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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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No Description
UC-CARE LTD
FPRSA00007
In Commercial Distribution

  • 07290016936032 ()
FPRSA00007

  • Rectal ultrasound navigational image processor
No Description
UC-CARE LTD
FPRSA00006
In Commercial Distribution

  • 07290016936025 ()
FPRSA00006

  • Rectal ultrasound navigational image processor
No Description
UC-CARE LTD
FPRMC0016A
In Commercial Distribution

  • 07290016936001 ()
FPRMC0016A

  • Rectal ultrasound navigational image processor
AUDIOMETER. Piccolo Basic is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction.
INVENTIS SRL
PICCOLO BASIC
In Commercial Distribution

  • 08054187380341 ()
10327

  • Tone audiometer, manual
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
No Description
Roland Consult Stasche & Finger GmbH
29
In Commercial Distribution

  • 04260157780293 ()


  • Electrooculograph
  • Electroretinograph
No Description
Roland Consult Stasche & Finger GmbH
27
In Commercial Distribution

  • 04260157780279 ()


  • Electroretinograph
  • Electrooculograph
No Description
Roland Consult Stasche & Finger GmbH
26
In Commercial Distribution

  • 04260157780262 ()


  • Electroretinograph
  • Electrooculograph
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