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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iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer
SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer
APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
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