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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No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution

  • 00842318130839 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution

  • 00842318130815 ()


  • Audiometric/hearing device software
Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution

  • 00884838123717 ()
989803221531

  • Centralized patient monitor
No Description
AUGMEDICS LTD
ASP07070
In Commercial Distribution

  • 27290113781195 ()
  • 17290113781181 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07073
In Commercial Distribution

  • 27290113781164 ()
  • 17290113781150 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07059
In Commercial Distribution

  • 27290113781041 ()
  • 17290113781044 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07056
In Commercial Distribution

  • 27290113781034 ()
  • 17290113781037 ()


  • Multi-purpose stereotactic surgery system
The Ballancer Pro Pants-Bot. conn inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
MEGO afek Agricultural Cooperative Society Ltd
Bal Pants Bot conn
In Commercial Distribution

  • 07290105874191 ()
L4MP4120

  • Multi-chamber venous compression system garment, reusable
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
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