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Nystagmograph
FDA product code GWN · Class 2 · Neurology
121
Registered devices
18
Adverse events
4
Recalls
60
510(k) clearances
Devices with this code
1091, ICS Dizcovery LCD Panels — Natus Medical Denmark ApSGN Otometrics A/S — Natus Medical Denmark ApSVNG — INVENTIS SRLVestibular First — Vestibular First, LLCInstrumentation Difra SA — Instrumentation Difra SAInteracoustics — Interacoustics A/SGN Otometrics A/S — Natus Medical Denmark ApSI-Portal Portable Assessment System — N K IVNG — INVENTIS SRLI-Portal Super VNG — N K INeurolign Dx100 — Spryson America, Inc.MedTrakVNG MobiTrak System — MEDTRAK VNG, INC.Interacoustics — Interacoustics A/SICS Impulse Vision Denied Solution 2 Kit (200 pcs) — NATUS MANUFACTURING LIMITEDSynapsys VHIT — INVENTIS SRLVNG — INVENTIS SRLNA — MEDTRONIC PS MEDICAL, INC.Interacoustics — Interacoustics A/SN/A — MEDTRONIC PS MEDICAL, INC.VNG 3D — EclerisMedTrakVNG Interface Controller — MEDTRAK VNG, INC.GN Otometrics A/S — Natus Medical Denmark ApSGN Otometrics A/S — Natus Medical Denmark ApSInstrumentation Difra — Instrumentation Difra SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-07-21 | Neuro Kinetics, Inc. | The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. |
| 2015-04-30 | Neuro Kinetics, Inc. | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. |
| 2014-07-09 | Integra LifeSciences Corp. | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment |
| 2013-11-21 | Neuro Kinetics, Inc. | The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notificatio |
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