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VNG
INVENTIS SRL · Model VNG BASIC WIRED · UDI-DI 08054187381027
GWN
Prescription
10
510(k) clearances
18
Adverse events
4
Recalls
16
Facilities
Description
Video nystagmograph
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.