STEALTH THERAPEUTICS, INC. 2000 Invisiport 4.4 Fr

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.

iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile.

Resin Artificial Teeth

Smart Port CT Low Profile Titanium Port System with Attachable 6.6F x 55cm Polyurethane Catheter and 7F Introducer Kit (Non-Filled Suture Holes)

PowerPort ClearVUE Slim Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Intermediate Kit

Vaccess CT Low-Profile Power-Injectable Implantable Port 6F (with Suture Plugs) (6F)

Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Valved Introducer and Non-Filled Suture Holes)

Vortex LP Single Titanium Port System with Attachable 9.6F x 76cm Silicone Catheter

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.

iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile.

Resin Artificial Teeth