CARILEX MEDICAL, INC. S1001-2180

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.

Tinted Liquid

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts andabsorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy,and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction.The device is intended for single use and should be changed daily or according to doctor’s instructions.

VAC Whitefoam Dressing Large

RITA Habib 4X Bipolar Resection Device, 10cm

Dressing, absorbent Primapore 8" x 4"

This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel tenaculum. The Valtchev Tenaculum is used to hold the VUM-6 uterine mobilizer in place when the cannulas 15A or 16A are used for injection of either dye or an X-ray contrast medium. This tenaculum has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part.

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.

Tinted Liquid

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts andabsorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy,and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction.The device is intended for single use and should be changed daily or according to doctor’s instructions.