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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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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
MM3
In Commercial Distribution

  • B632MDB01005 ()
MDB01005

  • 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
MM12
In Commercial Distribution

  • B632MDB01003 ()
MDB01003

  • 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
No Description
MEDIBLU MEDICAL LLC
MM17
In Commercial Distribution

  • B632MDB01001 ()
MDB01001

  • Multiple vital physiological parameter monitoring system, clinical
MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Infobionic, Inc.
01854
In Commercial Distribution

  • B690MK10 ()


  • Electrocardiography telemetric monitoring system transmitter
Software, Version 1.0, iDMS™ Data Management System The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1049889
In Commercial Distribution

  • M65810498890 ()
NA

  • Linear accelerator system
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