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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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Instrument selection software
Brainlab AG
1.5
In Commercial Distribution

  • 04056481142018 ()


  • Robotic surgical navigation system
M3.3 UP4 software
GE MEDICAL SYSTEMS
PRISTINA 0.0B
In Commercial Distribution

  • 00195278009289 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
Digital video software
NIHON KOHDEN AMERICA, INC.
QP-110AK
In Commercial Distribution

  • 00841983101274 ()
QP-110AK

  • Electroencephalograph
Exercise test software
NIHON KOHDEN AMERICA, INC.
QP-156E
Not in Commercial Distribution

  • 00841983101298 ()
QP-156E

  • Electrocardiograph, professional, multichannel
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder
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