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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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PaX-i3D Green - 08800016400137

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(H) / 1210SGA)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400137 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400120

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(H) / Xmaru2301CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400120 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400113

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(H))
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400113 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400106

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V) / 910SGA)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400106 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400090

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V) / 1210SGA)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400090 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400076

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(V))
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400076 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400052

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 1210SGA)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400052 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400045

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400045 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400038

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1215CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400038 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400021

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1404CF / 1210SGA)
VATECH CO., LTD.
PHT-30LFO
Not in Commercial Distribution

  • 08800016400021 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400014

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1404CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-30LFO
In Commercial Distribution

  • 08800016400014 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400007

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)
VATECH CO., LTD.
PHT-30LFO
In Commercial Distribution

  • 08800016400007 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

IOPI® - 10810091040239

The IOPI® Pro (Model 3.1) is used by healthcare professionals to measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Pro is intended for clinical use by healthcare professionals.
Iopi Medical LLC
Model 3.1
In Commercial Distribution

  • 10810091040253 ()
  • 10810091040239 ()
  • 10810091040321 ()
  • 10810091040260 ()
  • 10810091040420 ()
8-3101

  • Dynamometer force gauge

IOPI® - 10810091040048

The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Trainer is intended for clinical use and use by patients outside their therapy sessions under the direction of a healthcare professional.
Iopi Medical LLC
Model 3.2
In Commercial Distribution

  • 10810091040024 ()
  • 10810091040048 ()
  • 10810091040178 ()
8-3201

  • Dynamometer force gauge

IOPI® - 10810091040031

The IOPI® Pro (Model 3.1) is used by healthcare professionals to measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Pro is intended for clinical use by healthcare professionals.
Iopi Medical LLC
Model 3.1
In Commercial Distribution

  • 10810091040000 ()
  • 10810091040031 ()
  • 10810091040017 ()
  • 10810091040154 ()
  • 10810091040161 ()
8-3101

  • Dynamometer force gauge

VistaPano S Ceph 2.0 - 08800016401967

Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
VATECH CO., LTD.
VistaPano S Ceph
In Commercial Distribution

  • 08800016401967 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

EzRay Air 2 Wall - 08800016401912

VEX-S350W X-RAY SYSTEM(600MM)/EZRAY AIR2 W(USA)/MASTER
VATECH CO., LTD.
VEX-S350W
In Commercial Distribution

  • 08800016401912 ()


  • Hand-held intraoral dental x-ray system, digital

VistaIntra DC - 08800016401882

Dental Extraoral Source X-ray System (Horizontal Arm Length 450mm)
VATECH CO., LTD.
VistaIntra DC
In Commercial Distribution

  • 08800016401882 ()


  • Hand-held intraoral dental x-ray system, digital

VistaPano - 08800016401868

Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
VistaPano
Not in Commercial Distribution

  • 08800016401868 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i - 08800016400557

Digital X-ray Imaging System functioning Pano Image Acquisition. (Xmaru1501CF)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400557 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400540

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF-S / Xmaru1524CF-MP / Xmaru2301CF-HS)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400540 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400533

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400533 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

EzRay Premium VET - 08800016400526

Dental Extraoral Source X-ray System for animals (Horizontal Arm Length 900mm)
VATECH CO., LTD.
VEX-S100W
In Commercial Distribution

  • 08800016400526 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Premium VET - 08800016400519

Dental Extraoral Source X-ray System for animals (Horizontal Arm Length 600mm)
VATECH CO., LTD.
VEX-S100W
In Commercial Distribution

  • 08800016400519 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Premium VET - 08800016400502

Dental Extraoral Source X-ray System for animals (Horizontal Arm Length 450mm
VATECH CO., LTD.
VEX-S100W
In Commercial Distribution

  • 08800016400502 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Air - 08800016400496

Dental Extraoral Source Portable X-ray System (SSD 200mm)
VATECH CO., LTD.
VEX-P300
Not in Commercial Distribution

  • 08800016400496 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Air W - 08800016400489

Dental Extraoral Source X-ray System (Horizontal Arm Length 450mm)
VATECH CO., LTD.
VEX-S300W
In Commercial Distribution

  • 08800016400489 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Air W - 08800016400472

Dental Extraoral Source X-ray System (Horizontal Arm Length 600mm)
VATECH CO., LTD.
VEX-S300W
In Commercial Distribution

  • 08800016400472 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Air W - 08800016400465

Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)
VATECH CO., LTD.
VEX-S300W
In Commercial Distribution

  • 08800016400465 ()


  • Hand-held intraoral dental x-ray system, digital

PaX-i Insight - 08800016400458

Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400458 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i Insight - 08800016400441

Dental Digital X-ray Imaging System functioning Pano Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400441 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i Plus - 08800016400434

Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400434 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i Plus - 08800016400427

Dental Digital X-ray Imaging System functioning Pano Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400427 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green 18 - 08800016400410

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400410 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green 18 - 08800016400403

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400403 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green 16 - 08800016400397

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400397 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green 16 - 08800016400380

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400380 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green Smart - 08800016400373

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400373 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green Smart - 08800016400366

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400366 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green Premium / Green 21 - 08800016400359

Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data (Xmaru3104CF)
VATECH CO., LTD.
PCT-90LH
In Commercial Distribution

  • 08800016400359 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

ProVecta HD - 08800016400342

Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)
VATECH CO., LTD.
ProVecta HD
In Commercial Distribution

  • 08800016400342 ()


  • Hand-held intraoral dental x-ray system, digital

ProVecta HD - 08800016400335

Dental Extraoral Source X-ray System (Horizontal Arm Length 450mm)
VATECH CO., LTD.
ProVecta HD
In Commercial Distribution

  • 08800016400335 ()


  • Hand-held intraoral dental x-ray system, digital

ProVecta HD - 08800016400328

Dental Extraoral Source X-ray System (Horizontal Arm Length 600mm)
VATECH CO., LTD.
ProVecta HD
In Commercial Distribution

  • 08800016400328 ()


  • Hand-held intraoral dental x-ray system, digital

ProVecta S-Pan - 08800016400311

Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
ProVecta S-Pan
In Commercial Distribution

  • 08800016400311 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

ProVecta S-Pan - 08800016400304

Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF)
VATECH CO., LTD.
ProVecta S-Pan
In Commercial Distribution

  • 08800016400304 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i - 08800016400298

Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 910SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400298 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i - 08800016400281

Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 1210SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400281 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i - 08800016400274

Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
PCH-2500
In Commercial Distribution

  • 08800016400274 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i - 08800016400267

Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF)
VATECH CO., LTD.
PCH-2500
In Commercial Distribution

  • 08800016400267 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D - 08800016400250

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 910SGA)
VATECH CO., LTD.
PHT-6500
Not in Commercial Distribution

  • 08800016400250 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
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