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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
Onera B.V.
01.00
In Commercial Distribution

  • 08720256698197 ()
ONERA STS1 STATION SOFTWARE

  • Polysomnography analyser
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P17000-15
In Commercial Distribution

  • 00841517100032 ()


  • General-purpose ultrasound imaging system
  • Breast ultrasound imaging system
  • Obstetrical/gynaecological ultrasound imaging system
  • Cardiovascular ultrasound imaging system
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
t:connect Mobile Application (Android)
Tandem Diabetes Care, Inc.
1004127
In Commercial Distribution

  • 00850006613267 ()


  • Ambulatory insulin infusion pump software, data-display
No Description
KONAN MEDICAL, INC.
CD-15
In Commercial Distribution

  • 04582275250404 ()


  • Cell morphology analyser IVD, manual
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586332 ()


  • Dental x-ray image interpretive software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586318 ()


  • Dental x-ray image interpretive software
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