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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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Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software
tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101345
In Commercial Distribution

  • 07540261013454 ()


  • Pulmonary function analysis system, adult
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738820 ()
019.2033

  • Dental milling system, CAD/CAM, chairside
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738813 ()
019.2032

  • Dental milling system, CAD/CAM, laboratory
No Description
Aktina Corp.
50-135
In Commercial Distribution

  • B365501350 ()


  • Stereotactic system application software
No Description
Thought Technology Ltd.
SA7900
In Commercial Distribution

  • 07540191000449 ()


  • Psychophysiological biofeedback system
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000378424 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000376215 ()


  • ENT stereotactic surgery system
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