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Nystagmograph
FDA product code GWN · Class 2 · Neurology
120
Registered devices
18
Adverse events
4
Recalls
60
510(k) clearances
Devices with this code
N/A — MEDTRONIC PS MEDICAL, INC.GN Otometrics A/S — Natus Medical Denmark ApSN/A — MEDTRONIC PS MEDICAL, INC.VNG — INVENTIS SRLInteracoustics — Interacoustics A/SComplete Monocular wireless Smart Cam system with Xpress mask — SYNAPSYSInstrumentation Difra — Instrumentation Difra SAInstrumentation Difra SA — Instrumentation Difra SAGN Otometrics A/S — Natus Medical Denmark ApSInteracoustics — Interacoustics A/SICS Impulse Vision Denied Solution 2 Kit (200 pcs) — NATUS MANUFACTURING LIMITED1091, ICS Dizcovery LCD Panels — Natus Medical Denmark ApSInstrumentation Difra SA — Instrumentation Difra SANeuro Kinetics Inc — N K IComplete Monocular wireless Smart Cam system with Goggles Flex — SYNAPSYSMicromedical Technologies — MICROMEDICAL TECHNOLOGIES, INC.GN Otometrics A/S — Natus Medical Denmark ApSVNG 3D — EclerisVestibular First — Vestibular First, LLCOtometrics — Natus Medical Denmark ApSVNG — INVENTIS SRLNeurolign Dx SVNG — Spryson America, Inc.GN Otometrics A/S — Natus Medical Denmark ApSNA — MEDTRONIC PS MEDICAL, INC.
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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