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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Mobile Application tablet
Medidata Solutions, Inc.
BRCT01
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Wearable sensor patch
Medidata Solutions, Inc.
BRCS02
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile phone application
Medidata Solutions, Inc.
BRCP03
In Commercial Distribution



  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
Mobile application phone
Medidata Solutions, Inc.
BRCP02
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile application phone
Medidata Solutions, Inc.
BRCP01
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Intra-abdominal pressure measurement set, mechanical
Link Hub Smart Charger
Medidata Solutions, Inc.
BRCD02
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Adhesive Applicator
Medidata Solutions, Inc.
BRCA05
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
Web application
MC10, INC.
SW-0028
Not in Commercial Distribution

  • B493SW0028 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Investigator application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0027 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0026 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
MC10, INC.
SW-0025
Not in Commercial Distribution

  • B493SW0025 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0015
Not in Commercial Distribution

  • B493MC0015 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05
MC10, INC.
MC-0014
Not in Commercial Distribution

  • B493MC0014 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0013 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0013
Not in Commercial Distribution

  • B493MC0013 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0012 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0012
Not in Commercial Distribution

  • B493MC0012 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0008 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0008
Not in Commercial Distribution

  • B493MC0008 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05
MC10, INC.
MC-0007
Not in Commercial Distribution

  • B493MC0007 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0006 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0006
Not in Commercial Distribution

  • B493MC0006 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05
MC10, INC.
MC-0005
Not in Commercial Distribution

  • B493MC0005 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
MC-0004
Not in Commercial Distribution

  • B493MC0004 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
MC-0003
Not in Commercial Distribution

  • B493MC0003 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link Hub smart charger power supply
MC10, INC.
BSPS01
Not in Commercial Distribution

  • B493BSPS01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile application tablet
MC10, INC.
BRCT01
Not in Commercial Distribution

  • B493BRCT01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Wearable sensor patch
MC10, INC.
BRCS02
Not in Commercial Distribution

  • B493BRCS02 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile application phone
MC10, INC.
BRCP03
Not in Commercial Distribution

  • B493BRCP03 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile application phone
MC10, INC.
BRCP02
Not in Commercial Distribution

  • B493BRCP02 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Mobile application phone
MC10, INC.
BRCP01
Not in Commercial Distribution

  • B493BRCP01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link Hub smart charger
MC10, INC.
BRCD02
Not in Commercial Distribution

  • B493BRCD02 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link Hub smart charger
MC10, INC.
BRCD01
Not in Commercial Distribution

  • B493BRCD01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Adhesive applicator
MC10, INC.
BRCA05
Not in Commercial Distribution

  • B493BRCA05 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
No Description
VAREX IMAGING CORPORATION
i5 RF
In Commercial Distribution

  • 00854344007061 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DR
In Commercial Distribution

  • 00854344007047 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DSA
In Commercial Distribution

  • 00854344007009 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 RF
Not in Commercial Distribution

  • 00858086006054 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DR
Not in Commercial Distribution

  • 00858086006016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose
Control Swabs intended for use only with the ID NOW RSV product.
Alere Scarborough, Inc.
435-080
In Commercial Distribution

  • 10811877010538 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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