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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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SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
SW D00U004 SS PERCEPTA SERENA SOLERA
MEDTRONIC, INC.
D00U004
In Commercial Distribution

  • 00763000002046 ()


  • Implantable cardiac device management application software
SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
D00U003
In Commercial Distribution

  • 00763000002039 ()


  • Implantable cardiac device management application software
No Description
EMPATICA SRL
EmbracePlus2 Stretchable Band - Black
In Commercial Distribution

  • 00853858006584 ()
EBP2-1G-FB-B

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple vital physiological parameter monitoring system, home-use
This Digital 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
MILLENNIUM PLUS AT
In Commercial Distribution

  • 08436046001916 ()


  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital
This Digital 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
MILLENIUM PLUS TPC
In Commercial Distribution

  • 08436046001176 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X PLUS (LP) PLUS Radiographic Systems with (or without) Digital Detector are 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
SEDECAL X PLUS (LP) PLUS
In Commercial Distribution

  • 08436046000964 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X PLUS LP Radiographic Systems with (or without) Digital Detector are 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
SEDECAL X PLUS LP
In Commercial Distribution

  • 08436046000940 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X PLUS LP PLUS Radiographic Systems with (or without) Digital Detector are 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
SEDECAL X PLUS LP PLUS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital
The CHALLENGEX AP 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
Radiographic System Challenge X
In Commercial Distribution

  • 08436046002388 ()
ChallengeX AP

  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital
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