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Device Explorer · FDA GUDID · GMDN 46566

Neurophysiologic monitoring system

An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of acc

US‑registered devices350in commercial distribution
Companies13labelers on GUDID
Single‑use48%of device records
Sterile11%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Nuvasive, Inc.17650%
Alphatec Spine, Inc.3811%
Cadwell Industries, Inc.339%
Nihon Kohden America, Inc.278%
Nihon Kohden Corporation247%
Fhc, Inc.226%
Covidien Lp113%
Shenzhen Changke Connect Electronics Co., Ltd.82%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.17650%
Alphatec Spine, Inc.3811%
Cadwell Industries, Inc.339%
Nihon Kohden America, Inc.278%
Nihon Kohden Corporation247%
Fhc, Inc.226%
Covidien Lp113%
Shenzhen Changke Connect Electronics Co., Ltd.82%
Natus Manufacturing Limited72%
Digitimer Limited10%
Neurosoft, Ooo10%
G.Tec Medical Engineering Gmbh10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Changke ConnectDigitimerNANeuromaster G1NeuromasterNeuro-IOMcortiQ PROPULSENVM5LessRayReLineNuVasiveABS PlexisPMMARemote MonitoringNVJJB

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE210
ETNSTIMULATOR, NERVE202
IKNElectromyograph, diagnostic197
PDQNeurosurgical nerve locator190
OLOOrthopedic stereotaxic instrument136
HAWNeurological stereotaxic Instrument135

GMDN & GCC registration

  • GMDN code 46566 · non‑implantable
  • Single‑use 48% · sterile 11% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many neurophysiologic monitoring system products are registered in the US?

350 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Neurophysiologic monitoring system", from 13 companies. The largest labeler is Nuvasive, Inc. with 50% of records.

Which FDA product codes apply?

GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE), ETN (STIMULATOR, NERVE), IKN (Electromyograph, diagnostic), PDQ (Neurosurgical nerve locator)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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