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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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Quantib ND - 08719689791032

No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software

Quantib ND - 08719689791001

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791001 ()


  • MRI system application software

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

Neural Navigator - 08720299953703

Neural Navigation system - Essentials
Brain Science Tools B.V.
10.1
In Commercial Distribution

  • 08720299953703 ()


  • Surgical planning/navigation-enhancement system

Osstem - 08800000995014

The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Osstem Implant Co., Ltd._Gasan Branch
EXARO
In Commercial Distribution

  • 08800000995014 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001893

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL8HC
In Commercial Distribution

  • 08436046001893 ()


  • Portable basic diagnostic x-ray system, digital

SEDECAL - 08436046001886

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest,abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL4HC
In Commercial Distribution

  • 08436046001886 ()


  • Portable basic diagnostic x-ray system, digital
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