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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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No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017100159 ()


  • Nitrogen plasma skin surface treatment system
No Description
GENORAY CO., LTD.
ZEN-PX4
In Commercial Distribution

  • 08809244061226 ()


  • Portable basic diagnostic x-ray system, digital
No Description
GENORAY CO., LTD.
PORT-X IV
In Commercial Distribution

  • 08809244061202 ()


  • Portable basic diagnostic x-ray system, digital
The Multiple Name for PORT-XII is ZEN-PX2.
GENORAY CO., LTD.
PORT-XII
In Commercial Distribution

  • 08809244061035 ()


  • Portable basic diagnostic x-ray system, digital
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution

  • B632MDB01007 ()
MDB01007

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical
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