Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Stimulator, Nerve

FDA product code ETN · 94 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.1820
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-12-07 – 2026-02-27

ETN 2026-02-27

Evala Nerve Stimulator (EPNR002)

Applicant Epineuron Technologies, Inc.

K number K253536

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ETN 2026-02-10

NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

Applicant Medtronic Xomed, Inc.

K number K251672

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ETN 2025-06-13

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

Applicant Inomed Medizintechnik GmbH

K number K242852

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ETN 2024-12-13

Bioscope Neuromonitor Device

Applicant Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

K number K233001

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ETN 2024-07-31

EARP Nerve Cuff Electrode

Applicant Retropsoas Technologies, LLC

K number K241917

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ETN 2023-12-21

Disposable Laryngeal Electrodes

Applicant Suzhou Haishen Medical Device Associates Co., Ltd.

K number K232888

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ETN 2023-10-26

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

Applicant Medtronic Xomed, Inc.

K number K230320

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ETN 2023-10-06

EARP Nerve Cuff Electrode

Applicant Nvision Biomedical Technologies, Inc.

K number K230853

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ETN 2023-08-30

NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

Applicant Medtronic Xomed, Inc.

K number K231580

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ETN 2023-01-27

C2 Xplore

Applicant Inomed Medizintechnik GmbH

K number K223254

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ETN 2022-11-11

Mapping Suction Probe

Applicant Inomed Medizintechnik GmbH

K number K212164

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ETN 2022-03-21

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long

Applicant Medtronic Xomed, Inc.

K number K213246

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ETN 2021-08-26

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

Applicant Checkpoint Surgical

K number K212355

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ETN 2020-11-10

StimSite

Applicant Allotrope Medical, Inc.

K number K200886

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ETN 2016-05-06

FREMAP ELECTRODE

Applicant Ad-Tech Medical Instrument Corporation

K number K152769

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ETN 2016-02-01

C2 NerveMonitor System

Applicant Inomed Medizintechnik GmbH

K number K152505

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ETN 2013-10-31

INVOTEC LARYNGEAL ELECTRODE

Applicant Invotec International, Inc.

K number K122040

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ETN 2012-10-19

NONDISPOSABLE STIMULATING INSTRUMENTS

Applicant Neurovision Medical Products, Inc.

K number K121931

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ETN 2012-08-28

LARYNGEAL ELECTRODE

Applicant Technomed Europe

K number K121257

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ETN 2012-06-27

NEXT GEN EMG ENDOTRACHEAL TUBE

Applicant Medtronic Xomed, Inc.

K number K112686

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ETN 2012-04-13

NUVASIVE NVJJB SYSTEM

Applicant Nuvasive, Inc.

K number K112717

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ETN 2012-04-02

XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES

Applicant Xian Friendship Medical Electronics Co., Ltd.

K number K112426

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ETN 2012-03-16

NUVASIVE NVM5 SYSTEM

Applicant Nuvasive, Inc.

K number K112718

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ETN 2012-02-09

STIMULATION/DISSECTION INSTRUMENTS

Applicant Nu Vasive, Incorporated

K number K112709

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ETN 2011-12-28

SEASPINE MONOPOLAR PROBE SYSYEM

Applicant Seaspine, Inc.

K number K111671

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ETN 2011-11-03

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

Applicant Neurovision Medical Products, Inc.

K number K110989

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ETN 2011-10-13

DISPOSABLE STIMULATING ELECTRODE

Applicant Nuvasive, Inc.

K number K111597

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ETN 2011-09-22

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

Applicant Rhythmlink International, LLC

K number K112435

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ETN 2011-07-07

NEURO CHECK DEVICE WITH IO-FLEX WIRE

Applicant Baxano, Inc.

K number K110696

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ETN 2011-06-28

DRYTOUCH SUCTION STIMULATOR PROBE

Applicant Neurovision Medical Products, Inc.

