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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The Via X Anti-Gravity Treadmill is intended to be a used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support.
Lifeward CA, Inc.
Via X
In Commercial Distribution

  • 00850022788031 ()


  • Pneumatic-support treadmill
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
Lifeward CA, Inc.
Fit X
In Commercial Distribution

  • 00850022788017 ()


  • Pneumatic-support treadmill
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope 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
Non-powdered patient examination gloves
C&A Marketing, Inc.
X Large
In Commercial Distribution

  • 00843812168458 ()
  • 10843812168455 ()
WVEBNGXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.1.x
In Commercial Distribution

  • 04262459510028 ()


  • Diagnostic x-ray digital imaging system workstation application software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.0.x
Not in Commercial Distribution

  • 04262459510011 ()


  • Diagnostic x-ray digital imaging system workstation application software
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Small)
PT. SINTONG UNIGOLDEN GLOVE
X - Small
In Commercial Distribution

  • 18994452290029 ()
  • 08994452290022 ()
  • 08994452290084 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
SYRMA JOHARI MEDTECH LIMITED
X Trainer
In Commercial Distribution

  • 08908008085055 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
No Description
SYRMA JOHARI MEDTECH LIMITED
X FORCE
In Commercial Distribution

  • 08908008085048 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Blackford Platform v3.0.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
3.0.x
In Commercial Distribution

  • 05060570830150 ()


  • Radiological PACS software
Blackford Platform v2.4.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.4.x
In Commercial Distribution

  • 05060570830112 ()


  • Radiological PACS software
Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application, released under evaluation only.
BLACKFORD ANALYSIS LIMITED
1.4.x
In Commercial Distribution

  • 05060570830105 ()


  • Radiological PACS software
Blackford Platform v2.3.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.3.x
In Commercial Distribution

  • 05060570830099 ()


  • Radiological PACS software
Blackford Dashboard v1.2, monitoring tool for users of the Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830082 ()


  • Radiological PACS software
Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830075 ()


  • Radiological PACS software
Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.2.x
In Commercial Distribution

  • 05060570830068 ()


  • Radiological PACS software
Blackford Registration Application v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830044 ()


  • Radiological PACS software
Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.1.x
In Commercial Distribution

  • 05060570830037 ()


  • Radiological PACS software
Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830013 ()


  • Radiological PACS software
Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution

  • 05060570830006 ()


  • Radiological PACS software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution

  • 00628011382184 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution

  • 00628011382177 ()


  • Radiation therapy software
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Large)
PT. SINTONG UNIGOLDEN GLOVE
X - Large
In Commercial Distribution

  • 18994452290067 ()
  • 08994452290060 ()
  • 08994452290121 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
VAKU-8 + Blood Collection Set,25 G X ¾" ( 0.50X19MM) 7" TUBE MYCO RE-ORDER # SVMSP-25L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
25G X ¾"
In Commercial Distribution

  • 08903347023447 ()
  • 18903347023444 ()
  • 28903347023441 ()
  • 58903347023442 ()
02344

  • Venous butterfly needle/set
VAKU-8+ Blood Collection Set,23 G X ¾" ( 0.60X19MM) 7" TUBE MYCO RE-ORDER # SVMSP-23L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
23G X ¾"
In Commercial Distribution

  • 08903347023430 ()
  • 18903347023437 ()
  • 28903347023434 ()
  • 58903347023435 ()
02343

  • Venous butterfly needle/set
UNOLOK Luer Lock Infusion Set,22 G X ¾" ( 0.70X19MM) 12" TUBE MYCO RE-ORDER # 7001-22
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
22G X ¾"
In Commercial Distribution

  • 08903347003272 ()
  • 18903347003279 ()
  • 28903347003276 ()
  • 58903347003277 ()
00327

  • Venous butterfly needle/set
UNOLOK+ Luer Lock Infusion Set,25 G X ¾" ( 0.50X19MM) 7" TUBE MYCO RE-ORDER # 7001P-25L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
25G X ¾"
In Commercial Distribution

  • 08903347002367 ()
  • 18903347002364 ()
  • 28903347002361 ()
  • 58903347002362 ()
00236

  • Venous butterfly needle/set
UNOLOK+ Luer Lock Infusion Set,23 G X ¾" ( 0.60X19MM) 7" TUBE MYCO RE-ORDER # 7001P-23L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
23G X ¾"
In Commercial Distribution

  • 08903347002350 ()
  • 18903347002357 ()
  • 28903347002354 ()
  • 58903347002355 ()
00235

  • Venous butterfly needle/set
No Description
EverEx
1.2.X
In Commercial Distribution

  • 08809970060005 ()


  • Biomechanical function analysis/rehabilitation software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
3.X
In Commercial Distribution

  • 00850005944430 ()
81-02315-00R

  • Magnetic neural stimulation system
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
2.X
In Commercial Distribution

  • 00850005944423 ()
81-01315-00R

  • Magnetic neural stimulation system
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
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

  • 00842318117212 ()


  • 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
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
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