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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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
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
2.6 mm ASA w/ (3) 1.5 mm suture tapes on Inserter
Tigon Medical LLC
TM-ASAP003-02TTT
In Commercial Distribution

  • 00810155330170 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
2.3 mm ASA w/ (2) 1.5 mm suture tapes on Inserter
Tigon Medical LLC
TM-ASAP002-01TT
In Commercial Distribution

  • 00810155330149 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
2.3 mm ASA w/ (2) USP 2 suture cables on Inserter
Tigon Medical LLC
TM-ASAP002-01SS
In Commercial Distribution

  • 00810155330132 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician
Endotronix, Inc.
100256-02
In Commercial Distribution

  • 00850008997037 ()


  • Bedside monitor remote-viewing software, physiological parameter
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