Nystagmograph
Regulation 882.1460
1510(k)s in 12 months (60 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GWN
| Company | 510(k)s | Recalls |
|---|---|---|
| Neuro Kinetics | 4 | 3 |
| Interacoustics A/S | 5 | 0 |
| Ics Medical | 3 | 0 |
| Micromedical Technologies, Inc. | 3 | 0 |
| Philadelphia Medical Specialties | 3 | 0 |
| Bio-Logic Systems Corp. | 2 | 0 |
| Fall Prevention Technologies, LLC | 2 | 0 |
| Gn Otometrics | 2 | 0 |
| Kelleher Corp. | 2 | 0 |
| Synapsys SA | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K260566 | SMARTVERTIGO Vestibular Assessment System VertigoDx, Inc. | GWN |
| Aug 25, 2025 | K243709 | NeuroEars-Anna Neuroears, Inc., KR | GWN |
| Feb 14, 2025 | K242198 | ICS Dizcovery (1091) Natus Medical Denmark Aps, DK | GWN |
| Jan 3, 2025 | K242726 | Synapsys VHIT Inventis S.R.L., IT | GWN |
| Jun 29, 2023 | K223047 | NeuroSwift Pro Neurobit Technologies Co., Ltd., TW | GWN |
| Nov 12, 2020 | K203082 | Insight Infrared Video Goggles Vestibular First | GWN |
| Aug 12, 2020 | K200534 | VisualEyes Interacoustics A/S, DK | GWN |
| Nov 29, 2019 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragm Neurolign USA, LLC | GWN |
| Sep 28, 2018 | K181771 | RightEye Vision System Righteye, LLC | GWN |
| Sep 14, 2018 | K182214 | DizzyDoctor System 1.0.0 Dizzydoctor Systems, LLC | GWN |
| Jul 24, 2018 | K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking Syste Neuro Kinetics, Inc. | GWN |
| Nov 22, 2017 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc. | GWN |
| Sep 25, 2017 | K163270 | ISEN-Goggles with Data Viewer Isent Tech & Trading Company, Ltd., CN | GWN |
| Apr 26, 2017 | K163149 | VisualEyes Interacoustics A/S, DK | GWN |
| Mar 23, 2017 | K163558 | Synapsys Ulmer Video Nystagmograph Synapsys SA, FR | GWN |
| Apr 26, 2016 | K152727 | ISEN-Goggles Isen Tech & Trading Company, Ltd., CN | GWN |
| Jan 29, 2016 | K152915 | EYE-SYNC Syncthink, Inc. | GWN |
| Dec 29, 2015 | K152112 | VisualEyes Interacoustics A/S, DK | GWN |
| Nov 16, 2015 | K151504 | ICS Impulse Gn Otometrics, DK | GWN |
| Jul 8, 2015 | K143607 | I-Portal NOTC, VNG and VOG Neuro Kinetics, Inc. | GWN |
| Sep 6, 2013 | K131681 | EYESEECAM VHIT Interacoustics A/S, DK | GWN |
| Apr 26, 2013 | K130201 | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM Ototronix, LLC | GWN |
| Feb 1, 2013 | K122550 | ICS IMPULSE Gn Otometrics | GWN |
| Aug 6, 2009 | K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL Neuro Kinetics | GWN |
| Feb 5, 2008 | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM Interacoustics A/S | GWN |
| Sep 18, 2007 | K070670 | EYETRACKER/IDEAS S.A. Instrumentation Difra | GWN |
| Mar 30, 2007 | K070729 | BALANCEBACK MOBILE INTUITIVE VNG SYSTEM Fall Prevention Technologies, LLC | GWN |
| Oct 31, 2006 | K062015 | CHRONOS VISION EYE TRACKING DEVICE (C-ETD) Chronos Vision | GWN |
| Jul 11, 2006 | K061791 | FOCUS VNG/ENG TYPE 1068 Gn Otometrics A/S | GWN |
| May 23, 2005 | K050098 | DDAT OMT Ddat(Uk), Ltd., GB | GWN |
| Oct 6, 2004 | K042529 | BALANCEBACK VNG SYSTEM Fall Prevention Technologies, LLC | GWN |
| Dec 10, 2001 | K013060 | ICS MEDICAL MODEL VG-30 VIDEO GOGGLES Ics Medical | GWN |
| Feb 27, 2001 | K010059 | ENGPLUS Western Systems Research, Inc. | GWN |
| Feb 1, 2001 | K003644 | EYETECT TREMOR MONITOR UNIT (TMU) Eyetect, LLC | GWN |
| Aug 12, 1999 | K992473 | EXPRESSEYE Optomotor Laboratories, DE | GWN |
| Aug 3, 1999 | K991642 | EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX Bertec Corp. | GWN |
| Jul 28, 1999 | K991497 | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM Ics Medical Corp. | GWN |
| Sep 11, 1998 | K982103 | ULMER (VNG) VIDEO NYSTAGMOGRAPH Synapsys, Inc. | GWN |
| Sep 22, 1997 | K972631 | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER Ics Medical Corp. | GWN |
| Sep 10, 1997 | K972243 | 2D VOG - VIDEO-OCULOGRAPHY Sensomotoric Instruments, GmbH, DE | GWN |
| Jul 15, 1997 | K964646 | VIDEO EYE TRAKKER Micromedical Technologies, Inc. | GWN |
| Jul 15, 1997 | K964325 | VISUALEYES: VIDEO EYE MONITOR Micromedical Technologies, Inc. | GWN |
| Feb 3, 1995 | K941928 | VARIOUS ELECTRODES Bio-Logic Systems Corp. | GWN |
| Dec 15, 1994 | K926312 | INFRARED EYE MOVEMENT MONITOR Microguide, Inc. | GWN |
| Mar 23, 1994 | K925111 | HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM Eye Dynamics, Inc. | GWN |
| Jun 10, 1992 | K904385 | JANUS ATAC ENG ANALYSIS SYSTEM Life-Tech Intl., Inc. | GWN |
| Nov 23, 1988 | K884294 | NICOLET NYSTAR PLUS SYSTEM Nicolet Instrument Corp. | GWN |
| Jul 24, 1987 | K871466 | VESTIBULAR AUTOROTATION TEST Western Systems Research, Inc. | GWN |
| Mar 23, 1987 | K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE Micromedical Technologies, Inc. | GWN |
| Apr 30, 1986 | K860457 | ELECTROCARDIOGRAPH CONTINUOUS MONITOR Oxford Medilog, Inc. | GWN |
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