K number K110712

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ETN 2011-05-26

SURGICAL STIMULATORS

Applicant Technomed Europe

K number K110422

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ETN 2011-04-08

PAIRED HYDROGEL ELECTRODE

Applicant Neurovision Medical Products, Inc.

K number K110138

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ETN 2011-02-23

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

Applicant Cadwell Lab, Inc.

K number K103128

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ETN 2010-12-21

NEUROVISION SE (NERVEANA)

Applicant Neurovision Medical Products, Inc.

K number K102862

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ETN 2010-09-24

NEURALMAS

Applicant Innovative Surgical Solutions, LLC ("Iss")

K number K100992

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ETN 2010-08-24

LARYNGEAL SURFACE ELECTRODE

Applicant Spes Medica Srl

K number K093373

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ETN 2009-11-18

INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656

Applicant Inomed Medizintechnik GmbH

K number K091874

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ETN 2009-10-28

CHECKPOINT

Applicant Ndi Medical, LLC

K number K092292

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ETN 2009-10-02

BAXANO NEURO CHECK DEVICE

Applicant Baxano, Inc.

K number K092729

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ETN 2009-07-29

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

Applicant The Magstim Company , Ltd.

K number K083242

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ETN 2009-07-20

STIMULUS/DISSECTION INSTRUMENTS

Applicant Axon Systems, Inc.

K number K090838

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ETN 2008-09-17

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

Applicant Baxano, Inc.

K number K081742

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ETN 2008-01-22

RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT

Applicant Rhythmlink International, LLC

K number K072736

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ETN 2007-12-12

NEUROSIGN LARYNGEAL ELECTRODES

Applicant The Magstim Company , Ltd.

K number K071349

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ETN 2007-01-05

HILGER DUAL-STIM NERVE STIMULATOR

Applicant Wr Medical Electronics Co.

K number K063560

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ETN 2006-11-29

STIMULATING BUR GUARD

Applicant Medtronic Xomed, Inc.

K number K063305

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ETN 2006-10-04

XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238

Applicant Excel Tech. , Ltd.

K number K062549

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ETN 2006-07-12

CHECKPOINT WITH ACCUSTIM TECHNOLOGY

Applicant Ndi Medical, LLC

K number K061365

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ETN 2005-12-14

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

Applicant The Magstim Company , Ltd.

K number K053141

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ETN 2005-09-15

NUVASIVE NEUROVISION JJB SYSTEM

Applicant Nuvasive, Inc.

K number K051718

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ETN 2005-03-03

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE

Applicant Medtronic Xomed, Inc.

K number K050162

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ETN 2004-04-01

NUVASIVE NEUROVISION JJB SYSTEM

Applicant Nuvasive, Inc.

K number K040543

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ETN 2003-10-24

NUVASIVE NEUROVISION JJB SYSTEM

Applicant Nuvasive, Inc.

K number K032083

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ETN 2003-06-18

NIM-SPINE

Applicant Medtronic Xomed

K number K031510

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ETN 2003-04-11

STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

Applicant Medtronic Xomed, Inc.

K number K031003

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ETN 2002-10-24

GYRUS ENT NERVE STIMULATOR

Applicant Gyrus Ent LLC

K number K021595

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ETN 2002-04-17

NICOLET ELECTROCAUTERY DETECTOR

Applicant Nicolet Biomedical, Inc.

K number K020955

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ETN 2002-01-22

STIMULUS - DISSECTION INSTRUMENTS

Applicant Medtronic Xomed, Inc.

K number K014165

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ETN 2001-04-20

MODIFICATION TO CAVERMAP SURGICAL AID

Applicant Uromed Corp.

K number K010213

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ETN 2001-01-16

LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET

Applicant Rln Systems, Inc.

K number K003745

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ETN 2000-04-21

CAVERMAP SURGICAL AID

Applicant Uromed Corp.

K number K000507

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ETN 1999-10-07

XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE

Applicant Xomed, Inc.

K number K992869

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ETN 1999-05-19

NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR

Applicant The Magstim Company , Ltd.

