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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No Description
APK Technology Co.,Ltd.
A-XT-04
In Commercial Distribution

  • 06946725523360 ()


  • Blood pressure cuff, reusable
No Description
APK Technology Co.,Ltd.
A-XT-03
In Commercial Distribution

  • 06946725523353 ()


  • Blood pressure cuff, reusable
No Description
APK Technology Co.,Ltd.
A-XT-02
In Commercial Distribution

  • 06946725523346 ()


  • Blood pressure cuff, reusable
No Description
APK Technology Co.,Ltd.
A-XT-01
In Commercial Distribution

  • 06946725523339 ()


  • Blood pressure cuff, reusable
No Description
APK Technology Co.,Ltd.
A1315-SW104PU
In Commercial Distribution

  • 06946725521069 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A1315-SP104PU
In Commercial Distribution

  • 06946725521052 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A1315-SP104PV
In Commercial Distribution

  • 06946725521045 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A1315-SA104PU
In Commercial Distribution

  • 06946725521038 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A1315-SA104PV
In Commercial Distribution

  • 06946725521021 ()


  • Tissue saturation oximeter sensor, reprocessed
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008248 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008217 ()


  • Mental health/function therapeutic software, screen-viewed
CIN Agar / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
J49
In Commercial Distribution

  • 00816576026913 ()
  • 00816576026920 ()
J49

  • Multiple formulation agar culture medium IVD
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use
Care Assist
Philips Medical Systems Hsg
Care Assist Android 4.2
In Commercial Distribution

  • 00884838123724 ()
989803221541

  • Centralized patient monitor
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9141 Android (Version 17)
In Commercial Distribution

  • 00300021458553 ()
MA9141001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9161 Android (Version 15)
In Commercial Distribution

  • 00300021285555 ()
MA9161001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9159 Android (Version 14)
In Commercial Distribution

  • 00300021283551 ()
MA9159001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9152 Android (Version 13)
In Commercial Distribution

  • 00300021176556 ()
MA9152001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9135 ANDROID (Version 12)
In Commercial Distribution

  • 00300021174552 ()
MA9135001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for Android
In Commercial Distribution

  • 00842318130846 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for Android
In Commercial Distribution

  • 00842318130822 ()


  • Audiometric/hearing device software
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008187 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008156 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for Android
In Commercial Distribution

  • 00842318130808 ()


  • Audiometric/hearing device software
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