15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNGO.VIA
FDA 510(k)
FDA Class 2
·Radiology
SKINTACT
FDA 510(k)
FDA Class 2
·Cardiovascular
REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 26/260
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 26, 2019
INSTATRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·February 21, 2014
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·November 8, 2012
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GEI·January 16, 2008
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 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
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
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
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 -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 588keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015