Neurovision Medical Products Inc
Ventura, CA, US
NEUROVISION MEDICAL PRODUCTS, INC. appears in FDA device records in Ventura, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Neurovision Medical Products Inc between 2010 and 2013. The busiest year on record is 2011, with 4. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | BZQ | Substantially Equivalent | |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | PDQ | Substantially Equivalent | |
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | FAP | Substantially Equivalent | |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | ETN | Substantially Equivalent | |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | ETN | Substantially Equivalent | |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | GWF | Substantially Equivalent | |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | ETN | Substantially Equivalent | |
| K110138 | PAIRED HYDROGEL ELECTRODE | ETN | Substantially Equivalent | |
| K102862 | NEUROVISION SE (NERVEANA) | ETN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1930870 | 1930870 | NEUROVISION MEDICAL PRODUCTS, INC. | 4837 Mcgrath St Unit B, Ventura, CA 93003 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2100-2025 | 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 ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle | Product packaging contains the wrong part number and kit contents. | Class II | Open, Classified | |
| Z-2719-2024 | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | Class II | Open, Classified | |
| Z-2908-2020 | 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 laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2907-2020 | 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 laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2906-2020 | Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2905-2020 | Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2904-2020 | Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2903-2020 | Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2902-2020 | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2901-2020 | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-2900-2020 | 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 of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | Class II | Terminated | |
| Z-0798-2010 | 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve. | This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain