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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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
PhoeniX
In Commercial Distribution

  • 08436046002951 ()
3632

  • Mobile basic diagnostic x-ray system, digital
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
PhoeniX
In Commercial Distribution

  • 08436046002944 ()
3620

  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-50HF-B-D-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002609 ()


  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-40HF-B-D-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002593 ()


  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-32HF-B-D-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002586 ()


  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-20HF-B-D-KM (AeroDR X30)
Not in Commercial Distribution

  • 08436046002579 ()


  • Mobile basic diagnostic x-ray system, digital
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
Soltus 450
In Commercial Distribution

  • 08436046002562 ()
10451-01

  • Mobile basic diagnostic x-ray system, digital
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
Soltus 450
In Commercial Distribution

  • 08436046002555 ()
10451

  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-40HF-B-D-C
In Commercial Distribution

  • 08436046001510 ()


  • Mobile basic diagnostic x-ray system, digital
This mobile 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
SM-32HF-Batt
In Commercial Distribution

  • 08436046001466 ()


  • Mobile 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
This mobile 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
SM-40HF-Batt
In Commercial Distribution

  • 08436046001114 ()


  • Mobile basic diagnostic x-ray system, digital
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
No Description
THALES AVS FRANCE SAS
62833765
In Commercial Distribution

  • 03701440100172 ()


  • Stationary basic diagnostic x-ray system, digital
Definium Pace Select system designated medical device
GE Hualun Medical Systems Co., Ltd
Pace Select
In Commercial Distribution

  • 00195278526892 ()
B2604CAB

  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
Navigate
In Commercial Distribution

  • 00195278003348 ()


  • Mobile basic diagnostic x-ray system, digital
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital
Definium Pace Select ET System UDI
GE Hualun Medical Systems Co., Ltd
Pace Select ET
In Commercial Distribution

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital
XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Upgrade Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
NAVIGATE UPGRADE
In Commercial Distribution

  • 00195278798374 ()


  • Mobile basic diagnostic x-ray system, digital
Value Fixed Table
GE Hualun Medical Systems Co., Ltd
VFTBL-1
In Commercial Distribution

  • 00195278713766 ()
VFTBL-1

  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand
GE Hualun Medical Systems Co., Ltd
VMWS-1
In Commercial Distribution

  • 00195278713759 ()
VMWS-1

  • Stationary basic diagnostic x-ray system, digital
No Description
LIFE TECHNOLOGIES CORPORATION
A32444
In Commercial Distribution

  • 10190302006156 ()


  • PCR/NAT negative control IVD
ONC DX TARGET DNA CONTROL
LIFE TECHNOLOGIES CORPORATION
A32442
In Commercial Distribution

  • 10190302006095 ()


  • Nucleic acid hybridization detection IVD, control
ODXTT UG AND ADF 1.8 - US
LIFE TECHNOLOGIES CORPORATION
A32461
In Commercial Distribution

  • 10190302006071 ()


  • Human genomic analysis interpretive software
No Description
LIFE TECHNOLOGIES CORPORATION
A32443
In Commercial Distribution

  • 10190302006064 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29362
In Commercial Distribution

  • 10190302005852 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29361
In Commercial Distribution

  • 10190302005845 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A30320
In Commercial Distribution

  • 10190302000888 ()


  • PCR/NAT negative control IVD
No Description
SHIMADZU CORPORATION
566-16130-83
In Commercial Distribution

  • 04540217071616 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-16130-82
In Commercial Distribution

  • 04540217071609 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-16130-81
In Commercial Distribution

  • 04540217071593 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-16130-80
In Commercial Distribution

  • 04540217071586 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-64
In Commercial Distribution

  • 04540217071388 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-62
In Commercial Distribution

  • 04540217071364 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-60
In Commercial Distribution

  • 04540217071340 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-53
In Commercial Distribution

  • 04540217071326 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-65
In Commercial Distribution

  • 04540217071395 ()


  • Stationary basic diagnostic x-ray system, digital
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