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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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PRGM 8835 PERSONAL THRPY MG2 RFRB US
MEDTRONIC, INC.
8835-RFB
In Commercial Distribution

  • 00763000875695 ()


  • Infusion pump programmer
The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution

  • 17540176010002 ()


  • Virtual-display arm rehabilitation system, non-gravity-compensating
The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652085 ()
LV1055002

  • Virtual bronchoscopic navigation PACS software
The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652030 ()
LV1055001

  • Virtual bronchoscopic navigation PACS software
SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.
TECHNIDATA
TDGenet
In Commercial Distribution

  • 03770027519027 ()


  • Clinical laboratory information system application software
Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution

  • M65810604640 ()
NA

  • Linear accelerator system
Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.
TOBII DYNAVOX LLC
Indi 7
Not in Commercial Distribution

  • 07340074601042 ()
750518

  • Voice synthesizer/digitizer
Roentgen Works 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008247 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
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