Safeguard US Operating, LLC HHSCK01-EA Simplified Cricothyrotomy Kit

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support.Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.

The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports.

MICROSCOPE DRAPE FOR ZEISS 65MM FEAT VARI-LENS II GLASS LENS, 1-EACH

The EPF-1 Thunderbeat is part of the Olympus THUNDERBEAT surgical tissue management system, comprising the ESG-400 generator, the USG-400 generator, a communication cable, and monopolar single and dual footswitches. *Please note that the USG-400 on this listing has a cracked screen. However, the unit is 100% functional. *

Simplify Intervertebral Distractor

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.

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 Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support.Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.

The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports.