Atlas FDA

ETN

97 FDA 510(k) clearances · Product code

115 daysmedian time to decision
278 days90th percentile
97clearances measured

FDA profile

Official device name
Stimulator, Nerve
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1820
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2021: 197 · 2022: 247 · 2023: 390 · 2024: 748 · 2025: 1,156 · 2026: 342
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Evala Nerve Stimulator (EPNR002) (K253536)Epineuron Technologies, Inc.2026-02-27
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) (K251672)Medtronic Xomed, Inc.2026-02-10
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) (K242852)Inomed Medizintechnik GmbH2025-06-13
Bioscope Neuromonitor Device (K233001)Biosys Biyomedikal Muhendislik San. VE Tic. A.S.2024-12-13
EARP Nerve Cuff Electrode (K241917)Retropsoas Technologies, LLC2024-07-31
Disposable Laryngeal Electrodes (K232888)Suzhou Haishen Medical Device Associates Co., Ltd.2023-12-21
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320)Medtronic Xomed, Inc.2023-10-26
EARP Nerve Cuff Electrode (K230853)Nvision Biomedical Technologies, Inc.2023-10-06
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580)Medtronic Xomed, Inc.2023-08-30
C2 Xplore (K223254)Inomed Medizintechnik GmbH2023-01-27
Mapping Suction Probe (K212164)Inomed Medizintechnik GmbH2022-11-11
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246)Medtronic Xomed, Inc.2022-03-21
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (K212355)Checkpoint Surgical2021-08-26
StimSite (K200886)Allotrope Medical, Inc.2020-11-10
FREMAP ELECTRODE (K152769)Ad-Tech Medical Instrument Corporation2016-05-06
C2 NerveMonitor System (K152505)Inomed Medizintechnik GmbH2016-02-01
Checkpoint, Checkpoint Head & Neck (K150005)Ndi Medical, LLC2015-02-19
STIM PROBE (K133348)Spes Medica Srl2014-11-21
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS (K140400)Stryker Corporation2014-07-01
INVOTEC LARYNGEAL ELECTRODE (K122040)Invotec International, Inc.2013-10-31
NONDISPOSABLE STIMULATING INSTRUMENTS (K121931)Neurovision Medical Products, Inc.2012-10-19
LARYNGEAL ELECTRODE (K121257)Technomed Europe2012-08-28
NEXT GEN EMG ENDOTRACHEAL TUBE (K112686)Medtronic Xomed, Inc.2012-06-27
NUVASIVE NVJJB SYSTEM (K112717)Nuvasive, Inc.2012-04-13
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES (K112426)Xian Friendship Medical Electronics Co., Ltd.2012-04-02
NUVASIVE NVM5 SYSTEM (K112718)Nuvasive, Inc.2012-03-16
STIMULATION/DISSECTION INSTRUMENTS (K112709)Nu Vasive, Incorporated2012-02-09
SEASPINE MONOPOLAR PROBE SYSYEM (K111671)Seaspine, Inc.2011-12-28
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K110989)Neurovision Medical Products, Inc.2011-11-03
DISPOSABLE STIMULATING ELECTRODE (K111597)Nuvasive, Inc.2011-10-13
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (K112435)Rhythmlink International, LLC2011-09-22
NEURO CHECK DEVICE WITH IO-FLEX WIRE (K110696)Baxano, Inc.2011-07-07
DRYTOUCH SUCTION STIMULATOR PROBE (K110712)Neurovision Medical Products, Inc.2011-06-28
SURGICAL STIMULATORS (K110422)Technomed Europe2011-05-26
PAIRED HYDROGEL ELECTRODE (K110138)Neurovision Medical Products, Inc.2011-04-08
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, (K103128)Cadwell Lab, Inc.2011-02-23
NEUROVISION SE (NERVEANA) (K102862)Neurovision Medical Products, Inc.2010-12-21
NEURALMAS (K100992)Innovative Surgical Solutions, LLC ("Iss")2010-09-24
LARYNGEAL SURFACE ELECTRODE (K093373)Spes Medica Srl2010-08-24
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (K091874)Inomed Medizintechnik GmbH2009-11-18
CHECKPOINT (K092292)Ndi Medical, LLC2009-10-28
BAXANO NEURO CHECK DEVICE (K092729)Baxano, Inc.2009-10-02
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR (K083242)The Magstim Company , Ltd.2009-07-29
STIMULUS/DISSECTION INSTRUMENTS (K090838)Axon Systems, Inc.2009-07-20
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 (K081742)Baxano, Inc.2008-09-17
