Neurovision Medical Products Inc

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
9
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2100-2025Class IIBrand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number:May 19, 2025
Z-2719-2024Class IICobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERJuly 1, 2024
Z-2905-2020Class IICobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318BJuly 21, 2020
Z-2903-2020Class IICobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918BJuly 21, 2020
Z-2901-2020Class IINerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, SterileJuly 21, 2020
Z-2906-2020Class IICobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$706July 21, 2020
Z-2902-2020Class IINerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, SterilJuly 21, 2020
Z-2908-2020Class IICobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - ProJuly 21, 2020
Z-2904-2020Class IICobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418July 21, 2020
Z-2907-2020Class IICobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - ProJuly 21, 2020
Z-2900-2020Class IINerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile,July 21, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K130570NEUROVISION MEDICAL MOTION SENSORDecember 26, 2013
K130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEJuly 12, 2013
K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODEDecember 13, 2012
K121931NONDISPOSABLE STIMULATING INSTRUMENTSOctober 19, 2012
K110989NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODENovember 3, 2011
K110140NEUROVISION NERVE LOCATOR MONITORSeptember 30, 2011
K110712DRYTOUCH SUCTION STIMULATOR PROBEJune 28, 2011
K110138PAIRED HYDROGEL ELECTRODEApril 8, 2011
K102862NEUROVISION SE (NERVEANA)December 21, 2010