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 Class Implantable

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WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim iOS App, P1.3.2
Biim Ultrasound AS
P001417
In Commercial Distribution

  • 07090045490303 ()
P001417

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3.1
Biim Ultrasound AS
P001402
In Commercial Distribution

  • 07090045490228 ()
P001402

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.1
Biim Ultrasound AS
P001117
In Commercial Distribution

  • 07090045490013 ()
P001117

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747213072 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747213058 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747213065 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
Not in Commercial Distribution

  • 07332747176261 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
Not in Commercial Distribution

  • 07332747176254 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle LibreLink iOS US
ABBOTT DIABETES CARE INC
71733-01
In Commercial Distribution

  • 00357599000059 ()
71733-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747113778 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747113761 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747113754 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution

  • 05708296071432 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
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
APP,MY LIVELY 1.4,IOS
Gn Hearing A/S
21123000
In Commercial Distribution

  • 05708296169702 ()


  • Hearing aid/implant system remote control
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