Nystagmograph

Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. Thi

The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagno

complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters,

Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.

Normative Data Template CD for use with the I-Portal devices.

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.