ANGIODYNAMICS, INC. 12800204 SpeedLyser

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.

SpeedLyser Infusion Catheter Basic Kit

SpeedLyser Infusion Catheter Basic Kit

Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion

FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 5.5F 40CM

Convenience kit of Bioclear products used in dental restorations.

Convenience kit of Bioclear products used in dental restorations.

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.

SpeedLyser Infusion Catheter Basic Kit

SpeedLyser Infusion Catheter Basic Kit

Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion