Neurovision Medical Products Inc
FDA Regulatory Profile
Neurovision Medical Products Inc appears in FDA public data with 11 recalls, 9 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2100-2025, Class II) was initiated on May 19, 2025. Its most recent 510(k) clearance was granted on Dec 26, 2013.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2100-2025 | Class II | Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: | May 19, 2025 |
| Z-2719-2024 | Class II | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STER | Jul 1, 2024 |
| Z-2900-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, | Jul 21, 2020 |
| Z-2905-2020 | Class II | Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B | Jul 21, 2020 |
| Z-2904-2020 | Class II | Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418 | Jul 21, 2020 |
| Z-2907-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Pro | Jul 21, 2020 |
| Z-2901-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile | Jul 21, 2020 |
| Z-2903-2020 | Class II | Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B | Jul 21, 2020 |
| Z-2906-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$706 | Jul 21, 2020 |
| Z-2902-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Steril | Jul 21, 2020 |
| Z-2908-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Pro | Jul 21, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Dec 26, 2013 |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Jul 12, 2013 |
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Dec 13, 2012 |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Oct 19, 2012 |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Nov 3, 2011 |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Sep 30, 2011 |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Jun 28, 2011 |
| K110138 | PAIRED HYDROGEL ELECTRODE | Apr 8, 2011 |
| K102862 | NEUROVISION SE (NERVEANA) | Dec 21, 2010 |