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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CERAMAGE UP TG 5G
SHOFU DENTAL CORPORATION
2364
In Commercial Distribution

  • E23523640 ()
2364

  • Dental prosthesis veneer resin
Ceramage Trans Effects TG
SHOFU DENTAL CORPORATION
1934
In Commercial Distribution

  • E23519340 ()
1934

  • Dental prosthesis veneer resin
Chisel, Kirkland 13K/TG
Storz am Mark GmbH
12843.00
In Commercial Distribution

  • ESAM12843000 ()
  • ESAM12843001 ()
12843.00

  • Periodontal knife
#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
APP,AUDIGY ATTUNE,1.2,IOS
Gn Hearing A/S
20789000
In Commercial Distribution

  • 05708296097241 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,IOS
Gn Hearing A/S
20681400
In Commercial Distribution

  • 05708296095568 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,IOS
Gn Hearing A/S
20663900
In Commercial Distribution

  • 05708296095292 ()


  • Hearing aid/implant system remote control
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