K number K991583

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ETN 1998-09-04

NIM4

Applicant Xomed, Inc.

K number K982595

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ETN 1998-08-05

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

Applicant The Magstim Company , Ltd.

K number K980148

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ETN 1997-10-27

URO MED NERVE STIMULATOR

Applicant Uromed Corp.

K number K970971

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ETN 1997-06-06

NEURO PULSE II,III

Applicant Aaron Medical Industries

K number K971143

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ETN 1997-05-14

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

Applicant The Magstim Company , Ltd.

K number K964869

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ETN 1995-12-22

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION

Applicant Rln Systems, Inc.

K number K954601

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ETN 1995-06-02

NEUROSIGN 100 IMPEDANCE METER

Applicant The Magstim Company , Ltd.

K number K945799

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ETN 1995-05-09

NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR

Applicant The Magstim Company , Ltd.

K number K951641

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ETN 1994-12-27

NERVE MONITOR ELECTRODES/STIMULATOR PROBES

Applicant Micromed Development Corp.

K number K945242

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ETN 1994-07-20

STIMULATING SURGICAL INSTRUMENTS

Applicant Smith & Nephew Richards, Inc.

K number K934733

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ETN 1994-05-13

NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

Applicant Xomed-Treace, Inc.

K number K934426

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ETN 1993-11-19

R AND D BATTERIES, INC. PART NOS. 5038 & 5347

Applicant R & D Batteries, Inc.

K number K933491

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ETN 1993-08-17

XOMED-TREACE EMG ENDOTRACHEAL TUBEEN

Applicant Xomed-Treace, Inc.

K number K925640

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ETN 1992-11-24

RLN NERVE LOCATOR/MONITOR; MODEL A

Applicant Rln Systems, Inc.

K number K925008

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ETN 1992-11-24

NEUROSIGN MODEL 100

Applicant The Magstim Company , Ltd.

K number K923056

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ETN 1992-09-30

NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION

Applicant Rln Systems, Inc.

K number K912508

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ETN 1991-04-19

AXOSTIM NERVE STIMULATOR, MODIFICATION

Applicant Singer Medical Products, Inc.

K number K905035

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ETN 1991-03-15

NERVE LOCATOR/STIMULATOR

Applicant Aaron Medical Industries

K number K905045

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ETN 1990-03-27

BRACKMANN EMG MONITORING SYSTEM

Applicant Wr Medical Electronics Co.

K number K895838

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ETN 1990-03-27

DENTEC 4000

Applicant Dentec, Inc.

K number K894930

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ETN 1989-12-08

HEMOSTAT/STIMULATOR PROBE

Applicant Rln Systems, Inc.

K number K895676

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ETN 1988-07-15

RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS

Applicant Downs Surgical , Ltd.

K number K881757

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ETN 1988-06-01

NEUROPROBE

Applicant Inovx, Inc.

K number K874018

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ETN 1988-05-20

MONTGOMERY NERVE STIMULATOR

Applicant Boston Medical Products, Inc.

K number K880720

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ETN 1987-11-20

NICOLET DISPOSABLE PRASS PROBE

Applicant Nicolet Biomedical Instruments

K number K873964

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ETN 1987-10-20

POREX NERVE LOCATOR

Applicant Porex Medical

K number K872791

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ETN 1987-08-05

MODEL 6110C OTOPHOR

Applicant Life-Tech Intl., Inc.

K number K870272

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ETN 1985-05-21

EVOKED RESPONSE ELECTRICAL STIMULATOR

Applicant Nucleus, Ltd.

K number K843226

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ETN 1984-02-10

PULSATRON NERVE LOCATOR/STIMULATOR

Applicant Edward Weck, Inc.

K number K833646

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ETN 1983-07-07

NEUROTRAC

Applicant Hdc Corp.

K number K831715

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ETN 1978-12-07

NERVE LOCATER/STIMULATOR

Applicant Intermedics, Inc.

K number K781569

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