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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Quickie® S-6 Series electric wheelchairs are built tough for serious outdoor enthusiasts. Top speeds up to 8.5 mph, standard 4-pole motors, and dynamic suspension overcome tough terrain while the hybrid base maneuvers gracefully indoors. Seating options such as tilt, recline, and power elevating legrests ensure your positioning needs are met.
SUNRISE MEDICAL (US) LLC
S-646
In Commercial Distribution

  • 00016958044256 ()
EIS62

  • Electric-motor-driven wheelchair, occupant-controlled
SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces. the posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and cornea. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lens material is a thermoset copolymer dervied from fluorosilicone acrylate monomer. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable lenses deliver substantial attenuation of bright light and resultant reduction of glare. SportSight GP lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. All environmental UV radiation (including UVA and UVB) is reduced to less than 1% transmission. Blue light (below 500nm) is reduced to less than 10% in SportSight yellow and SportSight brown or 36% in SportSight gray.
Paragon Vision Sciences, Inc.
SportSight GP
In Commercial Distribution

  • B22215 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints, connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space. The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist. The dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.
Crane Dental Laboratory, Inc.
0002
In Commercial Distribution

  • 00860009255616 ()


  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
MERGE HEALTHCARE SOLUTIONS INC.
12.4
In Commercial Distribution

  • 00842000101123 ()


  • Radiology picture archiving and communication system workstation
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
MERGE HEALTHCARE SOLUTIONS INC.
12.3
In Commercial Distribution

  • 00842000101109 ()


  • Radiology picture archiving and communication system workstation
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