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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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Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.
VISARIS DOO
Vision X
In Commercial Distribution

  • 08606102809125 ()


  • Stationary basic diagnostic x-ray system, digital
A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
SUNRISE MEDICAL (US) LLC
QS5 X
In Commercial Distribution

  • 00016958059526 ()
EIF7

  • Push-rim manual wheelchair, non-bariatric
The Globus Volta X device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
DOMINO SRL
VOLTA X
In Commercial Distribution

  • 08032625822868 ()
G7096

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
No Description
Poskom Co., Ltd.
Rextar X
In Commercial Distribution

  • 08800040900047 ()


  • Diagnostic x-ray system generator, portable
No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839108 ()


  • Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839092 ()


  • Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software
No Description
QYNAPSE
1.X
In Commercial Distribution

  • 03770016198004 ()


  • Radiology DICOM image processing application software
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