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Fhc, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000012111 FEI 3002250546

Fhc, Inc. is a medical device manufacturer based in the United States, with 726 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I and IIa) and 29 FDA recalls as of 12 Nov 2026.

Devices
726
Registrations
EUDAMEDFDA
FDA recalls
291 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 714
  • EUDAMED 102
  • FDA 510(k) 12

A device listed in two registries counts in both.

Device classes
  • FDA Class II 708
  • EU Class I 8
  • FDA Class I 7
  • EU Class IIa 3
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000012111
  • FDA FEI 3002250546
  • DUNS 108179458

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
Termobit Prod SRLRO

What Fhc, Inc. makes

FHC, Inc. manufactures a range of neurosurgical devices including depth electrodes, implantable and non‑implantable intracerebral cannulas (both single‑use and reusable), a neurological stereotactic surgery system, neurosurgical micro‑targeting drives, a neurophysiologic monitoring system, and single‑use patient surgical drapes. Specific products include the microTargeting™ Insertion Tube with Stylet, WayPoint™ Sterilization Case, STar™ Drive MA/M/E, and the Nexprobe® system.

The portfolio is regulated as Class I and Class II medical devices and is listed in the FDA UDI registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue726

Newest first, rows 1-50 of 726

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Showing 1-50 of 726

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000012111
FDA FEI number
3002250546
DUNS number
108179458
EUDAMED status
Active
EUDAMED registered name
FHC Inc.
Registered address
1201, Main St, 04287, Bowdoin, United States
Phone
+1(800)326-2905
PRRC contact
Kelly Moeykens(public in EUDAMED)

FDA recalls29

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 29 recalls initiated by FHC, INC., the earliest on 2005-03-14 and the most recent on 2024-10-04. By recorded status: 1 ongoing and 28 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, electrical or power, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 15
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

12 initiated before 2017

Showing the 10 most recent of 29 recalls.

  • 2024

    • 4 Oct 2024 Z-0312-2025 Class I Ongoing A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage. Distribution: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA. Submission number: K011775

  • 2020

    • 17 Jun 2020 Z-2540-2020 Class II Terminated An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur. Distribution: US Nationwide distribution including in the states of CA, NC, TN, TX, WA. Submission number: K183123

  • 2018

    • 10 May 2018 Z-2345-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2346-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2347-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2348-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2349-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2350-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2351-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2352-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
Show the 25 most recent of 29 recalls

  • 2018

    • 10 May 2018 Z-2353-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011992
    • 10 May 2018 Z-2354-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2355-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2356-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011775
    • 10 May 2018 Z-2357-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2358-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K092562
    • 10 May 2018 Z-2359-2018 Class II Terminated The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure. Distribution: The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
      Full distribution text The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
      Submission number: K011992

  • 2010

    • 30 Mar 2010 Z-0311-2011 Unclassified (pre-2012) Terminated Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. Distribution: Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of…
      Full distribution text Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
      Submission number: K003776
    • 30 Mar 2010 Z-0312-2011 Unclassified (pre-2012) Terminated Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. Distribution: Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of…
      Full distribution text Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
      Submission number: K092562
    • 30 Mar 2010 Z-0313-2011 Unclassified (pre-2012) Terminated Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. Distribution: Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of…
      Full distribution text Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
      Submission number: K003776
    • 30 Mar 2010 Z-0314-2011 Unclassified (pre-2012) Terminated Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. Distribution: Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of…
      Full distribution text Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
      Submission numbers: K003776, K092562

  • 2009

    • 28 Dec 2009 Z-1143-2010 Unclassified (pre-2012) Terminated The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location. Distribution: Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania. Submission number: K071364

  • 2008

    • 20 Oct 2008 Z-0497-2009 Unclassified (pre-2012) Terminated Mislabeled: May contain an electrode longer than labeled size Distribution: Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR. Submission number: K991522
    • 20 Oct 2008 Z-0498-2009 Unclassified (pre-2012) Terminated Mislabeled: May contain an electrode longer than labeled size Distribution: Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR. Submission number: K991522
    • 20 Oct 2008 Z-0499-2009 Unclassified (pre-2012) Terminated Mislabeled: May contain an electrode longer than labeled size Distribution: Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR. Submission number: K991522

Frequently asked questions

How many devices does FHC, INC. have in the registry?

The registry currently lists 726 devices for FHC, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list FHC, INC.'s devices?

Among its 50 most recently registered devices, FHC, INC. has devices listed in EUDAMED (4 devices) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do FHC, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for FHC, INC.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for FHC, INC.?

FDA recall records list 29 recalls initiated by FHC, INC., the most recent initiated on 4 Oct 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from FHC, INC. in the registry?

The most recently registered devices listed for FHC, INC. include ATLAS Neurophysiology System, microTargeting™ Electrode 35325Z-00949, microTargeting™ Electrode MTDWLN(BP)(BP11)-00962 and microTargeting™ Insertion Tube 66-IT-IT2P-00769.

Generated automatically from registry data and not verified by a human reviewer.