510(k) Report

FDA applicant

Technomed Europe

Maastricht-Airport, NL13 decisions1999–20263 recalls

FDA records 13 decisions for Technomed Europe (Maastricht-Airport, NL) from 1999 to 2026: 13 510(k) clearances. Most are in product codes GXZ (Electrode, Needle) and IKT (Electrode, Needle, Diagnostic Electromyograph). Its devices cite 39 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Technomed Europe’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 32008: 12011: 12012: 12013: 12024: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2024

2021: 12022: 12024: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Technomed Europe by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXZElectrode, Needle4decisions
  • IKTElectrode, Needle, Diagnostic Electromyograph3decisions
  • GXYElectrode, Cutaneous3decisions
  • ETNStimulator, Nerve2decisions
  • GXIProbe, Radiofrequency Lesion1decision

Whose devices does it build on?

Its devices cite 39 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990015Electrode NeedlesTechnomed Europe · 19995cite it
  • K042375SMK, CX, Cxe, RCNTechnomed Europe · 20044cite it
  • K072016Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride ReusableTechnomed Europe · 20074cite it
  • K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeTechnomed Europe · 20054cite it
  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20133cite it
  • K062437Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledTechnomed Europe · 20073cite it

What has FDA decided for it lately?

  • K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026
  • K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode…Technomed Europe · 2026
  • K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20132 recalls
  • K121257Laryngeal ElectrodeTechnomed Europe · 2012
  • K110422Surgical StimulatorsTechnomed Europe · 20111 recall
  • K073532Disposable Adhesive Surface Electrodes, Disc ElectrodesTechnomed Europe · 2008
  • K072016Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride ReusableTechnomed Europe · 2007

All 13 as Technomed Europe →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K110422NEUROSIGN Disposable Stimulating Dissector, REF 5888-00Jul 25, 2024Class II
  • K130136Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25…Aug 9, 2022Class II
  • K130136Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers…Dec 8, 2021Class II

Other applicant names beginning “Technomed”

FDA records each applicant name separately; these may or may not be the same firm.

Technomed Medical Systems, SA 1