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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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RAPID - 07290101362128

WS accessory pack
Given Imaging, Inc.
FGS-0410
In Commercial Distribution

  • 07290101362128 ()


  • Video capsule endoscopy system application software

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

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

Innocor - 05713867000186

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

  • 05713867000186 ()


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

Innocor - 05713867000179

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1c
In Commercial Distribution

  • 05713867000179 ()


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

Innocor - 05713867000162

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1b
In Commercial Distribution

  • 05713867000162 ()


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

Innocor - 05713867000155

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1a
In Commercial Distribution

  • 05713867000155 ()


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

Innocor - 05713867000063

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00500
In Commercial Distribution

  • 05713867000063 ()


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

Innocor - 05713867000056

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00400
In Commercial Distribution

  • 05713867000056 ()


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

cable - 00690103206951

ACUMEN AFM CABLE
Edwards Lifesciences LLC
AAFMC
In Commercial Distribution

  • 00690103206951 ()
AAFMC

  • General-purpose multi-parameter bedside monitor
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