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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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Blue Sky Bio, LLC. - 00810060226346

Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software

Eye Tracker Camera - 07090042052023

No Description
Nordicneurolab AS
ETC 2.0
In Commercial Distribution

  • 07090042052023 ()


  • Eye movement analysis system

Audyx - 07290017820019

Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer

MedRx - 00810044582963

No Description
MEDRX, INC.
MedRx Kiosk
In Commercial Distribution

  • 00810044582963 ()


  • Tone audiometer

MedRx - 00810044580112

No Description
MEDRX, INC.
Avant AIR+
In Commercial Distribution

  • 00810044580112 ()


  • Tone audiometer

MedRx - 00810044580082

No Description
MEDRX, INC.
MedRx Tinnometer
Not in Commercial Distribution

  • 00810044580082 ()


  • Tone audiometer

MedRx - 00810044580044

No Description
MEDRX, INC.
Avant Stealth Audiometer
In Commercial Distribution

  • 00810044580044 ()


  • Tone audiometer

MedRx - 00810044580013

No Description
MEDRX, INC.
Avant ARC
In Commercial Distribution

  • 00810044580013 ()


  • Tone audiometer

MedRx - 00810044580006

No Description
MEDRX, INC.
Avant A2D+
In Commercial Distribution

  • 00810044580006 ()


  • Tone audiometer

MedRx - 00810044583045

No Description
MEDRX, INC.
MedRx AWRC
In Commercial Distribution

  • 00810044583045 ()


  • Tone audiometer

Grason-Stadler - 00810046701690

No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046701690 ()


  • Tone audiometer

Grason-Stadler - 00810046700488

No Description
Diagnostic Group LLC
GSI AudioStar Pro
In Commercial Distribution

  • 00810046700488 ()


  • Tone audiometer

Grason-Stadler - 00810046700273

No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046700273 ()


  • Tone audiometer

Grason-Stadler - 00810046700266

No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046700266 ()


  • Tone audiometer

Grason-Stadler - 00810046700235

No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046700235 ()


  • Tone audiometer

Grason-Stadler - 00810046700075

No Description
Diagnostic Group LLC
GSI Pello
In Commercial Distribution

  • 00810046700075 ()


  • Tone audiometer

Grason-Stadler - 00810046700006

No Description
Diagnostic Group LLC
GSI 18
In Commercial Distribution

  • 00810046700006 ()


  • Tone audiometer

Blue Sky Bio, LLC. - 00810060226063

Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software

Swissmeda powered by Carestream Dental - 60192155944543

Swissmeda powered by Carestream Dental
CARESTREAM DENTAL LLC
5944541
In Commercial Distribution

  • 60192155944543 ()
5944541

  • Dental treatment application software

MedTrakVNG Goggle - B292M9205200

No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system
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