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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2026 | K253536 | Evala Nerve Stimulator (EPNR002) Epineuron Technologies, Inc., CA | ETN |
| Feb 10, 2026 | K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotra Medtronic Xomed, Inc. | ETN |
| Jun 13, 2025 | K242852 | 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 T Inomed Medizintechnik GmbH, DE | ETN |
| Dec 13, 2024 | K233001 | Bioscope Neuromonitor Device Biosys Biyomedikal Muhendislik San. VE Tic. A.S., TR | ETN |
| Jul 31, 2024 | K241917 | EARP Nerve Cuff Electrode Retropsoas Technologies, LLC | ETN |
| Dec 21, 2023 | K232888 | Disposable Laryngeal Electrodes Suzhou Haishen Medical Device Associates Co., Ltd., CN | ETN |
| Oct 26, 2023 | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube Medtronic Xomed, Inc. | ETN |
| Oct 6, 2023 | K230853 | EARP Nerve Cuff Electrode Nvision Biomedical Technologies, Inc. | ETN |
| Aug 30, 2023 | K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Medtronic Xomed, Inc. | ETN |
| Jan 27, 2023 | K223254 | C2 Xplore Inomed Medizintechnik GmbH, DE | ETN |
| Nov 11, 2022 | K212164 | Mapping Suction Probe Inomed Medizintechnik GmbH, DE | ETN |
| Mar 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, Medtronic Xomed, Inc. | ETN |
| Aug 26, 2021 | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large Checkpoint Surgical | ETN |
| Nov 10, 2020 | K200886 | StimSite Allotrope Medical, Inc. | ETN |
| May 6, 2016 | K152769 | FREMAP ELECTRODE Ad-Tech Medical Instrument Corporation | ETN |
| Feb 1, 2016 | K152505 | C2 NerveMonitor System Inomed Medizintechnik GmbH, DE | ETN |
| Feb 19, 2015 | K150005 | Checkpoint, Checkpoint Head & Neck Ndi Medical, LLC | ETN |
| Nov 21, 2014 | K133348 | STIM PROBE Spes Medica Srl, IT | ETN |
| Jul 1, 2014 | K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS Stryker Corporation | ETN |
| Oct 31, 2013 | K122040 | INVOTEC LARYNGEAL ELECTRODE Invotec International, Inc. | ETN |
| Oct 19, 2012 | K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS Neurovision Medical Products, Inc. | ETN |
| Aug 28, 2012 | K121257 | LARYNGEAL ELECTRODE Technomed Europe, NL | ETN |
| Jun 27, 2012 | K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE Medtronic Xomed, Inc. | ETN |
| Apr 13, 2012 | K112717 | NUVASIVE NVJJB SYSTEM Nuvasive, Inc. | ETN |
| Apr 2, 2012 | K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES Xian Friendship Medical Electronics Co., Ltd., CN | ETN |
| Mar 16, 2012 | K112718 | NUVASIVE NVM5 SYSTEM Nuvasive, Inc. | ETN |
| Feb 9, 2012 | K112709 | STIMULATION/DISSECTION INSTRUMENTS Nu Vasive, Incorporated | ETN |
| Dec 28, 2011 | K111671 | SEASPINE MONOPOLAR PROBE SYSYEM Seaspine, Inc. | ETN |
| Nov 3, 2011 | K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE Neurovision Medical Products, Inc. | ETN |
| Oct 13, 2011 | K111597 | DISPOSABLE STIMULATING ELECTRODE Nuvasive, Inc. | ETN |
| Sep 22, 2011 | K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT Rhythmlink International, LLC | ETN |
| Jul 7, 2011 | K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE Baxano, Inc. | ETN |
| Jun 28, 2011 | K110712 | DRYTOUCH SUCTION STIMULATOR PROBE Neurovision Medical Products, Inc. | ETN |
| May 26, 2011 | K110422 | SURGICAL STIMULATORS Technomed Europe, NL | ETN |
| Apr 8, 2011 | K110138 | PAIRED HYDROGEL ELECTRODE Neurovision Medical Products, Inc. | ETN |
| Feb 23, 2011 | K103128 | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, Cadwell Lab, Inc. | ETN |
| Dec 21, 2010 | K102862 | NEUROVISION SE (NERVEANA) Neurovision Medical Products, Inc. | ETN |
| Sep 24, 2010 | K100992 | NEURALMAS Innovative Surgical Solutions, LLC ("Iss") | ETN |
| Aug 24, 2010 | K093373 | LARYNGEAL SURFACE ELECTRODE Spes Medica Srl, IT | ETN |
| Nov 18, 2009 | K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 Inomed Medizintechnik GmbH | ETN |
| Oct 28, 2009 | K092292 | CHECKPOINT Ndi Medical, LLC | ETN |
| Oct 2, 2009 | K092729 | BAXANO NEURO CHECK DEVICE Baxano, Inc. | ETN |
| Jul 29, 2009 | K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Jul 20, 2009 | K090838 | STIMULUS/DISSECTION INSTRUMENTS Axon Systems, Inc. | ETN |
| Sep 17, 2008 | K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 Baxano, Inc. | ETN |
| Jan 22, 2008 | K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT Rhythmlink International, LLC | ETN |
| Dec 12, 2007 | K071349 | NEUROSIGN LARYNGEAL ELECTRODES The Magstim Company , Ltd., GB | ETN |
| Jan 5, 2007 | K063560 | HILGER DUAL-STIM NERVE STIMULATOR Wr Medical Electronics Co. | ETN |
| Nov 29, 2006 | K063305 | STIMULATING BUR GUARD Medtronic Xomed, Inc. | ETN |
| Oct 4, 2006 | K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 Excel Tech. , Ltd., CA | ETN |
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