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Vestibular First
Vestibular First, LLC · Model Insight Disposable Cushions - 40-Count · UDI-DI 00860002280714
GWN
Prescription
1
510(k) clearances
18
Adverse events
4
Recalls
16
Facilities
Description
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.
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. |
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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.