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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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Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Planmeca Oy
ProMax 2D
In Commercial Distribution

  • 06430035420445 ()
30003108

  • Stationary panoramic dental x-ray system, digital
Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
Planmeca Oy
ProOne
In Commercial Distribution

  • 06430035420322 ()
30010469

  • Stationary panoramic dental x-ray system, digital
Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Planmeca Oy
ProMax 2D
In Commercial Distribution

  • 06430035420292 ()
10030688

  • Stationary panoramic dental x-ray system, digital
Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system
No Description
DENTAL XRAY COMPANY SRL
X-MIND prime
Not in Commercial Distribution

  • 08052870660015 ()


  • Stationary panoramic dental x-ray system, digital
Digital panoramic and cephalometric extra­oral X-­ray system.
CEFLA SOCIETA' COOPERATIVA
NewTom Giano (2D)
In Commercial Distribution

  • 08033837931416 ()
XGIAN2D

  • Stationary panoramic dental x-ray system, digital
Digital panoramic and cephalometric extra­oral X-­ray system.
CEFLA SOCIETA' COOPERATIVA
hyperion X9 (2D)
In Commercial Distribution

  • 08033837931409 ()
X92D015

  • Stationary panoramic dental x-ray system, digital
Extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
CEFLA SOCIETA' COOPERATIVA
hyperion X5 (2D)
In Commercial Distribution

  • 08033837930914 ()
XHYPEX5

  • Stationary panoramic dental x-ray system, digital
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