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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
No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution

  • G554LVIC0 ()


  • Radiology DICOM image processing application software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
No Description
PHILIPS FRANCE COMMERCIAL
2.4.x
In Commercial Distribution

  • G637CEA0 ()


  • Cardiopulmonary physiological parameter analysis software
AIRFLOW PLUS
E.M.S. Electro Medical Systems S.A.
DV-165/X
In Commercial Distribution

  • 07613353208264 ()


  • Dental abrasive powder
NEOLUX X 350-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4800X0 ()
864NL4800X

  • Ultraviolet phototherapy unit, professional
NEOLUX X 350-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4000X0 ()
864NL4000X

  • Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-24/24
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL2424X0 ()
864NL2424X

  • Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-20/20
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL2020X0 ()
864NL2020X

  • Ultraviolet phototherapy unit, professional
NEOLUX X 311-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL0048X0 ()
864NL0048X

  • Ultraviolet phototherapy unit, professional
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