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Sources: EU EUDAMED, US FDA
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NOWDIAGNOSTICS, INC.
FDA registration
NOWDIAGNOSTICS, INC.·4 products·🇺🇸 United States
AdexusDx hCG Test
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006193·Box of one test cartridge
AdexusDx hCG Test
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006209·Box of 25 cartridges/tests
AdexusDx hCG Control Set (unassayed)
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006230·hCG Control Set (unassayed)
First To Know Syphilis Test
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006018·25 count convenience pack
AdexusDx hCG Test
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006216·Box of 50 cartridges/tests
First To Know Syphilis Test
FDA UDI
NOWDIAGNOSTICS, INC.·00858022006001·Inner package containing one-count device
FIRST TO KNOW. HOME SYPHILIS TEST
FDA Adverse Event
Malfunction
·NOWDIAGNOSTICS, INC.·Product code SBZ·January 30, 2025
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 13, 2013
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 13, 2013
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
FDA Recall
Terminated
·Carestream Health Inc.·Product code MQB·August 29, 2013
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
FDA Recall
Terminated
·Carestream Health Inc.·Product code IZL·August 29, 2013
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·August 12, 2014
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
FDA Recall
Terminated
·MicroPort Orthopedics Inc.·Product code LWJ·July 31, 2020
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
FDA Recall
Terminated
·MicroPort Orthopedics Inc.·Product code LWJ·July 31, 2020