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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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Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system
No Description
ergoline GmbH
161801
In Commercial Distribution

  • 04059358001838 ()


  • Cardiopulmonary parameter spot-check measurement software
No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system
No Description
M DIALYSIS INC.
English
In Commercial Distribution

  • 07332699000751 ()
8001027

  • Bedside information system
No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation
tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101345
In Commercial Distribution

  • 07540261013454 ()


  • Pulmonary function analysis system, adult
SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution

  • 17350088671426 ()


  • Nurse call system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000378424 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000376215 ()


  • ENT stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000374167 ()


  • Neurological stereotactic surgery system
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