
FHC, INC.
MP-1 Micropositioner2007-11-06
FHC, INC.
Guideline System 30002007-11-06
FHC, INC.
microTargeting Electrode 1(electrode type)2(material with insulation)3(impedance)4(sterility)(x)(y)variations2007-11-06
FHC, INC.
microTargeting Drive System Acc.2007-11-06
FHC, INC.
MICROTARGETING GUIDELINE 40002007-07-25
FHC, INC.
MICROTARGETING GUIDELINE 40002006-04-10
FHC, INC.
MICROTARGETING DRIVE SYSTEM2006-04-10
FHC, INC.
MICROTARGETING DRIVE SYSTEM2006-04-10
FHC, INC.
MICRO TARGETING ELECTRODE2004-03-24
FHC, INC.
MICRO TARGETING DRIVE SYSTEM2001-08-30
FHC, INC.
FHC MICROTARGETING DRIVE SYSTEM2001-08-14
FHC, INC.
MICROTARGETING DRIVE SYSTEM2001-02-23
FHC, INC.
MICROTARGETING ELECTRODE2000-08-04

Related Finance Registrations
NCAGE Code4GQJ6FHC, INC.
CAGE Code4GQJ6FHC, INC.
S.A.M. Registration4GQJ6 [108179458]FHC, INC.

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