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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
EverEx
1.2.X
In Commercial Distribution

  • 08809970060005 ()


  • Biomechanical function analysis/rehabilitation software
No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution

  • G554LVIC0 ()


  • Radiology DICOM image processing application software
Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software
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
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
3.x
In Commercial Distribution

  • 03700757200834 ()


  • Orthopaedic/craniofacial implantation planning software
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
2.x
Not in Commercial Distribution

  • 03700757200827 ()
/

  • Orthopaedic/craniofacial implantation planning software
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
Poskom Co., Ltd.
Rextar X
In Commercial Distribution

  • 08800040900047 ()


  • Diagnostic x-ray system generator, portable
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
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
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