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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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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 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 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 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
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
DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS (EMEA)
Respironics, Inc.
DreamMapper Mobile App iOS EMEA - 2
In Commercial Distribution

  • 00606959057708 ()
1128264

  • Self-care monitoring/reporting software
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper App iOS (APAC)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044111 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper Application iOS (APAC)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041981 ()
1127959

  • Self-care monitoring/reporting software
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
Cara i500 ios System
Kulzer GmbH
66081716
In Commercial Distribution

  • J014660817160 ()
66081716

  • Dental milling system, CAD/CAM, laboratory
Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
OvuSense 2 App - iOS
VIO HEALTHTECH LIMITED
M032 iOS
In Commercial Distribution

  • 05060508530107 ()


  • Thermometric fertility analyser
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048584 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048577 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047549 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046788 ()
1127959

  • Self-care monitoring/reporting software
IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
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