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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FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
SFTWR MMT-6104 MM MBL CLIN IOS 2.0.2
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000521301 ()


  • Self-care monitoring/reporting software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
SFTWR MMT-6114 CL CONN CLIN IOS 2.1.1
MEDTRONIC MINIMED, INC.
MMT-6114
In Commercial Distribution

  • 00763000480653 ()


  • Patient health record information system application software
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747113747 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747113730 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747113723 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747113716 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747113709 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
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