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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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No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117205 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117199 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117182 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117175 ()


  • Audiometric/hearing device software
300W xenon light source with backup LED
ILO electronic GmbH
X 300AT-LED
In Commercial Distribution

  • 04250369707737 ()
818-1028

  • Endoscopic light source unit, line-powered
300W xenon light source with backup LED
ILO electronic GmbH
X 300M-LED
In Commercial Distribution

  • 04250369707713 ()
818-1023

  • Endoscopic light source unit, line-powered
300W xenon light source with backup LED
ILO electronic GmbH
X 300A-LED
In Commercial Distribution

  • 04250369707690 ()
818-1021

  • Endoscopic light source unit, line-powered
300W xenon light source
ILO electronic GmbH
X 300AT
In Commercial Distribution

  • 04250369707348 ()
818-0021

  • Endoscopic light source unit, line-powered
300W xenon light source
ILO electronic GmbH
X 300A
In Commercial Distribution

  • 04250369707324 ()
818-0019

  • Endoscopic light source unit, line-powered
300W xenon light source
ILO electronic GmbH
X 300M
In Commercial Distribution

  • 04250369707317 ()
818-0018

  • Endoscopic light source unit, line-powered
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940763 ()


  • Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940756 ()


  • Self-care monitoring/reporting software
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938854 ()


  • Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938847 ()


  • Bioelectrical body composition analyser
No Description
PHILIPS FRANCE COMMERCIAL
2.4.x
In Commercial Distribution

  • G637CEA0 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution

  • G554LVIC0 ()


  • Radiology DICOM image processing application software
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
No Description
EverEx
1.2.X
In Commercial Distribution

  • 08809970060005 ()


  • Biomechanical function analysis/rehabilitation software
NEOLUX X 350-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4800X0 ()
864NL4800X

  • Ultraviolet phototherapy unit, professional
NEOLUX X 350-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4000X0 ()
864NL4000X

  • Ultraviolet phototherapy unit, professional
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