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, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
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
APP replacement pad, deluxe
COMPASS HEALTH BRANDS CORP.
APP-DLXP
In Commercial Distribution

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable
APP Replacement pad, basic
COMPASS HEALTH BRANDS CORP.
APP-BPD
In Commercial Distribution

  • 80092237602023 ()
  • 00092237602027 ()


  • Alternating-pressure bed mattress overlay, reusable
HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software
BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable
Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software
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
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A2
In Commercial Distribution

  • 08051122040933 ()
SPM01A2

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
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