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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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SurgiCase OOS - 05404028000281

SurgiCase Mobile
Materialise NV
SurgiCase Mobile
In Commercial Distribution

  • 05404028000281 ()
SurgiCase Mobile

  • CAD/CAM software

Materialise Mimics Enlight - 05404028000199

Materialise Mimics Enlight
Materialise NV
Materialise Mimics Enlight
In Commercial Distribution

  • 05404028000199 ()
Materialise Mimics Enlight

  • CAD/CAM software

Mimics Plugin - 05404028000137

Mimics Plugin Compare Masks
Materialise NV
Compare Masks
In Commercial Distribution

  • 05404028000137 ()
Compare Masks

  • CAD/CAM software

Mimics Plugin - 05404028000120

Mimics Plugin Segment Thin Bone
Materialise NV
Segment Thin Bone
In Commercial Distribution

  • 05404028000120 ()
Segment Thin Bone

  • CAD/CAM software

Mimics - 05404028000090

Mimics Automatic Algorithms Knee MRI
Materialise NV
Knee MRI
In Commercial Distribution

  • 05404028000090 ()
Knee MRI

  • CAD/CAM software

IMPAX Clinical Applications - 05400874001205

IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
Agfa HealthCare NV
4
In Commercial Distribution

  • 05400874001205 ()


  • Radiological PACS software

Enterprise Imaging XERO Viewer - 05400874000710

Enterprise Imaging XERO Viewer 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software

Enterprise Imaging Desktops - 05400874000703

Enterprise Imaging Desktops 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software

Reality DTx - 05065012458121

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
HL2 v6
In Commercial Distribution

CX-HL2-0001

  • Neuromuscular rehabilitation software

Reality DTx - 05065012458114

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
ML2 v6
In Commercial Distribution

CX-ML2-0001

  • Neuromuscular rehabilitation software
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