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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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Surveyor S19 - 00817655021539

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-YAG-EXXBX
Not in Commercial Distribution

  • 00817655021539 ()


  • Centralized patient monitor

Surveyor S12 - 00817655021515

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-SAG-FXABX
Not in Commercial Distribution

  • 00817655021515 ()


  • Centralized patient monitor

Surveyor Central - 00817655021492

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-BAA-AJXEX
Not in Commercial Distribution

  • 00817655021492 ()


  • Centralized patient monitor

Surveyor Central - 00817655021485

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-HAE-BDFCA
Not in Commercial Distribution

  • 00817655021485 ()


  • Centralized patient monitor

Surveyor Central - 00817655021379

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-DAA-AXXEX
Not in Commercial Distribution

  • 00817655021379 ()


  • Centralized patient monitor

Surveyor Central - 00817655021348

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-AJBEX
Not in Commercial Distribution

  • 00817655021348 ()


  • Centralized patient monitor

Surveyor Central - 00817655020785

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-IAF-FBFAA
Not in Commercial Distribution

  • 00817655020785 ()


  • Centralized patient monitor

HScribe - 00817655020655

Holter Analysis System
MORTARA INSTRUMENT, INC.
V51-1GI
Not in Commercial Distribution

  • 00817655020655 ()


  • Centralized patient monitor

Surveyor S19 - 00817655020600

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-PAA-XXAAX
Not in Commercial Distribution

  • 00817655020600 ()


  • Centralized patient monitor

Surveyor Central - 00817655020556

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-CAA-AXBEX
Not in Commercial Distribution

  • 00817655020556 ()


  • Centralized patient monitor

Starling - 27290013030041

The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS10
In Commercial Distribution

  • 07290013030047 ()
  • 27290013030041 ()
CMS10

  • Multiple vital physiological parameter monitoring system, clinical

Caduceus S - 24719878713065

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713065 ()


  • Surgical planning/navigation-enhancement system

Caduceus S - 24719878713058

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713058 ()


  • Surgical planning/navigation-enhancement system

Caduceus S - 24719878713041

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713041 ()


  • Surgical planning/navigation-enhancement system

Starling Monitor with SpO2 Module - 72900130302906

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

SyMRI - 07340024700078

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software

SyMRI - 07340024700061

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software

SyMRI - 07340024700030

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
11
In Commercial Distribution

  • 07340024700030 ()


  • MRI system application software

SyMRI - 07340024700023

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution

  • 07340024700023 ()


  • MRI system application software

BCI - 30843418001099

No Description
ICU MEDICAL, INC.
WW3078
In Commercial Distribution

  • 30843418001099 ()


  • Multiple vital physiological parameter monitoring system, clinical

Basic American Medical Products - M368ZZA996748971

ZENITH 9000 SLIDE WIDE W/LOK
GF HEALTH PRODUCTS, INC.
ZZA99674-897
In Commercial Distribution

  • M368ZZA996748971 ()


  • Centralized patient monitor

Basic American Medical Products - M368ZZA996741

BED Z9100 APS W/ LOK SLIDE WIDE
GF HEALTH PRODUCTS, INC.
ZZA99674
In Commercial Distribution

  • M368ZZA996741 ()


  • Centralized patient monitor

Basic American Medical Products - M368ZZA99674061

BED ZENITH APS SLIDE WIDE 240V
GF HEALTH PRODUCTS, INC.
ZZA9967406
In Commercial Distribution

  • M368ZZA99674061 ()


  • Centralized patient monitor

Radmedix AcuityPDR+ - 00810035220461

No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220461 ()


  • Portable basic diagnostic x-ray system, digital

Radmedix AcuityPDR - 00810035220430

No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220430 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220362

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220362 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220355

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220355 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220348

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220348 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220294

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220294 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220287

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220287 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220263

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220263 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220119

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220119 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220331

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220331 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220300

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220300 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220270

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220270 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220256

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220256 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220249

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220249 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220232

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220232 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220225

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220225 ()


  • Portable basic diagnostic x-ray system, digital

AcuityPDR - 00810035220218

No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220218 ()


  • Portable basic diagnostic x-ray system, digital
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