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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
Atlas Lift Tech, Inc.
SE
Not in Commercial Distribution

  • 11968525122705 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD
Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
ERESEARCHTECHNOLOGY, INC.
APV2C
In Commercial Distribution

  • 00850023837035 ()


  • Kinesiology ambulatory recorder
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software
AcrySof® IQ Toric IOL Calculator
Alcon Laboratories, Inc.
Version 3
In Commercial Distribution

  • 00380659909467 ()


  • Intraocular lens calculation software
No Description
Carl Zeiss Meditec AG
6914
In Commercial Distribution

  • 04049539069146 ()


  • Ophthalmic surgical microscope data overlay unit
No Description
Brainlab AG
17700
In Commercial Distribution

  • 04056481142520 ()


  • Robotic surgical navigation system
  • Electromagnetic/optical surgical navigation device tracking system
PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
PC2K
In Commercial Distribution

  • 00690103193473 ()

  • Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m
PC2K

  • Patient monitoring system module, blood pressure, noninvasive
  • Patient positioning sensor
  • General-purpose multi-parameter bedside monitor
HEART REFERENCE SENSOR
Edwards Lifesciences LLC
EVHRS
In Commercial Distribution

  • 00690103193374 ()

  • Weight: 36 Gram, Cable Length: 48 Inch
EVHRS

  • Patient positioning sensor
DVD-RW DRIVE, EXTERNAL USB
PENTAX OF AMERICA, INC.
1111-1977
In Commercial Distribution

  • 04961333241842 ()


  • DVD recorder
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
Biofeedback device with software
QX WORLD LTD
NA
In Commercial Distribution

  • 05999860882015 ()


  • Biofeedback system application software
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-050177-00
In Commercial Distribution

  • 06944904098715 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Z319-10
In Commercial Distribution

  • 06944904090733 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-011007-00
In Commercial Distribution

  • 06944904033419 ()


  • DVD recorder
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
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
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
Neurofeedback Software
EEG SOFTWARE LLC
4
In Commercial Distribution

  • B258EEGER4 ()


  • Biofeedback system application software
No Description
Thought Technology Ltd.
SA7900AR
In Commercial Distribution

  • 07540191000647 ()


  • Biofeedback system application software
MEDIA DVD-R PANASONIC LM-RF120U
Smith & Nephew, Inc.
7210534
In Commercial Distribution

  • 00885554012354 ()
7210534

  • DVD recorder
Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD
Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD
CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6100-03
In Commercial Distribution

  • 00618874610036 ()


  • Epidural anaesthesia set, non-medicated
Access Point V2C is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM WEARABLE TECHNOLOGIES, INC.
AP
In Commercial Distribution

  • 00850067173021 ()


  • Kinesiology ambulatory recorder
Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070729 ()
100711

  • Electrocardiograph, professional, multichannel
Welch Allyn PCH-200 Holter Expert Software Kit including HR-300 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070705 ()
100713

  • Electrocardiograph, professional, multichannel
APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder
BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution

  • 07290018052037 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution

  • 07290018052020 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution

  • 07290018052013 ()


  • Radiology DICOM image processing application software
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