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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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Alpine BioMed - 00885074291635

G3 KEYPOINT WORKSTATION US
Alpine Biomed ApS
9031A0064AA
Not in Commercial Distribution

  • 00885074291635 ()


  • Electromyograph

Alpine BioMed - 00885074291611

KEYPOINT WORKST IT
Alpine Biomed ApS
9031A006406
Not in Commercial Distribution

  • 00885074291611 ()


  • Electromyograph

Alpine BioMed - 00885074291598

KEYPOINT WORKST NL
Alpine Biomed ApS
9031A006405
Not in Commercial Distribution

  • 00885074291598 ()


  • Electromyograph

Alpine BioMed - 00885074291574

KEYPOINT WORKST SP
Alpine Biomed ApS
9031A006404
Not in Commercial Distribution

  • 00885074291574 ()


  • Electromyograph

Alpine BioMed - 00885074291567

G3 KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006403
Not in Commercial Distribution

  • 00885074291567 ()


  • Electromyograph

Alpine BioMed - 00885074291529

KEYPOINT WORKST FR
Alpine Biomed ApS
9031A006402
Not in Commercial Distribution

  • 00885074291529 ()


  • Electromyograph

Alpine BioMed - 00885074291499

KEYPOINT WORKST UK
Alpine Biomed ApS
9031A006401
Not in Commercial Distribution

  • 00885074291499 ()


  • Electromyograph

Clear Guide CORE - B201CGCORE170

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-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer

Phantom - B214OSPTM3

No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object

Innocor - 05713867000193

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00500-1c
In Commercial Distribution

  • 05713867000193 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
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