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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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Medspira mcompass Anorectal Manometry FOB
MEDSPIRA, LLC
RMD-001-001
In Commercial Distribution

  • 00851607003044 ()
  • 10851607003041 ()
RMD-001-001

  • Manometric gastrointestinal motility analysis system
Adapter for QuikLinq FOB
MEDSPIRA, LLC
RMD-210-020
In Commercial Distribution

  • 10851607003003 ()
  • 00851607003006 ()


  • Manometric gastrointestinal motility analysis system
FLIP Topography Module
Covidien LP
DD-961
In Commercial Distribution

  • 05391530810142 ()


  • Manometric gastrointestinal motility analysis system
Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510807 ()


  • Red/blue light phototherapy unit
Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510685 ()


  • Red/blue light phototherapy unit
Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
I-SMART DEVELOPMENTS LIMITED
TN2112
In Commercial Distribution

  • 05060534510234 ()
135-OC

  • Red/blue light phototherapy unit
No Description
Luminance Medical Ventures Incorporated
TN1927D
In Commercial Distribution

  • 00860002593036 ()


  • Red/blue light phototherapy unit
No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution

  • 00860002177786 ()
910-01957

  • Alarm application software
No Description
STRYKER CORPORATION
910-01947
In Commercial Distribution

  • 00860002177779 ()
910-01947

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.5.0
In Commercial Distribution

  • 00860002177762 ()
910-01959

  • Alarm application software
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