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.
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™ Frame Adapter 66-FA-RD-012020-02-24
FHC, INC.
microTargeting™ Frame Adapter 66-FA-LX-012020-02-24
FHC, INC.
microTargeting™ Cleaning Brushes 66-CN-BR2020-02-21
FHC, INC.
Guideline 4000™ 5.0 C02172020-02-19
FHC, INC.
WayPoint™ Combination Driver Bit 66-WP-CD-012020-02-05
FHC, INC.
WayPoint™ Combination Driver Bit 66-WP-CD2020-02-05
FHC, INC.
microTargeting™ Platfrom Accessory MP-KIT-A-MS2020-02-04
FHC, INC.
microTargeting™ Insertion Tube 66-IT-MR32020-01-08
FHC, INC.
microTargeting™ Insertion Tube FC90022020-01-08
FHC, INC.
microTargeting™ STar™ Insertion Tube FC80092020-01-08
FHC, INC.
microTargeting™ Insertion Tube Set FC10362020-01-08
FHC, INC.
microTargeting™ Insertion Tube FC10192020-01-08
FHC, INC.
microTargeting™ Electrodes FC50002020-01-08
FHC, INC.
microTargeting™ Electrodes FC20042020-01-08
FHC, INC.
microTargeting™ Electrode FC20022020-01-08
FHC, INC.
microTargeting™Array Electrode Insertion Tube Set FC10122020-01-08
FHC, INC.
microTargeting™ Insertion Tube Set FC10112020-01-08
FHC, INC.
microTargeting™ Insertion Tube 66-IT-MR32020-01-07
FHC, INC.
microTargeting™ STar™ Insertion Tube Set FC90032020-01-06
FHC, INC.
microTargeting™ STar™ Insertion Tube FC90012020-01-06
FHC, INC.
microTargeting™ Insertion Tube FC7140LI2020-01-06
FHC, INC.
microTargeting™ Insertion Tube FC10182020-01-06
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit KTF10022020-01-06
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit FC71002020-01-06
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit FC40012020-01-06
FHC, INC.
microTargeting™ Electrode and Insertion Tube FC40002020-01-06
FHC, INC.
microTargeting™ Electrode FC20032020-01-06
FHC, INC.
microTargeting™ Electrode FC20012020-01-06
FHC, INC.
microTargeting™ Electrode FC10032020-01-06
FHC, INC.
microTargeting™ Electrode FC10022020-01-06
FHC, INC.
microTargeting™ Electrode 346802020-01-06
FHC, INC.
microTargeting™ Electrode 226702020-01-06
FHC, INC.
microTargeting™ Single Procedure Kit KTF10012020-01-06
FHC, INC.
WayPoint™ Entry Offset Mounting Hub 66-MP-EH2019-12-25
FHC, INC.
WayPoint™ Standard Mounting Hub 66-MP-MH2019-12-25
FHC, INC.
microTargeting™ Electrode FC10032019-12-20
FHC, INC.
microTargeting™ Electrode FC10022019-12-20
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit KTF10022019-12-20
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit FC71002019-12-20
FHC, INC.
microTargeting™ Electrodes FC20042019-12-20
FHC, INC.
microTargeting™ Electrode FC20032019-12-20
FHC, INC.
microTargeting™ Electrode FC20022019-12-20
FHC, INC.
microTargeting™ Electrode FC20012019-12-20
FHC, INC.
microTargeting™ Electrode 346802019-12-20
FHC, INC.
microTargeting™ Electrode 226702019-12-20
FHC, INC.
microTargeting™ STar™ Insertion Tube Set FC90032019-12-20
FHC, INC.
microTargeting™ Insertion Tube FC90022019-12-20
FHC, INC.
microTargeting™ STar™ Insertion Tube FC90012019-12-20
FHC, INC.
microTargeting™ STar™ Insertion Tube FC80092019-12-20
FHC, INC.
microTargeting™ Insertion Tube FC7140LI2019-12-20
FHC, INC.
microTargeting™ Electrodes FC50002019-12-20
FHC, INC.
microTargeting™ Electrode and Insertion Tube Kit FC40012019-12-20
FHC, INC.
microTargeting™ Electrode and Insertion Tube FC40002019-12-20
FHC, INC.
microTargeting™ Insertion Tube Set FC10362019-12-20
FHC, INC.
microTargeting™ Insertion Tube FC10192019-12-20
FHC, INC.
microTargeting™ Insertion Tube FC10182019-12-20
FHC, INC.
microTargeting™Array Electrode Insertion Tube Set FC10122019-12-20
FHC, INC.
microTargeting™ Insertion Tube Set FC10112019-12-20
FHC, INC.
microTargeting™ Single Procedure Kit KTF10012019-12-20
FHC, INC.
microTargeting™ Array Electrode Insertion Tube Set FC10122019-12-20
FHC, INC.
microTargeting™ Insertion Tube Set FC10112019-12-20
FHC, INC.
microTargeting™ Spacer Tube 66-PT(DB3)2019-11-07
FHC, INC.
microTargeting™ Depth Stop 66-AC-DS(1.8)2019-10-25
FHC, INC.
microTargeting™ Spacer Tube 66-PT(DB7)2019-10-18
FHC, INC.
microTargeting™ Electrode 45375Z2019-09-23
FHC, INC.
microTargeting™ Electrode 44375Z2019-09-23
FHC, INC.
microTargeting™ Electrode 35385Z2019-09-23
FHC, INC.
microTargeting™ Electrode 34385Z2019-09-23
FHC, INC.
microTargeting™ Array Electrode 25375Z2019-09-23
FHC, INC.
microTargeting™ Array Electrode 22375Z2019-09-23
FHC, INC.
microTargeting™ Electrode MTDPXN(SP)(AO9)2019-09-23
FHC, INC.
microTargeting™ Electrode MTDPXN(BP)(BP7)2019-09-23
FHC, INC.
microTargeting™ Electrode MTDPLN(PA)(DB2)2019-09-23
FHC, INC.
microTargeting™ Electrode MTDPBN(PA)(DB2)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBWBN(WH1)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBWAN(JJ2)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBPXN(EN3)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBPBN(KB1)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBPBN(EN2)2019-09-23
FHC, INC.
microTargeting™ Electrode MTBPBN(AZ1)2019-09-23
FHC, INC.
microTargeting™ Electrode 44935Z2019-09-23
FHC, INC.
microTargeting™ Electrode 34625Z2019-09-23
FHC, INC.
microTargeting™ Electrode 34625L2019-09-23
FHC, INC.
microTargeting™ Electrode 22635Z2019-09-23
FHC, INC.
microTargeting™ Electrode 22635L2019-09-23
FHC, INC.
microTargeting™ Electrode 22630R2019-09-23
FHC, INC.
microTargeting™ Electrode Lead Cable C02322019-09-23
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

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