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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 Class Implantable

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Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system
Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution

  • B981BN0010101 ()
BN001-01-01

  • Surgical planning/navigation-enhancement system
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system
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
No Description
MEDIBLU MEDICAL LLC
MM15
In Commercial Distribution

  • B632MDB01002 ()
MDB01002

  • Multiple vital physiological parameter monitoring system, clinical
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