Home › Vestibular First, LLC › Vestibular First
Vestibular First
Vestibular First, LLC · Model Insight Infrared Video Goggles · UDI-DI 00860002280707
GWN
Prescription
1
510(k) clearances
18
Adverse events
4
Recalls
16
Facilities
Description
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
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) notification process. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.