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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QUANTUM Talar Implant Flat Cut Right Size 4
IN2BONES
M50 SC144
In Commercial Distribution

  • 03701337602659 ()

  • Length: 38.91 Millimeter
  • Length: 3303 Millimeter
M50 SC144

  • Fixed-bearing total ankle prosthesis
QUANTUM Resection Guide For Talar Chamfer S6
IN2BONES
M05 01031
In Commercial Distribution

  • 03701337601157 ()

  • Length: 72.69 Millimeter
  • Width: 36.26 Millimeter
M05 01031

  • Osteotomy guide, reusable
QUANTUM Tibial Implant Guide
IN2BONES
M05 00731
In Commercial Distribution

  • 03701337605520 ()

  • Length: 28 Millimeter
  • Height: 31.8 Millimeter
M05 00731

  • Orthopaedic instrument surgical connector
Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD
Cardinal Health 200, LLC
CH6870
In Commercial Distribution

  • 50885380096745 ()
  • 20885380096744 ()
  • 10885380096747 ()
CH6870

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00856100006233 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00856100006172 ()


  • Radiation therapy software
OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software
No Description.
Quantib B.V.
2.8
In Commercial Distribution

  • 08719689791308 ()


  • Radiology DICOM image processing application software
No description.
Quantib B.V.
2.7
In Commercial Distribution

  • 08719689791285 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.6
Not in Commercial Distribution

  • 08719689791247 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.5
In Commercial Distribution

  • 08719689791193 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.4
In Commercial Distribution

  • 08719689791162 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.3
In Commercial Distribution

  • 08719689791124 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791100 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791049 ()


  • Radiology DICOM image processing application software
No Description
FCU
SC1
In Commercial Distribution

  • 08800076600157 ()


  • Hand-held ultrasound imaging system, body-surface
inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices). inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.1.0
In Commercial Distribution

  • 03770019599075 ()


  • Image segmentation application software
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977275 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977268 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software
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