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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REMOTELINK 2.1.0 IOS
Lehiso A/S
214712
Not in Commercial Distribution

  • 05713708000214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 IOS
Lehiso A/S
204456
Not in Commercial Distribution

  • 05713708000177 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.10 IOS
Lehiso A/S
199527
Not in Commercial Distribution

  • 05713708000153 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.9 IOS
Lehiso A/S
189260
Not in Commercial Distribution

  • 05713708000115 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.8 IOS
Lehiso A/S
185784
Not in Commercial Distribution

  • 05713708000054 ()


  • Hearing aid/implant system remote control
HEARLINK 1.0 IOS
Sbo Hearing A/S
199530
In Commercial Distribution

  • 05714464000012 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.5.0 IOS
Sbo Hearing A/S
228201
In Commercial Distribution

  • 05714464012855 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.4.0 IOS
Sbo Hearing A/S
226433
In Commercial Distribution

  • 05714464012107 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.4.0 IOS
Sbo Hearing A/S
226426
In Commercial Distribution

  • 05714464012039 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.3.0 IOS
Sbo Hearing A/S
220589
In Commercial Distribution

  • 05714464011261 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.3.0 IOS
Sbo Hearing A/S
220595
In Commercial Distribution

  • 05714464011193 ()


  • Hearing aid/implant system remote control
RemoteFit 3.4.0 iOS
Sbo Hearing A/S
236790
In Commercial Distribution

  • 05714464042487 ()


  • Hearing aid/implant system remote control
REMOTEFIT 3.5.0 IOS
Sbo Hearing A/S
247219
In Commercial Distribution

  • 05714464060290 ()


  • Hearing aid/implant system remote control
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

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

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43307
In Commercial Distribution

  • 09008737433079 ()


  • Audiometric/hearing device software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41341
In Commercial Distribution

  • 09008737413415 ()


  • Audiometric/hearing device software
DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

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

  • 00606959048560 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047525 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046740 ()
1101478

  • Self-care monitoring/reporting software
CUPTIMIZE Advanced iOS
DEPUY (IRELAND)
4515-80-071
In Commercial Distribution

  • 10603295552109 ()
451580071

  • Orthopaedic stereotactic surgery system
Cuptimize for Ios
DEPUY ORTHOPAEDICS, INC.
451580054
In Commercial Distribution

  • 10603295551270 ()
451580054

  • Orthopaedic stereotactic surgery system
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
Release 5.0 iOS
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838120266 ()


  • General-purpose ultrasound imaging system
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside
Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside
VeriPulse IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Veripulse IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
WHIP-MIX CORPORATION
70675
Not in Commercial Distribution

  • D040706751 ()


  • Dental milling system, CAD/CAM, chairside
OTICON ON 2.1.0 IOS
Oticon A/S
219645
In Commercial Distribution

  • 05707131395474 ()


  • Hearing aid/implant system remote control
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
REMOTE CARE 2.0 IOS
Oticon A/S
199529
In Commercial Distribution

  • 05707131349231 ()


  • Hearing aid/implant system remote control
OTICON ON 1.10 IOS
Oticon A/S
199520
In Commercial Distribution

  • 05707131349224 ()


  • Hearing aid/implant system remote control
REMOTE CARE 1.0 IOS
Oticon A/S
193798
In Commercial Distribution

  • 05707131343932 ()


  • Hearing aid/implant system remote control
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


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

  • 00851203006142 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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