STRADIS MEDICAL LLC HCT9849-1 Stradis Medical, LLC.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

X7-2T Transesophageal Transducer The X7-2T transesophageal transducer is a sophisticated medical imaging device designed for use in transesophageal echocardiography (TEE). This advanced probe is utilized to obtain high-resolution images of the heart and surrounding structures through the esophagus. Its proximity to the heart allows for superior image quality compared to standard transthoracic echocardiography.