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)
Top companies in ETN
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Xomed | 10 | 9 |
| Neurovision Medical Products, Inc. | 5 | 12 |
| The Magstim Company , Ltd. | 9 | 1 |
| Nuvasive, Inc. | 6 | 0 |
| Inomed Medizintechnik GmbH | 5 | 0 |
| Rln Systems, Inc. | 5 | 0 |
| Spes Medica Srl | 2 | 3 |
| Baxano, Inc. | 3 | 0 |
| Checkpoint Surgical | 1 | 2 |
| Ndi Medical, LLC | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2025 | Neurovision 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 |
ETN | None listed |
| Mar 26, 2025 | Checkpoint 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 |
ETN | K212355 |
| Mar 26, 2025 | Checkpoint 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 |
ETN | K212355 |
| Sep 12, 2024 | Technomed Europe NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 Open, Classified |
ETN | K110422 |
| Aug 23, 2024 | Neurovision Medical Products Inc Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO Open, Classified |
ETN | K110989 |
| Jan 10, 2024 | Medtronic 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 |
ETN | K112686 |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229307J
b) REF 8229308J
c) REF 8229306J Open, Classified |
ETN | None listed |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229308
b) REF 8229307
c) REF 8229306 Open, Classified |
ETN | K925640 |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM CONTACT EMG Endotracheal Tube, Part Numbers:
a) REF 8229508
b) REF 8229507
c) REF 8229506 Open, Classified |
ETN | K050162 |
| Dec 22, 2021 | Medtronic Xomed, Inc. NIM TRIVANTAGE EMG Endotracheal Tube Open, Classified |
ETN | K112686 |
| Apr 8, 2021 | Spes Medica Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring. Terminated |
ETN | K133348 |
| Apr 8, 2021 | Spes 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 |
ETN | K093373 |
| Apr 8, 2021 | Spes 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 |
ETN | K093373 |
| Dec 8, 2020 | The 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 |
ETN | K923056 |
| Jul 21, 2020 | Neurovision 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 |
ETN | K110989 |
| Jul 21, 2020 | Neurovision 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 |
ETN | K110989 |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying t Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the l Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision 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/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision Medical Products Inc Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessme Terminated |
ETN | K110989 |
| Jul 21, 2020 | Neurovision 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 |
ETN | K110989 |
| Jul 31, 2019 | Stryker 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 |
ETN | K152505 |
| Jul 31, 2019 | Stryker 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 |
ETN | K152505 |
| Jun 28, 2016 | Medtronic 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 |
ETN | K925640 |
| Jul 2, 2015 | Spine 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 |
ETN | K072736 |
| Jun 4, 2013 | Medtronic 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 |
ETN | K112686 |
| Feb 22, 2010 | Neurovision Medical Products Inc 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)
For use as a Surgical stimulator/locator for recurrent laryngeal nerve. Terminated |
ETN | K003745 |
| Mar 3, 2009 | Medtronic 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 |
ETN | K031003 |
| Dec 15, 2004 | Medtronic 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 |
ETN | K925640 |
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