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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CORE 500 Digital Stethoscope FIGS Earpiece - Grey
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298252 ()
CAC500_FGR

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope FIGS Earpiece - Black
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298245 ()
CAC500_FBL

  • Electronic acoustic stethoscope
Eko CORE 500 Founder's Edition Chestpiece
Eko Devices, Inc.
COR500FE
In Commercial Distribution

  • 00850010298214 ()
COR500FE

  • Electronic acoustic stethoscope
No Description
Eko Devices, Inc.
COR501FE
In Commercial Distribution

  • 00850010298207 ()
COR501FE

  • Electronic acoustic stethoscope
Eko CORE 500 and CAC500 Standard bundle
Eko Devices, Inc.
COR501
In Commercial Distribution

  • 00850010298191 ()
COR501

  • Electronic acoustic stethoscope
No Description
Eko Devices, Inc.
CAC500
In Commercial Distribution

  • 00850010298177 ()
CAC500

  • Electronic acoustic stethoscope
Eko CORE 500 Digital Stethoscope Chestpiece
Eko Devices, Inc.
COR500
In Commercial Distribution

  • 00850010298160 ()
COR500

  • 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.
E6
In Commercial Distribution

  • 00850010298016 ()


  • 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.
E6
In Commercial Distribution

  • 00850010298009 ()


  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope FIGS Earpiece - Seaglass
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298771 ()
CAC500_FSG

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope FIGS Earpiece - Dark Harbor
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298764 ()
CAC500_FDH

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Ruby Earpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298733 ()
CAC500_RED

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Amethyst Bundle
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298696 ()
COR501-PRP/PRP

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Amethyst Chestpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298689 ()
COR500_PRP

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Amethyst Earpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298672 ()
CAC500_PRP

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Sapphire Bundle
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298641 ()
COR501-BLU/BLU

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Wintergreen Bundle
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298634 ()
COR501-GRN/GRN

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Wintergreen Chestpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298610 ()
COR500_GRN

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Wintergreen Earpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298597 ()
CAC500_GRN

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Incase Bundle (Black)
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298481 ()
COR502-BLK/BLK

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Incase Bundle
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298443 ()
COR502-SLV/SLV

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Champagne Earpiece
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298429 ()
CAC500_CHP

  • Electronic acoustic stethoscope
CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon
Eko Devices, Inc.
E8
In Commercial Distribution

  • 00850010298399 ()
CAC500_FPR

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

  • 00634782555238 ()
  • 00634782055455 ()
657BK

  • 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
LivaNova Deutschland GmbH
System Panel
In Commercial Distribution

  • 04033817901433 ()


  • Cardiopulmonary bypass system, roller type
NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices.
Circassia AB
Apps / Panel
In Commercial Distribution

  • 07350047030519 ()
12-1004

  • Patient health record information system application software
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Smart Control Panel
MEDICAPTURE, INC.
MSP156
In Commercial Distribution

  • 00859151005293 ()
MSP156

  • Medical video image recorder
1-mode small panel
Biophotas, Inc.
CLEAR C/US
In Commercial Distribution

  • 00850523007037 ()
CLTC-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
Biophotas, Inc.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
Biophotas, Inc.
SKIN C/US
In Commercial Distribution

  • 00850523007600 ()
CSKN-001

  • Blue/red/infrared phototherapy lamp
E600 Built-In Panel
Beyes Dental Canada Inc
MT600TP
In Commercial Distribution

  • 00990010301771 ()
M600

  • Dental surgical power tool motorized handpiece/set, electric
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-3867
In Commercial Distribution

  • 00898142001944 ()
16-1P3-3867

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-9013
In Commercial Distribution

  • 00898142001746 ()
16-1P3-9013

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-4066
In Commercial Distribution

  • 00898142001739 ()
16-1P3-4066

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-8913
In Commercial Distribution

  • 00898142001692 ()
16-1P3-8913

  • Cranioplasty sheet
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