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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Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
OTICON ON 2.0 IOS
Oticon A/S
204454
In Commercial Distribution

  • 05707131357601 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.0 IOS
Oticon A/S
204452
In Commercial Distribution

  • 05707131357588 ()


  • Hearing aid/implant system remote control
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
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
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