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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APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system
#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual
VA 20mm FLL TG- VF
WEST PHARMA. SERVICES IL, . LTD
8072035
In Commercial Distribution

  • 27290108240652 ()
  • 17290108240655 ()
  • 07290108240658 ()


  • Vial/bottle adaptor, non-hermetic
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
In Commercial Distribution

25-4520

  • Dental implant suprastructure, permanent, preformed
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