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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Spine Guidance Enable
Stryker Leibinger GmbH & Co. KG
6002-710-300
In Commercial Distribution

  • 07613327545913 ()
6002-710-300

  • Surgical planning/navigation-enhancement system
Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system
CRANIALMAP PLANNING
Stryker Leibinger GmbH & Co. KG
6000-661-000
In Commercial Distribution

  • 07613327327212 ()
6000-661-000

  • Surgical planning/navigation-enhancement system
CRANIALMAP SERVICE UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-660-150
In Commercial Distribution

  • 07613327327205 ()
6000-660-150

  • Surgical planning/navigation-enhancement system
CRANIALMAP
Stryker Leibinger GmbH & Co. KG
6000-660-000
In Commercial Distribution

  • 07613327327199 ()
6000-660-000

  • Surgical planning/navigation-enhancement system
CRANIALMAP SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81036
In Commercial Distribution

  • 07613327327182 ()
81-81036

  • Surgical planning/navigation-enhancement system
CRANIALMAP ENABLE
Stryker Leibinger GmbH & Co. KG
6000-660-300
In Commercial Distribution

  • 07613327327175 ()
6000-660-300

  • Surgical planning/navigation-enhancement system
CRANIALMAP PLANNING SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81037
In Commercial Distribution

  • 07613327327151 ()
81-81037

  • Surgical planning/navigation-enhancement system
CRANIALMAP UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-660-100
In Commercial Distribution

  • 07613327327137 ()
6000-660-100

  • Surgical planning/navigation-enhancement system
Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system
No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system
No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system
THD DIGITAL MOBILE LIGHT is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform digital anoscopy, anorectal manometry and Transanal Ultrasound using dedicated hardwares. THD DIGITAL MOBILE LIGHT has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004).
THD SPA
THD DIGITAL MOBILE LIGHT
In Commercial Distribution

  • 68051887046715 ()
800320

  • Ultrasound imaging system application software
THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound. THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ADVANCED
In Commercial Distribution

  • 68051887043325 ()
800309

  • Ultrasound imaging system application software
THD DIGITAL MOBILE ECOGRAPHY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound. THD DIGITAL MOBILE ECOGRAPHY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ECOGRAPHY
In Commercial Distribution

  • 68051887043318 ()
800308

  • Ultrasound imaging system application software
THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry. THD DIGITAL MOBILE MANOMETRY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and THD Anopress (transportable anorectal manometer) for anorectal manometry.
THD SPA
THD DIGITAL MOBILE MANOMETRY
In Commercial Distribution

  • 68051887043301 ()
800307

  • Ultrasound imaging system application software
THD DIGITAL MOBILE is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound (optional). THD DIGITAL MOBILE has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004) and a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes.
THD SPA
THD DIGITAL MOBILE
In Commercial Distribution

  • 68051887043295 ()
800306

  • Ultrasound imaging system application software
A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution

  • 72900130302906 ()
CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical
RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system
RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system
USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system
RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system
Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system
Synergy Matrix Management SW Addtnl Lic
ARTHREX, INC.
AR-3200-1049
In Commercial Distribution

  • 00888867261648 ()
AR-3200-1049

  • Medical image management system
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution

  • B201CGONE1 ()
  • B201CGONE0 ()


  • Ultrasound imaging system application software
No Description
SUN NUCLEAR CORP.
159ABR
In Commercial Distribution

  • B136159ABR0 ()


  • Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
159A
In Commercial Distribution

  • B136159A0 ()


  • Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
156D
In Commercial Distribution

  • B136156D0 ()


  • Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
156
In Commercial Distribution

  • B1361560 ()


  • Mammographic x-ray phantom, test object
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution

  • B133NEUROQ1 ()


  • Neurosurgical ultrasound navigation system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution

  • B133NEUROQ0 ()


  • Neurosurgical ultrasound navigation system application software
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314170 ()


  • Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314160 ()


  • Ultrasound imaging system application software
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034040 ()
500-0034-04

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034030 ()
500-0034-03

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034020 ()
500-0034-02

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034010 ()
500-0034-01

  • Multiple vital physiological parameter monitoring system, clinical
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution

  • B3943950010000 ()
395-0010-00

  • Centralized patient monitor
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor
WVSM Management Suite - PC
ATHENA GTX, INC.
PC Software
In Commercial Distribution

  • B3943900004000 ()
390-0004-00

  • Centralized patient monitor
SYNERGYHD3 DICOM KEY
ARTHREX, INC.
AR-3200-1020
In Commercial Distribution

  • 00888867100619 ()
AR-3200-1020

  • Medical image management system
Synergy.Net Text Notification License K
ARTHREX, INC.
AR-3200-1046
In Commercial Distribution

  • 00888867200319 ()
AR-3200-1046

  • Medical image management system
Synergy.Net Reporting License Key
ARTHREX, INC.
AR-3200-1045
In Commercial Distribution

  • 00888867200302 ()
AR-3200-1045

  • Medical image management system
Synergy.Net OR Command License Key
ARTHREX, INC.
AR-3200-1044
In Commercial Distribution

  • 00888867200296 ()
AR-3200-1044

  • Medical image management system
Synergy.net Printing License Key
ARTHREX, INC.
AR-3200-1043
In Commercial Distribution

  • 00888867200289 ()
AR-3200-1043

  • Medical image management system
Synergy.Net HL7 Software Single License
ARTHREX, INC.
AR-3200-1047
In Commercial Distribution

  • 00888867226975 ()
AR-3200-1047

  • Medical image management system
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