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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
Thought Technology Ltd.
SA7900AR
In Commercial Distribution

  • 07540191000647 ()


  • Biofeedback system application software
Ultrasound-guided radio-frequency ablation system software
Gynesonics, Inc.
SW-001
Not in Commercial Distribution

  • 10817929020357 ()
SW-001

  • Ultrasound-guided radio-frequency ablation system software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000208 ()
ND3

  • Biofeedback system application software
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Ochs Labs LLC
LW3
In Commercial Distribution

  • G253LW30 ()


  • Biofeedback system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution

  • 07290019352037 ()


  • Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Seamless
In Commercial Distribution

  • 07290019352020 ()


  • Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Mobile
In Commercial Distribution

  • 07290019352013 ()


  • Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Platform
In Commercial Distribution

  • 07290019352006 ()


  • Ultrasound imaging system application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.5.y.z
In Commercial Distribution

  • 07290018052280 ()


  • Radiology DICOM image processing application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.4.x.y
In Commercial Distribution

  • 07290018052266 ()


  • Radiology DICOM image processing application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.3.x.y
In Commercial Distribution

  • 07290018052235 ()


  • Radiology DICOM image processing application software
No Description
STRYKER CORPORATION
01030300
In Commercial Distribution

  • 07613327459081 ()
0103-0300

  • Radiology DICOM image processing application software
No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution

  • 06973770840012 ()


  • Endoscopic video image interpretive software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution

  • 00810038851983 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution

  • 07613327382570 ()
3105001000

  • Radiology DICOM image processing application software
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