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Data / Medical devices / Electrode, Depth

Electrode, Depth (GZL): 16 FDA-registered makers in 6 countries

16 establishments in 6 countries are registered with the FDA to make Electrode, Depth (product code GZL, Class 2, 21 CFR 882.1330). 10 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on April 17, 2026, and lists 11 recall events (1 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
GZL
Device class
2
Regulation
882.1330
Medical specialty
Neurology

Makers by country

CountryMakers
United States9
Israel2
France2
Ireland1
Canada1
Denmark1

Makers of Electrode, Depth

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alpha Omega Engineering Ltd.Nof HaGalil Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer11March 30, 2025011api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer6May 18, 2023050api.fda.gov
PMT Corp.Chanhassen, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer5July 14, 2016000api.fda.gov
Blackrock MicrosystemsSalt Lake City, UT, United StatesManufacturer3February 9, 2011000api.fda.gov
FHC, Inc.Bowdoin, ME, United StatesManufacturer3December 20, 2018030api.fda.gov
Dixi MedicalMARCHAUX-CHAUDEFONTAINE Doubs, FranceComplaint file establishment, Manufacturer2November 18, 2021000api.fda.gov
Neuroone Medical Technologies Corp.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer2October 20, 2022000api.fda.gov
FISHER WALLACE LABORATORIES IncBrooklyn, NY, United StatesSpecification developer1September 7, 1990000api.fda.gov
Natus Manufacturing LimitedGORT, Co. Galway(County), IrelandComplaint file establishment, Specification developer1December 12, 2014000api.fda.gov
Sensomedical Labs Ltdnazareth Northern, IsraelManufacturer1April 17, 2026000api.fda.gov
Cirtec MedicalBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Diros Technology, Inc.MARKHAM Ontario, CanadaManufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Paul E. Danchell A/SJyderup Sjaelland, DenmarkContract manufacturer0000api.fda.gov
Qxmedical, LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov

Updated April 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.