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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
Owlet Baby Care, Inc.
OSS 3.0-M1
In Commercial Distribution

  • 00810099090031 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OBL 3.0-M1
In Commercial Distribution

  • 00810099090024 ()


  • Multiple vital physiological parameter monitoring system, home-use
THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.
THD SPA
THD HRStation
In Commercial Distribution

  • 58051887042642 ()
800299

  • 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
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
WinOMS Practice Management Software
CARESTREAM HEALTH, INC.
CS WinOMS
In Commercial Distribution

  • 60889978014576 ()
8014573

  • Physician-practice-management information system
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
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
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.88
In Commercial Distribution

  • B109VISAR2880 ()


  • Surgical planning/navigation-enhancement system
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.73
In Commercial Distribution

  • B109VISAR2730 ()


  • Surgical planning/navigation-enhancement system
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.1.5
In Commercial Distribution

  • B109VISAR2150 ()


  • Surgical planning/navigation-enhancement system
PC Set
Stryker Leibinger GmbH & Co. KG
0101-2000
In Commercial Distribution

  • 07613327312430 ()
0101-2000

  • Medical image management system
PC Unit
Stryker Leibinger GmbH & Co. KG
0101-2900
In Commercial Distribution

  • 07613327312393 ()
0101-2900

  • Medical image management system
ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system
CRANIALMAP PLANNING
Stryker Leibinger GmbH & Co. KG
6000-661-000
In Commercial Distribution

  • 07613327327212 ()
6000-661-000

  • Surgical planning/navigation-enhancement system
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