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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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LABSYSTEM™ PRO EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M004LSPRO400100
In Commercial Distribution

  • 00191506004392 ()
M004LSPRO400100

  • Cardiopulmonary physiological parameter analysis software
Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system
Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
In Commercial Distribution



  • Hand orthosis
Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software
Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system
Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system
Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution

  • 00801741161094 ()
SR8 USv2.1.0

  • General-purpose ultrasound imaging system
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