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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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V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.1
In Commercial Distribution

  • 00814905020007 ()


  • Parenteral-nutrition management software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M020101
In Commercial Distribution

  • 00817020020785 ()


  • Visual-reinforcement-audiometry reward system
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution

  • 07640153470157 ()
ST8000

  • Ocular volume ambulatory recording system software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution

  • 00817100020407 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution

  • 00889024511330 ()
20-8020-130-01

  • Robotic surgical navigation system application software
No Description
SIRIS MEDICAL, INC.
ISS100S
Not in Commercial Distribution

  • B244ISS100S0 ()
ISS100S

  • Radiation therapy software
No Description
M2S, INC.
4.x
Not in Commercial Distribution

  • B119PREVIEW0 ()


  • Radiology information system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314170 ()


  • Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314160 ()


  • Ultrasound imaging system application software
CS Orthodontic Imaging - Main Office
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851635 ()
1043272

  • Diagnostic x-ray digital imaging system workstation application software
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