18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ProLift Wedge Expandable Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266481·FRAZIER TUBE 10 FRENCH
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920638·
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 17, 2019
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A242826150·24mm H x 28mm W x 26mm L x 15 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A242826120·24mm H x 28mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A24282680·24mm H x 28mm W x 26mm L x 8 degrees ALIF
ADVIA Centaur Toxoplasma M (Toxo M)
FDA 510(k)
FDA Class 2
·Microbiology
IMMULITE® 2000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2013
E.cam or Symbia systems that use foresight detectors - Product Usage: 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 588keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·September 2, 2020
e.cam Gamma Camera, an emission computed tomography system. It is intended 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 588keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·November 11, 2015
e.cam camera system. Emission Computed Tomography System used 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 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·October 29, 2014
E.CAM emission computed tomography system used 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 588 keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·March 25, 2015
e.cam and Symbia E gamma camera systems with patient beds 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 588 keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·September 14, 2016