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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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ESO v3.0.1 SW Upgrade kit
Given Imaging, Inc.
FGS-8029
In Commercial Distribution

  • 07290101369042 ()


  • Manometric gastrointestinal motility analysis system
Assy, ManoScan Cart
Given Imaging, Inc.
FGS-8039
In Commercial Distribution

  • 07290101366973 ()


  • Manometric gastrointestinal motility analysis system
Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.
CAPILLUS, LLC
AST-804
Not in Commercial Distribution

  • 00810045461427 ()


  • Red/blue light phototherapy unit
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-HAA-XXXXX
Not in Commercial Distribution

  • 00817655020440 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-CAD-XXXXX
In Commercial Distribution

  • 00817655020433 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAC-XXXXX
Not in Commercial Distribution

  • 00817655020334 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AHD-XXXXX
Not in Commercial Distribution

  • 00817655022208 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-COA-XXXXX
In Commercial Distribution

  • 00817655022192 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-ABA-XXXXX
Not in Commercial Distribution

  • 00817655022086 ()


  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00817655020853 ()
H3PLUS-CAE-XXXXX

  • Electrocardiographic ambulatory recorder
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