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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Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
2.6 mm ASA w/ (3) 1.5 mm suture tapes on Inserter
Tigon Medical LLC
TM-ASAP003-02TTT
In Commercial Distribution

  • 00810155330170 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
2.3 mm ASA w/ (2) 1.5 mm suture tapes on Inserter
Tigon Medical LLC
TM-ASAP002-01TT
In Commercial Distribution

  • 00810155330149 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
2.3 mm ASA w/ (2) USP 2 suture cables on Inserter
Tigon Medical LLC
TM-ASAP002-01SS
In Commercial Distribution

  • 00810155330132 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
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