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
FUKUDA DENSHI CO.,LTD.
DS-7780
In Commercial Distribution

  • 04538612908316 ()


  • Centralized patient monitor
No Description
FUKUDA DENSHI CO.,LTD.
DS-7700L
In Commercial Distribution

  • 04538612908293 ()


  • Centralized patient monitor
No Description
FUKUDA DENSHI CO.,LTD.
LW-7080
In Commercial Distribution

  • 04538612908279 ()


  • Centralized patient monitor
No Description
FUKUDA DENSHI CO.,LTD.
LC-7019FT
In Commercial Distribution

  • 04538612908248 ()


  • Centralized patient monitor
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution

  • 00850001088008 ()


  • MRI system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
Remidio Connect is web-based application it is intended for displaying, storing images and data from Remidio ophthalmic imaging devices to aid in screening of eye disease.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio Connect
In Commercial Distribution

  • 08906096520069 ()


  • Medical image management system
N/A
Carl Zeiss Vision GmbH
000000-2433-519
In Commercial Distribution

  • 04250668606700 ()
000000-2433-519

  • Medical image management system
N/A
Carl Zeiss Vision GmbH
000000-2194-446
In Commercial Distribution

  • 04250668606663 ()
000000-2194-446

  • Medical image management system
Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00850028962442 ()


  • Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00850028962428 ()


  • Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00850028962237 ()


  • Multiple vital physiological parameter monitoring system, home-use
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
ENDOPRO CAPTURE WORKSTATION, STANDALONE
PENTAX OF AMERICA, INC.
KBM68346
In Commercial Distribution

  • 04961333248025 ()


  • Medical image management system
ENDOPRO CAPTURE WORKSTATION, NETWORK
PENTAX OF AMERICA, INC.
KBM68345
In Commercial Distribution

  • 04961333248018 ()


  • Medical image management system
ENDOPRO REVIEW WORKSTATION
PENTAX OF AMERICA, INC.
KBM68344
In Commercial Distribution

  • 04961333248001 ()
NA

  • Medical image management system
MS SQL STD SINGLE USER LICENSE
PENTAX OF AMERICA, INC.
MSSQL-UM01A
In Commercial Distribution

  • 04961333244706 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (20-30)
PENTAX OF AMERICA, INC.
M70218
In Commercial Distribution

  • 04961333243723 ()
  • 14961333243720 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (10-19)
PENTAX OF AMERICA, INC.
M70217
In Commercial Distribution

  • 04961333243709 ()
  • 14961333243706 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (1-4)
PENTAX OF AMERICA, INC.
M70216
In Commercial Distribution

  • 04961333243686 ()
  • 14961333243683 ()


  • Radiology information system
NURSING NOTES
PENTAX OF AMERICA, INC.
M70214-UP
In Commercial Distribution

  • 04961333243679 ()


  • Radiology information system
NURSING NOTES
PENTAX OF AMERICA, INC.
M70214
In Commercial Distribution

  • 04961333243662 ()


  • Radiology information system
MATROX VIO CAPTURE CARD
PENTAX OF AMERICA, INC.
M30119
In Commercial Distribution

  • 04961333243433 ()


  • Radiology information system
IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68406
In Commercial Distribution

  • 04961333243235 ()


  • Radiology information system
HD SDI IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68404
In Commercial Distribution

  • 04961333243228 ()


  • Radiology information system
HD DVI IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68403
In Commercial Distribution

  • 04961333243211 ()


  • Radiology information system
IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68401
Not in Commercial Distribution

  • 04961333243204 ()


  • Radiology information system
ASSY: SERVER, RACK MOUNT FORM FACTOR
PENTAX OF AMERICA, INC.
KBM68312
In Commercial Distribution

  • 04961333243198 ()


  • Radiology information system
ASSY: SERVER, TOWER FORM FACTOR
PENTAX OF AMERICA, INC.
KBM68311
In Commercial Distribution

  • 04961333243181 ()


  • Radiology information system
ASSY: REVIEW/SCHEDULING PC
PENTAX OF AMERICA, INC.
KBM68307
In Commercial Distribution

  • 04961333243174 ()


  • Radiology information system
ASSY: ECAP NTSC 6 CHANNEL
PENTAX OF AMERICA, INC.
KBM68306
In Commercial Distribution

  • 04961333243167 ()


  • Radiology information system
ASSY: MPS DV/SD CAPTURE
PENTAX OF AMERICA, INC.
KBM68303
In Commercial Distribution

  • 04961333243150 ()


  • Radiology information system
ENDOSERVER WORKSTATION LICENSE
PENTAX OF AMERICA, INC.
9282-3
In Commercial Distribution

  • 04961333242726 ()


  • Radiology information system
6 SDI TO SDI CABLE
PENTAX OF AMERICA, INC.
92215/6
In Commercial Distribution

  • 04961333242696 ()

  • Length: 6.0 Feet


  • Radiology information system
24 SDI TO SDI CABLE
PENTAX OF AMERICA, INC.
92215/24
In Commercial Distribution

  • 04961333242672 ()

  • Length: 24.0 Feet


  • Radiology information system
CABLE FOR FUJIFILM PROCESSORS
PENTAX OF AMERICA, INC.
92214/12
In Commercial Distribution

  • 04961333242658 ()

  • Length: 12.0 Feet


  • Radiology information system
VGA TO S-VIDEO CABLE
PENTAX OF AMERICA, INC.
92213/6
In Commercial Distribution

  • 04961333242641 ()

  • Length: 6.0 Feet


  • Radiology information system
VGA TO S-VIDEO CABLE
PENTAX OF AMERICA, INC.
92213/12
In Commercial Distribution

  • 04961333242627 ()

  • Length: 12.0 Feet


  • Radiology information system
CABLE:HD-SDI BNC-BNC 6
PENTAX OF AMERICA, INC.
92204/6
In Commercial Distribution

  • 04961333242580 ()

  • Length: 6.0 Feet


  • Radiology information system
S-VIDEO CABLE
PENTAX OF AMERICA, INC.
92026/6
In Commercial Distribution

  • 04961333242245 ()

  • Length: 6.0 Feet


  • Radiology information system
MATROX KX20 MALE TO 4 X DVI-I FEMALE CAB
PENTAX OF AMERICA, INC.
92216
In Commercial Distribution

  • 04961333241477 ()


  • Radiology information system
VIDEO CABLE FOR GMED SYSTEM
PENTAX OF AMERICA, INC.
92205
In Commercial Distribution

  • 04961333241460 ()


  • Radiology information system
CBL, USB
PENTAX OF AMERICA, INC.
92178
In Commercial Distribution

  • 04961333241453 ()


  • Radiology information system
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