149 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569
FDA Recall
Terminated
·Medline Industries Inc·Product code OIG·February 3, 2011
Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
FDA Recall
Terminated
·Medline Industries Inc·Product code OIG·February 3, 2011
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 2, 2014
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2013
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·August 5, 2009
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 30, 2013
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 5, 2013
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 16, 2015
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 19, 2014
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 16, 2014
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016