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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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Custom Sound Suite 4.4 Download
COCHLEAR LIMITED
P705392
In Commercial Distribution

  • 09321502033374 ()
P705392

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.2 ENGLISH (US)
COCHLEAR LIMITED
Z274923
In Commercial Distribution

  • 09321502020480 ()
Z274923

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH
COCHLEAR LIMITED
Z229456
In Commercial Distribution

  • 09321502018913 ()
Z229456

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 US ENGLISH
COCHLEAR LIMITED
Z220129
In Commercial Distribution

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 2.0 SR1 FRENCH
COCHLEAR LIMITED
Z194952
In Commercial Distribution

  • 09321502011921 ()
Z194952

  • Audiometric/hearing device software
CUSTOM SND SUITE 1.3 SERV RELEASE 1
COCHLEAR LIMITED
Z61155
In Commercial Distribution

  • 09321502011624 ()
Z61155

  • Audiometric/hearing device software
CLINICAL PROGRAMMING SYSTEM
COCHLEAR LIMITED
Z43102
In Commercial Distribution

  • 09321502002448 ()
Z43102

  • Audiometric/hearing device software
No Description
Cochlear Americas Corporation
P2002452CD
In Commercial Distribution

  • 09321502074148 ()


  • Audiometric/hearing device software
No Description
Sound Options Tinnitus Treatments Inc
2.0
In Commercial Distribution

  • 00627843723226 ()


  • Tinnitus masking application software
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
Momentum Health Inc
Momentum Spine
In Commercial Distribution

  • 00628774533007 ()


  • Posture imaging/analysis software
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