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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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ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system
Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system
SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system
DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software
Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software
Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device
Hearing Aid Fitting Software
INTRICON CORPORATION
hi-PS
In Commercial Distribution

  • 00858177007076 ()
22724

  • Hearing aid wireless-fitting computer-aided set
Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system
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