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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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No Description
Poskom Co., Ltd.
Rextar X
In Commercial Distribution

  • 08800040900047 ()


  • Diagnostic x-ray system generator, portable
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
Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software
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
Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be used with products of Nacera® Pearl (3Y-TZP).
DOCERAM medical ceramics GmbH
Blue X
Not in Commercial Distribution

  • EDMC4000LQ80300 ()

  • Weight: 15 Gram
4000LQ8030

  • Dental appliance fabrication material, ceramic
spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies.
ONEFIT MEDICAL
1.x
In Commercial Distribution

  • 03700757200858 ()


  • Orthopaedic/craniofacial implantation planning software
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