73 results
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20ms
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Sources: EU EUDAMED, US FDA
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·July 14, 2017
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·June 9, 2016
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·July 14, 2017
Fujifilm FDR Go Plus mobile X-ray system
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code IZL·July 19, 2019
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
FDA Recall
Terminated
·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code KPR·June 15, 2017
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
FDA Recall
Terminated
·Fujifilm Medical System USA, Inc.·Product code MQB·September 30, 2004
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
FDA Recall
Terminated
·Therasage, LLC.·Product code N/A·December 23, 2014
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
FDA Recall
Terminated
·Therasage, LLC.·Product code N/A·December 23, 2014
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
FDA Recall
Terminated
·Therasage, LLC.·Product code N/A·December 23, 2014
Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·March 19, 2007
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013