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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X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the right
DE GÖTZEN SRL
XMT PAN R CEPH R
Not in Commercial Distribution

  • D804W09002300 ()
W0900230

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
X-MIND trium PAN T version including one removable pan sensor with control panel on the left configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY L
Not in Commercial Distribution

  • D804W09002260 ()
W0900226

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN T version including one removable pan sensor with control panel on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY R
Not in Commercial Distribution

  • D804W09002250 ()
W0900225

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the left
DE GÖTZEN SRL
XMT PAN R CEPH L
Not in Commercial Distribution

  • D804W09000030 ()
W0900003

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-07817
In Commercial Distribution

  • M70890078170 ()


  • Multiple Candida species nucleic acid IVD, reagent
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
MESA BIOTECH, INC.
1028
In Commercial Distribution

  • B54010280 ()
1028

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
No Description
Ziehm-Orthoscan, Inc.
1000-0020
In Commercial Distribution

  • B225100000200 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
Image-Intensified Fluoroscopic X-Ray, Mobile
Ziehm-Orthoscan, Inc.
1000-0017
In Commercial Distribution

  • B225100000170 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
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