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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Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A1946
In Commercial Distribution

  • 00810117210014 ()


  • Nuclear medicine phantom, point source
PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software
PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software
PillCam™ Recorder DR3 SW upgrade
Given Imaging, Inc.
FGS-0664
In Commercial Distribution

  • 07290110360719 ()


  • Video capsule endoscopy system application software
PillCam™ WS v9 Dell T5810, USA
Given Imaging, Inc.
FGS-0640
In Commercial Distribution

  • 07290110360221 ()


  • Video capsule endoscopy system application software
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 US WS
Given Imaging, Inc.
FGS-0542
In Commercial Distribution

  • 07290101365280 ()


  • Video capsule endoscopy system application software
SW upgrade, v8.0 US
Given Imaging, Inc.
FGS-0541
In Commercial Distribution

  • 07290101365273 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 US
Given Imaging, Inc.
FGS-0540
In Commercial Distribution

  • 07290101365266 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 SCA WS
Given Imaging, Inc.
FGS-0480-01
In Commercial Distribution

  • 07290101365013 ()


  • Video capsule endoscopy system application software
SW upgrade, v8.0 SCA
Given Imaging, Inc.
FGS-0479-01
In Commercial Distribution

  • 07290101365006 ()


  • Video capsule endoscopy system application software
RAPID® SW kit, v8.0 SCA
Given Imaging, Inc.
FGS-0478-01
In Commercial Distribution

  • 07290101364993 ()


  • Video capsule endoscopy system application software
SW kit, v8.3 US WS
Given Imaging, Inc.
FGS-0525
In Commercial Distribution

  • 07290101364870 ()


  • Video capsule endoscopy system application software
SW upgrade, v8.3 US
Given Imaging, Inc.
FGS-0524
In Commercial Distribution

  • 07290101364863 ()


  • Video capsule endoscopy system application software
SW kit, v8.3 US
Given Imaging, Inc.
FGS-0523
In Commercial Distribution

  • 07290101364856 ()


  • Video capsule endoscopy system application software
WS, Dell T3400, SCA
Given Imaging, Inc.
FGS-0487
In Commercial Distribution

  • 07290101364207 ()


  • Video capsule endoscopy system application software
WS, Dell T3400, US
Given Imaging, Inc.
FGS-0485
In Commercial Distribution

  • 07290101364184 ()


  • Video capsule endoscopy system application software
RT SW kit, v8.0 WW
Given Imaging, Inc.
FGS-0472
In Commercial Distribution

  • 07290101363477 ()


  • Video capsule endoscopy system application software
WS accessory pack
Given Imaging, Inc.
FGS-0410
In Commercial Distribution

  • 07290101362128 ()


  • Video capsule endoscopy system application software
WS, Dell T3600 V8.5 US
Given Imaging, Inc.
FGS-0577
In Commercial Distribution

  • 07290101366058 ()


  • Video capsule endoscopy system application software
Access SW kit, v7.0 WS
Given Imaging, Inc.
FGS-0434
Not in Commercial Distribution

  • 07290101362784 ()


  • Video capsule endoscopy system application software
Access SW kit, v7.0
Given Imaging, Inc.
FGS-0396
In Commercial Distribution

  • 07290101362265 ()


  • Video capsule endoscopy system application software
SW upgrade, v7.0
Given Imaging, Inc.
FGS-0399
In Commercial Distribution

  • 07290101362234 ()


  • Video capsule endoscopy system application software
PillCam Software v9.0 WW WS
Given Imaging, Inc.
FGS-0626
In Commercial Distribution

  • 07290101369530 ()


  • Video capsule endoscopy system application software
recorder DR3 SW upgrade
Given Imaging, Inc.
FGS-0619
In Commercial Distribution

  • 07290101366904 ()


  • Video capsule endoscopy system application software
PillCam Software Upgrade v9 , USA
Given Imaging, Inc.
FGS-0613
In Commercial Distribution

  • 07290101366768 ()


  • Video capsule endoscopy system application software
PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software
WS, Dell T5810 V8.3 US
Given Imaging, Inc.
FGS-0600
In Commercial Distribution

  • 07290101366478 ()


  • Video capsule endoscopy system application software
WS, Dell T5810 V8.0 US
Given Imaging, Inc.
FGS-0599
In Commercial Distribution

  • 07290101366461 ()


  • Video capsule endoscopy system application software
BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature
BTS SPA
1.0
In Commercial Distribution

  • B179TMJ1 ()
  • B179TMJ ()
BTSEMB1BM

  • Electromyograph
Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
BTS SPA
2.0
In Commercial Distribution

  • B179THN1 ()
  • B179THN2 ()
BTSEMB1BM

  • Electromyograph
BTS OMNIsEMG is an instrument for the electromyographic surface analysis.
BTS SPA
1.0
In Commercial Distribution

  • B179OMN ()
BTSEMB1BM

  • Electromyograph
BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas. It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
BTS SPA
1000
In Commercial Distribution

  • B179FR11 ()
  • B179FR1 ()
BTSEMB1BM

  • Electromyograph
BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
BTS SPA
300
In Commercial Distribution

  • B179FE31 ()
  • B179FE3 ()
BTSFE3

  • Electromyograph
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG HeadBox Kit
In Commercial Distribution

  • 27290114060817 ()
750-020013-00

  • Electromyograph
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3015
In Commercial Distribution

  • 00810117211141 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
35-2-1
In Commercial Distribution

  • 00810117211134 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-01
In Commercial Distribution

  • 00810117211127 ()


  • Nuclear medicine phantom, point source
Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-05Z
In Commercial Distribution

  • 00810117211110 ()


  • Nuclear medicine phantom, point source
2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0502
Not in Commercial Distribution

  • 00885074322889 ()


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

  • 00885074291635 ()


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

  • 00885074291611 ()


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

  • 00885074291598 ()


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

  • 00885074291574 ()


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

  • 00885074291567 ()


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

  • 00885074291529 ()


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

  • 00885074291499 ()


  • Electromyograph
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
ACUMEN AFM CABLE
Edwards Lifesciences LLC
AAFMC
In Commercial Distribution

  • 00690103206951 ()
AAFMC

  • General-purpose multi-parameter bedside monitor
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