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT (K072736)Rhythmlink International, LLC2008-01-22
NEUROSIGN LARYNGEAL ELECTRODES (K071349)The Magstim Company , Ltd.2007-12-12
HILGER DUAL-STIM NERVE STIMULATOR (K063560)Wr Medical Electronics Co.2007-01-05
STIMULATING BUR GUARD (K063305)Medtronic Xomed, Inc.2006-11-29
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 (K062549)Excel Tech. , Ltd.2006-10-04
CHECKPOINT WITH ACCUSTIM TECHNOLOGY (K061365)Ndi Medical, LLC2006-07-12
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 (K053141)The Magstim Company , Ltd.2005-12-14
NUVASIVE NEUROVISION JJB SYSTEM (K051718)Nuvasive, Inc.2005-09-15
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162)Medtronic Xomed, Inc.2005-03-03
NUVASIVE NEUROVISION JJB SYSTEM (K040543)Nuvasive, Inc.2004-04-01
NUVASIVE NEUROVISION JJB SYSTEM (K032083)Nuvasive, Inc.2003-10-24
NIM-SPINE (K031510)Medtronic Xomed2003-06-18
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES (K031003)Medtronic Xomed, Inc.2003-04-11
GYRUS ENT NERVE STIMULATOR (K021595)Gyrus Ent LLC2002-10-24
NICOLET ELECTROCAUTERY DETECTOR (K020955)Nicolet Biomedical, Inc.2002-04-17
STIMULUS - DISSECTION INSTRUMENTS (K014165)Medtronic Xomed, Inc.2002-01-22
MODIFICATION TO CAVERMAP SURGICAL AID (K010213)Uromed Corp.2001-04-20
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET (K003745)Rln Systems, Inc.2001-01-16
CAVERMAP SURGICAL AID (K000507)Uromed Corp.2000-04-21
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE (K992869)Xomed, Inc.1999-10-07
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR (K991583)The Magstim Company , Ltd.1999-05-19
NIM4 (K982595)Xomed, Inc.1998-09-04
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K980148)The Magstim Company , Ltd.1998-08-05
URO MED NERVE STIMULATOR (K970971)Uromed Corp.1997-10-27
NEURO PULSE II,III (K971143)Aaron Medical Industries1997-06-06
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K964869)The Magstim Company , Ltd.1997-05-14
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION (K954601)Rln Systems, Inc.1995-12-22
NEUROSIGN 100 IMPEDANCE METER (K945799)The Magstim Company , Ltd.1995-06-02
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR (K951641)The Magstim Company , Ltd.1995-05-09
NERVE MONITOR ELECTRODES/STIMULATOR PROBES (K945242)Micromed Development Corp.1994-12-27
STIMULATING SURGICAL INSTRUMENTS (K934733)Smith & Nephew Richards, Inc.1994-07-20
NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (K934426)Xomed-Treace, Inc.1994-05-13
R AND D BATTERIES, INC. PART NOS. 5038 & 5347 (K933491)R & D Batteries, Inc.1993-11-19
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (K925640)Xomed-Treace, Inc.1993-08-17
NEUROSIGN MODEL 100 (K923056)The Magstim Company , Ltd.1992-11-24
RLN NERVE LOCATOR/MONITOR; MODEL A (K925008)Rln Systems, Inc.1992-11-24
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION (K912508)Rln Systems, Inc.1992-09-30
AXOSTIM NERVE STIMULATOR, MODIFICATION (K905035)Singer Medical Products, Inc.1991-04-19
NERVE LOCATOR/STIMULATOR (K905045)Aaron Medical Industries1991-03-15
DENTEC 4000 (K894930)Dentec, Inc.1990-03-27
BRACKMANN EMG MONITORING SYSTEM (K895838)Wr Medical Electronics Co.1990-03-27
HEMOSTAT/STIMULATOR PROBE (K895676)Rln Systems, Inc.1989-12-08
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS (K881757)Downs Surgical , Ltd.1988-07-15
NEUROPROBE (K874018)Inovx, Inc.1988-06-01
MONTGOMERY NERVE STIMULATOR (K880720)Boston Medical Products, Inc.1988-05-20
NICOLET DISPOSABLE PRASS PROBE (K873964)Nicolet Biomedical Instruments1987-11-20
POREX NERVE LOCATOR (K872791)Porex Medical1987-10-20
MODEL 6110C OTOPHOR (K870272)Life-Tech Intl., Inc.1987-08-05
EVOKED RESPONSE ELECTRICAL STIMULATOR (K843226)Nucleus, Ltd.1985-05-21
PULSATRON NERVE LOCATOR/STIMULATOR (K833646)Edward Weck, Inc.1984-02-10
NEUROTRAC (K831715)Hdc Corp.1983-07-07
NERVE LOCATER/STIMULATOR (K781569)Intermedics, Inc.1978-12-07

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