ClearanceBrief
Panels › Ear, Nose, Throat › Product code ETN · Class 2

Stimulator, Nerve

Regulation 874.1820

2510(k)s in 12 months (97 all time)
0recalls in 12 months (31 all time)
29recalls that name a 510(k)
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Top companies in ETN

DateFirm and productCodeLinked 510(k)
Jul 9, 2025Neurovision Medical Products Inc
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; RE
Open, Classified
ETNNone listed
Mar 26, 2025Checkpoint Surgical Inc
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian
Open, Classified
ETNK212355
Mar 26, 2025Checkpoint Surgical Inc
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian In
Open, Classified
ETNK212355
Sep 12, 2024Technomed Europe
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Open, Classified
ETNK110422
Aug 23, 2024Neurovision Medical Products Inc
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Open, Classified
ETNK110989
Jan 10, 2024Medtronic Xomed, Inc.
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738
Open, Classified
ETNK112686
Sep 1, 2022Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Open, Classified
ETNNone listed
Sep 1, 2022Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Open, Classified
ETNK925640
Sep 1, 2022Medtronic Xomed, Inc.
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Open, Classified
ETNK050162
Dec 22, 2021Medtronic Xomed, Inc.
NIM TRIVANTAGE EMG Endotracheal Tube
Open, Classified
ETNK112686
Apr 8, 2021Spes Medica
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Terminated
ETNK133348
Apr 8, 2021Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
Terminated
ETNK093373
Apr 8, 2021Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
Terminated
ETNK093373
Dec 8, 2020The Magstim Company Limited
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT
Terminated
ETNK923056
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngea
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngea
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying t
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the l
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessme
Terminated
ETNK110989
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment
Terminated
ETNK110989
Jul 31, 2019Stryker Instruments Div. of Stryker Corporation
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio
Terminated
ETNK152505
Jul 31, 2019Stryker Instruments Div. of Stryker Corporation
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio
Terminated
ETNK152505
Jun 28, 2016Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Terminated
ETNK925640
Jul 2, 2015Spine Wave, Inc.
Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprise
Terminated
ETNK072736
Jun 4, 2013Medtronic Xomed, Inc.
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are
Terminated
ETNK112686
Feb 22, 2010Neurovision Medical Products Inc
2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
Terminated
ETNK003745
Mar 3, 2009Medtronic Xomed, Inc.
VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to
Terminated
ETNK031003
Dec 15, 2004Medtronic Xomed, Inc.
Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [
Terminated
ETNK925640

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