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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Electronic Scope-658,Adult, Metallic Ceil Blue
AMERICAN DIAGNOSTIC CORP
658MCB
In Commercial Distribution

  • 00634782584719 ()
  • 00634782083328 ()
658MCB

  • Electronic acoustic stethoscope
Electronic Scope-658,Adult, Dark Green
AMERICAN DIAGNOSTIC CORP
658DG
In Commercial Distribution

  • 00634782584696 ()
  • 00634782083304 ()
658DG

  • Electronic acoustic stethoscope
Electronic Scope-657,Adult, Black, 28"
AMERICAN DIAGNOSTIC CORP
657BK
In Commercial Distribution

  • 00634782555238 ()
  • 00634782055455 ()
657BK

  • Electronic acoustic stethoscope
Electronic Scope-658,Adult, Black
AMERICAN DIAGNOSTIC CORP
658BK
In Commercial Distribution

  • 00634782554576 ()
  • 00634782054793 ()
658BK

  • Electronic acoustic stethoscope
No Description
ECHONOUS, INC.
R006115
In Commercial Distribution

  • 09353278000489 ()


  • Electronic acoustic stethoscope
Electronic stethoscope
ECHONOUS, INC.
P006115
In Commercial Distribution

  • 09353278000212 ()


  • Electronic acoustic stethoscope
The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable sample recording, playback, visualization, analysis, reporting and sharing with other authorized users.
M3DICINE PTY LTD
1
In Commercial Distribution

  • 09351356000017 ()


  • Electronic acoustic stethoscope
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
IMEDIPLUS INC.
Omni-Steth
In Commercial Distribution

  • 04719874400026 ()


  • Electronic acoustic stethoscope
The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
IMEDIPLUS INC.
DS3011AP
In Commercial Distribution

  • 04719874400040 ()


  • Electronic acoustic stethoscope
The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
IMEDIPLUS INC.
DS101
In Commercial Distribution

  • 04719874400019 ()


  • Electronic acoustic stethoscope
The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs. The microphone-equipped disposable sensor detects and amplifies the sounds from the patient’s body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece. The multi-channel design allows healthcare professionals to attach disposable sensors onto patient’s body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
Heroic Faith International Ltd.
AS101M2
In Commercial Distribution

  • 04719882170065 ()
AS101

  • Electronic acoustic stethoscope
The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs. The microphone-equipped disposable sensor detects and amplifies the sounds from the patient’s body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece. The multi-channel design allows healthcare professionals to attach disposable sensors onto patient’s body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
Heroic Faith International Ltd.
AS-P01V4
In Commercial Distribution

  • 04719882170041 ()


  • Electronic acoustic stethoscope
The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
Heroic Faith International Ltd.
AS101
In Commercial Distribution

  • 04719882170034 ()


  • Electronic acoustic stethoscope
No Description
Eko Devices, Inc.
E5
In Commercial Distribution

  • 00863609000327 ()


  • Electronic acoustic stethoscope
The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution

  • 00863609000310 ()


  • Electronic acoustic stethoscope
The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution

  • 00863609000303 ()


  • Electronic acoustic stethoscope
The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated. The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills.
THINKLABS MEDICAL, LLC
One
In Commercial Distribution

  • 00899529001106 ()

  • Weight: 0.075 Pound
  • Height: 1.2 Inch
  • Outer Diameter: 1.75 Inch


  • Electronic acoustic stethoscope
E-Scope Hearing Impaired
CARDIONICS INC
7187710
In Commercial Distribution

  • B37871877100 ()
718-7710

  • Electronic acoustic stethoscope
Clinical E-Scope
CARDIONICS INC
7187700
In Commercial Distribution

  • B37571877000 ()
718-7700

  • Electronic acoustic stethoscope
The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Crackle” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Crackles Detection
In Commercial Distribution

  • 07290020123008 ()


  • Electronic acoustic stethoscope
The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Wheeze Detection _US
In Commercial Distribution

  • 07290016672886 ()


  • Electronic acoustic stethoscope
The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Wheeze Detection _US
Not in Commercial Distribution

  • 07290016672725 ()


  • Electronic acoustic stethoscope
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
TYTO CARE LTD
Tyto Stethoscope, Plastic, black, US
In Commercial Distribution

  • 07290016672404 ()
800-00027

  • Electronic acoustic stethoscope
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
TYTO CARE LTD
Tyto Stethoscope, Zamak, Gray, US
In Commercial Distribution

  • 07290016672374 ()
800-00023

  • Electronic acoustic stethoscope
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
TYTO CARE LTD
Tyto Stethoscope, Zamak, BLK, US
In Commercial Distribution

  • 07290016672343 ()
800-00019

  • Electronic acoustic stethoscope
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
TYTO CARE LTD
Tyto Stethoscope
In Commercial Distribution

  • 07290016672190 ()
800-00008

  • Electronic acoustic stethoscope
No Description
TYTO CARE LTD
Not in use
In Commercial Distribution

  • 07290016672046 ()


  • Electronic acoustic stethoscope
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto stethoscope is intended for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.
TYTO CARE LTD
Tyto Stethoscope
In Commercial Distribution

  • 07290016672015 ()
  • 17290016672012 ()
800-00001

  • Electronic acoustic stethoscope
No Description
OXOS Medical, Inc.
ACSY-S009
In Commercial Distribution

  • 00860008892751 ()


  • Flat panel x-ray detector/film cassette weight-bearing protector
Image Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013831906 ()
NA

  • Radiation therapy digital imager
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