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
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183752
In Commercial Distribution

  • 04056869002446 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183312
In Commercial Distribution

  • 04056869002408 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764039
In Commercial Distribution

  • 04056869002286 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764035
In Commercial Distribution

  • 04056869002262 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764032
In Commercial Distribution

  • 04056869002217 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10273987
In Commercial Distribution

  • 04056869002170 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10273985
In Commercial Distribution

  • 04056869002163 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764040
In Commercial Distribution

  • 04056869002156 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10763972
In Commercial Distribution

  • 04056869002149 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10763971
In Commercial Distribution

  • 04056869002132 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716644
In Commercial Distribution

  • 04056869002125 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716669
In Commercial Distribution

  • 04056869002118 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716511
In Commercial Distribution

  • 04056869002101 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716651
In Commercial Distribution

  • 04056869002095 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589577
In Commercial Distribution

  • 04068151009453 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589500
In Commercial Distribution

  • 04068151009460 ()


  • PET system application software
  • SPECT system application software
After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Canary Medical USA LLC
43-5570-006-14
In Commercial Distribution

  • 00850015699016 ()


  • Patient health record information system
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
FUJIFILM CORPORATION
CR-VW674
In Commercial Distribution

  • 04547410316926 ()


  • Diagnostic x-ray digital imaging system workstation
Data Management Monitor
SPECTRUM MEDICAL LIMITED
VIPER DM
Not in Commercial Distribution

  • 05060434420015 ()
3005-001-200

  • Patient health record information system
Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
Not in Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system
"RADIMETRICS Enterprise Platform (60777193)"
BAYER MEDICAL CARE INC.
EXP-XX
In Commercial Distribution

  • 00616258008851 ()
EXP-XX

  • Patient health record information system
A complete telehealth platform that offers secure telemedicine software solutions with diagnostic and clinical workflow capabilities combined with interoperable services that work with an existing platform including scheduling, video consultations, data integration, and integration management services.
Globalmed Holdings, LLC
eNcounter
In Commercial Distribution

  • 00850033167115 ()


  • Patient health record information system
DreamStation SpO2 Connection Module
Respironics, Inc.
DreamStation Spo2 Connection Module
In Commercial Distribution

  • 00606959061132 ()
1147056

  • Clinical laboratory information system
DreamStation Cellular Modem Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058873 ()
200602C

  • Clinical laboratory information system
Cellular Modem with Oximetry, Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058859 ()
200601C

  • Clinical laboratory information system
DreamStation Cellular Modem, Dipole, Europe
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058828 ()
200625C

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, Dipole, EU
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058804 ()
200624C

  • Clinical laboratory information system
DreamStation Cellular Modem, Device, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058224 ()
200675C

  • Clinical laboratory information system
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